FDA 510(k) Applications Received During August, 2014

FDA 510(k) Number Submission Date Device Name Applicant Contact
K142402 08/27/2014 BigEasy Non-Rebreathing Valve 12th Man Technologies, Inc. Alex Stenzler
K142112 08/04/2014 4WEB SPINAL IMPLANT PRODUCTS 4WEB, INC. RICH JANSEN
K142415 08/28/2014 Hi-Torque JET Guide Wire Family ABBOTT VASCULAR INC. JANET BENSON
K142391 08/27/2014 Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ) ACON LABORATORIES, INC. QIYI XIE
K142355 08/25/2014 Vaginal Tactile Imager Advanced Tactile Imaging, Inc. Vladimir Egorov
K142122 08/04/2014 RADAR VASCULAR COMPRESSION DEVICE ADVANCED VASCULAR DYNAMICS MATTHEW SEMLER
K142150 08/05/2014 AIS MODULIFT VBR SYSTEM AESCULAP IMPLANT SYSTEM, INC. LISA M BOYLE
K142315 08/19/2014 MINOP Disposable Introducer 26F AESCULAP, INC. KATHY RACOSKY
K142184 08/08/2014 DX-D IMAGING PACKAGE AGFA HEALTHCARE N.V. SHAEANN CAVANAGH
K142316 08/19/2014 IMPAX Agility AGFA HEALTHCARE N.V. Jodi Coleman
K142284 08/18/2014 CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE ALCON LABORATORIES, INC. ALICIA PLESNARSKI
K142347 08/22/2014 Amedica Valeo II Interbody Fusion Device Amedica Corp William D Jordan
K142264 08/15/2014 Valeo C Spacer System, Valeo II C IBF Device Amedica Corp. William D Jordan
K142333 08/21/2014 SMART LABEL, PROPOFOL AMERICAN I.V. PRODUCTS, INC dba AIV, INC SHANNON HOUCHEN
K142285 08/18/2014 AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz AmeriWater Brian R Bowman
K142256 08/14/2014 Applied BioPhotonics Phototherapy System ABPT1003 APPLIED BIOPHOTONICS LTD. ERIC HSIEH
K142427 08/29/2014 TISSUE CONTAINMENT SYSTEM; 10, 14, 17, 25 APPLIED MEDICAL RESOURCES AEREE LEE
K142336 08/21/2014 GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System ARKRAY FACTORY INC. Kazuya Yorimitsu
K142327 08/20/2014 smARTrack Feeding Tube System ART Healthcare Ltd. Liron Elia
K142413 08/28/2014 TITAN Modular Total Shoulder System Ascension Orthopedics Frederic Testa
K142124 08/04/2014 AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM ASEPTICO, INC. CHERIE TREGONING
K142120 08/04/2014 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP ATRICURE, INC. JONATHAN MCELWEE
K142203 08/11/2014 Atricure Cryo Module System; cryoICE cryoablation probe ATRICURE, INC. Jonathan McElwee
K142147 08/05/2014 EEVA SYSTEM AUXOGYN, INC. JULIA S ANASTAS
K142261 08/14/2014 Ultraverse 035 PTA Balloon Dilatation Catheter Bard Peripheral Vascular, Inc. Mario Thomas
K142425 08/29/2014 Uroflowmeter BE TECHNOLOGIES, INC. Edward Belotserkovsky
K142346 08/22/2014 Urine/CSF Albumin, Urine/CSF Albumin Calibrator Beckman Coulter Ireland Inc. Anne-Marie Shine
K142373 08/25/2014 Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. Syst BECKMAN COULTER, INC. Ryan Severson
K142362 08/25/2014 Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel Dxl Immuno. BECKMAN COULTER, INC. RYAN SEVERSON
K142170 08/07/2014 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTESM - TIGECYCLINE (0.313-4UG/ML) GP Becton, Dickinson and Company MONICA E GIGUERE
K142363 08/25/2014 NUSTAT, NUSTAT XR Beeken Biomedical Richard Kendall
K142340 08/21/2014 Infrared Therapy System Beijing Huatai Healthcare Technology Co., Ltd. Bingxian Zheng
K142219 08/12/2014 GammaBeam 100 Best Theratronics Limited Mike de van der Schueren
K142099 08/01/2014 CUTANEOUS ELECTRODES BIO PROTECH, INC. Terry Kim
K142332 08/20/2014 BT-400 Bio-Med USA Young Chi
K142204 08/11/2014 Bioceptive Suction Cervical Retractor Bioceptive Inc. Steward B. Davis, M.D.
K142174 08/07/2014 BIOMATE DENTAL IMPLANT SYSTEM BIOMATE MEDICAL DEVICES TECHNOLOGY CO., LTD. WAYNE CHEN
K142292 08/18/2014 Speed, Speed Shift, Speed Titan, Speed Arc BioMedical Enterprises, Inc. Joe Soward
K142097 08/01/2014 SELEC-3 I.V.ADMINISTRATION SET BIOMEDIX, INC. MYRA J BENDER
K142295 08/18/2014 Sirius Femoral Stem, Size 30A Biomet, Inc. Jason Dugger
K142432 08/29/2014 StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit BIONESS, INC. Robert Schulz, RAC
K142129 08/04/2014 RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR SET, RAPIDFRET ORAL FLUID COCAINE CONTROL SET BIOPHOR DIAGNOSTICS, INC. NATAHANIEL G BUTLIN
K142293 08/18/2014 Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls BIOPHOR DIAGNOSTICS, INC. Nathaniel G. Butlin
K142276 08/15/2014 MCS Bone Graft BIOSTRUCTURES, LLC John Brunelle, Ph.D.
K142379 08/26/2014 Passeo-35 PTA Catheter BIOTRONIK, INC. Jon Brumbaugh
K142337 08/21/2014 Blackford Analysis Registration Product Family BLACKFORD ANALYSIS LTD Gordon McNeilly
K142259 08/14/2014 Direxion Torqueable Microcatheter BOSTON SCIENTIFIC CORP. Mark Lanz
K142108 08/04/2014 RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSIS BRAINLAB AG ALEXANDER SCHWIERSCH
DEN140025 08/20/2014 BrainScope Ahead 100 BRAINSCOPE COMPANY, INC Michael E. Singer
K142267 08/15/2014 Sherlock 3CG Tip Positioning System Stylet C.R.Bard, Inc. Bryan Stone
K142372 08/25/2014 Pico Way Laser System CANDELA CORPATION Ruthie Amir
K142225 08/13/2014 Pilot Elite Diode Laser CAO Group, Inc. Robert K Larsen
K142223 08/13/2014 Pilot Pro Diode Laser CAO GROUP, INC. ROBERT K. LARSEN
K142226 08/13/2014 Pilot Ultra Diode Laser CAO GROUP, INC. ROBERT K. LARSEN
K142399 08/27/2014 DualCap IV Pole Strips(Disinfectant Caps for Male Luers) CATHETER CONNECTIONS, INC. Donald d Soloman
K142396 08/27/2014 Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests Chemtron Biotech, Inc. Jane Zhang
K142216 08/12/2014 Tranberg CLS Thermal Therapy System Clinical Laserthermia Systems AB Lars-Erik Eriksson
K142429 08/29/2014 CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector Cable Codman & Shurtleff, Inc Hannah Foley
K142193 08/11/2014 COGENT MED-LIF XL COGENT SPINE LLC JUDE PAGANELLI
K142325 08/20/2014 Veenstra Instruments VDC-506 Dose Calibrator Comecer Netherlands b.v. Gert Jan Klok
K142404 08/27/2014 iTotal Posterior Stabilized (PS) Knee Replacement System ConforMIS Inc. Amita Shah
K142161 08/06/2014 ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM CONFORMIS, INC. AMITA SHAH
K142134 08/04/2014 C-WIRE DOUBLE ENDED ORTHOPEDIC WIRES CONMED CORPORATION, LARGO JOY LOVETT
K142357 08/25/2014 DuraSheath Introducer Sheath System CONTRACT MEDICAL INTERNATIONAL GMBH JAN KLOBOUCNIK
K142301 08/18/2014 Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath COOK VASCULAR, INC. Thomas J. Kardos
K142094 08/01/2014 COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM COPAN ITALIA S.P.A. TINA WU
K142294 08/18/2014 FlexiMarc Marker CORTEX MANUFACTURING, INC. Andrew Jones
K142128 08/04/2014 KANGAROO ENTERAL FEEDING SYRINGES WITH ENFIT CONNECTOR COVIDIEN SHANNON GREEN
K142335 08/21/2014 RapidVac Smoke Evacuator System COVIDIEN JOSE MARQUEZ
K142296 08/18/2014 Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula Covidien Danielle Mueller
K142298 08/18/2014 Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff Covidien Kelsey Lee
K142364 08/25/2014 Barrx RFA Self Sizing Balloon Catheter Covidien llc Rachel Silva
K142198 08/11/2014 BNX Fine Needle Aspiration System Covidien LLC Saket Bhatt
K142428 08/29/2014 Shock Pulse-SE Lithotripsy System CYBERWAND II CYBERSONICS, INC. Jeff Vaitekunas
K142376 08/26/2014 Palomar Icon Aesthetic System CYNOSURE, INC. Allyson Connor
K142329 08/20/2014 BBS REVOLUTION dBMEDx INC. DAVE SHINE
K142106 08/01/2014 DECISIO HEALTH PATIENT DASHBOARD DECISIO HEALTH, INC. RONALD S WARREN
K142313 08/19/2014 OneQ-SL Implant System DENTIS CO. LTD. Jeong Seop Keun
K142178 08/08/2014 PROROOT MTA WHITE, PROROOT MTA GRAY DENTSPLY INTERNATIONAL INC. HELEN LEWIS
K142185 08/08/2014 EXPEDIUM VERSE SPINE SYSTEM DEPUY SPINE, INC. CATHERINE KILSHAW
K142168 08/06/2014 NATURE'S BOND 600 AND NATURE'S BOND 603 DEVON MEDICAL PRODUCTS, INC. Ruth Wu
K142132 08/04/2014 POOL NORM Diagnostics Stago S.A.S. MARIE COMPAGNON-RIOBE
K142228 08/13/2014 Heated Eye Pad Digital Heat Corporation John Devine
K142229 08/13/2014 Laparoscopic FMsealer DOMAIN SURGICAL, INC. CURTIS JENSEN
K142426 08/29/2014 EBI External Implant System EBI Inc Mi Sook Kim
K142107 08/01/2014 ECHO TRUE 3D VIEWER ECHO PIXEL INC. SERGIO AGUIRRE
K142173 08/07/2014 NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE ECOLAB, INC. JENNIFER WILLNER
K142199 08/11/2014 Ascendra Balloon Aortic Valvaloplasty Catheter EDWARDS LIFESCIENCES Susan Reynolds
K142398 08/27/2014 Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow Ellex Medical Pty. Ltd. KEVIN HOWARD
K142410 08/28/2014 Elliquence Electrodes ELLIQUENCE LLC Paul D Buhrke
K142319 08/20/2014 SCIg60 Infuser, Infuset EMED TECHNOLOGIES CORPORATION PETER KOLLINGS
K142194 08/11/2014 CytoSure Urinary Access System Emmy Medical Christine G Santagate
K142155 08/06/2014 ENDOCHOICE WATER BOTTLE CAP SYSTEM ENDOCHOICE, INC. DANIEL HOEFER
K142113 08/04/2014 ESOPHYX2 HD ENDOGASTRIC SOLUTIONS, INC. MICHAEL A DANIEL
K142252 08/14/2014 XprESS Multi-Sinus Dilation Tool ENTELLUS MEDICAL, INC. Karen E. Peterson
K142245 08/13/2014 EpiAccess System EpieP, Inc. Pamela Bunes
K142207 08/11/2014 TransferMan 4m Micromanipulator EPPENDORF AG CORNELIA HILDEBRANDT
K142421 08/28/2014 G-scan Brio ESAOTE, S.P.A. Donatella Ragghianti
K142306 08/19/2014 Flower Upper Extremity Plating Set Flower Orthopedics Corporation Gary Barnett
K142365 08/25/2014 Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack FOCUS DIAGNOSTICS Sharon Young
K142160 08/06/2014 LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM GE HEALTHCARE BRYAN BEHN
K142288 08/18/2014 MAC 800 Resting ECG Analysis System GE MEDICAL SYSTEMS CHINA CO., LTD. Sun YanLi
K142323 08/20/2014 Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System GE MEDICAL SYSTEMS ISRAEL LTD. Bryan Behn
K142361 08/25/2014 Discovery MR750 3.0T GE MEDICAL SYSTEMS, LLC Jenny Wong
K142383 08/26/2014 Optima XR200amx, Optima XR220amx GE Medical Systems, LLC Chris Paulik
K142098 08/01/2014 SIGNA PET/MR GE MEDICAL SYSTEMS, LLC ROBIN MARTIN
K142291 08/18/2014 GMX Series Medical Air/Oxygen Blender GENTEC (SHANGHAI) CORPORATION Dongjian Lin
K142218 08/12/2014 Coalition AGX Plate and Coalition AGX Spacer GLOBUS MEDICAL INC. Kelly Baker
K142409 08/27/2014 Vinyl Co-Polymer Powder Free Examination Gloves GRAND WORK PLASTIC PRODUCTS CO., LTD. DENG ZHANYONG
K142088 08/01/2014 DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR SWBPM22 SERIES GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED PATRICK CHOW
K142369 08/25/2014 Urinary Incontinence System GUANGZHOU FINECURE MEDICAL EQUIPMENT CO., LTD Chiping Ma
K142164 08/06/2014 MANIPULATOR; MANIPULATOR PRO GYNETECH PTY. LTD. KEVIN MACDONALD
K142350 08/22/2014 PK J-HOOK GYRUS ACMI INC. NEIL KELLY
K142289 08/18/2014 PK Spatula Gyrus ACMI Inc. Neil Kelly
K142154 08/06/2014 PK NEEDLE GYRUS ACMI, INC. NEIL KELLY
K142423 08/28/2014 EyeSuite Imaging HAAG-STREIT AG Oscar Banz
K142270 08/15/2014 LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200 MICROGRAM OR LESS PER GRAM OF GLOVE HARTALEGA SDB. BHD. KUAN KAM HON
K142280 08/15/2014 Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card) HEALGEN SCIENTIFIC LLC Jianqiu Fang
K142348 08/22/2014 OsteoSeal Bone Hemostat HEMOSTASIS, LLC Bernard Horwath
K142157 08/06/2014 PALACOS R+G PRO HERAEUS MEDICAL GMBH ASTRID MARX
K142368 08/25/2014 NOBLUS DIAGNOSTIC ULTRASOUND SCANNER HITACHI ALOKA MEDICAL, LTD. ANGELA VAN ARSDALE
K142433 08/29/2014 Hospira Extension Set Hospira, Inc. David Blonski
K142367 08/25/2014 Hospira Primary Sets HOSPIRA, INC. CATHERINE KANG
K142300 08/18/2014 Arrow GPSCath Balloon Dialation Catheter (150 cm) HOTSPUR TECHNOLOGIES, INC., ERICK ANKERUD
K142418 08/28/2014 I.T.S. Hand Locking Plates System - HLS I.T.S. GmbH Al Lippincott
K142135 08/04/2014 REDUCE FRACTURE PLATING SYSTEM LINE EXTENSION ICON ORTHOPEDIC CONCEPTS, LLC DBA EDGE ORTHOPAEDIC JAN TRIANI
K142351 08/22/2014 25-Hydroxy Vitamin Ds EIA IMMUNODIAGNOSTIC SYSTEMS LTD. Mick Henderson
K142244 08/13/2014 CLEO PATIENT MONITOR INFINIUM MEDICAL SULEYMAN BILGUTAY
K142192 08/11/2014 Insightra Freedom Ventral Hernia Repair System Insightra Medical Neerav Parikh
K142238 08/13/2014 MAYFIELD Skull Clamp INTEGRA LIFESCIENCES CORPORATION Brian Hoy
K142414 08/28/2014 Miltex N-Tralig Intraligamentary Syringe INTEGRA LIFESCIENCES CORPORATION Judith E. O'Grady
K142389 08/27/2014 Variolink Esthetic IVOCLAR VIVADENT AG SANDRA CAKEBREAD
K142374 08/26/2014 ivWatch Model 400 ivWatch, LLC Javier Garriz
K142344 08/22/2014 DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System IZI MEDICAL PRODUCTS LLC QIANG CAO
K142360 08/25/2014 Everest Spinal System K2M, Inc Nancy Giezen
K142212 08/12/2014 Pyrenees Cervical Plate System K2M, Inc Nancy Giezen
K142179 08/08/2014 D-KAT Z-YPE KEELER LTD. EUGENE R VAN ARSDALE
K142330 08/20/2014 Kobold Ring and Tandem Applicator Set KOBOLD, LLC Spencer Fillmore
K142197 08/11/2014 ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX PROBE C5-2 KONICA MINOLTA INC. SHIGEYUKI KOJIMA
K142393 08/27/2014 PREDICATE III GUIDEWIRE LAKE REGION MEDICAL MATHEW PEXA
K142397 08/27/2014 Predicate III Guidewire Lake Region Medical Mathew Pexa
K142246 08/14/2014 LightStim for Acne/ LightStim for Acne Mini LED INTELLECTUAL PROPERTIES, LLC Steve Marchese
K142359 08/25/2014 Vasc Band hemostat Lepu Medical Technology (Beijing) Co., LTD Kim Xiangdan
K142253 08/14/2014 SOLSTICE OCT System LIFE SPINE, INC Randy Lewis
K142326 08/20/2014 HP Tissue Matrix LifeCell Corporation Mira Leiwant
K142172 08/07/2014 LIGHTMED TRUSCAN 577 LIGHTMED CORP. ANGEL HSIEH
K142139 08/05/2014 SMR 40MM GLENOSPHERE LIMACORPORATE S.P.A. STEPHEN PEOPLES
K142386 08/27/2014 Operating Room Light Handle Adapter Litex Manufacturing, Inc. Noel Gharibian
K142215 08/12/2014 Power Twin21-50/Power Twin21-100 LIVETEC GMBH Klaus Reichebach
K142420 08/28/2014 Patient Positioning Devices MACROMEDICS BV C de Keijzer
K142394 08/27/2014 Masimo Root Monitoring System and Accesories MASIMO CORPORATION MARGUERITE THOMLINSON
K142125 08/04/2014 New Medax Biopsy Systems MEDAX SRL UNIPERSONALE Stefano Cavalieri
K142167 08/06/2014 MEDENTIKA ABUTMENT SYSTEM MEDENTIKA GMBH LINDA SCHULZ
K142258 08/14/2014 PolyCatch Retrieval Device Medi-Globe Corporation Scott Karler
K142303 08/18/2014 NeumoFilt Ergo/Neumo Filt BiteOn Medical Respiratory Devices S.L. Jose Alberto Hernandez
K142163 08/06/2014 MALE CIRCUMCISION KITS:RAPIDECLAMP MEDICFIT TECHNOLOGY SDN BHD JIGAR SHAH
K142345 08/22/2014 Talos-C(HA) Cervical Intervertebral Body Fusion Devices MEDITECH SPINE, LLC JASON GROMEK
K142096 08/01/2014 T-PIECE RESUSCITATOR MERCURY MEDICAL PAUL DRYDEN
K142265 08/15/2014 ONE Snare Endovascular Microsnare System MERIT MEDICAL SYSTEMS, INC. Mark Mullaney
K142162 08/06/2014 MERITS TRANSFORMER POWER SCOOTER, S941 MERITS HEALTH PRODUCTS CO., LTD. VINCENT CHEN
K142119 08/04/2014 PROCOTYL L-O ACETABULAR SYSTEM MICROPORT ORTHOPEDICS INC. BYRON LEDBETTER
K142105 08/01/2014 ELI 380 ELECTROCARDIOGRAPH MORTARA INSTRUMENT, INC AMY YANG
K142342 08/21/2014 NacrousPowder Free Vinyl Patient Examination Gloves, Clear (non-colored) Nacrous Plastic Co., Ltd WANG LI
K142104 08/01/2014 NANOFUSE DBM NANOTHERAPEUTICS, INC. DORIS SNOW
K142275 08/15/2014 Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens NEO VISION CO., LTD. Kyung Hwa Kim
K142419 08/28/2014 Mini and Micro Fragments Reconstruction System-NEOFIX NEOORTHO PRODUCTOS ORTHOPEDICOS S/A Mariana de Oliveira Quinzani
K142388 08/27/2014 Neo Total Knee System New Era Orthopedics, LLC Craig Corrance
K142286 08/18/2014 NS3000 Holmium Laser System New Star Lasers, Inc. Natalie Vollrath
K142260 08/14/2014 NobelActive NOBEL BIOCARE AB PHUONG NGUYEN SON
K142424 08/29/2014 DR300 HOLTER MONITOR NORTH EAST MONITORING INC. SHERRY STEELE
K142220 08/12/2014 Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators) NOVA BIOMEDICAL CORPORATION Paul W. MacDonald
K142111 08/04/2014 ARCAD COMPRESSIVE OSTEOSYNTHESIS STAPLE, EXPRESS COMPRESSIVE OSTEOSYNTHESIS STAPLE NOVATSEP GILLES AUDIC
K142439 08/29/2014 Martinez Prostate Template Set Nucletron BV Rudolf Vos
K142205 08/11/2014 NuVasive X-CORE(R) Expandable VBR System NUVASIVE, INC. OLGA LEWIS
K142299 08/18/2014 CoRoent Small Interlock System NUVASIVE, INCORPORATED Cynthia Adams
K142328 08/20/2014 nvc NVISION BIOMEDICAL TECHNOLOGIES, LLC BRIAN KIESER
K142201 08/11/2014 OMNI Interface Acetabular System OMNLIFE SCIENCE Vani Sindwani
K142209 08/11/2014 Pulse oximeter NBM-200 ORSENSE LTD Aharon Weinstein
K142146 08/05/2014 IBIS PEDICLE SCREW SYSTEM ORTHO DEVELOPMENT CORP. MIKE ENSIGN
K142339 08/21/2014 HEMASORB Resorbable Hemostatic Bone Putty ORTHOCON, LLC Howard L Schrayer
K142152 08/06/2014 CONSTRUX MINI PEEK; SPACER SYSTEM, TI SPACER SYSTEM, CERVICAL STAND ALONE SYSTEM ORTHOFIX, INC. NATALIA VOLOSEN
K142148 08/05/2014 ORTHOHELIX STAPLE SYSTEM ORTHOHELIX SURGICAL DESIGNS, INC. BRIAN HOCKETT
K142141 08/05/2014 STARBAND, STARLIGHT ORTHOMERICA PRODUCTS, INC. DAVID L.HOOPER
K142090 08/01/2014 REBOSSIS ORTHOREBIRTH CO., LTD. KEVIN A.THOMAS
K142358 08/25/2014 Osstell IDx OSSTELL AB KARIN BREDING
K142321 08/19/2014 Benchmark Intracranial Access System PENUMBRA, INC. Michaela Mahl
K142273 08/15/2014 EmboGuide PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Liselotte Kornmann
K142126 08/04/2014 EP NAVIGATOR REL. 5.0 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. LISELOTTE KORNMANN
K142430 08/29/2014 LIFEPAK 15 monitor/defibrillator PHYSIO-CONTROL, INC. Sylvia Lemke
K142438 08/29/2014 Nerve Monitoring Cable System Pioneer Surgical Technology, Inc. (RTI Surgical, Inc.) Sarah McIntyre
K142408 08/28/2014 FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) POLYMED THERAPEUTICS, INC FRANK LUO
K142302 08/18/2014 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
K142282 08/15/2014 HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS) PRECEPTIS MEDICAL KEITH LELAND
K142378 08/26/2014 Interspinous Plate System Precision Spine, Inc. Michael C. Dawson
K142118 08/04/2014 INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: STRAUMANN BONE LEVEL, NOBEL BIOCARE BRANAE PRISMATIK DENTALCRAFT, INC. BRANDON SHEPARD
K142115 08/04/2014 INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT PRISMATIK DENTALCRAFT, INC. BRANDON SHEPARD
K142190 08/08/2014 Polychloroprene Powder-free Surgical Glove (White) Tested for Use with Chemotherapy Drugs; Polychloroprene Powder-free Surgical Glove (Green) Tested for Use with Chemotherapy Drugs PT MEDISAFE TECHNOLOGIES Anil Taneja
K142366 08/25/2014 Puritan OptiTranz Liquid Stuart Collection and Transport System PURITAN MEDICAL PRODUCTS LLC Mehdi Karamchi
K142222 08/13/2014 NewTom 5G QR S.r.l. Lorenzo Bortolotti
K142384 08/26/2014 DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) QUALIMED SRL Tereza Uhrova
K142262 08/14/2014 AUTION CHECK PLUS QUANTIMETRIX CORP. KALYNA SNYLYK
K142181 08/08/2014 RANDOX ALDOLASE CALIBRATION SERUM RANDOX LABORATORIES LIMITED PAULINE ARMSTRONG
K142123 08/04/2014 REACH ACCESS TELEMEDICINE DOSE CALCULATOR REACH HEALTH, INC. BETH DESTASIO
K142304 08/18/2014 Viberect Penile Vibratory Stimulation Device REFLEXONIC, LLC Kambiz Tajkarimi
K142269 08/15/2014 Reliance Cervical IBF System Reliance Medical Systems, LLC Bret M Berry
K142217 08/12/2014 Reliance Interspinous Plate System Reliance Medical Systems, LLC Jeremy Alsup
K142095 08/01/2014 RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM Renovis Surgical Technologies, Inc. Sharyn Orton
K142211 08/12/2014 OT EQUATOR Rhein '83 SRL Claudia Nardi
K142127 08/04/2014 ELECSYS ESTRADIOL III CALCHECK 5 Roche Diagnostics KELLI TURNER
K142133 08/04/2014 ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM Roche Diagnostics Sarah Baumann
K142089 08/01/2014 ACCU-CHEK AVIVA EXPERT SYSTEM ROCHE DIAGNOSTICS CORPORATION Greg Mondics
K142422 08/28/2014 cobas Cdiff Test ROCHE MOLECULAR SYSTEMS, INC. Wilk von Gustedt
K142159 08/06/2014 DISPOSABLE PRE-GELLED SURFACE ELECTRODE ROCHESTER ELECTRO MEDICAL, INC. WAYNE GLOVER
K142352 08/22/2014 CardiacLinx Ross Medical Technology, Inc ALEXANDER CHIU
K142243 08/13/2014 LessRay with Tracking SAFERAY SPINE, LLC Michael Alrutz
K142416 08/28/2014 Luma Wrap Salter Labs Aurelia Browndridge
K142249 08/14/2014 SCHOELLY SINUSCOPE SCHOELLY FIBEROPTIC GMBH SANDRA BAUMANN
K142180 08/08/2014 TELESENSE SCOTTCARE CORPORATION SNEHRAJ MERCHANT
K142156 08/06/2014 SEEGENE ANYPLEX II HSV-1/2 ASSAY SEEGENE FRAN WHITE
K142241 08/13/2014 LARIAT sulture Delivery Device SENTREHEART INC. Kit Cariquitan
K142263 08/14/2014 Applanation Tonometer SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO. LTD. Weida Zhan
K142186 08/08/2014 DIODE LASER HAIR REMOVAL SYSTEM SHENZHEN GSD TECH. CO., LTD. Diana Hong
K142341 08/21/2014 X-RAY TV SYSTEM SONIALVISION G4 SHIMADZU CORP. TOSHIO KADOWAKI
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K142395 08/27/2014 SC2000 and ACUSON X300 Diagnostic Ultrasound Systems SIEMENS MEDICAL SOLUTIONS USA, INC. Shelly Pearce
K142436 08/29/2014 3S Safety Insulin Syringe Sincere Medical Device Co., Ltd. Garfield Wang
K142435 08/29/2014 3S Safety Syringe with/without Needle Sincere Medical Device Co., Ltd. Garfield Wang
K142091 08/01/2014 PARIETENE MACROPOROUS MESH SOFRADIM PRODUCTION JENNIFER BRENNAN
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K142221 08/12/2014 MEMO 3D ReChord SORIN GROUP ITALIA S.R.L MAURO ERCOLANI
K142116 08/04/2014 LLD EZ SPECTRANETICS, INC. PHAROAH GARMA
K142101 08/01/2014 ABACUS (TM) SPACER SYSTEM SPINE WAVE, INC. ROAIDA JOHNSON
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K142213 08/12/2014 VIA SPINOUS PROCESS FIXATION SYSTEM SPINEOLOGY, INC. TIM CRABTREE
K142272 08/15/2014 SNaP Wound Care System SPIRACUR, INC. Lawrence Hu
K142235 08/13/2014 CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter St. Jude Medical ZACHARY PRICE
K142239 08/13/2014 CPS Direct MediGuide Enabled outer catheter St. Jude Medical Geena George
K142254 08/14/2014 CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel MediGuide Guidewire Connector St. Jude Medical Geena George
K142130 08/04/2014 ORAL BOND STEINER LABORATORIES GREGORY G STEINER
K142109 08/04/2014 STERILUCENT STERILIZATION CONTAINER SYSTEM STERILUCENT, INC PETER KALKBRENNER
K142407 08/28/2014 Straight Stud Attachment Sterngold Dental, LLC Maria Rao
K142381 08/26/2014 Xia 3 Spinal System STRYKER CORP. GARRY T HAYECK
K142237 08/13/2014 Aviator Anterior Cervical Plate (ACP) System Stryker Corporation Soraya King
K142251 08/14/2014 AVS AS PEEK Spacer Stryker Corporation Garry T Hayeck
K142114 08/04/2014 XIA 4.5 SPINAL SYSTEM STRYKER CORPORATION GARRY T HAYECK, PH.D.
K142310 08/19/2014 Stryker Infrared Fluorescence (IRF) Imaging System Stryker Endoscopy Golnaz Moeini
K142142 08/05/2014 QUALITY REPORTS SUN NUCLEAR CORPORATION JAMES LUKER
K142431 08/29/2014 WaterProof PROFILER SUN NUCLEAR CORPORATION NOEL DOWNEY
K142100 08/01/2014 AIXPLORER SUPERSONIC IMAGINE AURELIE GRUENER
K142290 08/18/2014 KangLi pedical screw spinal system SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO., LTD Jin Hua Huang
K142242 08/13/2014 PREMIUM, SHELTA Implant Systems SWEDEN & MARTINA S.P.A. GLORIANNA ZANGIACOMI
K142309 08/19/2014 GEM Flow COUPLER Device and System Synovis Life Technologies, Inc. Troy Thome
K142371 08/25/2014 Luminesse PMMA TALLADIUM, INC. Elina Faskhutdinova
K142343 08/21/2014 Hongyun Powder-Free Vinyl Patient Examination Gloves, Clear( Non-colored) TANGSHAN HONGYUN PLASTIC PRODUCTS CO., LTD RJ WANG
K142103 08/01/2014 CUFF PILOT, SURE SEAL Teleflex Medical, Inc. PAUL DRYDEN
K142153 08/06/2014 HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML Teleflex Medical, Inc. JAMES A COCHIE
K142138 08/05/2014 ISO-GARD MASK Teleflex Medical, Inc. BRIAN GALL
K142349 08/22/2014 TM eCloud ECG Analysis System Telemed Solutions, Inc. Ken Burns
K142183 08/08/2014 GLIDESHEATH SLENDER Terumo Medical Corporation Erin Doyle
K142151 08/06/2014 SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES Thermo Fisher Scientific Cynthia Knapp
K142338 08/21/2014 Sensititre HP MIC Susceptibility Plate with Tedizolid (0.002-4 mcg/ml) THERMO FISHER SCIENTIFIC CYNTHIA KNAPP
K142417 08/28/2014 SP-1PSpecular Microscope TOPCON CORPORATION Michael Gusel
K142182 08/08/2014 FRIMAP ADAPTER CONNECTOR (MAC) TOPERA, INC. DENNIS POZZO
K142208 08/11/2014 Monopolar Laparascopic Accessories UNIMICRO MEDICAL SYSTEMS (SHENZHEN) CO., LTD. Weizhong Chen
K142248 08/14/2014 Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy Return Electrode, Prostiva RF Therapy Tubing System, Prostiva RF Therapy Telescope Urologix, Inc. Georgiann Keyport
K142230 08/13/2014 Apollo Suture Anchor System and Titan Screws Valeris Medical Daniel Lanois
K142268 08/15/2014 Varian Verification System (VVS) VARIAN MEDICAL SYSTEMS, INC. Peter J. Coronado
K142136 08/04/2014 ACCUCATH MIDLINE CATHETER SYSTEM VASCULAR PATHWAYS, INC. SCOTT PEASE
K142377 08/26/2014 The OnControl Bone Marrow Biopsy System by Vidacare VIDACARE LLC DIANA MONTEZ
K142093 08/01/2014 V20 SYSTEM VIORA LTD. OMRI KESLER
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K142236 08/13/2014 BioniCare Hand System VISION QUEST INDUSTRIES, INC. MOHAMED OUERGHI
K142353 08/21/2014 First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test W.H.P.M., Inc. John Wan
K142187 08/08/2014 LINK MP RECONSTRUCTION PROSTHESIS WALDEMAR LINK GMBH & CO. KG THOMAS MEHLER
K142356 08/25/2014 Connex Spot Monitor,901058 Vital Signs Monitor Core WELCH ALLYN, INC. Kevin Crossen
K142149 08/05/2014 OXYTOTE INFINITY SERIES VIPR SYSTEMS WESTERN/SCOTT FETZER CO. DAVID C SIMO
K142233 08/13/2014 zenostar MO, Zenostar T, Zenostar VisualiZr WIELAND DENTAL + TECHNIK GMBH & CO. KG Betina Kistner
K142144 08/05/2014 DISPOSABLE INJECTION NEEDLE WILSON INSTRUMENTS (SHANGHAI) COMPANY LIMITED LIJUAN ZHANG
K142385 08/27/2014 Whisper Pump System Wound RX Medical, LLC Richard Deslauriers
K142117 08/04/2014 INVISION TOTAL ANKLE REVISION SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. VAL MYLES
K142121 08/04/2014 VALOR HINDFOOT FUSION NAIL SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. JEANINE REDDEN
K142297 08/18/2014 Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vive 3S Medication Extension Set XERIDIEM (FORMERLY MRI) Jesus Valencia
K142283 08/15/2014 Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White Color) YTY INDUSTRY (MANJUNG) SDN. BHD. Arivalagan Subramaniam
K142392 08/27/2014 Zavation Posterior LEIF ZAVATION, LLC LAWERENCE WALKER
K142271 08/15/2014 Zavation Z-Link Lumbar Zavation, LLC Lawrence Walker
K142206 08/11/2014 Dental Unit Zhuhai Siger Medical Equipment Co., Ltd Huisheng Wang
K142403 08/27/2014 Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System ZIMMER GMBH Roberto Tommasini
K142281 08/15/2014 ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEM ZIMMER, INC. PATRICK MCCULLAGH


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