FDA 510(k) Applications Received During January, 2014

FDA 510(k) Number Submission Date Device Name Applicant Contact
K140250 01/31/2014 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE 3M HEALTH CARE KRISTIN TOTUSHEK
K143258 11/13/2014 PLIF STS, TLIF STS, OLIF STS (Spinal Truss System) 4WEB,INC. JESSEE HUNT
K140101 01/27/2014 ABMEDICA REUSABLE LAPAROSCOPIC HAND INSTRUMENTS AND TROCARS ABMEDICA SAS DANIEL DONOVAN
K140219 01/29/2014 PICASSO II MIS SPINAL SYSTEM ACCEL SPINE LISA PETERSON
K140160 01/22/2014 RELIEVA SCOUT SINUS DILATION SYSTEM ACCLARENT, INC. JAMES P GARVEY, II
K143269 11/13/2014 Delivery Analysis ACCURAY INCORPORATED Keith Picker
K143207 11/07/2014 Revitive IX (OTC) Actegy, Ltd Angela Glover
K143394 11/26/2014 Acumed Small Fragment Base Set ACUMED LLC Nathan Wolf
K143385 11/26/2014 Acumed Ankle Plating System Acumed, llc Nathan Wolf
K143276 11/14/2014 Acumed Small Bone IM Nail System Acumed, LLC Nathan Wolf
K140190 01/24/2014 NIGHT SHIFT ADVANCED BRAIN MONITORING, INC. ADRIENNE LENZ
K143204 11/07/2014 AOS Clavicle Intramedullary Device ADVANCED ORTHOPAEDIC SOLUTIONS, INC. ANNA HWANG
K140249 01/31/2014 LONG PULSE ND: YAG LASER SYSTEM ADVANCED TECHNOLOGY LASER CO., LTD. Diana Hong
K143397 11/26/2014 ICIS View Agfa HealthCare N.V. JODI COLEMAN
K140077 01/13/2014 ALBAAD PLASTIC APPLICATOR TAMPONS UNSCENTED ALBAAD LTD. ROBERT J STAAB, PH.D.
K143354 11/24/2014 Natrelle 133 Plus Tissue Expander ALLERGAN, INC. Bruce Krattenmaker
K140005 01/02/2014 ALMA DIODE TABLETOP LASER ALMA LASERS LTD. KATHY MAYNOR
K140009 01/02/2014 SOPRANO ICE MULTI-APPLICATION & MULTI-TECHNOLOGY PLATFORM ALMA LASERS LTD. KATHY MAYNOR
K143149 11/03/2014 Arsenal Spinal Fixation System ALPHATEC SPINE, INC. RENEE MURPHY
K143337 11/20/2014 CONELOG Titanium base CAD/CAM ALTATEC GMBH DENNIS PAPPAS
K143372 11/25/2014 AWARE AMBIENT CLINICAL ANALYTICS ALLEN BERNING
K140126 01/16/2014 SONIC WINDOW ANALOGIC CORPORATION ALBERT C CEFALO
K140093 01/14/2014 TABLE ANATOMAGE INC. MIKE MENDEZ
K140121 01/16/2014 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR ANDON HEALTH CO., LTD LIU YI
K140247 01/30/2014 MTA FILLAPEX ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS SA TARA CONRAD
K140097 01/14/2014 AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM APPLIED MEDICAL TECHNOLOGY, INC. JOSHUA MEINKE
K140036 01/07/2014 APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITH APTUS ENDOSYSTEMS, INC. BURT GOODSON
K140201 01/27/2014 AXERA 2 ACCESS SYSTEM ARSTASIS, INC. GRACE LI
K140019 01/03/2014 ARTHREX BIOSUTURE ARTHREX, INC. COURTNEY SMITH
K143139 11/03/2014 Arthrex Fracture System ARTHREX, INC. David Rogers
K140058 01/10/2014 ATRICURE CRYO MODULE SYSTEM ATRICURE, INC. KARL DAHLQUIST
K140039 01/07/2014 POLYCRYL AUROLAB KRISHNA KUMAR.R
K140185 01/24/2014 OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE AVINGER, INC. SHERRY KIM
K143157 11/03/2014 Coronis Fusion 4MP LED BARCO NV LIEVEN DE WANDEL
K143157 11/03/2014 Coronis Fusion 4MP LED BARCO NV LIEVEN DE WANDEL
K140111 01/24/2014 BD MAX(TM) ENTERIC BACTERIAL PANEL;BD MAX(TM) INSTRUMENT BECTON, DICKINSON AND COMPANY PAUL SWIFT
K143150 11/03/2014 CO2 monitoring line with and without in-line filter BESMED HEALTH BUSINESS CORP. WINNIE CHUNG
K140147 01/22/2014 BCT ANTIMICROBIAL DRESSING & BCT SILVER BANDAGE BIO-MEDICAL CARBON TECHNOLOGY CO., LTD. DIANE SUDDUTH
K143379 11/25/2014 Liquichek Maternal Serum II Control Bio-Rad Laboratories Elizabeth Platt
K143178 11/04/2014 FilmArray 2.0 System BioFire Diagnostics, LLC Kristen Kanack, PhD
K143171 11/04/2014 FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0 Biofire Diagnostics, LLC. Kristen Kanack, PhD
K140120 01/16/2014 EPIC 10 BIOLASE, INC. COLLEEN BOSWELL
K143188 11/05/2014 3.Omm Biomet Cannulated Screw System BIOMET MANUFACTURING CORP. VICTORIA SCHEITLIN
K143336 11/20/2014 Biomet Microfixation OmniMax MMF System BIOMET MICROFIXATION Lauren Jasper
K140018 01/03/2014 TSP HIP FRACTURE PLATING SYSTEM BIOMET, INC. GARY BAKER
K143192 11/06/2014 Vanguard 360 Revision Knee System Biomet, Inc. Jason Heckaman
K143387 11/26/2014 GE333 Blood Glucose Monitoring System Bionime Coporation Tino Lee
K140210 01/28/2014 RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS GM720 BIONIME CORPORATION Feng-Yu Lee
K143292 11/17/2014 TheraCal DC Bisco Inc Michelle Schiltz-Taing
K143298 11/17/2014 Ultrasound Scanner System bk2300 BK MEDICAL APS RANDI HAUERBERG
K140104 01/15/2014 BARRICADE EMBOLIZATION COIL SYSTEM BLOCKADE MEDICAL REBECCA K PINE
K143267 11/13/2014 TempTraq TT-100 Blue Spark Technologies Inc. Jennifer Cartledge
K143193 11/06/2014 Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters BOSTON SCIENTIFIC Anna Deraney
K134054 01/16/2014 BOVIE IDS-310 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A3350 HIGH FREQUENCY ELECTROSURGICAL GENERATOR BOVIE MEDICAL CORPORATION RICHARD A KOZLOFF
K143280 11/14/2014 BHV VIVID (etafilcon A) Soft (Hydropholic) Contact Lens Brien Holden Vision Pty Ltd. Randall May
K143151 11/03/2014 Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact) BSN MEDICAL GMBH MARTIN SPENGLER
K140020 01/03/2014 HYPERQ ACS-100 SYSTEM BSP-BIIOLOGICAL SIGNAL PROCESSING, LTD. AHAVA STEIN
K140151 01/22/2014 EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT BTG INTERNATIONAL, INC. JOCELYN KERSTEN
K143380 11/25/2014 Phasix ST Mesh C. R. Bard Inc Tony John
K143208 11/10/2014 Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavain Delivery Kit C.R. Bard, Inc Laurie Sang
K140122 01/16/2014 CANDELA GENTLEMAX FAMILY OF LASER SYSTEM CANDELA CORP. SAM WADE
K143199 11/06/2014 Capillus 272 Pro Capillus, LLC Frances Pina Brea
K140118 01/16/2014 MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 BLUE CARTRIDGE CARDICA, INC. VEE ARYA
K140170 01/23/2014 MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 WHITE CARTRIDGE CARDICA, INC. VEE ARYA
K140155 01/22/2014 SECURE-GARD SURGICAL AND PROCEDURE FACE MASK CARDINAL HEALTH 200, LLC LAVENIA FORD
K140015 01/02/2014 CARDIOSOLUTIONS DEXTERITY STEERABLE INTRODUCER CARDIOSOLUTIONS INC CHRISTINE SANTAGATE
K134044 01/03/2014 EP-TRACER SYSTEM, EP-TRACER SYSTEM, EP-TRACER SYSTEM CARDIOTEK, B.V. MELISSA WALKER
K143234 11/10/2014 MaxZero Administration Sets CAREFUSION LARRY WALKER
K143234 11/10/2014 MaxZero Administration Sets CAREFUSION LARRY WALKER
K143275 11/14/2014 IOLMaster700 Carl Zeiss Meditec, Inc. Christine Dunbar
K133519 01/13/2014 CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR CAROLINA LIQUID CHEMISTRIES CORP. MELISSA F THOMPSON
K143392 11/26/2014 Quattro Bolt Tenodesis Screw CAYENNE MEDICAL, INC Shima Hashemian
K143247 11/12/2014 Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White Colored) CENTRAL MEDICARE SDN BHD TH Chong
K140144 01/28/2014 BENDA WEDGE CENTRIX, INC. GREG MOREAU
K143302 11/17/2014 Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80 CEPHEID KERRY J FLOM
K140141 01/28/2014 LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM CERAGEM MEDISYS INC. DANA MOON
K143356 11/24/2014 NovoStitch Plus Meniscal Repair System Ceterix Orthopaedics, Inc. Michael Hendricksen
K140142 01/22/2014 CHOICE SPINE LUMBAR SPACER SYSTEM (SABRE, SHARK, HORNET, HARPOON) CHOICE SPINE, LP KIM FINCH
K143396 11/26/2014 omni TRAX Active Patient Tracker CIVCO Medical Instruments Co Inc dba CIVCO Medical Solutions Amanda Stahle
K140139 01/22/2014 CLEARVIEWHD CLEARVIEW DIAGNOSTICS INC. CHRISTINE PODILCHUK
K140163 01/22/2014 KOALA TOCO CLINICAL INNOVATIONS, LLC JOANNE BRONIKOWSKI
K140215 01/28/2014 ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD CO-INNOVATION BIOTECH CO., LTD. HONG FENG
K140080 01/14/2014 ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB CODMAN & SHURTLEFF, INC. HANNAH FOLEY
K140116 01/16/2014 RESTORELLE Y CONTOUR MESH COLOPLAST A/S TIM CRABTREE
K143182 11/05/2014 Speedicath Compact Male COLOPLAST A/S Brian Schmidt
K140070 01/15/2014 LUXER SHADED ZIRCONIA CONTINENTAL DENTAL CERAMICS, INC. JERRY DOVIACK
K140033 01/07/2014 TARGET3D FUSION CONVERGENT LIFE SCIENCES, INC. DINESH KUMAR
K140085 01/13/2014 UNIVERSA PERCULTANEOUS DRAINAGE CATHETER COOK INCORPORATED ELYSIA EASTON
K140169 01/23/2014 VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM COOK INCORPORATED THOMAS J KARDOS
K143415 11/28/2014 Air Bubble Based Infuser (ABBI) CooperSurgical, Inc James Keller
K143412 11/28/2014 ADROIT Guiding Catheter CORDIS CORPORATION BABU PERIASAMY
K140022 01/03/2014 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
K143161 11/03/2014 Force FX-8(S), Force FX-8C(S), Force FX-8CA(S) COVIDIEN Sharon McDermott
K143263 11/13/2014 Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets COVIDIEN KARIN DESJARDINS
K140064 01/10/2014 SURGISLEEVE WOUND PROTECTOR COVIDIEN MICHAEL KOCZOCIK
K140038 01/07/2014 DIGIMATCH ORTHODOC ROBODOC ENCORE SURGICAL SYSTEM CUREXO TECHNOLOGY CORPORATION GLEN EMELOCK
K143317 11/19/2014 Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes) Currie Medical Specialties, Inc. Owen J. Bry
K140092 01/14/2014 CURRIE MEDICAL REPROCESSED ALP CALF/THIGH/FOOT COMPRESSION SLEEVE (ALL SIZES) CURRIE MEDICAL SPECIALTIES, INC. OWEN J BRY
K143143 11/03/2014 PATHWAY ELIF CUSTOM SPINE, INC. Mahmoud Abdelgany
K140158 01/22/2014 S.E.A.L. FRACTURE FUSION TUBE D.N.E., LLC J.D. WEBB
K143378 11/25/2014 AQUARIUS Gastrostomy Replacement Tube DEGANIA SILICONE LTD Zoya Lee
K140175 01/23/2014 INTRAVASCULAR ADMINISTRATION SET DELTA MED SPA ROGER GRAY
K143362 11/24/2014 extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister Devon Medical Products John Siegel
K140031 01/09/2014 SUCTION PUMP DING HWA CO., LTD ROBERT O DEAN
K143318 11/19/2014 DR Systems Zero Download 3D Viewer (Z3D) DR Systems, Inc Kimberly J Meade
K133886 01/15/2014 PERSEUS A500 DRAEGER MEDICAL GMBH BETH ZIS
K140168 01/23/2014 EASYSTIM TN28_OTC EASYMED INSTRUMENTS CO., LTD. JEFFERY WU
K140123 01/16/2014 POLARIS SPINAL SYSTEM -TRANSLATION SCREW EBI, LLC MIKE MEDINA
K140241 01/30/2014 EDWARDS TRANSFEMORAL BALLOON CATHETER EDWARDS LIFESCIENCES, LLC. ERIC CARRIER
K143325 11/20/2014 OC-Light S FIT EIKEN CHEMICAL CO. LTD Yoshinori Ota
K143261 11/13/2014 2.3MP Color LCD Monitor, RadiForce MX242W EIZO CORPORATION Hiroaki Hashimoto
K143261 11/13/2014 2.3MP Color LCD Monitor, RadiForce MX242W EIZO CORPORATION Hiroaki Hashimoto
K134002 01/07/2014 6MP COLOR LCD MONITOR, RADIFORCE RX650 EIZO CORPORATION TOSHIMINE HIRAKI
K140178 01/24/2014 ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM ELLIPSE TECHNOLOGIES, INC. JOHN MCINTYRE
K140133 01/22/2014 INFUSET FLOW CONTROL EXTENSION SET EMED TECHNOLOGIES CORPORATION PETER KOLLINGS
K140131 01/28/2014 SUB-Q SUBCUTANEOUS TISSUE INFUSION SET EMED TECHNOLOGIES CORPORATION PETER KOLLINGS
K140107 01/15/2014 EMERGE MEDICAL DISTAL RADIUS SET EMERGE MEDICAL MEREDITH MAY
K140119 01/16/2014 EMERGE MEDICAL PERIARTICULAR AND LOCKING LARGE FRAGMENT SYSTEM EMERGE MEDICAL MEREDITH MAY MS, RAC
K140098 01/14/2014 EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM EMERGE MEDICAL MEREDITH MAY MS, RAC
K143365 11/24/2014 Eminent Foot Plate System Eminent Spine Dave Freehill
K140006 01/02/2014 ENDOSHIELD BURN PROTECTION SYSTEM ENCISION INC. MIKE BIGGS
K143242 11/12/2014 Rebel 3DKNEE System ENCORE MEDICAL, L.P. Teffany Hutto
K140130 01/17/2014 X-ALT HIGHLY CROSS LINKED ACETABULAR LINERS WITH VITAMIN E, NEUTRAL, 10 DEGREE HOODED, 20 DEGREE HOODED ENCORE MEDICAL, L.P. TEFFANY HUTTO
K140094 01/14/2014 SPRINGTMS TOTAL MIGRAINE SYSTEM ENEURA THERAPEUTICS, LLC LARRY GETLIN
K143186 11/05/2014 Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector ERBE USA, INC. JOHN TARTAL
K140063 01/13/2014 EQUINOXE EXTRA SHORT HUMERAL HEAD EXACTECH, INC. PATRICK HUGHES
K143402 11/28/2014 Extremity Medical Calcaneal Osteotomy Device EXTREMITY MEDICAL LLC Brian Smekal
K140113 01/15/2014 O2 NASAL CANNULA WITH CO2 MONITORING FLEXICARE MEDICAL LTD. CHRIS WATKINS
K133930 01/03/2014 FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SET FLOWER ORTHOPEDICS CORPORATION GARY BARNETT
K140211 01/28/2014 ULTRASONIC MESH NEBULIZER FOSHAN GAUNYING ELECTRONICS CO., LTD. GUENTER GINSBERG
K143228 11/10/2014 Ancora LLC Interbody Fusion Device FRONTIER MEDICAL DEVICES, INC. ERIC SEABORG
K140062 01/10/2014 FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER FSC LABORATORIES, INC. PAUL DRYDEN
K140149 01/22/2014 EPX-4440HD DIGITAL VIDEO PROCESSOR FUJIFILM MEDICAL SYSTEMS U.S.A., INC. MARY K MOORE
K140071 01/13/2014 HUMELOCK II CEMENTED SHOULDER SYSTEM FX SOLUTIONS JEAN-JACQUES MARTIN
K140028 01/06/2014 GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER GALT MEDICAL CORP. DAVID DERRICK
K143140 11/03/2014 G-Premio BOND GC AMERICA, INC. Dr. Mark Heiss
K143361 11/24/2014 Mammo Workstation GE HEALTHCARE Mounir Zaouali
K143251 11/12/2014 SIGNA Creator, SIGNA Explorer GE HEALTHCARE (GE MEDICAL SYSTEMS,LLC) GLEN SABIN
K143389 11/26/2014 3.0T GEM RT Open Array GE HEALTHCARE COILS (USA INSTRUMENTS INC.) Candice C Mandera
K143345 11/21/2014 SIGNA Pioneer GE HEALTHCARE JAPAN CORPORATION Toru Shimizu
K143270 11/13/2014 Optima XR646 GE HUALUN MEDICAL SYSTEMS CO. LTD Kenny Ma
K133882 01/22/2014 CARESCAPE CENTRAL STATION (FORMALLY KNOWN AS CIC PRO) GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. ROBERT CASARSA
K143368 11/25/2014 GenIQ GE MEDICAL SYSTEMS, LLC. Jenny Wong
K143156 11/03/2014 Sentinella 102; Sentinella 102 Horus GENERAL EQUIPMENT FOR MEDICAL IMAGING (ONCOVISION- Jose Montes
K143156 11/03/2014 Sentinella 102; Sentinella 102 Horus GENERAL EQUIPMENT FOR MEDICAL IMAGING (ONCOVISION- Jose Montes
K140041 01/08/2014 ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEM GENORAY CO., LTD. KAITLYNN MIN
K140086 01/14/2014 PERSONAL KINETIGRAPH (PKG) SYSTEM GKC MANUFACTURING PTY LTD. MARIE SCHROEDER
K143245 11/12/2014 GPC Intramedullary Nailing Systems GPC MEDICAL LIMITED Vikas Narang
K143312 11/18/2014 Portrait GBS Assay GREAT BASIN CORPORATION Chuck Owen
K140195 01/27/2014 SURGICAL DRAPE GRIFFITH-LUCAS LLC MIKE GU
K140089 01/14/2014 CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO) GUANGZHOU WONDFO BIOTECH CO., LTD. JOE SHIA
K143287 11/17/2014 Fluidshield* Surgical Mask with Expanded Chamber Halyard Health, Inc. Roberto F. Refeca
K143219 11/10/2014 NIRO-200NX Hamamatsu Photonics K.K. SUSUMU SUZUKI
K143183 11/05/2014 Maxima XTEND Handpiece Maintenance System HANDPIECE HEADQUARTERS Timothy Ropchan
K143227 11/10/2014 Magellan Robotic System, Magellan Robotic Catheter 10Fr HANSEN MEDICAL, INC. TODD MILHOLLAND
K143419 11/28/2014 Patient Examination Gloves HARTALEGA NGC SDN. BHD. Kuan Mun Leong
K133953 01/13/2014 LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M HARTALEGA SDN BHD NURUL AISYAH KONG BT ABDULLAH
K140050 01/09/2014 NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE HARTALEGA SDN BHD NURUL AISHYAH KONG
K143187 11/05/2014 Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card) Healgen Scientific LLC Jianqiu Fang
K143414 11/28/2014 Hill-Rom Wireless Connectivity Module HILL-ROM ANN WATERHOUSE
K140248 01/30/2014 S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2) HITACHI CHEMICAL DIAGNOSTICS, INC. ERIKA AMMIRATI
K140096 01/14/2014 HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE HMICRO, INC. KIM TOMPKINS
K140074 01/16/2014 HYGEDENT ALGINATE IMPRESSION MATERIAL HYGEDENT INC MIKE GU
K140129 01/23/2014 PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER ICU MEDICAL, INC. KRISTIN CASPER
K143339 11/20/2014 Mini me ILUMINAGE LTD.(FORMERLY SYNERON BEAUTY LTD.) BOBAE KIM
K143324 11/19/2014 IDS-iSYS CTX-I Calibration Verifiers IMMUNODIAGNOSTIC SYSTEMS LTD. ROMA YOUNG
K140216 01/28/2014 ORTHOPEDIC FIXATION SYSTEMS IMPACT MEDICAL, LLC EJ DUFFY
K143323 11/19/2014 OS2-V Varisation Staple IN2Bones SAS MORGANE GRENIER
K133932 01/06/2014 INION FREEDOMPIN INION OY KATI MARTTINEN
K140238 01/30/2014 EXCELLA III-D SPINAL DEFORMITY SYSTEM INNOVASIS, INC. MASHALL MCCARTY
K143213 11/10/2014 INOmax DSIR Plus MRI INO Therapeutics/Ikaria Robert Bovy
K140078 01/13/2014 TECOTHERM NEO (T NEO) INSPIRATION HEALTHCARE LTD WAYNE IDDON
K143301 11/17/2014 NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit Integrated Healing Technologies Ian Baird
K140198 01/29/2014 IMDX HSV-1/2 FOR ABBOTT M2000 INTELLIGENT MEDICAL DEVICES, INC. FRAN WHITE
K143217 11/10/2014 12 mm & Stapler Bladeless Obturators INTUITIVE SURGICAL, INC. Manish Patel
K140189 01/24/2014 ENDOWRIST VESSEL SEALER INTUITIVE SURGICAL, INC. NADINE NASR
K143154 11/03/2014 IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID) IRIDEX CORPORATION PAUL H HARDIMAN
K143241 11/12/2014 MDT Navigable Brain Biopsy Cannula IZI MEDICAL PRODUCTS LLC Qiang Cao
K143155 11/03/2014 LISTERINE Sensitivity Defense Mouthrinse Johnson & Johnson Healthcare Products, Division of McNeil-PP ANGELINA M. HUNT
K140214 01/28/2014 30.0 INCH COLOR LCD MONITOR CCL650I2 (CL30650, MD302C6) JVC KENWOOD CORPORATION TSUKASA TASHIRO
K143334 11/20/2014 Range/Denali/Mesa Spinal System K2M, INC NANCY GIEZEN
K143350 11/24/2014 Nile Alternative Fixation K2M, Inc. Nancy Giezen
K134043 01/14/2014 NO TOUCH+FOREHEAD NTF 3000 THERMOMETER KAZ USA, INC (A SUBSIDIARY OF KAZ INC) RAJ KASBEKAR
K143164 11/03/2014 ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set KIMBERLY-CLARK CORPORATION MARIA E WAGNER
K140072 01/13/2014 CRYOTOP(R) SC KITAZATO BIOPHARMA CO., LTD. RICHARD VINCINS
K140052 01/09/2014 J2I IMPLANT SYSTEM KJ MEDITECH CO., LTD. Priscilla Chung
K140051 01/09/2014 KJ EXTERNAL IMPLANT SYSTEM KJ MEDITECH CO., LTD. Priscilla Chung
K143177 11/04/2014 KleenGel Dispenser KleenGel, LLC Suzanne Mair
K143332 11/20/2014 Fast Sphyg by Koven KOVEN TECHNOLOGY, INC. HEATHER BELL
K143271 11/13/2014 CastleLoc-P Anterior Cervical Plate System L&K BIOMED Co., Ltd Ki-Hyang Kim
K143360 11/24/2014 LnK Cervical Interbody Fusion Cage System L&K BIOMED Co., Ltd Yerim An
K143279 11/14/2014 LnK Anterior Cervical Plate System L&K BIOMED Co., Ltd. Ki-Hyang Kim
K143278 11/14/2014 LnK Posterior Cervical Fixation System L&K BIOMED Co., Ltd. An Yerim
K143363 11/24/2014 VENUS Spinal Fixation System L&K BIOMED Co., Ltd. Ki-Hyang Kim
K140026 01/15/2014 COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST LACRIMEDICS, INC. REBECCA DUTTON
K143152 11/03/2014 TM-ABI system LD TECHNOLOGY LLC Albert Maarek
K140042 01/08/2014 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME LEMAITRE VASCULAR, INC. BRYAN COWELL
K140236 01/30/2014 AILERON INTERSPINOUS FIXATION SYSTEM LIFE SPINE, INC RANDY LEWIS
K143249 11/12/2014 SOLSTICE OCT System LIFE SPINE, INC Randy Lewis
K143277 11/14/2014 Cream Stretch Vinyl Patient Examination Glove (Non-Sterile),White Vinyl Patient Examination Glove (Non-Sterile), Lifestyle Safety Products (Hui Zhou) Co., Ltd. Lee Hong Chong
K143359 11/24/2014 CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector LifeWatch Technologies Ltd. Asher Kassel
K143256 11/13/2014 SMR Modular Glenoid Limacorporate S.P.A. Stephen J. Peoples
K143145 11/03/2014 SafeAir Smoke Pencil LiNA Medical ApS Anne Klitgard
K133958 01/13/2014 FLOW-I ANESTHESIA SYSTEM C20, C30 & C40 MAQUET CRITICAL CARE AB LIA LIEBGOLD
K140188 01/24/2014 MASIMO ROOT MONITORING SYSTEM MASIMO CORPORATION MARGUERITE THOMLINSON
K140027 01/06/2014 ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SYSTEM/PLANNER MATERIALISE N.V. OLIVER CLEMENS
K140222 01/29/2014 SAIPH KNEE SYSTEM MATORTHO MARCOS VELEZ-DURAN
K140167 01/23/2014 RENAISSANCE X SYSTEM MAZOR ROBOTICS LTD AHAVA STEIN
K143191 11/06/2014 IntelliSense Drill McGinley Innovations Joseph McGinley
K133914 01/08/2014 VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLE MEDCOM GMBH LUCA SALVATORE
K143238 11/12/2014 C3 Wave MEDCOMP (MEDICAL COMPONENTS) Courtney Nix
K143304 11/18/2014 Sickbay Clinical Platform Medical Informatics Corp Ralph Krog
K143257 11/13/2014 KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic System MEDICATECH USA George Makar
K143147 11/03/2014 Gemini Bonded Sterilization Wrap MEDLINE INDUSTRIES, INC. Matt Clausen
K143322 11/19/2014 Medline Natural Lubricating Liquid MEDLINE INDUSTRIES, INC. JENNIFER MASON
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K143297 11/17/2014 Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE) Zimmer Spine, Inc. Donna M. Semlak
K143165 11/03/2014 Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini Bone Screw Zimmer, Inc. Patrick McCullagh
K143321 11/19/2014 ITST Intertrochanteric/Subtrochanteric Fixation System ZIMMER, INC. PATRICK MCCULLAGH
K143331 11/20/2014 Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS ZIMMER, INC. Patrick McCullagh


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