| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K140938 |
10/10/2014 |
OSTOM-I ALERT |
11 HEALTH AND TECHNOLOGIES LLC |
E J SMITH |
| K140684 |
10/24/2014 |
CLINPRO PROPHY POWDER |
3M DEUTSCHLAND GMBH |
DESI W SOEGIARTO |
| K141570 |
10/31/2014 |
IMPLANT STUDIO |
3SHAPE MEDICAL A/S |
HANNE NIELSEN |
| K141160 |
10/07/2014 |
A&D MEDICAL UA-651 DIGITAL BLOOD PRESSURE MONITOR |
A & D CO., LTD. |
JERRY WANG |
| K141201 |
10/08/2014 |
A&D MEDICAL UA-767F AND UA-767FAC DIGITAL BLOOD PRESSURE MONITOR |
A & D CO., LTD. |
JERRY WANG |
| K141659 |
10/09/2014 |
PRISM ZIRCONIA, ST-98 |
A & D DENTAL INNOVATIONS |
YOONHO JUN |
| K140293 |
10/31/2014 |
TOUAREG NP CLOSEFIT DENTAL IMPLANTS SYSTEM |
ADIN DENTAL IMPLANTS SYSTEMS LTD. |
NISSIM SHAKED |
| K141912 |
10/29/2014 |
AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BON |
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
ANNA HWANG |
| K140249 |
10/08/2014 |
LONG PULSE ND: YAG LASER SYSTEM |
ADVANCED TECHNOLOGY LASER CO., LTD. |
Diana Hong |
| K140619 |
10/10/2014 |
MECA XPRESSFISH |
ADVANDX, INC. |
RON EISENWINTER |
| K133360 |
10/17/2014 |
AERONEB SOLO; AERONEB SOLO ADAPTER |
AEROGEN LTD |
MARTIN CREHAN |
| K142150 |
10/29/2014 |
AIS MODULIFT VBR SYSTEM |
AESCULAP IMPLANT SYSTEM, INC. |
LISA M BOYLE |
| K142184 |
10/16/2014 |
DX-D IMAGING PACKAGE |
AGFA HEALTHCARE N.V. |
SHAEANN CAVANAGH |
| K142884 |
10/28/2014 |
E-CUBE 12 |
ALPINION MEDICAL SYSTEMS CO., LTD |
Donghwan Kim |
| K142733 |
10/28/2014 |
E-CUBE 5 |
ALPINION MEDICAL SYSTEMS CO., LTD |
DONGHWAN KIM |
| K142614 |
10/10/2014 |
AngioDynamics VenaCure EVLT TreÆ Sheath and VenaCure EVLT NeverTouch Procedure Kits |
AngioDynamics, Inc. |
Teri Juckett |
| K141865 |
10/15/2014 |
DANA |
ANTHROTRONIX, INC |
CORINA E LATHAN, PHD, PE |
| K141522 |
10/06/2014 |
APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES |
APEX MEDICAL CORP. |
ALAN CHANG |
| K141742 |
10/17/2014 |
ARDO CARUM AND CALYPSO POWERED BREAST PUMPS |
ARDO MEDICAL AG |
YARMELA PAVLOVIC |
| K141339 |
10/23/2014 |
ASAHI RG3 GUIDEWIRE/ASAHI RG3 SOFT GUIDEWIRE |
ASAHI INTECC CO., LTD. |
CANDACE CEDERMAN |
| K140463 |
10/10/2014 |
INTEGRA EXTERNAL FIXATION SYSTEM |
ASCENSION ORTHOPEDIC |
STEVE BROWN |
| K131987 |
10/15/2014 |
MULTIPULSE HOPLUS |
ASCLEPION LASER TECHNOLOGIES GMBH |
ANTJE KATZER |
| K142078 |
10/30/2014 |
VELASII THERAPY LASER SYSTEM |
ASPEN LASER SYSTEMS, LLC |
A. BRAUN HENDERSON |
| K142441 |
10/29/2014 |
cryoICE croablation probe |
ATRICURE, INC. |
Jonathan McElwee |
| K142425 |
10/27/2014 |
Uroflowmeter |
BE TECHNOLOGIES, INC. |
Edward Belotserkovsky |
| K142346 |
10/15/2014 |
Urine/CSF Albumin, Urine/CSF Albumin Calibrator |
Beckman Coulter Ireland Inc. |
Anne-Marie Shine |
| K142170 |
10/28/2014 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTESM - TIGECYCLINE (0.313-4UG/ML) GP |
Becton, Dickinson and Company |
MONICA E GIGUERE |
| K141973 |
10/06/2014 |
DIODE LASER HAIR REMOVAL SYSTEM |
BEIJING ANCHORFREE TECHNOLOGY CO., LTD |
Diana Hong |
| K133975 |
10/03/2014 |
MSA100 PEAK FLOW METER |
BEIJING M&B ELECTRONIC INSTRUMENTS, CO., LTD |
MIKE GU |
| K133441 |
10/10/2014 |
ONESTEP CPR II MULTI-FUNCTION ELECTRODE |
BIO-DETEK, INC. |
SHANNON DUHAMEL |
| K140590 |
10/30/2014 |
ASTROGLIDE SENSUAL STRAWBERRY |
BIOFILM, INC. |
Sherry Castello |
| K140120 |
10/10/2014 |
EPIC 10 |
BIOLASE, INC. |
COLLEEN BOSWELL |
| K141791 |
10/09/2014 |
BIOMET FUSION SYSTEM |
BIOMET SPINE |
TED KUHN |
| K140908 |
10/02/2014 |
JUGGERKNOT MINI SOFT ANCHOR |
BIOMET SPORTS MEDICINE |
Jared Cooper |
| K141331 |
10/27/2014 |
BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS) |
BIOMET, INC. |
TRACY BICKEL JOHNSON |
| K141407 |
10/27/2014 |
VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL |
BIOMET, INC. |
JULIE GANTENBERG, M.S. |
| K141326 |
10/08/2014 |
NEEDLE VIEW CH SCOPE KITS |
BIOVISION TECHNOLOGIES, LLC |
|
| K140577 |
10/01/2014 |
INNESIS PEEK TL CAGE |
BK MEDITECH CO., LTD. |
ELAINE DUNCAN |
| K141335 |
10/17/2014 |
EXPEL APD DRAINAGE CATHETER SYSTEM |
BOSTON SCIENTIFIC CORP. |
MATT BEAUCHANE |
| K141344 |
10/17/2014 |
EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM |
BOSTON SCIENTIFIC CORP. |
MATT BEAUCHANE |
| K141820 |
10/21/2014 |
JAGWIRE HIGH PERFORMANCE GUIDWIRE |
BOSTON SCIENTIFIC CORP. |
ALLISON BAILLIE |
| K141378 |
10/08/2014 |
IDC INTERLOCKING DETACHABLE COIL |
Boston Scientific Corporation |
LIZ JOHNSTON |
| K141584 |
10/16/2014 |
ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM |
Boston Scientific Corporation |
THOMAS HIRTE |
| K140020 |
10/28/2014 |
HYPERQ ACS-100 SYSTEM |
BSP-BIIOLOGICAL SIGNAL PROCESSING, LTD. |
AHAVA STEIN |
| K142443 |
10/30/2014 |
Site-Rite 6 Ultrasound System with Pinpoint GT Technology |
C.R. Bard, Inc |
Kerrie Hamblin |
| K142575 |
10/31/2014 |
Bard RiteCath Intermittent Urinary Catheter |
C.R. Bard, Inc. |
Michele Davis |
| K142267 |
10/17/2014 |
Sherlock 3CG Tip Positioning System Stylet |
C.R.Bard, Inc. |
Bryan Stone |
| K140940 |
10/27/2014 |
PROCESS INDICATOR TAPE FOR STEAM STERILIZATION |
CANADIAN TECHNICAL TAPE, LTD. |
GARY SOCOLA |
| K142372 |
10/30/2014 |
Pico Way Laser System |
CANDELA CORPATION |
Ruthie Amir |
| K141297 |
10/03/2014 |
FORUM GLAUCOMA WORKPLACE |
CARL ZEISS MEDITEC AG |
MANDY AMBRECHT |
| K140581 |
10/17/2014 |
CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSITION CONNECTOR FOR MEDICATION PORT |
CEDIC S.R.L. |
ROGER GRAY |
| K142079 |
10/24/2014 |
STALIF CTI, STALIF C |
CENTINEL SPINE, INC. |
JUSTIN EGGLETON |
| K142396 |
10/09/2014 |
Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests |
Chemtron Biotech, Inc. |
Jane Zhang |
| K133069 |
10/24/2014 |
CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES |
CODENT TECHNICAL INDUSTRY CO., LTD. |
CHIN-TING WEN |
| K142193 |
10/15/2014 |
COGENT MED-LIF XL |
COGENT SPINE LLC |
JUDE PAGANELLI |
| K132592 |
10/09/2014 |
FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET |
COOK, INC. |
DAVID LEHR |
| K140754 |
10/23/2014 |
COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM |
COOPER SURGICAL, INC. |
TIM LOHNES |
| K140022 |
10/24/2014 |
NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANISTER 250-ML, NISUS NPWT CANISTER 500-ML, CORK MEDICAL PRODUCT |
CORK MEDICAL PRODUCTS LLC |
JON SPEER |
| K142869 |
10/30/2014 |
Premium Surgiclip III |
COVIDIEN |
Michael Koczocik |
| K142364 |
10/01/2014 |
Barrx RFA Self Sizing Balloon Catheter |
Covidien llc |
Rachel Silva |
| K142198 |
10/08/2014 |
BNX Fine Needle Aspiration System |
Covidien LLC |
Saket Bhatt |
| K142654 |
10/28/2014 |
Fortrex 0.035 OTW PTA Balloon Catheter |
Covidien LLC |
Rupali Gupta |
| K141542 |
10/02/2014 |
NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS ) |
Covidien LLC |
MIA M WARE |
| K141894 |
10/06/2014 |
SHARKCORE FINE NEEDLE BIOPSY SYSTEM |
COVIDIEN LLC (FORMERLY BEACON ENDOSCOPIC CORP) |
Saket Bhatt |
| K141801 |
10/16/2014 |
HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM |
COVIDIEN, LLC |
JULIE UNDERDAHL |
| K141809 |
10/27/2014 |
RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM |
DEFIBTECH, LLC |
Ed Horton |
| K141753 |
10/16/2014 |
AQUARIUS NASAL FEEDING TUBE |
DEGANIA SILICONE, LTD. |
ZOYA LEE |
| K142517 |
10/31/2014 |
SoftVue |
DELPHINUS MEDICAL TECHNOLOGIES, INC |
Andrea N Wallen-Gerding |
| K142574 |
10/24/2014 |
4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
TRACEY HANNON |
| K140605 |
10/03/2014 |
MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC |
DIMA ITALIA SRL |
DARIO BASCIU |
| K140598 |
10/16/2014 |
PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC |
DIMA ITALIA SRL |
DARIO BASCIU |
| K140728 |
10/17/2014 |
MPI - MOLECULAR PRECISION IMPLANT, CPI - CYLINDRICAL PRECISION IMPLANT, OPI - ONE PIECE IMPLANT, DENTAL ABUTMENTS AND PR |
DITRON PRECISION LTD |
TALI HAZAN |
| K141623 |
10/07/2014 |
EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE WITH CHEMOTHERAPY DRUG LABELING CLAIM |
ECO MEDI GLOVE SDN BHD |
SURESH KUMAR |
| K141579 |
10/17/2014 |
EMG BLACK NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE |
ECO MEDI GLOVE SDN. BHD |
SURESH KUMAR |
| K141510 |
10/07/2014 |
EMG WHITE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) |
ECO MEDI GLOVE SDN. BHD |
SURESH KUMAR |
| K141745 |
10/31/2014 |
IQQA-BODYIMAGING SOFTWARE |
EDDA TECHNOLOGY |
DANIEL KAMM |
| K142199 |
10/29/2014 |
Ascendra Balloon Aortic Valvaloplasty Catheter |
EDWARDS LIFESCIENCES |
Susan Reynolds |
| K141855 |
10/08/2014 |
CLARITY |
ELEKTA LTD. |
|
| K141739 |
10/07/2014 |
RESIDUAL LIMB LENGTHENING SYSTEM |
ELLIPSE TECHNOLOGIES INC. |
REBECCA SHELBURNE |
| K141347 |
10/02/2014 |
EMERGE MEDICAL IM NAIL SYSTEM |
EMERGE MEDICAL |
MICHELLE POTVIN |
| K140467 |
10/07/2014 |
FLEX-MT + |
EMSI |
CHERITA JAMES |
| K140472 |
10/17/2014 |
BONASTENT TRACHEAL / BRONCHIAL |
ENDOCHOICE, INC. |
Bosmat Friedman |
| K142252 |
10/17/2014 |
XprESS Multi-Sinus Dilation Tool |
ENTELLUS MEDICAL, INC. |
Karen E. Peterson |
| K142245 |
10/29/2014 |
EpiAccess System |
EpieP, Inc. |
Pamela Bunes |
| K142042 |
10/21/2014 |
ERCHONIA SHL |
ERCHONIA CORPORATION |
Kevin Walls |
| K141560 |
10/23/2014 |
ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE |
ETHICON, INC. |
SUSAN LIN |
| K141776 |
10/15/2014 |
STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES |
ETHICON, INC. |
PETER CECCHINI |
| K141456 |
10/08/2014 |
THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL |
FIAGON GMBH |
DIRK MUCHA |
| K133225 |
10/24/2014 |
E-FIT EF-1280 EMS MACHINE |
FIT-PRO KFT LTD. |
RHONDA ALEXANDER, M.S., M.P.A. |
| K141850 |
10/27/2014 |
FLOSPINE PEDICLE SCREW SYSTEM |
FLOSPINE |
RICH JANSEN |
| K141106 |
10/10/2014 |
FRONTIER DEVICES FUSIO SCREW FUZE SYSTEM |
FOLSOM METAL PRODUCTS, INC. DBA FRONTIER DEVICES |
KEVIN ETHERIDGE |
| K140062 |
10/03/2014 |
FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER |
FSC LABORATORIES, INC. |
PAUL DRYDEN |
| K142003 |
10/21/2014 |
FDR D-EVO II FLAT PANEL DETECTOR SYSTEM |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
KATHERINE Y CHOI |
| K141765 |
10/03/2014 |
FDR D-EVO FLAT PANEL DETECTOR SYSTEM |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
KATHERINE Y CHOI |
| K142160 |
10/10/2014 |
LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM |
GE HEALTHCARE |
BRYAN BEHN |
| K142323 |
10/10/2014 |
Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System |
GE MEDICAL SYSTEMS ISRAEL LTD. |
Bryan Behn |
| K133245 |
10/08/2014 |
GENESYS SPINE ANTERIOR CERVICAL PLATE II SYSTEM |
GENESYS SPINE |
WILLIAM W SOWERS |
| K141700 |
10/31/2014 |
PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM |
GENORAY CO., LTD. |
KAITLYNN MIN |
| K142534 |
10/03/2014 |
HyProCure II |
Graham Medical Technologies, L.L.C. dba GraMedica |
ANGELA RECCHIA |
| K142088 |
10/31/2014 |
DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR SWBPM22 SERIES |
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
PATRICK CHOW |
| K131925 |
10/10/2014 |
HS NOTA |
H.S. HOSPITAL SERVICES S.P.A. |
LUCIO IMPROTA |
| K142063 |
10/28/2014 |
#8C RENEGADE DENTAL HANDPIECE |
HANDPIECE CLUB, LLC |
TINA WU |
| K141125 |
10/23/2014 |
U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE |
HANDPIECE HEADQUARTERS |
TINA STEFFANIE-OAK |
| K142280 |
10/16/2014 |
Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card) |
HEALGEN SCIENTIFIC LLC |
Jianqiu Fang |
| K141869 |
10/10/2014 |
QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT |
HEMEDEX INCORPORATED |
DEAN HONKONEN |
| K142618 |
10/16/2014 |
Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System, ARIETTA 70 Diagnostic Ultrasound System |
Hitachi Aloka Medical America, Inc. |
Angela Van Arsdale |
| K142037 |
10/10/2014 |
QUANTRA |
HOLOGIC, INC. |
CATHERINE WILLIAMS |
| K141242 |
10/17/2014 |
GLIDE DEVICE |
HOME SKINOVATIONS LTD. |
AHAVA STEIN |
| K140929 |
10/17/2014 |
Z1 CPAP SYSTEM |
HUMAN DESIGN MEDICAL, LLC |
MAUREEN O'CONNELL |
| K141713 |
10/28/2014 |
SMARTGRAFT 200 SYSTEM |
INGENERON, INC. |
ANITA KADALA |
| K133810 |
10/30/2014 |
VC150 VITAL SIGNS MONITOR |
INNOKAS YHTYMA |
Tiina Kotipalo |
| K140805 |
10/09/2014 |
ITCLAMP 50 |
INNOVATIVE TRAUMA CARE INC |
RICHARD WAITE |
| K133390 |
10/16/2014 |
NDX DORSAL APPLIANCE |
INSTITUTE FOR QUALITY RESOURCE MANAGEMENT |
LEAH AMIR, MS, MHA |
| K142414 |
10/30/2014 |
Miltex N-Tralig Intraligamentary Syringe |
INTEGRA LIFESCIENCES CORPORATION |
Judith E. O'Grady |
| K131487 |
10/08/2014 |
FLUOR PROTECTOR S |
IVOCLAR VIVADENT AG |
DONNA M HARTNETT |
| K142484 |
10/31/2014 |
Sternal Closure System |
JACE Medical LLC |
Justin May |
| K142460 |
10/01/2014 |
EXPEDIUM Spine System/Synapse System |
JOHNSON AND JOHNSON |
Jaclyn Porsolt |
| K142536 |
10/03/2014 |
21.5 inch (54.5 cm) Color LCD Monitor CCL220 (CL22220) |
JVC KENWOOD CORPORATION |
TSUKASA TASHIRO |
| K142540 |
10/03/2014 |
24.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244) |
JVC KENWOOD CORPORATION |
Tsukasa Tashiro |
| K142556 |
10/23/2014 |
Flexible Video-Uretero-Choledochoscope System |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
Mike Samuels |
| K140052 |
10/30/2014 |
J2I IMPLANT SYSTEM |
KJ MEDITECH CO., LTD. |
Priscilla Chung |
| K140051 |
10/30/2014 |
KJ EXTERNAL IMPLANT SYSTEM |
KJ MEDITECH CO., LTD. |
Priscilla Chung |
| K141539 |
10/29/2014 |
KUBTEC X250 |
KUB TECHNOLOGIES, INC |
VIKRAM BUTANI |
| K141221 |
10/28/2014 |
LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES TURBO+ PR |
LARES RESEARCH, INC. |
JASON ORGAIN |
| K141908 |
10/22/2014 |
DUAL SWITCH |
LASER ENGINEERING, INC. |
LAURIE DOBBS |
| K142660 |
10/17/2014 |
Antegrade LeMills Valvulotome |
LeMaitre Vascular, Inc. |
Xiang (Vic) Zhang |
| K142359 |
10/23/2014 |
Vasc Band hemostat |
Lepu Medical Technology (Beijing) Co., LTD |
Kim Xiangdan |
| K131737 |
10/23/2014 |
SUPERNOVA C5 MRI SYSTEM |
LIAONING KAMPO MEDICAL SYSTEM CO., LTD. |
SHAO KAI |
| K141723 |
10/22/2014 |
UPCERA COLORING LIQUID (I AND II ) |
LIAONING UPCERA CO.,LTD |
CHARLES SHEN |
| K141724 |
10/22/2014 |
UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANK |
LIAONING UPCERA CO.,LTD |
CHARLES SHEN |
| K140236 |
10/20/2014 |
AILERON INTERSPINOUS FIXATION SYSTEM |
LIFE SPINE, INC |
RANDY LEWIS |
| K141658 |
10/22/2014 |
LIGHT SCALPEL |
LIGHT SCALPEL LLC |
DAVID WALTERS |
| K142757 |
10/23/2014 |
LiNA PowerBlade Plus HC |
LiNA Medical ApS |
Louisa Memborg |
| K142538 |
10/06/2014 |
LiNA SafeAir Smoke Pencil |
LINA MEDICAL APS |
Louisa Memborg |
| K133849 |
10/22/2014 |
VANTERA CLINICAL ANALYZER |
LIPOSCIENCE |
SUZETTE WARNER |
| K140647 |
10/24/2014 |
XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP(TDAS GPP) |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
Tina Ip |
| K140927 |
10/24/2014 |
UNIVERSAL NAVIGATION INSTRUMENTS |
MEDOS INTERNATIONAL SARL |
KIRSTEN LEHMULLER |
| K134009 |
10/15/2014 |
UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONAL |
MEDTEK LIGHTING |
SUSAN ANTHONEY-DE WET |
| K141704 |
10/06/2014 |
NOVASHIELD INJECTABLE NASAL PACKING AND STENT |
MEDTRONIC INC. |
RISHI SINHA |
| K142847 |
10/27/2014 |
CD HORIZON Spinal System |
MEDTRONIC SOFAMOR DANCK USA, INC. |
LAVEEDA LEFLORE |
| K142450 |
10/01/2014 |
DIVERGENCE Anterior Cervical Fusion System |
MEDTRONIC SOFAMOR DANEK USA, INC |
Shweta Sharma |
| K141604 |
10/21/2014 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
LILA JOE |
| K142784 |
10/24/2014 |
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface |
Medtronic, Inc |
Lisa Stone |
| K133157 |
10/23/2014 |
TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6 |
MEDTRONIC, INC. |
JESSICA SIXBERRY |
| K142096 |
10/17/2014 |
T-PIECE RESUSCITATOR |
MERCURY MEDICAL |
PAUL DRYDEN |
| K140251 |
10/22/2014 |
UNIVERSAL DIGITAL INTERFACE 2, UDI 2 |
MERIDIAN MEDICAL SYSTEMS, LLC |
LARRY CORNELL |
| K142636 |
10/17/2014 |
Merit 10mL Syringe |
Merit Medical Systems, Inc. |
Mridi Kumathe |
| K140543 |
10/16/2014 |
PRELUDEEASE HYDROPHILIC SHEATH INTRODUCER |
MERIT MEDICAL SYSTEMS, INC. |
MICHAELA RIVKOWICH |
| K141491 |
10/22/2014 |
SOLITAIRE 2 REVASCULARIZATION DEVICE |
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
LARRY BOUCHER |
| K142014 |
10/10/2014 |
SOFIA DISTAL ACCESS CATHETER |
MICROVENTION, INC. |
Naomi Gong |
| K141603 |
10/22/2014 |
Ultra Silver Dressings |
MILLIKEN HEALTHCARE PRODUCTS, LLC |
GORDON MACFARLANE |
| K133040 |
10/07/2014 |
LED CURING LIGHT |
MONITEX INDUSTRIAL CO., LTD. |
SHU-LUNG WANG |
| K142033 |
10/10/2014 |
VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP) |
NANOSPERE,INC. |
NOAH LERMER |
| K140530 |
10/02/2014 |
Electro Auricular Device |
NAVIGANT CONSULTING, INC. |
COLLEEN HITTLE |
| K142616 |
10/14/2014 |
PICC Maximal Barrier Nursing Kit |
NAVILYST MEDICAL, INC. |
WANDA CARPINELLLA |
| K141660 |
10/31/2014 |
NAWALUTION SKIN AND WOUND CLEANSER |
NAWA HEILMITTEL GMBH |
ALLYSON B MULLEN |
| K142084 |
10/28/2014 |
EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX |
NCONTACT SURGICAL, INC. |
JANE RICUPERO |
| K142275 |
10/07/2014 |
Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens |
NEO VISION CO., LTD. |
Kyung Hwa Kim |
| K141731 |
10/24/2014 |
NEPHROS DSU-H, NEPHROS SSU-H |
NEPHROS, INC. |
JAMES SUMMERTON |
| K142286 |
10/31/2014 |
NS3000 Holmium Laser System |
New Star Lasers, Inc. |
Natalie Vollrath |
| K142220 |
10/17/2014 |
Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators) |
NOVA BIOMEDICAL CORPORATION |
Paul W. MacDonald |
| K141207 |
10/31/2014 |
NOVABONE BIOACTIVE STRIP |
NovaBone Products, LLC |
Lisa Simpson |
| K132853 |
10/30/2014 |
NOVAPACS |
NOVARAD CORP. |
AMY HOFFMAN |
| K140319 |
10/09/2014 |
COROENT TI-C SYSTEM |
NUVASIVE, INC. |
JEREMY MARKOVICH |
| K142050 |
10/29/2014 |
NUVASIVE COROENT SMALL CONTOURED INTERBODY SYSTEM |
NUVASIVE, INCORPORATED |
MICHELLE CHEUNG |
| K141759 |
10/24/2014 |
OAK RIDGE PRODUCTS MULTI-PURPOSE SHARPS CONTAINERS |
OAK RIDGE PRODUCTS, LLC |
CONOR J O'MALLEY |
| K140470 |
10/15/2014 |
OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBER |
OBERON GMBH FIBER TECHNOLOGIES |
ARMIN KAUS |
| K141502 |
10/03/2014 |
HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTY |
ORTHOCON, INC. |
Howard Schrayer |
| K142727 |
10/24/2014 |
CrossCLIP Implant System |
OrthoDiscovery Group LLC(D.B.A. CrossRoads Extremity Systems |
Vernon Hartdegen |
| K141842 |
10/06/2014 |
STARBAND, STARLIGHT |
ORTHOMERICA PRODUCTS, INC. |
DAVID C KERR |
| K142090 |
10/29/2014 |
REBOSSIS |
ORTHOREBIRTH CO., LTD. |
KEVIN A.THOMAS |
| K140309 |
10/03/2014 |
CRANIOPLUG |
OSSDSIGN AB |
DAVID WEISSBURG |
| K141200 |
10/02/2014 |
PADI-LOCK |
PADI-LOCK, LLC |
MARIA GRIFFIN |
| K140023 |
10/16/2014 |
ELEVATION |
PDG PRODUCT DESIGN GROUP, INC. |
EDWARD A KROLL |
| K140025 |
10/15/2014 |
AQUAMAX (ETAFILCON A) BI-WEEKLY DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES |
Pegavision Corporation |
TONY HSU |
| K142698 |
10/23/2014 |
PerkinElmer, XRpad 4343 F MED Flat Panel Detector |
PerkinElmer, Inc |
Dawn Spooner |
| K140493 |
10/30/2014 |
ELIA SCL-70S IMMUNOASSAY |
PHADIA GMBH |
MARTIN R MANN |
| K140225 |
10/27/2014 |
ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO |
PHADIA US INC. |
MARTIN MANN |
| K142708 |
10/22/2014 |
VERADIUS UNITY |
PHILIPS MEDICAL SYSTEMS NETHRLANDS BV |
Jeanette Becker |
| K142027 |
10/07/2014 |
888 WNLE POWERED WHEELCHAIR |
PIHSIANG MACHINERY MFG. CO., LTD. |
DAVID LIN |
| K141600 |
10/17/2014 |
NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT |
PIONEER SURGICAL TECHNOLOGY, INC. (RTI SURGICAL, I |
SARAH MCINTYRE |
| K141816 |
10/23/2014 |
HEMOPORE |
Polyganics BV |
BETTY IJMKER |
| K142302 |
10/02/2014 |
BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemis |
Polymer Technology Systems, Inc. |
Jack Rogers |
| K141211 |
10/22/2014 |
INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH STRAUMANN TISSUE LEVEL IMPLANTS |
PRISMATIK DENTALCRAFT, INC. |
Armin Zehtabchi |
| K132771 |
10/28/2014 |
KINGSTON ENDOSCOPIC SURGICAL INSTRUMENTS |
QINGDAO KINGSTON MEDICAL DEVICES LTD |
WU HANHUA |
| K141931 |
10/09/2014 |
LYRA ADENOVIRUS ASSAY |
QUIDEL CORPORATION |
Ronald H Lollar |
| K141927 |
10/09/2014 |
LYRA PARAINFLUENZA VIRUS ASSAY |
QUIDEL CORPORATION |
Ronald H Lollar |
| K141743 |
10/03/2014 |
FUSION DIGITAL DIAGNOSTIC X-RAY UPGRADE KIT |
RADIOLOGY SOLUTIONS LLC |
DANIEL KAMM, P.E. |
| K141881 |
10/31/2014 |
RAPIDRESULTS |
RAMSOFT, INC. |
LELY LAM-HONG |
| K141860 |
10/23/2014 |
RAYSTATION |
RAYSEARCH LABORATORIES AB |
DAVID HEDFORS |
| K142304 |
10/03/2014 |
Viberect Penile Vibratory Stimulation Device |
REFLEXONIC, LLC |
Kambiz Tajkarimi |
| K141954 |
10/15/2014 |
XCEL 455 SLIT LAMP |
REICHERT, INC. |
THOMAS M HECKMANN |
| K133990 |
10/09/2014 |
IEVA REHABILITATIVE POSITIONAL DEVICE |
REMENDIUM LABS, LLC |
YOLANDA LORIE |
| K142095 |
10/15/2014 |
RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM |
Renovis Surgical Technologies, Inc. |
Sharyn Orton |
| K141175 |
10/24/2014 |
RENOVOCATH RC120 |
RENOVORX, INC. |
RON S WARREN |
| K142755 |
10/23/2014 |
Siemens 3.0 Blanket Array Coil |
RESONANCE INNOVATIONS LLC |
Randall Jones |
| K140268 |
10/20/2014 |
SIMPLE T YOUTH NASAL MASK |
RESPIRONICS, INC. |
COLLEEN WITT |
| K141664 |
10/02/2014 |
SAFE'N'SOUND STAKED PASSIVE DELIVERY SYSTEM - CONE VERSION |
REXAM HEALTHCARE |
BEATRICE GRAND DEMARS |
| K141426 |
10/17/2014 |
ELECSYS FOLATE III |
Roche Diagnostics |
KELLI TURNER |
| K142133 |
10/24/2014 |
ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM |
Roche Diagnostics |
Sarah Baumann |
| K142070 |
10/27/2014 |
FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS |
RTI SURGICAL, INC. |
KRISTINA HALL |
| K142466 |
10/03/2014 |
UGEO PT60A Diagnostic Ultrasound System |
SAMSUNG MEDISON CO., LTD |
PARK KYEONG-MI |
| K141416 |
10/09/2014 |
BLOOD PRESSURE MONITOR |
SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. |
XIE QIONGYU |
| K142811 |
10/29/2014 |
IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM) |
Siemens Healthcare Diagnostics Inc. |
Asha Gartland |
| K142864 |
10/29/2014 |
ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI) Master Curve Material (MCM) |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
Fatima Pacheco |
| K142878 |
10/30/2014 |
IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High Sensitivity CRP Calibration Verification Material |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
Donna Velasquez |
| K142876 |
10/23/2014 |
ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
NANCY BURKE |
| K142515 |
10/08/2014 |
MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Skyra |
Siemens Medical Solutions USA, Inc. |
Cordell L. Fields |
| K133677 |
10/16/2014 |
SYNGO CT SINGLE SOURCE DUAL ENERGY |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KIMBERLY MANGUM |
| K142628 |
10/10/2014 |
Acuson SC2000 Diagnostic Ultrasound System |
SIEMENS MEDICAL SOLUTIONS, INC. |
Kevin Kong |
| K140304 |
10/07/2014 |
SIMPLY SLICK PERSONAL LUBRICATING LOTION |
SIMPLY SOLUTIONS, LLC |
JOHN GOEPFERT |
| K141686 |
10/28/2014 |
EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING BLANKET, SNUGGLE WARM PEDIATRICFULL BODY |
SMITH MEDICAL ASD, INC. |
JIM JOHNSON |
| K142091 |
10/17/2014 |
PARIETENE MACROPOROUS MESH |
SOFRADIM PRODUCTION |
JENNIFER BRENNAN |
| K142900 |
10/28/2014 |
Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh |
SOFRADIM PRODUCTION |
Eric Jague |
| K140383 |
10/28/2014 |
ALLOX2 TISSUE EXPANDERS |
SPECIALTY SURGICAL PRODUCTS, INC. |
SHERRY NULL |
| K142101 |
10/23/2014 |
ABACUS (TM) SPACER SYSTEM |
SPINE WAVE, INC. |
ROAIDA JOHNSON |
| K142277 |
10/14/2014 |
JULIET PO |
SPINEART |
Franck Pennesi |
| K142026 |
10/20/2014 |
SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICE |
SPINEFRONTIER, INC. |
MEREDITH l MAY |
| K141312 |
10/31/2014 |
STERILUCENT PROCESS CHALLENGE DEVICE |
STERILUCENT, INC |
PETER KALKBRENNER |
| K140464 |
10/31/2014 |
STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZER |
STERILUCENT, INC |
PETER KALKBRENNER |
| K141152 |
10/17/2014 |
ADVANTAGE |
STEVENSON INDUSTRIES, INC. |
SERRAH NAMINI |
| K141399 |
10/10/2014 |
FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM |
STIMWAVE TECHNOLOGIES INCORPORATED |
Elizabeth Greene |
| K142381 |
10/21/2014 |
Xia 3 Spinal System |
STRYKER CORP. |
GARRY T HAYECK |
| K141941 |
10/31/2014 |
SPINEMASK TRACKER, SPINEMAP 3D 3.0-SOFTWARE,SPINEMAP 3D 3.0-UPGREADE, SPINEMAP 3D 3.0-ENABLE, SPINEMAP 3D 3.0-SALES D |
STRYKER CORPORATE |
LILIAN ECKERT |
| K142114 |
10/27/2014 |
Xia« Growth Rod Conversion Set |
STRYKER CORPORATION |
GARRY T HAYECK, PH.D. |
| K142603 |
10/23/2014 |
Stryker Precision HD Camera System |
Stryker Endoscopy |
Angela Wong |
| K142984 |
10/29/2014 |
Leo Minor |
SUNNEX, INC. |
TISH MENDICK |
| K141708 |
10/06/2014 |
ULTRASHAPE SYSTEM |
SYNERON MEDICAL LTD. |
JANICE M HOGAN |
| K141165 |
10/17/2014 |
MATRIXWAVE MMF SYSTEM |
SYNTHES (USA) PRODUCTS LLC |
Damon Lees |
| K142653 |
10/16/2014 |
G-Lok and G-Lok XL Extender |
T.A.G. Medical Products Corporation, Ltd |
Tomer Alon |
| K141758 |
10/31/2014 |
T:SLIM INSULIN DELIVERY SYSTEM |
TANDEM DIABETES CARE, INC. |
JANICE HOGAN |
| K142138 |
10/30/2014 |
ISO-GARD MASK |
Teleflex Medical, Inc. |
BRIAN GALL |
| K140197 |
10/21/2014 |
PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM |
Teleflex Medical, Inc. |
HOLLY KORNEGAY |
| K140205 |
10/23/2014 |
PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM |
Teleflex Medical, Inc. |
HOLLY KORNEGAY |
| K140008 |
10/31/2014 |
VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM |
Terumo Cardiovascular Systems Corporation |
GARRY COURTNEY |
| K141651 |
10/21/2014 |
SENSITITRE SUSCEPTIBILITY PLATES |
Thermo Fisher Scientific |
Cynthia Knapp |
| K142589 |
10/17/2014 |
Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TL |
TITAN SPINE, LLC |
Jane Rodd |
| K141953 |
10/27/2014 |
ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL |
TITAN SPINE, LLC |
CHRISTINE SCIFERT |
| K141325 |
10/23/2014 |
TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERA |
TOPCON CORP. |
MAUREEN O'CONNELL |
| K141459 |
10/28/2014 |
APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM, V5.0 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
ORLANDO TADEO |
| K141972 |
10/09/2014 |
KLASSIC HD ACETABULAR INSERT WITH E-LINK POLY |
TOTAL JOINT ORTHOPEDICS, INC. |
CHRIS WEABER |
| K132490 |
10/20/2014 |
SKORE AND MULTIPLE BRANDS |
TTK PROTECTIVE DEVICES LIMITED (FORMERLY TTK-LIG L |
MANOJ ZACHARIAS |
| K141917 |
10/17/2014 |
UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR DAILY WEAR |
UNICON OPTICAL CO., LTD. |
MICHAEL LEE |
| K142851 |
10/30/2014 |
CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact Lens |
Unilens Corp., USA |
Alan J. Frazer |
| K141126 |
10/31/2014 |
UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE |
UNISIS CORP. |
DIANE RUTHERFORD |
| K142268 |
10/02/2014 |
Varian Verification System (VVS) |
VARIAN MEDICAL SYSTEMS, INC. |
Peter J. Coronado |
| K141699 |
10/07/2014 |
VASSEN COLOR |
VASSEN CO., LTD. |
BRET ANDRE |
| DEN130044 |
10/14/2014 |
INFLOW INTRAURETHRAL VALVE-PUMP |
VESIFLO, INC. |
KEVIN M CONNOLLY |
| K141904 |
10/21/2014 |
VIORA V-TOUCH |
VIORA LTD. |
YORAM LEVY |
| K140993 |
10/20/2014 |
IONOSTAR MOLAR |
VOCO GMBH |
T GERKENSMEIER |
| K133488 |
10/16/2014 |
PIEZOMED |
W & H DENTALWERK BUERMOOS GMBH |
ANJA LINDNER |
| K142353 |
10/07/2014 |
First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test |
W.H.P.M., Inc. |
John Wan |
| K142563 |
10/28/2014 |
Well Lead PVC Urethral Catheter |
WELL LEAD MEDICAL CO., LTD. |
Han Guang Yuan |
| K142670 |
10/22/2014 |
Vericore Zirconia Blanks |
WHIP MIX CORPORATION |
JOHN WATERS |
| K141714 |
10/24/2014 |
PRO-TOE X-FLEX HAMMERTOE FIXATION SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
VAL MYLES |
| K142602 |
10/22/2014 |
VALOR Hindfoot Fusion Nail System |
WRIGHT MEDICAL TECHNOLOGY, INC. |
VAL MYLES |
| K142082 |
10/28/2014 |
ZIMMER 3.1MM DENTAL IMPLANT;2.9MM ANGLED ABUTMENT;STRAIGHT HEX, 2.9MM CONTOUR ABUTEMENT |
ZIMMER DENTAL INC. |
CHRISTINA BOYDSON |
| K141544 |
10/22/2014 |
ZIMMER ZFX TITANIUM ABUTMENT FOR BIOMET 3I CERTAIN IMPLANT SYSTEM |
ZIMMER DENTAL INC. |
CHRISTINA BOYDSTON |
| K141564 |
10/24/2014 |
OPTON PRO |
ZIMMER MEDIZINSYSTEMS GMBH |
ARMIN PETRASCHKA |
| K142053 |
10/29/2014 |
UNIVERSAL CLAMP SPINAL FIXATION SYSTEM |
ZIMMER SPINE, INC. |
HOLLY SEPPANEN |
| K142442 |
10/03/2014 |
MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEM |
ZIMMER, INC. |
PATRICK MCCULLAGH |
| K142281 |
10/22/2014 |
ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEM |
ZIMMER, INC. |
PATRICK MCCULLAGH |
| K142579 |
10/22/2014 |
Zimmer Periarticular Plating System |
ZIMMER, INC. |
Patrick McCullagh |
| K141139 |
10/03/2014 |
SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER |
ZOLL CIRCULATION |
SUSAN NORIEGA |
| K140783 |
10/17/2014 |
HALO AMBULATORY INFUSION SYSTEM |
ZYNO MEDICAL LLC. |
MEI ZHANG |
