February 2016 510(k) Clearances
510(k) summaries or 510(k) statements for final decisions rendered during the period February 2016.
TOTAL 510(k)s THIS PERIOD 224
TOTAL WITH SUMMARIES 213
TOTAL WITH STATEMENTS 11
February 2016 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD February 2016
DEVICE: ANI Monitor
MDOLORIS MEDICAL SYSTEMS SAS 510(k) NO: K142969(Traditional)
ATTN: MATHILDE COLLET PHONE NO : 011 333 62092081
6, RUE DU PR LAGUESSE SE DECISION MADE: 23-FEB-16
LILLE FR 59037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DBSWIN and VistaEasy Imaging Software
Durr Dental AG 510(k) NO: K143290(Traditional)
ATTN: Oliver Lange PHONE NO : 49 07142 7050
Hopfigheimer Strasse 17 SE DECISION MADE: 18-FEB-16
Bietigheim-Bissingen DE D-74321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINIARS SCREWS
OVERMED SRL. 510(k) NO: K143596(Traditional)
ATTN: DAVIDE PIZZAMIGLIO PHONE NO : 39 02 45712515
VIA LUCANIA 23 BUCCINASCO SE DECISION MADE: 05-FEB-16
MILAN IT 20090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AnapnoGuard 100 Respiratory Guard System
HOSPITECH RESPIRATION LTD. 510(k) NO: K150157(Traditional)
ATTN: Yoram Levy PHONE NO : 972 3 9191648
20 HAMAGSHIMIM ST. KIRYAT MATALON SE DECISION MADE: 16-FEB-16
PETACH TIKVA IL 49348 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pain Therapy System, Model PTS-II
COUNTER SCIENTIFIC DEVELOPMENT (GZ510(k) NO: K150277(Traditional)
ATTN: Eagle Eagle PHONE NO : 86 20 38289980
2ND &3RD FLOOR, BLD. 6, DAPIAN INDSE DECISION MADE: 12-FEB-16
GUANGZHOU CN 510665 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Oxyless Blood Tubing Set
Oxyless Ltd 510(k) NO: K150304(Abbreviated)
ATTN: Bob Duffy PHONE NO : 440 207383 9888
Third Floor, Bewlay House, 2 SwallSE DECISION MADE: 24-FEB-16
London GB 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs
K2 Medical GmbH & Co. KG 510(k) NO: K150468(Traditional)
ATTN: Harald Jung PHONE NO : 49 7462 94799182
Unter Buchsteig 5 SE DECISION MADE: 29-FEB-16
Tuttlingen DE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-Suit NIR Biliary Metallic Stent
MEDINOL LTD. 510(k) NO: K150487(Traditional)
ATTN: Michal Hershkovitz PHONE NO : 972 3 7679000
KIRYAT ATIDIM, BUILDING 8 SE DECISION MADE: 12-FEB-16
TEL AVIV IL 6158101 510(k) STATEMENT
DEVICE: Ora-GUARD Dental Grind Guard
Bite Tech Inc. 510(k) NO: K150492(Traditional)
ATTN: Jeff Padovan PHONE NO : 203 9876898
20 Glover Avenue SE DECISION MADE: 19-FEB-16
Norwalk CT 06850 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite
PHADIA AB 510(k) NO: K150597(Traditional)
ATTN: Carina Magnusson PHONE NO : 46 18 165000
RAPSGATAN 7P SE DECISION MADE: 29-FEB-16
UPPSALA SE 75137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nutra Face Lift Model PE8050
NUTRA LUXE MD, LLC 510(k) NO: K150826(Traditional)
ATTN: PETER VON BERG PHONE NO : 1 877 2410459
6835 INTERNATIONAL CENTER BLVD UNISE DECISION MADE: 10-FEB-16
FORT MYERS FL 33912 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments
CAREFUSION 2200 INC. 510(k) NO: K151036(Traditional)
ATTN: JANE WEBER PHONE NO : 847 3628094
72 N. FAIRWAY DRIVE SE DECISION MADE: 01-FEB-16
VERNON HILLS IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle
SPECTRA MEDICAL DEVICES, INC. 510(k) NO: K151069(Traditional)
ATTN: Agustin Turriza PHONE NO : 757 2208917
260 F/H Fordham Road SE DECISION MADE: 05-FEB-16
WILMINGTON MA 01887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Short Suture Anchors
Arthrex, Inc. 510(k) NO: K151092(Traditional)
ATTN: David L Rogers PHONE NO : 239 6435553 71924
1370 Creekside Boulevard SE DECISION MADE: 23-FEB-16
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture
AESCULAP, INC. 510(k) NO: K151165(Traditional)
ATTN: KATHY A. RACOSKY PHONE NO : 610 9849291
3773 CORPORATE PARKWAY SE DECISION MADE: 17-FEB-16
CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser (OTC)
ABL Medical, LLC 510(k) NO: K151185(Traditional)
ATTN: Robert Holladay PHONE NO : 801 7638000
705 E 50 S SE DECISION MADE: 05-FEB-16
American Fork UT 84003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nutrisafe 2- ENFit Adaptor
VYGON 510(k) NO: K151237(Traditional)
ATTN: Jillian Mikovich PHONE NO : 800 4735414
2750 MORRIS ROAD, SUITE A200 SE DECISION MADE: 09-FEB-16
LANSDALE PA 19446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arm automatic blood pressure monitor
SHENZHEN PUMP MEDICAL SYSTEM CO., 510(k) NO: K151258(Special)
ATTN: Xie Qiongyu PHONE NO : 086 0755 26710795
2/F WEST, M-7 SINOSTEEL BUILDING, SE DECISION MADE: 18-FEB-16
NANSHAN DISTRICT, SHENZHEN, GUANGD510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Venturi Gauze Wound Care Sets with Portal Drain
TALLEY GROUP LTD. 510(k) NO: K151263(Traditional)
ATTN: ROBERT MACDONALD PHONE NO : 44 1794 503575
PREMIER WAY, ABBEY PARK INDUSTRIALSE DECISION MADE: 19-FEB-16
ROMSEY GB SO51 9DQ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dr’s Finder
GOOD DOCTORS CO., LTD. 510(k) NO: K151274(Traditional)
ATTN: Sungro Joo PHONE NO : 82 32 4246325
#208, Woolim Lions Valley B-dong, SE DECISION MADE: 04-FEB-16
Incheon KR 403-911 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICONACY(TM) I-Hip (TM)
ICONACY ORTHOPEDIC IMPLANTS, LLC 510(k) NO: K151307(Traditional)
ATTN: ROY Y HORI PHONE NO : 574 2694622
4130 CORRIDOR DRIVE SE DECISION MADE: 26-FEB-16
WARSAW IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set
SCHOELLY FIBEROPTIC, GMBH 510(k) NO: K151308(Traditional)
ATTN: SANDRA BAUMANN PHONE NO : 49 7666 9080
ROBERT-BOSCH-STR. 1-3 SE DECISION MADE: 09-FEB-16
DENZLINGEN DE 79211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Safe Block Pen Needle
Artsana S.P.A 510(k) NO: K151311(Abbreviated)
ATTN: Cassani Mauro PHONE NO :
Via Saldarini Catelli 1 SE DECISION MADE: 10-FEB-16
Grandate IT 22070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Strialite
Centre Light Solutions, LLC 510(k) NO: K151337(Traditional)
ATTN: Carrie Colburn PHONE NO : 574 6123381
611 East Douglas Rd. Suite 108 SE DECISION MADE: 24-FEB-16
Mishawaka IN 46545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ProTrach Dualcare
ATOS MEDICAL AB 510(k) NO: K151404(Traditional)
ATTN: Ferenc Dahner PHONE NO : 46 415 19800
KRAFTGATAN 8 SE DECISION MADE: 12-FEB-16
HORBY SE SE-242 22 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cogent Lateral Interbody System
COGENT SPINE LLC 510(k) NO: K151406(Traditional)
ATTN: JUDE PAGANELLI PHONE NO : 858 7747897
101 N. ACACIA AVE SUITE 106 SE DECISION MADE: 25-FEB-16
SOLANA BEACH CA 92075 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APEX Compounding System Transfer Set
B. BRAUN MEDICAL INC. 510(k) NO: K151423(Traditional)
ATTN: TRACY MADDOCK PHONE NO : 610 5962545
901 MARCON BLVD. SE DECISION MADE: 19-FEB-16
ALLENTOWN PA 18109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols
INOVA DIAGNOSTICS, INC. 510(k) NO: K151429(Traditional)
ATTN: GABRIELLA LAKOS PHONE NO : 858 5869900 1393
9900 OLD GROVE ROAD SE DECISION MADE: 12-FEB-16
SAN DIEGO CA 92131-1638 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MRCAT
PHILIPS MEDICAL SYSTEMS MR FINLAND510(k) NO: K151435(Traditional)
ATTN: JANNE MARVOLA PHONE NO : 358 9 615800
AYRITIE 4 SE DECISION MADE: 25-FEB-16
VANTAA FI 01510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLANTIS ISUS
DENTSPLY INTERNATIONAL, INC. 510(k) NO: K151439(Traditional)
ATTN: HELEN LEWIS PHONE NO : 717 4871332
221 WEST PHILADELPHIA ST. SUITE 60SE DECISION MADE: 19-FEB-16
YORK PA 17401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)
FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K151474(Traditional)
ATTN: MARY MOORE PHONE NO : 973 6862498
10 HIGH POINT DRIVE SE DECISION MADE: 18-FEB-16
WAYNE NJ 07470 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EndoChoice Select Injection Needle
ENDOCHOICE, INC. 510(k) NO: K151475(Traditional)
ATTN: THERON GOBER PHONE NO : 1 678 7084420
11810 WILLS RD. SE DECISION MADE: 08-FEB-16
ALPHARETTA GA 30009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Beactive Brace
NATURES PILLOWS, INC. 510(k) NO: K151476(Traditional)
ATTN: WILLIAM McALISTER PHONE NO : 215 633 9801
2607 INTERPLEX DRIVE SE DECISION MADE: 26-FEB-16
TREVOSE PA 19053 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Epix Electrosurgical Probe with Smoke Evacuation
APPLIED MEDICAL RESOURCES 510(k) NO: K151480(Traditional)
ATTN: FRANS VANDENBROEK PHONE NO : 949 7138369
22872 Avenida Empresa SE DECISION MADE: 19-FEB-16
Rancho Santa Margarita CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BCR-30-min BI? and RBIP-ST30? Readout Accessory
BCR DIAGNOSTICS, INC. 510(k) NO: K151482(Traditional)
ATTN: BORIS ROTMAN PHONE NO : 480 8096156
1123 E. THUNDERHILL PL. SE DECISION MADE: 26-FEB-16
PHOENIX AZ 85048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IRENE Locking Compression Plate System
TIANJIN ZHENGTIAN MEDICAL INSTRUME510(k) NO: K151508(Traditional)
ATTN: YIFAN FU PHONE NO : 0086 10 82292929
NO.318, JINGYI ROAD, AIRPORT ECONOSE DECISION MADE: 25-FEB-16
TIANJIN CN 300308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Star 60
SKANRAY TECHNOLOGIES PRIVATE LIMIT510(k) NO: K151512(Traditional)
ATTN: MAHADEVAN J PHONE NO : 91 821 2415559 501
PLOT #360, KIADB INDUSTRIAL AREA, SE DECISION MADE: 14-FEB-16
MYSORE IN 570018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Oscar 2
SunTech Medical, Inc. 510(k) NO: K151520(Abbreviated)
ATTN: Charles Setzer PHONE NO : 919 6542300
507 Airport Blvd, Suite 117 SE DECISION MADE: 19-FEB-16
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator
SIEMENS HEALTHCARE DIAGNOSTICS, IN510(k) NO: K151529(Traditional)
ATTN: JULIE WARREN PHONE NO : 302 6318722
500 GBC DR. P.O. BOX 6101 M/S 514SE DECISION MADE: 11-FEB-16
NEWARK DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Anterior Cervical Plate System
Osteomed Implantes, LTDA 510(k) NO: K151553(Traditional)
ATTN: J.D. WEBB PHONE NO : 19 3532 3411
Washington Luiz Road, km 172, CondSE DECISION MADE: 10-FEB-16
Rio Claro – SP BR 13501-600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tranberg CLS Laser Fiber
Clinical Laserthermia Systems AB 510(k) NO: K151569(Traditional)
ATTN: Lars Erik Eriksson PHONE NO : 46 461 52100
Scheelevagen 2 SE DECISION MADE: 12-FEB-16
Lund SE 22381 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D.N.E. External Fixation System
DNE, LLC 510(k) NO: K151580(Special)
ATTN: NICHOLAS RICCIONE PHONE NO : 610 4421017
2225 PARK PLACE SE DECISION MADE: 16-FEB-16
SLATINGTON PA 18080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CapsoCam (SV-1)
CapsoVision, Inc. 510(k) NO: K151635(Traditional)
ATTN: AZIMUN JAMAL PHONE NO : 408 6241488
18805 Cox Ave Suite 250 SE DECISION MADE: 09-FEB-16
Saratoga CA 95070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Masimo Root Vital Signs Monitoring System and Accessories
MASIMO CORPORATION 510(k) NO: K151644(Traditional)
ATTN: MARGUERITE THOMLINSON PHONE NO : 949 2977683
52 DISCOVERY SE DECISION MADE: 12-FEB-16
IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Patient Examination Gloves, Blue Color
SUQIAN XINGYE GLOVE CO, LTD 510(k) NO: K151680(Traditional)
ATTN: JIAN ZHONG-DENG PHONE NO : 86 527 82860533
DONGWU ROAD, THE ECONOMIC DEVELOPMSE DECISION MADE: 12-FEB-16
SUQIAN CITY CN 223800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: twion
Alber GmbH 510(k) NO: K151717(Traditional)
ATTN: Bernd Engels PHONE NO : 490 7432 2006180
Vor dem Weissen Stein 21 SE DECISION MADE: 23-FEB-16
Albstadt DE D72461 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MedicVOD System
Orpheus Medical Ltd. 510(k) NO: K151737(Traditional)
ATTN: Asaf Omer PHONE NO : 972 4 6968800
PO Box 15140 SE DECISION MADE: 25-FEB-16
Haifa IL 31905 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THUNDERBEAT Open Fine Jaw
OLYMPUS MEDICAL SYSTEMS CORP. 510(k) NO: K151743(Traditional)
ATTN: TOSHIYUKI NAKAJIMA PHONE NO : 81 42 6422694
2951 ISHIKAWA-CHO SE DECISION MADE: 26-FEB-16
HACHIOJI-SHI JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Actreen Mini Intermittent Urinary Catheters
B. BRAUN MEDICAL INC. 510(k) NO: K151772(Traditional)
ATTN: SIERRA M. MERTZ PHONE NO : 1 610 2660500
901 MARCON BLVD. SE DECISION MADE: 09-FEB-16
ALLENTOWN PA 18109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InMode RF System
INMODE MD LTD. 510(k) NO: K151793(Traditional)
ATTN: AHAVA STEIN PHONE NO : 972 4 9097470
TABOR BUILDING, SHAAR YOKNEAM SE DECISION MADE: 19-FEB-16
YOQNEAM ILLIT IL 2069200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 AST-YS Caspofungin <=0.125 – >=8 ug/mL
BIOMERIEUX INC 510(k) NO: K151817(Traditional)
ATTN: KAREN RUSSELL PHONE NO : 314 7318639
595 ANGLUM ROAD SE DECISION MADE: 18-FEB-16
HAZELWOOD MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vital Signs Patch System
LIFEWATCH TECHNOLOGIES LTD. 510(k) NO: K151835(Special)
ATTN: ASHER KASSEL PHONE NO : 1 972 89484000
2 PEKERIS ST. SE DECISION MADE: 05-FEB-16
REHOVOT IL 7670202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD BACTEC Peds Plus/F Culture Vials (plastic)
BECTON DICKINSON AND COMPANY 510(k) NO: K151866(Traditional)
ATTN: ASHANTI C. BROWN PHONE NO : 410 3164766
7 LOVETON CIRCLE, MC 694 SE DECISION MADE: 25-FEB-16
SPARKS MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIR-FLOW handy 3.0 PLUS
E.M.S. ELECTRO MEDICAL SYSTEMS S.A510(k) NO: K151912(Traditional)
ATTN: Suzanne Fassio-Hardy PHONE NO : 41 2299 44700
Rte de Champ-Colin 2 SE DECISION MADE: 03-FEB-16
Nyon CH CH-1260 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist
BAUSCH & LOMB INCORPORATED 510(k) NO: K151918(Traditional)
ATTN: Barbara Klube-Falso PHONE NO : 585 3388503
1400 North Goodman Street SE DECISION MADE: 11-FEB-16
Rochester NY 14609 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Triumph Resin Dam
DENALI CORPORATION 510(k) NO: K151945(Traditional)
ATTN: JAN G. STANNARD PHONE NO : 1 781 8269190
134 OLD WASHINGTON STREET SE DECISION MADE: 18-FEB-16
HANOVER MA 02339 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: YuGo System
BIOGAMING LTD. 510(k) NO: K151955(Traditional)
ATTN: RONIT HARPAZ PHONE NO : 972 5 47070792
HAMGSHIMIM 20 SE DECISION MADE: 05-FEB-16
PETACH TIKVA IL 4934829 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FS-PACS
EC-WEB CO., LTD. 510(k) NO: K152034(Traditional)
ATTN: KE-MIN JEN PHONE NO : 886 2 25504790
4F., NO.89, TAIYUAN RD., DATONG DISE DECISION MADE: 23-FEB-16
TAIPEI CITY TW 103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vesocclude Polymer Ligating Clip
Vesocclude Medical, LLC 510(k) NO: K152082(Traditional)
ATTN: Freddy Cannady PHONE NO : 919 2013142
7429 ACC BLVD Suite 101 SE DECISION MADE: 26-FEB-16
Raleigh NC 27617 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Liquid CO2-2 (LCO2-2)
RANDOX LABORATORIES LTD 510(k) NO: K152085(Traditional)
ATTN: PAULINE ARMSTRONG PHONE NO : 44 0 2894422413 2275
55 DIAMOND ROAD SE DECISION MADE: 24-FEB-16
ARDMORE GB BT29 4QY 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IV-eye
Novarix Limited 510(k) NO: K152088(Traditional)
ATTN: JOHN SCOTT PHONE NO : 44 01235 828292
The Core Business Centre, Milton HSE DECISION MADE: 24-FEB-16
Abingdon GB OX13 6AB 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CorMatrix Tyke
CORMATRIX CARDIOVASCULAR, INC. 510(k) NO: K152127(Traditional)
ATTN: ANDREW M. GREEN PHONE NO : 470 5144019
1100 OLD ELLIS ROAD SE DECISION MADE: 04-FEB-16
ROSWELL GA 30076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Recovery Cone Removal System
C.R. Bard, Inc. 510(k) NO: K152136(Traditional)
ATTN: Joni Creal PHONE NO : 480 6382906
1625 West Third Street SE DECISION MADE: 18-FEB-16
Tempe AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: High Pressure Tanning Lamps
BLV Licht-und Vakuumtechnik GmbH 510(k) NO: K152141(Traditional)
ATTN: Heinz-Jurgen Wesseling PHONE NO : 49 8094 906206
Munchener Strasse 10 SE DECISION MADE: 25-FEB-16
Steinhoring DE 85643 510(k) STATEMENT
DEVICE: Navik 3D
APN Health, LLC 510(k) NO: K152160(Traditional)
ATTN: David Geddam PHONE NO : 1 844 2768713
4900 Hopyard Road, Suite 100 SE DECISION MADE: 23-FEB-16
Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Love Liquid Personal Lubricant
The Kama Sutra Company 510(k) NO: K152168(Traditional)
ATTN: Marla Lee PHONE NO : 805 4957479
2151 Anchor Court SE DECISION MADE: 05-FEB-16
Thousand Oaks CA 91320 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARCHITECT SHBG
BIOKIT, S.A. 510(k) NO: K152185(Traditional)
ATTN: ANGELS ROMA PHONE NO : 34 938 609000
CAN MALE, S/N SE DECISION MADE: 11-FEB-16
LLICA D AMUNT ES 08186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off Screws
MERETE MEDICAL GMBH 510(k) NO: K152187(Traditional)
ATTN: EMMANUEL ANAPLIOTIS PHONE NO : 49 30 779980114
ALT-LANKWITZ 102 SE DECISION MADE: 12-FEB-16
BERLIN DE 12247 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Erchonia EVRL
ERCHONIA CORPORATION 510(k) NO: K152196(Traditional)
ATTN: STEVEN SHANKS PHONE NO : 214 5442227
2021 COMMERCE DR SE DECISION MADE: 18-FEB-16
MCKINNEY TX 75069 510(k) STATEMENT
DEVICE: Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire
BOSTON SCIENTIFIC CORPORATION 510(k) NO: K152231(Traditional)
ATTN: Nikki M Wahlberg PHONE NO : 763 4942381
One Scimed Place SE DECISION MADE: 12-FEB-16
Maple Grove MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The Entasis Dual-Lead Sacroiliac Implant
CoreLink, LLC 510(k) NO: K152237(Traditional)
ATTN: Dan Hoehn PHONE NO : 888 3497808
7606 Forsyth Blvd SE DECISION MADE: 04-FEB-16
St.Louis MO 63105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Patient Examination Gloves, Black color
SUQIAN XINGYE GLOVE CO,LTD 510(k) NO: K152271(Traditional)
ATTN: JIAN ZHANG DENG PHONE NO : 86 527 82860533
DONGWU ROAD,THE ECONOMIC DEVELOPMESE DECISION MADE: 09-FEB-16
SUQIAN CITY CN 223800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOFLOW II – Irrigation, Warming and Suction System
PROMEPLA SAM 510(k) NO: K152278(Traditional)
ATTN: ALEXANDRE BAREILLE PHONE NO : 377 97 984244
9 AVENUE ALBERT II SE DECISION MADE: 09-FEB-16
MONACO MC 98000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OBS Anchorage Screw
BOMEI CO., LTD 510(k) NO: K152297(Traditional)
ATTN: LINNEY CHIANG PHONE NO : 886 3 3554989
4F., NO.1492-2, CHUNRIH RD., TAOYUSE DECISION MADE: 09-FEB-16
TAOYUAN CITY TW 33051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HeartLight Deflectable Sheath
CARDIOFOCUS, INC. 510(k) NO: K152310(Traditional)
ATTN: Seema Paliwal PHONE NO : 508 6587208
500 NICKERSON ROAD SUITE 500-200 SE DECISION MADE: 24-FEB-16
MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: YAHUA Spinal System
BEIJING WEIGAO YAHUA ARTIFICIAL JO510(k) NO: K152324(Traditional)
ATTN: XINJIAN LV PHONE NO : 86 10 69416956
NO.7, NIUHUI STREET, NIULANSHAN TOSE DECISION MADE: 01-FEB-16
BEIJING CN 101301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Perfectio LED infrared device
OMM IMPORTS INC DBA ZERO GRAVITY 510(k) NO: K152332(Traditional)
ATTN: OHAD MENACHEM PHONE NO : 954 80548856
1945 S OCEAN DR APT 509 HALLANDLE SE DECISION MADE: 25-FEB-16
HALLANDLE FL 33009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Direct Bilirubin
RANDOX LABORATORIES LIMITED 510(k) NO: K152343(Traditional)
ATTN: PAULINE ARMSTRONG PHONE NO : 44 0 2894422413
55 DIAMOND ROAD, CRUMLIN SE DECISION MADE: 16-FEB-16
COUNTY ANTRIM GB BT29 4QY 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Top Fine Pen Needle
MEDEXEL CO., LTD. 510(k) NO: K152410(Traditional)
ATTN: CHA DONG IK PHONE NO : 82 32 6778004
252, GEUMGWANGOSAN-RO, GUEMGWANG-MSE DECISION MADE: 02-FEB-16
ANSEONG-SI KR 17535 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Indego
PARKER HANNIFIN CORPORATION 510(k) NO: K152416(Traditional)
ATTN: ACHILLEAS DOROTHEOU PHONE NO : 216 8962044
1390 E. HIGHLAND ROAD SE DECISION MADE: 26-FEB-16
MACEDONIA OH 44056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FREND? Free T4 Test System
NANOENTEK USA INC 510(k) NO: K152422(Traditional)
ATTN: JIMMY CHEN PHONE NO : 925 2250108
5627 STONERIDGE DRIVE SUITE 304 SE DECISION MADE: 17-FEB-16
PLEASANTON CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PC ECG
EDAN INSTRUMENTS, INC. 510(k) NO: K152427(Traditional)
ATTN: QUEENA CHEN PHONE NO : 86 755 26858736
3/F – B, NANSHAN MEDICAL EQUIPMENTSE DECISION MADE: 05-FEB-16
SHENZHEN CN 518067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ETView VivaSight-SL (TVT) system
ETVIEW LTD. 510(k) NO: K152438(Traditional)
ATTN: YORAM LEVY PHONE NO : 972 72 2607063
M.P MISGAV SE DECISION MADE: 25-FEB-16
MISGAV BUSINESS PARK IL 201790 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Exofin High Viscosity Tissue Adhesive
CHEMENCE MEDICAL PRODUCTS INC. 510(k) NO: K152476(Abbreviated)
ATTN: Kenneth Broadley PHONE NO : 770 2550493
200 Technology Drive SE DECISION MADE: 09-FEB-16
Alpharetta GA 30005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLASH Mini Ostial System – 3.0mm x 8mm x 135cm, FLASH Mini Ostial System – 3.5mm x 8mm x 135cm, FLASH Mini Ostial System – 4.0mm x 8mm x 135cm, FLASH Mini Ostial System – 4.5mm x 8mm x 135cm
OSTIAL CORPORATION 510(k) NO: K152485(Traditional)
ATTN: JAKE WOLENBERG PHONE NO : 408 5411006
1221 INNSBRUCK DRIVE SE DECISION MADE: 16-FEB-16
SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray
PANORAMIC CORP. 510(k) NO: K152489(Traditional)
ATTN: Doug Pack PHONE NO : 800 6542027
4321 Goshen Rd SE DECISION MADE: 04-FEB-16
FT. WAYNE IN 46818 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CPX 4 Breast Tissue Expander
MENTOR WORLDWIDE LLC 510(k) NO: K152496(Traditional)
ATTN: Manchi Cheung PHONE NO : 805 7082747
201 MENTOR DRIVE SE DECISION MADE: 19-FEB-16
SANTA BARBARA CA 93111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C2 NerveMonitor System
INOMED MEDIZINTECHNIK GMBH 510(k) NO: K152505(Traditional)
ATTN: SASCHKA BUSCH PHONE NO : 49 7641 941487
IM HAUSGRUEN 29 SE DECISION MADE: 01-FEB-16
EMMENDINGEN BADEN- WUERTTEMBERG D510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NaturaLase CO2 Laser System
FOCUS MEDICAL, LLC 510(k) NO: K152529(Abbreviated)
ATTN: JOHN B LEE PHONE NO : 203 7308885
23 FRANCIS J CLARKE CIRCLE SE DECISION MADE: 04-FEB-16
BETHEL CT 06801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SpineView X-Pac Expandable Lumbar Cage System
SPINE VIEW, INC. 510(k) NO: K152539(Traditional)
ATTN: Mbithi Muthini PHONE NO : 510 6231931
48810 KATO ROAD SUITE 100E SE DECISION MADE: 24-FEB-16
FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dental Implant System
AriaBio International Inc 510(k) NO: K152555(Traditional)
ATTN: Hagai Jacobsen PHONE NO :
229 Overland Ave, Suite 118 SE DECISION MADE: 11-FEB-16
Los Angeles CA 90064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters
G21 s.r.l. 510(k) NO: K152557(Traditional)
ATTN: Maurizio Foroni PHONE NO : 39 0535 30312
Via S. Pertini, 8 SE DECISION MADE: 23-FEB-16
San Possidonio IT 41039 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C-VBR
CARDINAL SPINE, LLC 510(k) NO: K152568(Traditional)
ATTN: NATASHA LONNON PHONE NO : 502 777 4788
12307 OLD LAGRANGE ROAD, SUITE 105SE DECISION MADE: 11-FEB-16
LOUISVILLE KY 40245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DermaScalp Laser Cap
DERMASCALP LLC 510(k) NO: K152587(Traditional)
ATTN: JOHN CARULLO PHONE NO : 214 6830724
1700 ALMA DR SUITE 400 SE DECISION MADE: 04-FEB-16
PLANO TX 75075 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LATEX EXAMINATION GLOVE POWDER FREE
Careplus (M) SDN BHD 510(k) NO: K152593(Traditional)
ATTN: LIM KWEE SHYAN PHONE NO : 60 6 6772781
Lot 120 & 121, Jalan Senawang 3, SSE DECISION MADE: 25-FEB-16
SEREMBAN MY 70450 510(k) STATEMENT
DEVICE: Intact® Gen2 System
INTACT MEDICAL CORPORATION 510(k) NO: K152596(Traditional)
ATTN: JOHN VACHA PHONE NO : 508 6557820
550 COCHITUATE RD SUITE 25 SE DECISION MADE: 15-FEB-16
FRAMINGHAM MA 01701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V20 system
VIORA LTD. 510(k) NO: K152611(Traditional)
ATTN: OMRI KESLER PHONE NO : 972 9 9551344
3 MASKIT STREET SE DECISION MADE: 19-FEB-16
HERZLIYA IL 4673303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: H3+ Holter Recorder
MORTARA INSTRUMENT, INC 510(k) NO: K152626(Traditional)
ATTN: Margaret Mucha PHONE NO : 414 3541600
7865 NORTH 86TH ST. SE DECISION MADE: 26-FEB-16
MILWAUKEE WI 53224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dictum Health
DICTUM HEALTH, INC 510(k) NO: K152645(Abbreviated)
ATTN: PAUL LANDESMAN PHONE NO : 510 9003590
255 3RD AVENUE, SUITE 102 SE DECISION MADE: 09-FEB-16
OAKLAND CA 94607 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ennova Self-adhesive Electrode
Suzhou Ennova Electronics Technolo510(k) NO: K152648(Traditional)
ATTN: N/A N/A PHONE NO :
Jinsigang Industrial Park, GuoxianSE DECISION MADE: 18-FEB-16
Suzhou CN 215124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EDS Universal Cement
ESSENTIAL DENTAL SYSTEMS, INC 510(k) NO: K152691(Traditional)
ATTN: JEFFREY WAN PHONE NO : 201 4879090
89 LEUNING STREET, SUITE 8 SE DECISION MADE: 25-FEB-16
SOUTH HACKENSACK NJ 07606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO)
ENT BIOTECH SOLUTIONS 510(k) NO: K152702(Traditional)
ATTN: LAURA YAMADA PHONE NO : 313 9224615
75 LEWISTON ROAD SE DECISION MADE: 18-FEB-16
GROSS POINTE FARMS MI 48236 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HAINING NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR
HAINING MEDICAL PRODUCTS CO., LTD 510(k) NO: K152715(Traditional)
ATTN: ZHANG LIANG PHONE NO : 86 315 4169201
WEST OF DIANCHANG ROAD LUANNAN COUSE DECISION MADE: 25-FEB-16
TANGSHAN CN 063500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKIN CARE
C.I.S LTD 510(k) NO: K152736(Traditional)
ATTN: ILAN SHARON PHONE NO : 972 8 9154553
4 BEN GURION ST. SE DECISION MADE: 25-FEB-16
NES ZIONA IL 7403201 510(k) STATEMENT
DEVICE: Electronic Thermometer
GUANGDONG BIOLIGHT MEDITECH CO., L510(k) NO: K152739(Traditional)
ATTN: JING LIANG PHONE NO : 86 756 3399967
INNOVATION FIRST ROAD, TECHNOLOGY SE DECISION MADE: 09-FEB-16
ZHUHAI CN 519085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)
MICROLINE SURGICAL, INC. 510(k) NO: K152743(Traditional)
ATTN: ANU GAUR PHONE NO : 978 8671726
50 DUNHAM ROAD SUITE 1500 SE DECISION MADE: 08-FEB-16
BEVERLY MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM
B.BRAUN INTERVENTIONAL SYSTEMS INC510(k) NO: K152765(Traditional)
ATTN: PETER FLOSDORF PHONE NO : 610 9974694
824 TWELFTH AVENUE SE DECISION MADE: 26-FEB-16
BETHLEHEM PA 18018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip
ASSURE TECH. CO., LTD. 510(k) NO: K152768(Traditional)
ATTN: ERIC LIN PHONE NO : 86 871 81022698
2ND. FLOOR, BUILDING 1, NO. 10, XISE DECISION MADE: 24-FEB-16
HANGZHOU CN 310030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Adena-Zina System
SHANGHAI SANYOU MEDICAL CO, LTD 510(k) NO: K152781(Traditional)
ATTN: DAVID FAN PHONE NO : 86 21 58389980
1988 JIATANG ROAD SE DECISION MADE: 12-FEB-16
JIADIANG DISTRICT CN 201807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Amecath Peripheral inserted Central Venous Catheter Sets
AMECO MEDICAL INDUSTRIES 510(k) NO: K152819(Traditional)
ATTN: Samy Hamboly PHONE NO : 20 115 383066
INDUSTRIAL AREA B4-PLOT #119 EAST SE DECISION MADE: 05-FEB-16
10TH OF RAMADAN CITY EG 510(k) STATEMENT
DEVICE: Weely Manual Wheelchair
Rupiani 510(k) NO: K152827(Traditional)
ATTN: Jean-Marie Mangenot PHONE NO : 33 6645 5173
74 Avenue Du 8 Mai 1945 SE DECISION MADE: 19-FEB-16
Vaudex En Velin FR 69120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spot Skan
SKANRAY TECHNOLOGIES PRIVATE LIMIT510(k) NO: K152831(Traditional)
ATTN: MAHADEVAN J PHONE NO : 91 821 2407202
PLOT #360, KIADB INDUSTRIAL AREA, SE DECISION MADE: 23-FEB-16
MYSORE IN 570018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIVIX-S 1012N
VIEWORKS CO., LTD. 510(k) NO: K152855(Traditional)
ATTN: YOONJAE IM PHONE NO : 82 70 70116176
(GWANYANG-DONG) 41-3, BURIM-RO 170SE DECISION MADE: 26-FEB-16
ANYANG-SI KR 431-060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ExpressBraid Graft Manipulation
BIOMET MANUFACTURING CORP. 510(k) NO: K152868(Traditional)
ATTN: ADAM CARGILL PHONE NO : 574 3711006
56 EAST BELL DRIVE PO BOX 587 SE DECISION MADE: 08-FEB-16
WARSAW IL 46581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUNTEC Mechanical Wheelchair, model ST-WL-1000
DANYANG SUNTEC AUTO PARTS CO., LTD510(k) NO: K152878(Traditional)
ATTN: JEN KE-MIN PHONE NO : 86 511 86380900
JIEPAI INDUSTRIAL ZONE, JIEPAI, DASE DECISION MADE: 03-FEB-16
ZHENJIANG CN 212300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIVIX-S 1717N
Vieworks Co., Ltd 510(k) NO: K152894(Traditional)
ATTN: Yoonjae Im PHONE NO : 82 70 70116176
(Gwanyang-dong) 41-3, Burim-ro 170SE DECISION MADE: 26-FEB-16
Anyang-si KR 431-060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIODE LASER THERAPY SYSTEMS
BEIJING SINCOHEREN SCIENCE AND TEC510(k) NO: K152898(Traditional)
ATTN: XIN WANG PHONE NO : 86 010 57734966
ROOM 305, NO.43, XIZHIMEN NORTH STSE DECISION MADE: 09-FEB-16
BEIJING CN 100044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K152902(Traditional)
ATTN: YANHONG BAI PHONE NO : 86 755 81885635
MINDRAY BUILDING, KEJI 12TH ROAD SSE DECISION MADE: 18-FEB-16
SHENZHEN CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ViziShot FLEX
SPIRATION, INC. 510(k) NO: K152922(Traditional)
ATTN: Cyndy J Adams PHONE NO : 425 6365450
6675 185th Ave NE SE DECISION MADE: 19-FEB-16
REDMOND WA 98052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BlastGen
ORIGIO A/S 510(k) NO: K152932(Traditional)
ATTN: TOVE KJAER PHONE NO : 45 4679 0220
KNARDRUPVEJ 2 SE DECISION MADE: 29-FEB-16
MALOV DK 2760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline Anti-Fog Solution
Medline Industries, Inc. 510(k) NO: K152948(Traditional)
ATTN: Matt Clausen PHONE NO : 847 6434785
One Medline Place SE DECISION MADE: 04-FEB-16
Mundelein IL 60060 510(k) STATEMENT
DEVICE: Mammotome revolve Dual Vacuum Assist Biopsy System
DEVICOR MEDICAL PRODUCTS, INC. 510(k) NO: K152989(Traditional)
ATTN: SHAWNA M. ROSE PHONE NO : 513 8649178
300 E-BUSINESS WAY, FIFTH FLOOR SE DECISION MADE: 25-FEB-16
CINCINNATI OH 45241 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OptoWire Deux
OPSENS 510(k) NO: K152991(Traditional)
ATTN: Vanessa Mootoosamy PHONE NO : 418 6829996 239
2014, CYRILLE DUQUET STREET, #125 SE DECISION MADE: 11-FEB-16
QUEBEC CA G1N 4N6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Adaptivo
Aurora Technology Development, LLC510(k) NO: K152994(Traditional)
ATTN: Gustavo H Olivera PHONE NO : 608 8315419
555 D’Onofrio Dr., Suite 104 SE DECISION MADE: 03-FEB-16
Madison WI 53719 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Clear Guide SCENERGY
CLEAR GUIDE MEDICAL 510(k) NO: K153004(Traditional)
ATTN: Jack Kent PHONE NO : 410 9297720
3600 Clipper Mill Road, Suite 400 SE DECISION MADE: 12-FEB-16
Baltimore MD 21211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue
ZIBO HUIYING MEDICAL PRODUCTS, CO.510(k) NO: K153028(Traditional)
ATTN: Fufang Wang PHONE NO : 86 189533 86552
NO. 3 DA WU ROAD SE DECISION MADE: 05-FEB-16
LINZI CN 255400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N5-1
NUGA MEDICAL CO., LTD 510(k) NO: K153054(Traditional)
ATTN: JONG SOO LEE PHONE NO : 82 33 7300001
185, JIRAEUL-RO, JIJEONG-MYEON SE DECISION MADE: 05-FEB-16
Wonju KR 220-821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HF1202H PowerPlus Portable X-ray Equipment
MINXRAY, INC. 510(k) NO: K153059(Special)
ATTN: Keith Kretchmer PHONE NO : 847 5640323
3611 COMMERCIAL AVE. SE DECISION MADE: 02-FEB-16
NORTHBROOK IL 60062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BostonSight IC Corneal Lens, BostonSight IC Scleral Lens
Boston Foundation for Sight 510(k) NO: K153066(Traditional)
ATTN: Eugene Bonte PHONE NO : 781 7267503
464 Hillside Avenue, Suite 205 SE DECISION MADE: 09-FEB-16
Needham MA 02494 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Microlife Upper Arm Automatic Digital Blood Pressure Monitor
MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K153077(Traditional)
ATTN: GERHARD FRICK PHONE NO : 41 717 277000
ESPENSTRASSE 139 SE DECISION MADE: 12-FEB-16
WIDNAU CH 9443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RTVue XR OCT Avanti with AngioVue Software
OPTOVUE, INC. 510(k) NO: K153080(Traditional)
ATTN: EDWARD SINCLAIR PHONE NO : 510 8971575
2800 BAYVIEW DRIVE SE DECISION MADE: 11-FEB-16
FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Clear Bi-Light
Michael Todd, LP 510(k) NO: K153081(Traditional)
ATTN: Lilia Friend PHONE NO : 772 3430222
648 Port St Lucie Blvd SE DECISION MADE: 15-FEB-16
Port St Lucie FL 34953 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rampart A Lumbar Interbody Fusion Device
SPINEOLOGY, INC. 510(k) NO: K153082(Traditional)
ATTN: JACQUELINE A HAUGE PHONE NO : 651 2568500
7800 3RD STREET N, SUITE 600 SE DECISION MADE: 04-FEB-16
ST. PAUL MN 55128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPLANT 3D
Media Lab S.r.l. 510(k) NO: K153091(Traditional)
ATTN: Massimo Ivani PHONE NO : 39 018 7517775
Via Trieste 4 SE DECISION MADE: 25-FEB-16
Follo IT 19020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROP Resorbable Hemostasis Material
Resorbable Orthopedic Products, LL510(k) NO: K153095(Traditional)
ATTN: Barry E Constantine PHONE NO : 732 8311797
16633 Dallas Parkway, Suite 250 SE DECISION MADE: 17-FEB-16
Addison TX 75001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARESTREAM Vue PACS
CARESTREAM HEALTH, INC. 510(k) NO: K153103(Traditional)
ATTN: Diane Koetter PHONE NO : 585 6276505
150 VERONA STREET SE DECISION MADE: 12-FEB-16
ROCHESTER NY 14468 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITAL SIGNS MONITOR
GUANGDONG BIOLIGHT MEDITECH CO., L510(k) NO: K153135(Special)
ATTN: Jin Liang PHONE NO : 86 756 3399967
INNOVATION FIRST ROAD TECHNOLOGY ISE DECISION MADE: 25-FEB-16
ZHUHAI CN 519085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DyeVert Contrast Modulation System
OSPREY MEDICAL, INC. 510(k) NO: K153141(Traditional)
ATTN: MELANIE HESS PHONE NO : 952 9558252
5600 ROWLAND ROAD SUITE 250 SE DECISION MADE: 04-FEB-16
MINNETONKA MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIO-H DIGITAL RADIOGRAPHY SENSOR
DENTTIO, INC. 510(k) NO: K153144(Traditional)
ATTN: YOUNG HAN PHONE NO : 323 2541000
3235 N. SAN FERNANDO ROAD BLDG 7B SE DECISION MADE: 10-FEB-16
LOS ANGELES CA 90065 510(k) STATEMENT
DEVICE: MOR Implant System
STERNGOLD DENTAL, LLC 510(k) NO: K153173(Abbreviated)
ATTN: MARIA RAO PHONE NO : 508 2265660
23 FRANK MOSSBERG DR SE DECISION MADE: 05-FEB-16
ATTLEBORO MA 02703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Calcium Bridge
DENALI CORPORATION 510(k) NO: K153191(Traditional)
ATTN: Jan G Stannard PHONE NO : 781 8269190
134 OLD WASHINGTON STREET SE DECISION MADE: 26-FEB-16
HANOVER MA 02339 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Prevena Plus Incision Management System Kit with Customizable Dressing, Prevena Plus Customizable Dressing 5-Pack
KCI USA, INC. 510(k) NO: K153199(Traditional)
ATTN: MARGARET MARSH PHONE NO : 210 2556481
6203 FARINON DRIVE SE DECISION MADE: 29-FEB-16
SAN ANTONIO TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Navigation Instruments
GLOBUS MEDICAL INC. 510(k) NO: K153203(Traditional)
ATTN: Kelly J Baker PHONE NO : 610 9301800 1670
2560 GENERAL ARMISTEAD AVENUE SE DECISION MADE: 03-FEB-16
AUDUBON PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: In2Bones Kirschner wire
IN2BONES SAS 510(k) NO: K153204(Traditional)
ATTN: Morgane Grenier PHONE NO : 33 4 72292626
28 CHEMIN DU PETIT BOIS SE DECISION MADE: 01-FEB-16
ECULLY FR 69130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M-Fix Acromioclavicular Device
CORACOID SOLUTIONS, INC. 510(k) NO: K153211(Traditional)
ATTN: STEVE GOLDEN PHONE NO : 650 7400306
15 NORMANS WAY SE DECISION MADE: 02-FEB-16
PARK CITY UT 84060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SmartBase for Arthrex Glenoid IRIS
Custom Orthopaedic Solutions, Inc.510(k) NO: K153215(Traditional)
ATTN: Keith Grafmeyer PHONE NO : 216 4453403
10000 Cedar Avenue SE DECISION MADE: 19-FEB-16
Cleveland OH 44106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Alpine Cemented Hip System
ORTHO DEVELOPMENT CORPORATION 510(k) NO: K153216(Traditional)
ATTN: Drew Weaver PHONE NO : 801 6193419
12187 SOUTH BUSINESS PARK DRIVE SE DECISION MADE: 18-FEB-16
DRAPER UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Synergy UHD4 System
ARTHREX, INC. 510(k) NO: K153218(Traditional)
ATTN: DAVID L ROGERS PHONE NO : 239 6435553 71924
1370 CREEKSIDE BOULEVARD SE DECISION MADE: 12-FEB-16
NAPLES OH 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: syngo.CT Single Source Dual Energy (Twin Beam)
Siemens Medical Solutions USA, Inc510(k) NO: K153220(Traditional)
ATTN: Kimberly Mangum PHONE NO : 610 4486477
40 Liberty Boulevard, Mail Code 65SE DECISION MADE: 19-FEB-16
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VitalStim(R) Plus Electrotherapy System
DJO, LLC 510(k) NO: K153224(Traditional)
ATTN: Natalia Shirina PHONE NO : 760 7345534
1430 DECISION STREET SE DECISION MADE: 17-FEB-16
VISTA CA 92081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cios Select
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K153232(Special)
ATTN: PATRICIA D JONES PHONE NO : 610 4486474
40 LIBERTY BLVD 65-1A SE DECISION MADE: 10-FEB-16
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PTFE Super Sheath Introducer 2.1
MEDCOMP (MEDICAL COMPONENTS, INC.)510(k) NO: K153246(Special)
ATTN: COURTNEY NIX PHONE NO : 215 2564201
1499 DELP DR. SE DECISION MADE: 12-FEB-16
HARLEYSVILLE PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fusion Compact Navigation System
MEDTRONIC NAVIGATION, INC. 510(k) NO: K153247(Traditional)
ATTN: RISHI SINHA PHONE NO : 269 9034373
826 COAL CREEK CIRCLE SE DECISION MADE: 18-FEB-16
LOUISVILLE CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aingeal Activity System
Intelesens, Ltd. 510(k) NO: K153275(Traditional)
ATTN: Patricia Pepper PHONE NO : 440 28 90736801
17 Heron Road SE DECISION MADE: 26-FEB-16
Belfast GB BT3 9LE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TandemLung Oxygenator
CARDIAC ASSIST, INC. 510(k) NO: K153295(Traditional)
ATTN: GREG JOHNSON PHONE NO : 412 9637770 266
240 ALPHA DR. SE DECISION MADE: 26-FEB-16
PITTSBURGH PA 15238 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hansen Medical Magellan Robotic Catheter eKit
Hansen Medical, Inc. 510(k) NO: K153304(Traditional)
ATTN: Marysa Loustalot PHONE NO : 650 4045824
800 E Middlefield Road SE DECISION MADE: 01-FEB-16
Mountain View CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HS SutureTape
RIVERPOINT MEDICAL 510(k) NO: K153307(Special)
ATTN: Edwin Anderson PHONE NO : 503 5178001
825 NE 25th Avenue SE DECISION MADE: 12-FEB-16
Portland OR 97232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Vacutainer UltraTouch Push Button Blood Collection Set
BECTON, DICKINSON AND COMPANY 510(k) NO: K153309(Special)
ATTN: Pasquale Amato PHONE NO : 201 8474513
1 BECTON DRIVE SE DECISION MADE: 12-FEB-16
FRANKLIN LAKES NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Palisade Pedicular Fixation System
SPINEOLOGY, INC. 510(k) NO: K153323(Traditional)
ATTN: JACQUELINE A HAUGE PHONE NO : 651 2568500
7800 3RD STREET NORTH SE DECISION MADE: 23-FEB-16
SAINT PAUL MN 55128-5455 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FreeStyle Precision Neo H Blood Glucose Monitoring System
Abbott Diabetes Care Inc. 510(k) NO: K153330(Traditional)
ATTN: Arul Sterlin PHONE NO : 510 8644310
1360 South Loop Road SE DECISION MADE: 19-FEB-16
Alameda CA 94202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Epic Extremity Plate System
Epic Extremity, LLC 510(k) NO: K153340(Traditional)
ATTN: DAN SCHWARTZBAUER PHONE NO : 412 9560320
120 Marguerite Dr, Ste 301 SE DECISION MADE: 09-FEB-16
Cranberry Twp PA 16066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Relieva Scout Multi-Sinus Dilation System
ACCLARENT, INC. 510(k) NO: K153341(Traditional)
ATTN: JAMES PATRICK GARVEY PHONE NO : 650 6874807
1525-B O’BRIEN DRIVE SE DECISION MADE: 12-FEB-16
MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Radiance V3
GMV SOLUCIONES GLOBALES INTERNET S510(k) NO: K153368(Traditional)
ATTN: CARLOS ILLANA PHONE NO : 34 918 072270
CALLE DE ISAAC NEWTON, 11 SE DECISION MADE: 16-FEB-16
MADRID ES 28760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Caspian OCT/MESA Mini/DENALI Mini Spinal System
K2M, Incorporated 510(k) NO: K153370(Traditional)
ATTN: Nancy Giezen PHONE NO : 571 9192000
751 Miller Drive SE SE DECISION MADE: 16-FEB-16
Leesburg VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Low Potassium Dextran Solution with Tris Diluent
United Therapeutics Corporation 510(k) NO: K153384(Traditional)
ATTN: Rita Lee PHONE NO : 919 4858350
55 TW Alexander Drive, PO Box 1418SE DECISION MADE: 19-FEB-16
Research Triangle Park NC 27709 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OS2-C Compression Staple
IN2BONES SAS 510(k) NO: K153395(Traditional)
ATTN: MORGANE GRENIER PHONE NO : 33 4 72292626
28 CHEMIN DU PETIT BOIS SE DECISION MADE: 18-FEB-16
ECULLY FR 63130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Comprehensive SRS/Nexel Elbow
BIOMET MANUFACTURING CORP. 510(k) NO: K153398(Traditional)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 574 2676639
56 BELL DRIVE SE DECISION MADE: 03-FEB-16
WARSAW IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ArcScan Insight 100
ARCSCAN, INC. 510(k) NO: K153416(Special)
ATTN: Andy Levien PHONE NO : 773 3875548
443 PARK POINT DR, SUITE 225 SE DECISION MADE: 02-FEB-16
GOLDEN CO 80401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-CUBE i7
ALPINION MEDICAL SYSTEMS CO., LTD.510(k) NO: K153424(Traditional)
ATTN: Donghwan KIM PHONE NO : 82 707 4652068
1FL and 6FL Verdi Tower, 72, DigitSE DECISION MADE: 26-FEB-16
SEOUL KR 08393 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION and IPC POWEREASE Systems
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K153442(Traditional)
ATTN: Lila Joe PHONE NO : 901 3992309
1800 Pyramid Place SE DECISION MADE: 18-FEB-16
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASAHI Astato XS 40
ASAHI INTECC CO., LTD. 510(k) NO: K153443(Traditional)
ATTN: YOSHIHIKO FUKUI PHONE NO : 81 527 681211
1703 WAKITA-CHO, MORIYAMA-KU SE DECISION MADE: 25-FEB-16
NAGOYA JP 463-0024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series
BIOCHEMICAL DIAGNOSTICS, INC 510(k) NO: K153474(Traditional)
ATTN: ALLEN PANETZ PHONE NO : 631 5959200
180 HEARTLAND BLVD SE DECISION MADE: 23-FEB-16
EDGEWOOD NY 11717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System
NINEPOINT MEDICAL, INC 510(k) NO: K153479(Traditional)
ATTN: EMAN NAMATI PHONE NO : 617 2507190
12 OAK PARK DRIVE SE DECISION MADE: 16-FEB-16
BEDFORD MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS
ARROW INTERNATIONAL, INC. (Subsidi510(k) NO: K153487(Special)
ATTN: Elizabeth Duncan PHONE NO : 610 3780131
2400 BERNVILLE ROAD SE DECISION MADE: 04-FEB-16
READING PA 19605 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Occlusion Perfusion Catheter
Advanced Catheter Therapies, Inc. 510(k) NO: K153488(Traditional)
ATTN: Paul Joseph Fitzpatrick PHONE NO : 1 423 3218964
25 E. Main Street, Suite 205 SE DECISION MADE: 25-FEB-16
Chattanooga TN 37408 510(k) STATEMENT
DEVICE: Cryocare CS Surgical System
Health Tronics 510(k) NO: K153489(Traditional)
ATTN: Maritza Ward PHONE NO : 512 4398361
9825 Spectrum Dr. SE DECISION MADE: 05-FEB-16
Austin TX 78717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stryker CMF MEDPOR Customized Implant
Stryker 510(k) NO: K153508(Traditional)
ATTN: Jonathan Schell PHONE NO : 269 3895596
750 Trade Centre Way, Suite 200 SE DECISION MADE: 05-FEB-16
Portage MI 49002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUSION Vascular Graft
MAQUET CARDIOVASCULAR, LLC 510(k) NO: K153523(Traditional)
ATTN: Mark Dinger PHONE NO : 973 7097691
45 BARBOUR POND DRIVE SE DECISION MADE: 16-FEB-16
WAYNE NJ 07470 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PacEndo EDTA
PAC-DENT INTERNATIONAL, INC. 510(k) NO: K153528(Traditional)
ATTN: Wenying Zhu PHONE NO : 909 8390888
670 ENDEAVOR CIRCLE SE DECISION MADE: 01-FEB-16
Brea CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WS80A Diagnostic Ultrasound System
SAMSUNG MEDISON CO., LTD. 510(k) NO: K153529(Third Party – Traditional)
ATTN: Kyeong-Mi Park PHONE NO : 82 2 21941373
42, TEHERAN-RO 108-GIL GANGNAM-GU SE DECISION MADE: 02-FEB-16
SEOUL KR 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Bridge Occlusion Balloon
SPECTRANETICS, INC. 510(k) NO: K153530(Traditional)
ATTN: Christopher McLellan PHONE NO : 719 4472000
9965 FEDERAL DRIVE SE DECISION MADE: 05-FEB-16
COLORADO SPRINGS CO 80921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WHILL Model M
WHILL, INC. 510(k) NO: K153543(Third Party – Traditional)
ATTN: TERESE BOGUCKI PHONE NO : 650 4887799
285 OLD COUNTY RD, SUITE 6 SE DECISION MADE: 12-FEB-16
SAN CARLOS CA 94070 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
VISIONSENSE LTD 510(k) NO: K153548(Traditional)
ATTN: ALEX CHANIN PHONE NO : 972 3 9244339
20 HAMAGSHIMIM ST SE DECISION MADE: 22-FEB-16
PETACH TIKVA, HAMERKAZ IL 49348 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Axxent Electronic Brachytherapy System Model 110 XP 1200
ICAD INC. 510(k) NO: K153570(Traditional)
ATTN: John DeLucia PHONE NO : 603 5467430
98 SPITBROOK ROAD, SUITE 100 SE DECISION MADE: 25-FEB-16
NASHUA NH 03062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tyber Medical Trauma Screw
TYBER MEDICAL LLC 510(k) NO: K153575(Traditional)
ATTN: Mark F Schenk PHONE NO : 610 5078255
89 HEADQUARTERS PLAZA NORTH #1464 SE DECISION MADE: 26-FEB-16
MORRISTOWN NJ 07960 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex iBalance TKA System
Arthrex, Inc. 510(k) NO: K153586(Traditional)
ATTN: Leon Brown PHONE NO : 239 6435553 72028
1370 Creekside Boulevard SE DECISION MADE: 19-FEB-16
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EndoChoice Water Bottle Cap System
ENDOCHOICE, INC. 510(k) NO: K153588(Special)
ATTN: Daniel Hoefer PHONE NO : 678 7084743
11810 WILLS RD. SE DECISION MADE: 24-FEB-16
ALPHARETTA GA 30009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD HORIZON Spinal System
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K153589(Traditional)
ATTN: ANKIT K. SHAH PHONE NO : 901 3963133
1800 PYRAMID PLACE SE DECISION MADE: 10-FEB-16
MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CliniscanSM MRI
PICOFEMTO LLC 510(k) NO: K153593(Traditional)
ATTN: Jessica Phillips PHONE NO : 646 8283612
228 EAST 45TH STREET SE DECISION MADE: 17-FEB-16
NEW YORK NY 10017 510(k) STATEMENT
DEVICE: ivWatch Model 400
ivWatch, LLC 510(k) NO: K153605(Special)
ATTN: Jaclyn Lautz PHONE NO : 855 4892824 7023
469 McLaws Circle SE DECISION MADE: 11-FEB-16
Williamsburg VA 23185 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vitoss BiModal Bone Graft Substitute Foam Strip
ORTHOVITA, INC. 510(k) NO: K153608(Special)
ATTN: LYNN LUNDY PHONE NO : 1 610 4075256
45 GREAT VALLEY PARKWAY SE DECISION MADE: 12-FEB-16
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution)
BOSTON SCIENTIFIC CORPORATION 510(k) NO: K153617(Special)
ATTN: Eric Elliott PHONE NO : 510 6241314
47215 LAKEVIEW BLVD SE DECISION MADE: 25-FEB-16
FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single Use Injector NM600/610
OLYMPUS MEDICAL SYSTEMS CORP. 510(k) NO: K153625(Traditional)
ATTN: TOSHIYUKI NAKAJIMA PHONE NO : 81 42 6422694
2951 ISHIKAWA-CHO SE DECISION MADE: 12-FEB-16
HACHIOJI-SHI JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zimmer Virage OCT Spinal Fixation System
Zimmer Spine, Inc 510(k) NO: K153631(Special)
ATTN: Ted Kuhn PHONE NO : 303 5018549
7375 Bush Lake Road SE DECISION MADE: 16-FEB-16
Minneapolis MN 55439 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TSolution One w/ACG+ Surgical System
THINK SURGICAL INC. 510(k) NO: K153647(Traditional)
ATTN: IN K. MUN PHONE NO : 510 2492300
47320 MISSION FALLS COURT SE DECISION MADE: 16-FEB-16
FREMONT CA 94539 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The Cellfina System
ULTHERA, INC. 510(k) NO: K153677(Special)
ATTN: Suzon Lommel PHONE NO : 408 6454979
1840 S Stapley Dr, Suite 200 SE DECISION MADE: 25-FEB-16
Mesa AZ 85204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PriMatrix Dermal Repair Scaffold
TEI BioSciences Inc. 510(k) NO: K153690(Traditional)
ATTN: David D Cox PHONE NO : 617 2681616
7 Elkins Street SE DECISION MADE: 22-FEB-16
Boston MD 02127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spirit Hair Removal laser Family
ACTIVE OPTICAL SYSTEMS , LTD. 510(k) NO: K153718(Third Party – Traditional)
ATTN: GIL Bidas PHONE NO : 972 3 9236610
11 SHOHAM ST. SE DECISION MADE: 12-FEB-16
PETACH-TIKVA IL 49591 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SIGN Compression Screw System
SIGN FRACTURE CARE INTERNATIONAL 510(k) NO: K153759(Traditional)
ATTN: ROB R. TEETER PHONE NO : 509 3711107
451 Hills Street, Suite B SE DECISION MADE: 25-FEB-16
Richland WA 99354 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TraumaCad Mobile Release 2.0
Voyant Health Ltd 510(k) NO: K160001(Special)
ATTN: Yael Guttentag PHONE NO : 972 392 90929
35 Efal Street SE DECISION MADE: 12-FEB-16
Petach-Tikva IL 4951132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sniper (R) Spine System
SPINE WAVE, INC. 510(k) NO: K160003(Traditional)
ATTN: KELLY Barbieri PHONE NO : 203 9449494
3 ENTERPRISE DRIVE SUITE 210 SE DECISION MADE: 26-FEB-16
SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iHealth Track Blood Pressure Monitor
Andon Health Co., Ltd 510(k) NO: K160014(Special)
ATTN: Liu Yi PHONE NO : 86 22 60526161 8060
No. 3 Jin Ping Street, Ya An Road,SE DECISION MADE: 02-FEB-16
Tianjin CN 300190 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Image1 SPIES System
KARL STORZ ENDOSCOPY AMERICA, INC.510(k) NO: K160044(Special)
ATTN: SUSIE S. CHEN PHONE NO : 424 2188201
2151 E. GRAND AVE SE DECISION MADE: 01-FEB-16
EL SEGUNDO CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: McLaren Proton Therapy System
McLaren Health Care Corporation 510(k) NO: K160063(Traditional)
ATTN: Ryan Vlcko PHONE NO : 810 3421174
G-3235 Beecher Rd., Suite B SE DECISION MADE: 25-FEB-16
Flint MI 48532 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FilmArray Respiratory Panel (RP) for use with FilmArray Torch
BioFire Diagnostics, LLC 510(k) NO: K160068(Special)
ATTN: KRISTEN J. KANACK PHONE NO : 801 7366354 330
390 Wakara Way SE DECISION MADE: 08-FEB-16
Salt Lake City UT 84108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Digital Electrocardiograph
SHENZHEN BIOCARE BIO-MEDICAL EQUIP510(k) NO: K160092(Special)
ATTN: Hongbo Zhong PHONE NO : 86 755 36615333
#A735,Shenzhen Mingyou Industrial SE DECISION MADE: 12-FEB-16
Shenzhen CN 518102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InZone Detachment System
STRYKER NEUROVASCULAR 510(k) NO: K160096(Special)
ATTN: KATE TAYLOR PHONE NO : 510 4132175
47900 BAYSIDE PARKWAY SE DECISION MADE: 19-FEB-16
FREMONT CA 94538-6515 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Synapse PACS
FUJIFILM MEDICAL SYSTEMS U.S.A., I510(k) NO: K160108(Traditional)
ATTN: Jyh-Shyan Lin PHONE NO : 301 2511092
419 WEST AVENUE SE DECISION MADE: 03-FEB-16
STAMFORD CT 06902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ST AIA-PACK hsE2 Calibrator Set
TOSOH BIOSCIENCE, INC. 510(k) NO: K160113(Traditional)
ATTN: ROBERT L WICK PHONE NO : 650 6368117
6000 SHORELINE COURT SUITE 101 SE DECISION MADE: 17-FEB-16
SOUTH SAN FRANCISCO CA 94080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
Becton, Dickinson & Co. 510(k) NO: K160161(Special)
ATTN: Gregory P. Payne PHONE NO : 858 7957890
10865 Road to the Cure, Suite 200 SE DECISION MADE: 24-FEB-16
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Veritor System for Rapid Detection of Flu A + B Labratory Kit
Becton, Dickinson & Co. 510(k) NO: K160164(Special)
ATTN: Gregory P. Payne PHONE NO : 858 7957890
10865 Road to the Cure, Suite 200 SE DECISION MADE: 25-FEB-16
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Illuminated Mediastinal Access Port
Aegis Surgical Ltd 510(k) NO: K160171(Special)
ATTN: William Starling PHONE NO : 919 2519755
4020 Stirrup Creek Drive Suite 115SE DECISION MADE: 26-FEB-16
Durham NC 27703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)
Boston Scientific Corporation 510(k) NO: K160173(Special)
ATTN: Eric Elliott PHONE NO : 510 6241314
47215 Lakeview Boulevard SE DECISION MADE: 26-FEB-16
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOGIQ S7 Expert
GE Healthcare 510(k) NO: K160182(Special)
ATTN: Bryan Behn PHONE NO : 414 7214214
9900 Innovation Dr. SE DECISION MADE: 26-FEB-16
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Voluson S6, Voluson S8, Voluson S10
GE HEALTHCARE 510(k) NO: K160184(Traditional)
ATTN: TRACEY ORTIZ PHONE NO : 262 6766120
9900 W. INNOVATION DRIVE SE DECISION MADE: 25-FEB-16
WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fujifilm Video Colonoscope Model EC-600WL V2
FUJIFILM Medical Systems U.S.A., I510(k) NO: K160196(Special)
ATTN: Shraddha More PHONE NO : 973 6862627
10 High Point Drive SE DECISION MADE: 23-FEB-16
Wayne NJ 07470 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UreTron MultiProbe Lithotripter System
Med-Sonics Corp 510(k) NO: K160198(Special)
ATTN: Jennifer Rautine PHONE NO : 814 8996500
4960 Pittsburgh Avenue Suite A SE DECISION MADE: 23-FEB-16
Erie PA 16509 510(k) STATEMENT
DEVICE: 2MP Color LCD Monitor, RadiForce RX250 and RX250-AR
EIZO Corporation 510(k) NO: K160247(Traditional)
ATTN: Hiroaki Hashimoto PHONE NO : 81 76 2742468
153 Shimokashiwano SE DECISION MADE: 23-FEB-16
Hakusan JP 924-8566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Optimus ALIF System
Amendia, Inc. 510(k) NO: K160291(Special)
ATTN: Kristen Allen PHONE NO : 877 7553329
1755 West Oak Parkway SE DECISION MADE: 18-FEB-16
Marietta GA 30062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I4 (Integrated Intelligent Imaging Informatics) system
PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K160315(Third Party – Traditional)
ATTN: Ilana Ben Moshe PHONE NO : 972 525 233496
VEENPLUIS 4-6 SE DECISION MADE: 19-FEB-16
BEST NL 5684 PC 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: syngo.via MI Workflows
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K160317(Special)
ATTN: Veronica Padharia PHONE NO : 630 8775761
2501 N. BARRINGTON RD SE DECISION MADE: 29-FEB-16
Hoffman Estates IL 60192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)
JVC KENWOOD Corporation 510(k) NO: K160326(Traditional)
ATTN: Tsukasa Tashiro PHONE NO : 81 258 246611
3-12, Moriya-cho, Kanagawa-ku SE DECISION MADE: 23-FEB-16
Yokohama JP 221-0022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIVA ZSP2105CMI with QUBYX PerfectLum bundle
THE LINDEN GROUP CORP. 510(k) NO: K160328(Traditional)
ATTN: ROBERT COLAIZZO PHONE NO : 973 9838809
2B WING DR SE DECISION MADE: 25-FEB-16
CEDAR KNOLLS NJ 079271020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Novilase Laser Therapy System, Model LTS-2
NOVIAN HEALTH, INC. 510(k) NO: K160392(Special)
ATTN: WILLIAM GRAVEMAN PHONE NO : 312 2667200
430 W. ERIE ST., SUITE 500 SE DECISION MADE: 26-FEB-16
CHICAGO IL 60654 510(k) SUMMARY AVAILABLE FROM FDA
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