FDA 510(k) Decisions During May, 2015  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K150547 05/15/2015 .decimal Astroid Dosimetry App .decimal, inc KEVIN ERHART
K143434 05/06/2015 One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series ABBOTT MEDICAL OPTICS INC Nooshin Azizi
K150453 05/20/2015 TULA Iontophoresis System with Earset ACCLARENT, INC. PAVAN SETHI
K142543 05/11/2015 Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control ACON LABORATORIES, INC. Qiyi Xie
K150069 05/22/2015 Fine Structure Analysis(fineSA) Acuitas Medical Ltd. John Heinrich
K150544 05/29/2015 Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System AESCULAP IMPLANT SYSTEMS, LLC Julie Tom Wing
K143060 05/21/2015 Intelli-Ox AIR LIQUIDE HEALTHCARE ANGIE BEYER
K151097 05/15/2015 Active Breathing Coordinator AKTINA MEDICAL CORPORATION TONY SPACCAROTELLA
K143740 05/22/2015 Battalion Universal Spacer System ALPHATEC SPINE, INC. Nadine Smith
K143750 05/07/2015 MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System APEX BIO TECHNOLOGY CORP Hsue-Mei Lee
K142971 05/26/2015 AMT Bridle - Nasal Tube Retention System Applied Medical Technology, Inc. Joshua Meinke
K151078 05/15/2015 Arthrex RetroFusion Screw ARTHREX, INC. DAVID L ROGERS
K150129 05/28/2015 AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION) Aseptico, Inc. Cherie Tregoning
K150138 05/08/2015 Aspen Laser Systems Therapy Laser System ASPEN LASER SYSTEMS, LLC PAUL SCHWEN
K151102 05/22/2015 Bausch + Lomb Injector System Bausch & Lomb, Inc. Joyce Zhong
K143462 05/08/2015 AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use) BENQ MATERIALS CORPORATION Kenix Chang
K150198 05/02/2015 CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel Bio-Detek, Inc. Chuck Kolifrath
K150055 05/02/2015 OneStep Pediatric CPR Multi-Function Electrode BIO-DETEK, INC. CHUCK KOLIFRATH
K150125 05/11/2015 Elite Nitinol Fixation System BioMedical Enterprises, Inc. Joe Soward
K150424 05/15/2015 JuggerStitch Meniscal Repair Device BIOMET MANUFACTURING CORP. Patricia S. Beres
K151173 05/26/2015 Biomet Microfixation RibFix Blu Thoracic Fixation System Biomet Microfixation Lauren Jasper
K150522 05/01/2015 G7 Dual Mobility System BIOMET, INC. Amy Walriven
K150679 05/29/2015 EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector BOSTON SCIENTIFIC CORP. Virginia Garcia
K143643 05/15/2015 Brainscope Ahead 200 BRAINSCOPE COMPANY, INC. Michael E Singer
K150345 05/11/2015 Magic3 Go Intermittent Urinary Catheter C.R. BARD, INC. WILLIAM HEARD
K142586 05/28/2015 Captiva Spine FuselOX Cervical IBF System CAPTIVA SPINE Tamala J Wampler
K143496 05/29/2015 Piccolo Composite Plate System CarboFix Orthopedics Ltd. Yael Rubin
K143714 05/04/2015 Powerheart G5 AED CARDIAC SCIENCE CORPORATION Kathleen Roberts
K150151 05/21/2015 SmartGownTM surgical gown CARDINAL HEALTH 200, INC. Lavenia Ford
K150342 05/08/2015 Touch Ultrasound CARESTREAM HEALTH, INC. CAROLYN L WAGNER
K150467 05/21/2015 Retina Workplace CARL ZEISS MEDITEC AG MICHAEL HAISCH
K150620 05/08/2015 740 SELECT CAS MEDICAL SYSTEMS, INC. Ron Jeffrey
K142806 05/22/2015 DualCap CATHETER CONNECTIONS, INC. Mark Endo
K150137 05/27/2015 SpiroThor Cohero Health LLC Melissa Manice
K150927 05/27/2015 Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff COLOPLAST A/S LEEANNE SWIRIDOW
K150615 05/01/2015 Vaginal Moisturizing Gel COMBE INCORPORATED Pushpa Rao
K150970 05/12/2015 Coda LP Balloon Catheter COOK INCORPORATED Chad Schulenburg
K150802 05/28/2015 Heavy Double Flexible Tipped Wire Guide COOK INCORPORATED JULIA FERGUSON
K150733 05/21/2015 Vital-Port Vascular Access System Power Injectable Port COOK INCORPORATED STEVEN LAWRIE
K150187 05/19/2015 ELITECROSS Support Catheter Cordis Corporation, A Johnson & Johnson Company Michelle Ragozzino Rodgers
K150007 05/04/2015 Modified Bencox Hip System Corentec Co., Ltd Goon Hee Lee
K150778 05/29/2015 Various Brands of Ultraviolet Lamps COSMEDICO LIGHT, INC. Steven Schlitt
K143263 05/29/2015 Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets COVIDIEN KARIN DESJARDINS
K151163 05/29/2015 Signia Loading Unit, Tri-Staple 2.0 Cartridge Covidien LLC Frank Gianelli
K150891 05/01/2015 BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System Covidien LLC( Formerly Beacon Endoscopic Corp.) Saket Bhatt
K150230 05/15/2015 SculpSure CYNOSURE, INC. KEVIN O'CONNELL
K150359 05/07/2015 Tensyn Plug DALLEN MEDICAL, INC. Al Memmolo
K142666 05/22/2015 Scrambler Therapy MC-5 A Device Delta International Services & Logistics S.r.l Donatella Ruscito
K143679 05/01/2015 Nuance FLOW Den-Mat Holdings, LLC Helen Ragus
K143660 05/21/2015 Milagro / Milagro Advance Interference Screw DEPUY MITEK, A JOHNSON & JOHNSON COMPANY Yayoi Fujimaki
K143430 05/29/2015 SmartTENS EASYMED INSTRUMENT CO., LTD. Jeffery Wu(Tingjie Wu)
K150999 05/06/2015 Acclarix Diagnostic Ultrasound System EDAN INSTRUMENTS, INC. QUEENA CHEN
K150885 05/29/2015 MAGEC 2 Spinal Bracing and Distraction System Ellipse Technologies, Incorporated REBECCA SHELBURNE
K142692 05/31/2015 Occlusion Balloon Catheter EMBOLX, INC. Michael P Allen
K143242 05/15/2015 Rebel 3DKNEE System ENCORE MEDICAL, L.P. Teffany Hutto
K150271 05/29/2015 Prime Adaptive Ultrasonic Scalpel System ENDOPRIME, INC. RICHARD GRANT
K151041 05/04/2015 ERBECRYO 2 Cryosurgical Unit with accessories ERBE USA, INC. John Tartal
K150446 05/21/2015 Erchonia Zerona 6 headed scanner EZ6 ERCHONIA CORPORATION Steve Shanks
K150026 05/18/2015 Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler ETHICON ENDO-SURGERY, LLC Marjorie Medina
K150130 05/28/2015 Ascendant TM Cervical Spacer System EXACTECH, INC. DAWN DAVISSON
K150458 05/14/2015 Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere EXACTECH, INC. Thomas McNamara
K150890 05/29/2015 Exactech Optetrak Logic CC EXACTECH, INC. PATRICK HUGHES
K150152 05/11/2015 The Octane Straight Intervertebral Fusion Device, Ti Coated EXACTECH, INC. Dawn Davisson
K150900 05/15/2015 Flexicare Heated Wire Breathing Systems FLEXICARE MEDICAL LTD. Joel Biddle
K150471 05/22/2015 CalcaNail Orthopedic Arthrodesis Nail Fournitures Hospitalieres Industrie Patricia Donnard
K150463 05/22/2015 CalcaNail Orthopedic Nail Fournitures Hospitalieres Industrie Patricia Donnard
K142629 05/14/2015 EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes FUJIFILM MEDICAL SYSTEM U.S.A., INC. Mary Moore
K142895 05/21/2015 LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators FUJIREBIO DIAGNOSTICS, INC Diana Dickson
K142719 05/20/2015 E-App GC MEDTECH, LLC Robert Ramirez
K143667 05/07/2015 GC KommonBase GC Orthodontics America Inc. Tom Macari
K150420 05/26/2015 Centricity Universal Viewer GE HEALTHCARE CHERYL BORK
K150681 05/12/2015 GEMORE OTC TENS GEMORE TECHNOLOGY CO., LTD. Boden S.P Lai
K150171 05/14/2015 Tinnitus Sound Generator Module GN RESOUND A/S Lars Hagander
K143734 05/02/2015 Digital Automatic Blood Pressure Monitor BPM28 Series - MD2800, MD2810 GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED Patrick Chow
K150356 05/13/2015 Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card HEALGEN SCIENTIFIC LLC JIANQIU FANG
K150056 05/06/2015 Luxisse+ HEANY INDUSTRIES INC Cliff Rabidoux
K150513 05/28/2015 Imed Technology Intravascular Administration Set, Imed Technology Extension Set IMED TECHNOLOGY, INC. KYLE ADAMS
K143502 05/20/2015 Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls IMMUNALYSIS CORPORATION JOSEPH GINETE
K143759 05/07/2015 JAZZ System IMPLANET S.A. REGIS LE COUEDIC
K150954 05/07/2015 Elite L Expandable Lumbar Fusion System INNOVA SPINAL TECHNOLOGIES, LLC ARMANDO VARELA
K150707 05/27/2015 IntelePACS INTELERAD MEDICAL SYSTEMS INCORPORATED Ms. Luce Caron
K150284 05/15/2015 IS4000 da Vinci EndoWrist Instruments INTUITIVE SURGICAL, INC. Sarah Rizk
K150243 05/01/2015 Invictus Medical GelShield Invictus Medical, Inc. Chris Gilmer
K143436 05/21/2015 InvisionECG System InvisionHeart Inc. Michael Wurst
K142549 05/26/2015 Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray, Oral7 Toothpaste J.C.E.C. Company, Inc. (doing business as Fountain Health Ca John Canvin
K151017 05/13/2015 JMS Harmony A.V. Fistula Needle Set JMS NORTH AMERICA CORPORATION SHO HOSOKI
K151007 05/08/2015 21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550) JVC KENWOOD CORPORATION Tsukasa Tashiro
K151134 05/27/2015 21.3 inch (54cm) Color LCD Monitor CCL210 (CL21210) JVC KENWOOD CORPORATION Tsukasa Tashiro
K151222 05/22/2015 Cautery Tip Cleaner KEY SURGICAL, INC. AMY YANTA
K150126 05/11/2015 Life Spine Cannulated Screws LIFE SPINE INC. Randy Lewis
K150237 05/05/2015 ILUMIEN, Drageonfly OPTIS Imaging Catheter LIGHTLAB IMAGING, INC. ERDIE DE PERALTA
K143256 05/28/2015 SMR Modular Glenoid Limacorporate S.P.A. Stephen J. Peoples
K142567 05/19/2015 RETeval Visual Electrodiagnostic Device LKC Technologies, Inc Quentin Davis
K150691 05/15/2015 Datalys Multi-Parameter Patient Monitor Lutech Industries, Inc. RONALD VACHULA
K143531 05/08/2015 Rapid Therapy System MAGSTIM COMPANY LIMITED Charles Hounsell
K150267 05/07/2015 QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators MAQUET CARDIOPULMONARY AG Whitney Torning
K142744 05/07/2015 Mecta-C TiPEEK Medacta International Adam Gross
K150887 05/29/2015 Para-Fix C&S Medium MEDICAL CHEMICAL CORPORATION KRIS J KONTIS
K143304 05/26/2015 Sickbay Clinical Platform Medical Informatics Corp Ralph Krog
K143147 05/07/2015 Gemini Bonded Sterilization Wrap MEDLINE INDUSTRIES, INC. Matt Clausen
K150333 05/08/2015 MedSource Sharps Dart MedSource International, LLC Laura Riggen
K150297 05/21/2015 PlasmaBlade UPPP and Suction Coagulator MEDTRONIC ADVANCED ENERGY Lydia Sakakeeny
K151236 05/19/2015 MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal) MEDTRONIC MINIMED, INC. Liane R. Miller
K142648 05/22/2015 SPINEDESIGN Spine Surgery Planning (Software Application) MEDTRONIC SOFAMOR DANEK USA, INC. Lila Joe
K151110 05/27/2015 Intersept Filtered Cardiotomy Reservoir Medtronic, Inc Chelsea L Pioske
K150530 05/08/2015 Level Sensor, Level Sensor Tape Medtronic, Inc Rahul Shah
K150117 05/27/2015 Medtronic Patient Asistant Medtronic, Inc. Eric Kalmes
K150269 05/26/2015 Ballancer 505 System, Model 1201-AC Mego Afek AC Ltd. Aharon Cohen
K151055 05/20/2015 Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE MENTOR WORLDWIDE LLC Sarah McManus
K150779 05/22/2015 LipoFilter - Hospital Pack, LipoFilter - Clinic Pack MICROAIRE SURGICAL INSTRUMENTS, LLC Chris Spofford
K150341 05/12/2015 Miromatrix Biological Mesh RS MIROMATRIX MEDICAL INC. JEFF ROSS
K143101 05/01/2015 Helio A7 Manual Wheelchair, Move Manual Wheelchair MOTION COMPOSITES Vincent Leuyer
K150407 05/15/2015 BioFlo Midline Catheter NAVILYST MEDICAL, INC. Brandon M Brackett
K150772 05/08/2015 Snap-Off Self-Compressive Screw NEOSTEO JD Webb
K142717 05/07/2015 Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eye Contact Lens Case Ni Hau Industrial Co., Ltd. Lyn Chiu
K143608 05/04/2015 NovaCross Microcatheter Nitiloop Ltd. Michael A Daniel
K150281 05/06/2015 StatStrip Glucose Hospital Meter NOVA BIOMEDICAL CORPORATION Paul W. MacDonald
K150461 05/20/2015 StatStrip Xpress Glucose Hospital Meter System NOVA BIOMEDICAL CORPORATION Paul W. MacDonald
K143561 05/19/2015 ELM PTA Balloon Dilatation Catheter O'CONNELL REGULATORY CONSULTANTS, INC. Maureen O'Connell
K143028 05/29/2015 Azure Anterior Cervical Plate System ORTHOFIX, INC. Natalia Volosen
K150822 05/15/2015 Centurion POCT System ORTHOFIX, INC. JACKI GEREN
K150600 05/22/2015 Response 5.5/6.0 Spine System ORTHOPEDIATRICS CORP. MARK FOX
K150663 05/07/2015 Diagnostic X-ray System OSKO, INC. WANG CHOI
K150946 05/08/2015 FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x 135cm, FLASH Ostial System OTW-7.0mm x 12mm x 80cm, FLASH Ostial System OTW-7.0mm x 12mm x 135cm OSTIAL CORPORATION Jake Wolenberg
K150880 05/01/2015 Tablo Console with Wireless Capability Outset Medical Nancy Gallo
K142870 05/26/2015 Penumbra Embolectomy Aspiration System [INDIGO System] PENUMBRA, INC. Michael Mahl
K150454 05/26/2015 Acryfree Denture Base Material and Biosens Denture Base Material PERFLEX RAY KELLY
K143606 05/08/2015 MultiBand SENSE PHILIPS MEDICAL SYSTEMS NETHRLANDS BV Jan van de Kerkhof
K150310 05/13/2015 IntelliVue Patient Monitor PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH JOHANNES SCHMID
K143435 05/14/2015 Planmed Verity PLANMED OY Lars Moring
K142729 05/15/2015 Chi Lites Orthodontic Sapphire Bracket PROGRESSIVE TECHNOLOGY, INC. Shannon Rogers
K150139 05/22/2015 Rachel's Remedy Rachel's Remedies, LLC Rachel E. Jackson
K150226 05/13/2015 Hematocrit and Metabolite QUALICHECK RADIOMETER MEDICAL APS Mette Skytte Harpsoee
K150563 05/22/2015 Marrow Cellution Bone Marrow Aspiration Needle RANFAC CORP CHRISTOPHER P. WHELAN
K150627 05/27/2015 Rapid Aid Instant Disposable Infant Heel Warmer RAPID AID CORP. Rose Ren
K150797 05/01/2015 Digital Dental Intra Oral Sensor, EzSensor Smart Rayence Co., Ltd Kevin Kim
K143511 05/20/2015 K-Y BRAND TOUCH All-in-one Warming Caressing Creme and Personal Lubricant RECKITT BENCKISER ELIZABETH TORRE
K143647 05/11/2015 Renovis Surgical Hip Replacement System Renovis Surgical Technologies, Inc. Anthony DeBenedictis
K143603 05/21/2015 Darlinghurst Vented, Darlinghurst NV-AAV RESMED LTD. Jean-Nicholas Boudaud
K143694 05/15/2015 Rhondium One-Visit-Crown(OVC) Rhondium, Ltd. Greer Fricker
K150955 05/01/2015 Elecsys Progesterone III Cal Check 5 ROCHE DIAGNOSTICS ADAM CLARK
K150521 05/15/2015 Interbody Fusion (IBF)/Vertebral Body Replacement(VBR) System RTI SURGICAL, INC. dba RTI BIOLOGICS Jennifer Bonacci
K150816 05/08/2015 Jumong Series SG HEALTHCARE CO LTD YOSEP PARK
K143585 05/06/2015 Electric Breast Pump SHANTOU XINGHE ELECTRICAL APPARATUSES CO., LTD Jun Deng
K150282 05/27/2015 Shaser Skin Beauty Intense Pulsed Light System Family for Acne SHASER, INC. Anthony Burns
K143196 05/12/2015 syngo.CT Lung CAD SIEMENS AG MEDICAL SOLUTIONS JAMES E KUHN JR.
K150403 05/01/2015 ADVIA Centaur TSH3-Ultra SIEMENS HEALTHCARE DIAGNOSTICS, INC. MATTHEW GEE
K150785 05/18/2015 syngo.CT Dental SIEMENS MEDICAL SOLUTIONS USA, INC. EVE DAVIS
K150217 05/08/2015 ORTHOPHOS SL Sirona Dental Systems GMBH Thomas Diesch
K150675 05/12/2015 Dorsal Spanning Plate SKELETAL DYNAMICS, LLC ANN M. ESCAGEDO
K150091 05/26/2015 Versatex Monofilament Mesh SOFRADIM PRODUCTION Benjamin Rochette
K150941 05/22/2015 Somnowell Mandibular Advancement Appliance (MAA) Somnowell Ltd. Simon Ash
K143448 05/01/2015 Sonendo GentleWave System Sonendo, Inc. JENNY FAM
K150061 05/19/2015 Lucent; Lucent Ti-Bond Systems Spinal Elements Inc. Julie Lamothe
K143683 05/22/2015 APEX-DL Spine System SPINECRAFT LLC AMI AKALLAL-ASAAD
K150417 05/19/2015 ASTRA SPINE SYSTEM SPINECRAFT LLC AMI AKALLAL-ASAAD
K150036 05/07/2015 Blue Mountain Cervical Plate System SPINEWAY JULIEN THAO MY
K150185 05/12/2015 Mont Blanc Spinal System SPINEWAY Julien Thao My
K143562 05/20/2015 Reprocessed Cordless Ultrasonic Dissection Device STERILMED, INC. Nicole Boser
K142568 05/05/2015 Stryker MEDPOR TITAN 3D Orbital Floor Implant Stryker Julie Schoell
K143399 05/08/2015 Stryker Footed Attachments and Cutting Accessories STRYKER CORP. VISHAL KANANI
K150539 05/12/2015 OASYS System Stryker Corporation GARRY T. HAYECK
K150801 05/22/2015 Stryker Maestro Air Motors STRYKER CORPORATION DEVAL PATEL
K143540 05/01/2015 Stryker MIS Attachments and Cutting Accessories STRYKER CORPORATION Mairead Twomey
K151076 05/22/2015 MicroTaper Needle Introducer Set Summit Access, LLC Fred Piazza
K142768 05/29/2015 Instru-Safe Instrument Protection System SUMMIT MEDICAL, INC. NICOLE DOVE
K150511 05/27/2015 Coating Material SUN MEDICAL CO., LTD MR. YUKIHITO YUKIMUNE
K150848 05/20/2015 Dose Calculator SUN NUCLEAR CORPORATION JAMES LUKER
K143728 05/15/2015 Minhua Disposable Blood Pressure Cuff SUZHOU MINHUA MEDICAL APPARATUS Ji Dong Yang
K143078 05/14/2015 Bookwalter Gordon Adjustable Compression Element SYMMETRY SURGICAL Victoria Rogers
K143198 05/27/2015 Synapse Transcutaneous Electrical Stimulation Device Synapse Electroceutical Limited JOHN GILDERSLEEVE
K143285 05/28/2015 Mandible External Fixator - MR Conditional Synthes USA Products, LLC Susan Lewandowski
K143326 05/14/2015 T.A.G. Dental Implant System T.A.G. MEDICAL PRODUCTS CORPORATION, LTD EREZ ADIV
K143185 05/07/2015 entr? Model PD08-U TACTILE SYSTEMS TECHNOLOGY INC DANIEL G CHASE
K143467 05/07/2015 FORA GD43 Blood Glucose Monitoring System TaiDoc Technology Corporation C. W. CHEN
K150824 05/28/2015 TD-Wand TDM SURGITECH, INC MICHAEL WEBER
K150533 05/09/2015 Terason uSmart3200T Ultrasound System TERATECH CORP. Steven R Broadstone
K150536 05/05/2015 Terumo Circuit Tubing Terumo Cardiovascular Systems Corporation Garry Courtney
K150542 05/01/2015 Terumo Pump Tubing TERUMO CARDIOVASCULAR SYSTEMS CORPORTION JOSHUA EWING
K142954 05/28/2015 PTA 14 Balloon Dilatation Catheter OTW Texas Medical Technologies, Inc. Aaron Chiu
K143118 05/26/2015 Human Microalbumin kit for use on SPAPLUS THE BINDING SITE GROUP LTD Marianne Sender
K150526 05/30/2015 Optilite IgG4 Kit THE BINDING SITE GROUP LTD Andrea Thomas
K143294 05/15/2015 Adaptive Motion Correction (AMC), CSMC-001A and 4D Airways TOSHIBA MEDICAL SYSTEMS CORPORATION Paul Biggins
K143629 05/19/2015 U&U Bowie-Dick Test Pack U&U MEDICAL TECHNOLOGY CO., LTD GARFIELD WANG
K150636 05/08/2015 VariSeed 9.0 VARIAN MEDICAL SYSTEMS, INC. Peter J. Coronado
K150706 05/08/2015 VitalBeam VARIAN MEDICAL SYSTEMS, INC. PETER J. CORONADO
K150389 05/06/2015 Spiral Flow Peripheral Vascular Graft VASCULAR FLOW TECHNOLOGIES LTD Edwin Lindsay
K150628 05/22/2015 VentriPoint Medical System VENTRIPOINT, INC. JIM BODTKE
K150161 05/12/2015 Venus Viva SR Device Venus Concept Ltd. Orit Ron Edoute
K150035 05/01/2015 V10 system VIORA LTD. OMRI KESLER
K143212 05/01/2015 Bifix Temp VOCO GMBH M. Th. Plaumann
K151145 05/26/2015 2.4mm X 127 cm Phoenix Atherectomy Deflecting System Volcano AtheroMed, Inc. JEAN CHANG
K142724 05/20/2015 BIOFOAM Bone Wedge WRIGHT MEDICAL TECHNOLOGY, INC. Val Myles
K150213 05/08/2015 Subtalar Spacer System (STS) WRIGHT MEDICAL TECHNOLOGY, INC. TARA CONRAD
K150224 05/12/2015 BLUE VINYL GLOVES POWDER FREE ZIBO SANYING TRADE CO., LTD Jing Li
K143528 05/01/2015 Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System ZIMMER DENTAL INC. CHRISTINA BOYDSTON
K143321 05/29/2015 ITST Intertrochanteric/Subtrochanteric Fixation System ZIMMER, INC. PATRICK MCCULLAGH
K150626 05/01/2015 Rush Medullary Pins Zimmer, Inc. Patrick McCullagh
K150818 05/01/2015 Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System ZIMMER, INC. PATRICK MCCULLAGH
K150090 05/20/2015 Zimmer Persona Personalized Knee System ZIMMER, INC. Keith Proctor
K151175 05/15/2015 ZONARE ZS3 Diagnostic Ultrasound System ZONARE MEDICAL SYSTEMS, INC. STEVE GEERDES


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