FDA 510(k) Applications Received During November, 2014

FDA 510(k) Number Submission Date Device Name Applicant Contact
K143258 11/13/2014 PLIF STS, TLIF STS, OLIF STS (Spinal Truss System) 4WEB,INC. JESSEE HUNT
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
K143204 11/07/2014 AOS Clavicle Intramedullary Device ADVANCED ORTHOPAEDIC SOLUTIONS, INC. ANNA HWANG
K143397 11/26/2014 ICIS View Agfa HealthCare N.V. JODI COLEMAN
K143354 11/24/2014 Natrelle 133 Plus Tissue Expander ALLERGAN, INC. Bruce Krattenmaker
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
K143308 11/18/2014 GelPOINT Transvaginal Access Platform APPLIED MEDICAL RESOURCES Frans VandenBroek
K143139 11/03/2014 Arthrex Fracture System ARTHREX, INC. David Rogers
K143235 11/10/2014 RF20000a Controller, FLOW 50 Wand ARTHROCARE CORPORATION Ashley J Dawson
K143157 11/03/2014 Coronis Fusion 4MP LED BARCO NV LIEVEN DE WANDEL
K143150 11/03/2014 CO2 monitoring line with and without in-line filter BESMED HEALTH BUSINESS CORP. WINNIE CHUNG
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
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
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
K143292 11/17/2014 TheraCal DC Bisco Inc Michelle Schiltz-Taing
K143298 11/17/2014 Ultrasound Scanner System bk2300 BK MEDICAL APS RANDI HAUERBERG
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
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
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
K143199 11/06/2014 Capillus 272 Pro Capillus, LLC Frances Pina Brea
K143234 11/10/2014 MaxZero Administration Sets CAREFUSION LARRY WALKER
K143275 11/14/2014 IOLMaster700 Carl Zeiss Meditec, Inc. Christine Dunbar
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
K143302 11/17/2014 Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80 CEPHEID KERRY J FLOM
K143356 11/24/2014 NovoStitch Plus Meniscal Repair System Ceterix Orthopaedics, Inc. Michael Hendricksen
K143396 11/26/2014 omni TRAX Active Patient Tracker CIVCO Medical Instruments Co Inc dba CIVCO Medical Solutions Amanda Stahle
K143182 11/05/2014 Speedicath Compact Male COLOPLAST A/S Brian Schmidt
K143415 11/28/2014 Air Bubble Based Infuser (ABBI) CooperSurgical, Inc James Keller
K143412 11/28/2014 ADROIT Guiding Catheter CORDIS CORPORATION BABU PERIASAMY
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
K143317 11/19/2014 Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes) Currie Medical Specialties, Inc. Owen J. Bry
K143143 11/03/2014 PATHWAY ELIF CUSTOM SPINE, INC. Mahmoud Abdelgany
K143378 11/25/2014 AQUARIUS Gastrostomy Replacement Tube DEGANIA SILICONE LTD Zoya Lee
K143310 11/18/2014 MoisturemeterD DELFIN TECHNOLOGIES LTD. Theodore Sullivan
K143362 11/24/2014 extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister Devon Medical Products John Siegel
K143318 11/19/2014 DR Systems Zero Download 3D Viewer (Z3D) DR Systems, Inc Kimberly J Meade
K143290 11/17/2014 DBSWIN and VistaEasy Imaging Software Durr Dental AG Oliver Lange
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
K143365 11/24/2014 Eminent Foot Plate System Eminent Spine Dave Freehill
K143242 11/12/2014 Rebel 3DKNEE System ENCORE MEDICAL, L.P. Teffany Hutto
K143169 11/04/2014 MyGlucoHealth Wireless System ENTRA HEALTH SYSTEMS RICHARD STROBRIDGE
K143186 11/05/2014 Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector ERBE USA, INC. JOHN TARTAL
K143306 11/18/2014 ERBE WaterJet Model ERBEJET« 2 System with HybridAPC Probe ERBE USA, INC. JOHN TARTAL
K143402 11/28/2014 Extremity Medical Calcaneal Osteotomy Device EXTREMITY MEDICAL LLC Brian Smekal
K143228 11/10/2014 Ancora LLC Interbody Fusion Device FRONTIER MEDICAL DEVICES, INC. ERIC SEABORG
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
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
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
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
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
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
K143420 11/28/2014 SYMBIS Surgical System IMRIS, Inc. Sanjay Shah
K143323 11/19/2014 OS2-V Varisation Staple IN2Bones SAS MORGANE GRENIER
K143213 11/10/2014 INOmax DSIR Plus MRI INO Therapeutics/Ikaria Robert Bovy
K143301 11/17/2014 NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit Integrated Healing Technologies Ian Baird
K143217 11/10/2014 12 mm & Stapler Bladeless Obturators INTUITIVE SURGICAL, INC. Manish Patel
K143369 11/25/2014 MRidium 3860+ MRI infusion Pump/ Monitoring System IRADIMED CORPORATION FRANCIS X CASEY
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
K143142 11/03/2014 JDENTALCARE Implant System J DENTAL CARE S.r.l Giacomo Grandi
K143155 11/03/2014 LISTERINE Sensitivity Defense Mouthrinse Johnson & Johnson Healthcare Products, Division of McNeil-PP ANGELINA M. HUNT
K143334 11/20/2014 Range/Denali/Mesa Spinal System K2M, INC NANCY GIEZEN
K143350 11/24/2014 Nile Alternative Fixation K2M, Inc. Nancy Giezen
K143164 11/03/2014 ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set KIMBERLY-CLARK CORPORATION MARIA E WAGNER
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
K143152 11/03/2014 TM-ABI system LD TECHNOLOGY LLC Albert Maarek
DEN140033 11/10/2014 Companion LGCH, INC Mike Girouard
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
K143191 11/06/2014 IntelliSense Drill McGinley Innovations Joseph McGinley
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
K143175 11/04/2014 AEx Generator; PlasmaBlade T MEDTRONIC ADVANCED ENERGY Deep Pal
K143141 11/03/2014 CD HORIZON Spinal System MEDTRONIC SOFAMOR DANEK USA, INC Gregory Maschek
K143375 11/25/2014 CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments MEDTRONIC SOFAMOR DANEK USA, INC Becky Ronner
K143316 11/19/2014 Attain Hybrid Guide Wire Medtronic, Inc. Mia Hunt
K143203 11/07/2014 AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe, AveCure Microwave Medium Antenna-Probe, AveCure Microwave Small Antenna-Probe, AveCure Microwave Mini Antenna-Probe MEDWAVES INCORPORATED TED ORMSBY
K143232 11/10/2014 Universal Digital Interface 2W, UDI 2W MERIDIAN MEDICAL SYSTEMS, LLC Larry Cornell
K143255 11/13/2014 Prelude SNAP Splittable Sheath Introducer MERIT MEDICAL SYSTEMS, INC. Alina Stubbs
K143341 11/21/2014 Microlife Upper Arm Automatic Digital Blood Pressure Monitor MICROLIFE INTELLECTUAL PROPERTY GMBH GERHARD FRICK
K143366 11/24/2014 ADVANCE Porous Coated Spiked Tibial Base MicroPort Orthopedics Inc. Caroline Fryar
K143222 11/10/2014 FIREFLY Pedicle Screw Navigation Guide Mighty Oak Medical Inc Heidi Frey
K143348 11/21/2014 BC-3600 Auto Hematology Analyzer MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD Tan Chuanbin
K143233 11/10/2014 Mitsar-EEG MITSAR CO., LTD Semchenkov Ales
K143252 11/13/2014 Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches (orange) NEEDLETECH PRODUCTS, INC. Dennis Shay
K143344 11/21/2014 NeoMed NeoConnect Enteral Syringes with ENFit Connector NEOMED, INC. TONY LAIR
K143327 11/20/2014 Neoss Ti Reinforced Membrane Neoss Ltd Karin Darle Olsson
K143230 11/10/2014 Palladian Lumbar Pedicle Screw System Neurostructures, Inc. Moti Altarac
K143197 11/06/2014 Nice1 NICE RECOVERY SYSTEMS, LLC MICHAEL ROSS
K143351 11/24/2014 iCase Contact Lens Case Novabay Pharmaceuticals, Inc Charles Francavilla
K143229 11/10/2014 Nexis osteosynthesis compressive screws NOVASTEP Gilles Audic
K143146 11/03/2014 Nexis osteosynthesis snap-off screws NOVASTEP Gilles Audic
K143388 11/26/2014 Affix IIS Spinous Process Plate System NuVasive, Incorporated Olga Lewis
K143313 11/19/2014 NxStage Therapeutic Plasma Exchange (TPE) Cartridge NxStage Medical, Inc. Randall J Covill
K143153 11/03/2014 EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V OLYMPUS MEDICAL SYSTEMS CORP. Toshiyuki Nakajima
K143303 11/18/2014 Single Use Biliary Balloon Dilator OLYMPUS MEDICAL SYSTEMS CORP. Sheri Musgnung
K143338 11/20/2014 Argulated Locking Plates OSTEOMED L.P. Anita Zacherl
K143395 11/26/2014 Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit OTODYNAMICS, LTD. Julian Rutherford
K143244 11/12/2014 The Panthera Anti-Snoring Device Panthera Dental Inc. Guy Bernard Bantsiele
K143355 11/24/2014 The Simple Locking IntraMedullary (SLIM) System PEGA MEDICAL INC. Ariel R Dujovne
K143202 11/07/2014 ANGIO-PRESS DVT Compression Device Model Name: IPCS Pegasus Medical Supply, Inc. PAO-MING SHIH
K143218 11/10/2014 Penumbra Smart Coil Penumbra, Inc. Charles DeNault
K143180 11/04/2014 F3 PERMOBIL AB JAN ASTROM
K143253 11/13/2014 O-MAR PHILIPS MEDICAL SYSTEMS, NEDERLAND B.V. JAN VAN DE KERKHOF
K143349 11/24/2014 Gynomunal POLICHEM S.A. Daria Mari
K143248 11/12/2014 Reform Pedicle Screw System PRECISION SPINE, INC. MICHAEL C. DAWSON
K143383 11/25/2014 Q6 Edge EM Pride Mobility Product Corporation Kimberly Elmes
K143330 11/20/2014 BruxZir Anterior PRISMATIK DENTALCRAFT, INC. Armin Zehtabchi
K143353 11/24/2014 Hahn Tapered Implant System PRISMATIK DENTALCRAFT, INC. Brandon Shepard
K143206 11/07/2014 AmpliVue Bordetella Assay QUIDEL CORPORATION RONALD H. LOLLAR
K143329 11/20/2014 AmpliVue Trichomonas Assay QUIDEL CORPORATION RONALD H LOLLAR
K143307 11/18/2014 RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector RAYNER INTRAOCULAR LENSES LTD. Juliette Cook
K143272 11/14/2014 ApneaLink Air RESMED GERMANY INC. Sandra Grunwald
K143405 11/28/2014 Option (TM) ELITE Vena Cava Filter 100cm System REX MEDICAL, LP Erich Bressler
K143284 11/17/2014 Elecsys Estradiol III Calcheck ROCHE DIAGNOSTICS Kelli Turner
K143342 11/21/2014 Elecsys T-Uptake Calset Roche Diagnostics Kelli Turner
K143335 11/20/2014 Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC) Roosin Medical Devices Co., Ltd Chengyu Shen
K143418 11/28/2014 STRONG Dental Handpieces Saeshin Precision Co., Ltd. Choi Sae Kwan
K143411 11/28/2014 TRAUS ENDO SAESHIN PRECISION CO., LTD. Sae Kwan Choi
K143264 11/13/2014 H60 V2.00 Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD Kyeong-Mi Park
K143221 11/10/2014 Schoelly Laparoscope Schoelly Fiberoptic Gmbh Sandra Baumann
K143398 11/26/2014 Plato MICROCATH 27B Microcatheter SCIENTIA VASCULAR , LLC Sharon Rockwell
K143382 11/25/2014 DentiAnn Smart Sil SeilGlobal Co., Ltd. Pack Seong Uk
K143160 11/03/2014 FOXTROT NC PTCA Balloon Catheter SHANGHAI MICROPORT MEDICAL (GROUP) CO., LTD JINGWEN LI
K143268 11/13/2014 TENS AND POWERED MUSCLE STIMULATOR SHENZHEN AS-TEC TECHNOLOGY CO., LTD CONNIE LI
K143195 11/06/2014 Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1) Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd Yanhong Bai
K143196 11/06/2014 syngo.CT Lung CAD SIEMENS AG MEDICAL SOLUTIONS JAMES E KUHN JR.
K143376 11/25/2014 ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material SIEMENS HEALTHCARE DIAGNOSTICS, INC. FATIMA PACHECO
K143194 11/06/2014 ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve Material (MCM) SIEMENS HEALTHCARE DIAGNOSTICS, INC. FATIMA PACHECO
K143352 11/24/2014 IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material SIEMENS HEALTHCARE DIAGNOSTICS, INC. Sara Kastrup
K143373 11/25/2014 IMMULITE« 2000 Calcitonin Calibration Verification Material , IMMULITE« 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material SIEMENS HEALTHCARE DIAGNOSTICS, INC. DONNA VELASQUEZ
K143254 11/13/2014 eSie Apps Suite SIEMENS MEDICAL SOLUTIONS USA, INC. NANCY BURKE
K143409 11/28/2014 SOMATOM Definition AS Open (VA48) Siemens Medical Solutions USA, Inc. Eve Davis
K143400 11/28/2014 SOMATOM Definition AS/AS+ SIEMENS MEDICAL SOLUTIONS USA, INC. Kimberly Mangum
K143401 11/28/2014 SOMATOM Definition Edge SIEMENS MEDICAL SOLUTIONS USA, INC. KIMBERLY MANGUM
K143416 11/28/2014 SOMATOM Definition Flash (VA48) SIEMENS MEDICAL SOLUTIONS USA, INC. Eve Davis
K143319 11/19/2014 Syngo X-workplace SW VD10 Siemens Medical Solutions, Inc Patricia D. Jones
K143205 11/07/2014 Viscoelastic Injector Sight Sciences, Inc. Paul Badawl
K143184 11/05/2014 Evolve UniPolar Head Signature Orthopaedics Pty Ltd. Declan Brazil
K143172 11/04/2014 ACL SMART System SMITH & NEPHEW, INC. SAMIR IBRAHIM
K143226 11/10/2014 Visionaire Disposable Instruments SMITH & NEPHEW, INC. Shereen Bienz
K143386 11/26/2014 Progrip Laparoscopic Self-Fixating Mesh SOFRADIM PRODUCTION Eric Jague
K143214 11/10/2014 SCARLET« AC-T Secured Anterior Cervical Cage SPINEART Franck PENNESI
K143377 11/25/2014 PedFuse Pedicle Screw System SPINEFRONTIER, INC. Manthan J Damani
K143159 11/03/2014 Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip ?4.0mm, PediGuard Tri Tip ?3.2mm, PediGuard Tri Tip ?2.5mm, PediGuard ?2.5mm XS, PediGuard Curv, PediGuard Curv SpineGuard, S.A. Stephane Bette
K143403 11/28/2014 Threshold Pedicular Fixation System Spineology, Inc. Tim Crabtree
K143260 11/13/2014 Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider STERILMED, INC. NICOLE BOSER
K143333 11/20/2014 Revital-Ox RESERT Solution Test Strip STERIS Corporation Anthony Piotrkowski
K143173 11/04/2014 Stryker CMF MEDPOR Customized Implant Stryker Julie Schoell
K143320 11/19/2014 Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments STRYKER CORP. Brittney M. Larsen
K143399 11/28/2014 Stryker Footed Attachments and Cutting Accessories STRYKER CORP. VISHAL KANANI
K143163 11/03/2014 AVS« AL and ALign PEEK Spacers, AVS« PL and UniLIF PEEK Spacers, AVS« TL PEEK Spacer, AVS« Navigator PEEK Spacer, AVS« ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS« Anchor-L Spacer, Aero-AL Lumbar Cage System STRYKER CORPORATION GARRY T HAYECK
K143393 11/26/2014 Triathlon Tritanium Cone Augments STRYKER ORTHOPAEDICS Margaret Klippel
K143138 11/03/2014 AxSOS 3 Ti Locking Plate System Stryker Trauma AG ELIJAH N WREH
K143265 11/13/2014 Acrylic Block SUN MEDICAL CO., LTD. YUKIHITO YUKIMUNE
K143166 11/04/2014 Medline ReNewal Reprocessed Compression Limb Sleeves Surgical Instrument Service and Savings (dba Medline ReNewal Richard D. Wynkoop
K143404 11/28/2014 SurgiQuest AirSeal iFS System SURGIQUEST, INC. Daniel Donovan
K143209 11/10/2014 SonicFill 2 SYBRON DENTAL SPECIALTIES KERRI CASINO
K143198 11/06/2014 Synapse Transcutaneous Electrical Stimulation Device Synapse Electroceutical Limited JOHN GILDERSLEEVE
K143285 11/17/2014 Mandible External Fixator - MR Conditional Synthes USA Products, LLC Susan Lewandowski
K143326 11/20/2014 T.A.G. Dental Implant System T.A.G. MEDICAL PRODUCTS CORPORATION, LTD EREZ ADIV
K143185 11/05/2014 entr? Model PD08-U TACTILE SYSTEMS TECHNOLOGY INC DANIEL G CHASE
K143189 11/05/2014 t:flex Insulin Delivery System Tandem Diabetes Care, Inc. John Sheridan
K143299 11/17/2014 Percuvance(R) Percutaneous Surgical System Teleflex Medical, Inc. Holly Hallock
K143314 11/19/2014 Progressive Orthopaedic Total Hip System The Progressive Orthopaedic Company, LLC SCOTT KEISER
K143236 11/12/2014 Theranos Herpes Simplex Virus-1 IgG Assay THERANOS, INC. Brad Arington
K143288 11/17/2014 Sensititre Susceptibility plates THERMO FISHER SCIENTIFIC CYNTHIA KNAPP
K143381 11/25/2014 Sensititre Susceptibility Plates Thermo Fisher Scientific Cynthia Knapp
K143374 11/25/2014 BLUEPRINT Patient Specific Instrumentation TORNIER, SAS AYMEN AZAIEZ
K143294 11/17/2014 Adaptive Motion Correction (AMC), CSMC-001A and 4D Airways TOSHIBA MEDICAL SYSTEMS CORPORATION Paul Biggins
K143223 11/10/2014 CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT TOSHIBA MEDICAL SYSTEMS CORPORATION Paul Biggins
K143225 11/10/2014 INFX-8000V with Wireless Footswitch TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K143281 11/14/2014 Ultimax-i TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K143296 11/17/2014 AIA-PACK C-Peptide Control Set Tosoh BioScience, Inc. Robert L Wick
K143144 11/03/2014 ST AIA-PACK PROG II Calibrator Set Tosoh BioScience, Inc. Robert L Wick
K143407 11/28/2014 Klassic HD Hip System Total Joint Othopedics, Inc. Chris Weaber
K143311 11/18/2014 Pre-vacuum Tabletop Autoclave TUTTNAUER USA CO. LTD. Robert Basile
K143417 11/28/2014 ANAX 5.5 Spinal System U&I Corporation Young-Geun Kim
K143176 11/04/2014 UltraLinq ULTRALINQ HEALTHCARE SOLUTIONS, INC. Stephen Farber
K143224 11/10/2014 TrueBeam-TrueBeam STx-Edge Varian Medical Systems, Inc. Peter J. Coronado
K143211 11/10/2014 myVision Track Model 005 VITAL ART AND SCIENCE INCORPORATED Michael Bartlett
K143212 11/10/2014 Bifix Temp VOCO GMBH M. Th. Plaumann
K143328 11/20/2014 1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip Volcano AtheroMed, Inc. Jean Chang
K143179 11/04/2014 The LINK« Endo-Model« Knee System Waldemar Link GmbH & Co. KG Helmut D. Link
K143148 11/03/2014 Disposable Pressure Manometer (DPM) Westmed, Inc. DIANA UPP
K143220 11/10/2014 SIDEKICK EZ FRAME External Fixation System WRIGHT MEDICAL TECHNOLOGY, INC. Leslie Fitch
K143158 11/03/2014 Xenco Medical Lumbar Interbody System Xenco Medical, LLC Gustavo Prado
K143216 11/10/2014 Assurance Alar / Nasal SpO2 Sensor Xhale, Inc. Jeffrey Hoebelheinrich
K143413 11/28/2014 J+PRAS YOUNG'S Thread Y. Jacobs Medical, Inc. Joo Hwan Jeon
K143289 11/17/2014 NON-STERILE, POWER FREE NITRILE EXAMINATION GLOVES-ORANGE, GREEN, BLUE AND VIOLET COLOR YTY INDUSTRY (MANJUNG) SDN. BHD. Arivagalan Subramaniam
K143190 11/05/2014 Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens YUNG SHENG OPTICAL CO., LTD. WEN-HAN CHEN
K143200 11/06/2014 MIS Z-Pedicle Screw System Z-Medical GmbH & Co. KG ALEXANDER HENNINGER
K143346 11/21/2014 Powder-Free White Vinyl Patient Examination Gloves Zibo Changda Plastic Products Company, Limited Coco Kou
K143340 11/21/2014 Powder Free Vinyl Patient Examination Gloves, Yellow Color Zibo Ling Yun Medical Products Co, Ltd Eric Wang
K143347 11/21/2014 Powder-Free Yellow Vinyl Patient Examination Gloves Zibo Zhouheng Plastic Products Co. Ltd Cherry Xu
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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