FDA 510(k) Applications Received During February, 2015

FDA 510(k) Number Submission Date Device Name Applicant Contact
K150477 02/24/2015 3M Comply Indicator Tape for Ethylene Oxide (EO) Sterilization 3M COMPANY MATT MORTENSEN
K150332 02/10/2015 FreeStyle Lite Blood Glucose Monitoring System ABBOTT LABORATORIES Sai Sriharshada Tatavarty
K150510 02/27/2015 Total Bilirubin ABBOTT LABORATORIES SUSHMA RAO
K150453 02/20/2015 TULA Iontophoresis System with Earset ACCLARENT, INC. PAVAN SETHI
K150330 02/10/2015 Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) ACON Laboratories, Inc. Qiyi Xie
K150233 02/02/2015 NIOX VERO Airway Inflammation Monitor AEROCRINE AB Kathleen Rickard
K150457 02/20/2015 AlfaSight 9000 Thermographic System ALFA THERMODIAGNOSTICS, INC. Daniel Beilin
K150395 02/18/2015 Omega LIF System AMENDIA, INC. Bruce Hooper
K150256 02/03/2015 SILVERLON BURN CONTACT DRESSINGS ARGENTUM MEDICAL C.Richard Foster
K150456 02/20/2015 Arthrex Plates, Screws, and Staples Arthrex, Inc. David L Rogers
K150402 02/18/2015 Endoluminal Occlusion System-EOS ARTVENTIVE MEDICAL GROUP, INC Roberta Hines
K150445 02/20/2015 ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) ASAHI INTECC CO., LTD. Yoshihiko Fukui
K150296 02/06/2015 Biodenta Customized Abutment-Hybrid BIODENTA SWISS AG David Elier
K150424 02/19/2015 JuggerStitch Meniscal Repair Device BIOMET MANUFACTURING CORP. Patricia S. Beres
K150503 02/26/2015 Echo Bi-Metric Microplasty Line Extension BIOMET, INC. AMY WALRIVEN
K150303 02/06/2015 XXL Vascular Balloon Dilatation Catheter BOSTON SCIENTIFIC CORP. Melanie Raska
K150235 02/02/2015 CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels BOSTON SCIENTIFIC CORPORATION MAYLIN TRUESDELL
K150345 02/11/2015 Magic3 Go Intermittent Urinary Catheter C.R. BARD, INC. WILLIAM HEARD
K150326 02/09/2015 PicoWay Laser System Candela Corporation Ruthie Amir
K150289 02/05/2015 CARDIOLINE S.p.A. CARDIOLINE S.p.A Emanuele Ercoli
K150342 02/11/2015 Touch Ultrasound CARESTREAM HEALTH, INC. CAROLYN L WAGNER
K150467 02/23/2015 Retina Workplace CARL ZEISS MEDITEC AG MICHAEL HAISCH
K150320 02/09/2015 COMPASS CENTERVUE SPA ROBERTO GABRIOTTI
K150265 02/04/2015 Model 206 Electrometer/Dosimeter CNMC COMPANY INCORPORATED THOMAS KRAUS
K150319 02/09/2015 MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS CODMAN & SHURTLEFF, INC. Hannah Foley
K150350 02/11/2015 Flexi-Seal Signal Fecal Management System ConvaTec Ltd. Clare Williamson
K150251 02/03/2015 Barrx Anorectal RFA Wand Covidien LLC RACHEL SILVA
K150484 02/24/2015 Penguin In-Line Warmer Creche Innovations REBECCA P PINE
K150321 02/09/2015 EVOS Lumbar Interbody System Cutting Edge Spine, LLC John Souza
K150413 02/18/2015 QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve Stimulator CyMedica Orthopedics, Inc. Kereshmeh Shahriari
K150230 02/02/2015 SculpSure CYNOSURE, INC. KEVIN O'CONNELL
K150400 02/18/2015 Renu Gel CYTOPHIL, INC. BOB VOIGTS
K150359 02/12/2015 Tensyn Plug DALLEN MEDICAL, INC. Al Memmolo
K150347 02/11/2015 Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+ DELTEX MEDICAL LIMITED Paul Dwane
K150344 02/11/2015 Dentis Dental Implant System DENTIS CO., LTD. JINJU LEE
K150375 02/13/2015 LIAISON VZV IgG, LIAISON Control VZV IgG DiaSorin Inc. John Walter
K150371 02/13/2015 Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH DIROS TECHNOLOGY, INC. GEORGE DARMOS
K150327 02/10/2015 Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2 Dunamis LLC Prithviraj Chavan
K150239 02/02/2015 FibroScan Echosens Celine Fournier
K150271 02/04/2015 Prime Adaptive Ultrasonic Scalpel System ENDOPRIME, INC. RICHARD GRANT
K150446 02/20/2015 Erchonia Zerona 6 headed scanner EZ6 ERCHONIA CORPORATION Steve Shanks
K150491 02/25/2015 ER36 Series OAE Test System ETYMOTIC RESEARCH, INC. Steve Iseberg
K150458 02/23/2015 Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere EXACTECH, INC. Thomas McNamara
K150309 02/09/2015 Extremity Medical Calcaneal Osteotomy Device EXTREMITY MEDICAL, LLC Brian Smekal
K150473 02/23/2015 FlexPointer 1.5 mm FIAGON GMBH DR. DIRK MUCHA
K150471 02/23/2015 CalcaNail Orthopedic Arthrodesis Nail Fournitures Hospitalieres Industrie Patricia Donnard
K150463 02/23/2015 CalcaNail Orthopedic Nail Fournitures Hospitalieres Industrie Patricia Donnard
K150430 02/19/2015 Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor FUDAKANG INDUSTRIAL CO., LTD BOB YU
K150349 02/11/2015 Rapid Hair Removal Pads FULL POWER AED Jahn Power
K150420 02/18/2015 Centricity Universal Viewer GE HEALTHCARE CHERYL BORK
K150245 02/02/2015 CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX GE HEALTHCARE FINLAND OY Mari Salmenkaita
K150373 02/13/2015 Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model No.: MD25x0/ MD26x0] GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED Patrick Chow
K150356 02/12/2015 Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card HEALGEN SCIENTIFIC LLC JIANQIU FANG
K150311 02/09/2015 Full Automatic (NIBP)Blood Pressure Monitor Health & Life Co., Ltd. Sarah Su
K150340 02/11/2015 POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue) HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD Shaozhang Nan
K150490 02/25/2015 UnicLine Mobile Heka Dental A/S Claus van der Goot
K150293 02/06/2015 EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D), EZvue Colors, Soft Daily Wear Contact Lenses (ocufilcon D) I-SEE VISION TECHNOLOGY INC. ISAAC HUANG
K150513 02/27/2015 Imed Technology Intravascular Administration Set, Imed Technology Extension Set IMED TECHNOLOGY, INC. KYLE ADAMS
K150275 02/04/2015 Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls Immunalysis Corporation Joseph Ginete
K150414 02/18/2015 Midas Touch-Nitrile Examination Gloves- Powder free, Orange, XS, Model SNAEFT-240OR-XS; Midas Touch-Nitrile Examination Gloves -Powder free, Orange, XXL, Model SNAEFT-240OR-XXL INDUSTRIAL CLOTHINGS (PVT) LTD S.N. HARI
K150274 02/04/2015 GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System Infopia Co., Ltd. NA YUN KIM
K150500 02/26/2015 Px PEEK IBF System INNOVASIS, INC. Marshall McCarty
K150365 02/12/2015 Cloud9 System inSleep Technologies, LLC Marty Kerber
K150428 02/19/2015 Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs INTEGRA LIFESCIENCES CORP. Judith E O'Grady
K150343 02/11/2015 V8 Transluminal BAV Catheter InterValve, Inc. Mark Ungs
K150284 02/05/2015 IS4000 da Vinci EndoWrist Instruments INTUITIVE SURGICAL, INC. Sarah Rizk
K150243 02/02/2015 Invictus Medical GelShield Invictus Medical, Inc. Chris Gilmer
K150393 02/18/2015 TETRIC EVOFLOW BULK FILL IVOCLAR VIVADENT AG SANDRA CAKEBREAD
K150486 02/24/2015 Halo J & J Solutions, Inc. d/b/a/Corvida Medical Dana Schramm
K150248 02/03/2015 ORL Video NasoPharyngo-Larngoscope JEDMED INSTRUMENT COMPANY CRAIG PARKS
K150367 02/12/2015 Neodent Implant System JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S Jacson Cambruzzi
K150325 02/09/2015 Range/Denali/Mesa Spinal System K2M, Inc Nancy Giezen
K150481 02/24/2015 Cascadia Interbody System K2M, Inc. Nancy Giezen
K150507 02/26/2015 Santis Pedicle Screw System LANTERNA MEDICAL TECHNOLOGIES Horace Hale
K150368 02/12/2015 Tarsa-Link Wedge Fixation System Life Spine Randy Lewis
K150229 02/02/2015 SOLSTICE OCT System LIFE SPINE, INC Randy Lewis
K150390 02/18/2015 Nautilus Spinal System LIFE SPINE, INC. RANDY LEWIS
K150237 02/02/2015 ILUMIEN, Drageonfly OPTIS Imaging Catheter LIGHTLAB IMAGING, INC. ERDIE DE PERALTA
K150466 02/23/2015 ZX2 Laser System LZR7, Inc Randy Rinkleib
K150307 02/09/2015 RESTORIS Multicompartmental Knee System MAKO SURGICAL CORP. Jonathan Reeves
K150410 02/18/2015 RESTORIS POROUS PARTIAL KNEE SYSTEM MAKO SURGICAL CORPORATION JONATHAN REEVES
K150267 02/04/2015 QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators MAQUET CARDIOPULMONARY AG Whitney Torning
K150499 02/26/2015 Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty MEDELA AG ORLANDO ANTUNES
K150286 02/05/2015 Medline Enteral Feeding Sets MEDLINE INDUSTRIES, INC. Stephanie Blair
K150333 02/10/2015 MedSource Sharps Dart MedSource International, LLC Laura Riggen
K150297 02/06/2015 PlasmaBlade UPPP and Suction Coagulator MEDTRONIC ADVANCED ENERGY Lydia Sakakeeny
K150465 02/23/2015 Medtronic Confida Brecker Guidewire Medtronic CoreValve, LLC. Genevieve Balutowski Dunbar
K150460 02/23/2015 KYPHON (R) HV-R(R) Bone Cement MEDTRONIC SOFAMOR DANCK USA, INC. Kathy L. Remsen
K150231 02/02/2015 Navigated Disc Prep Instruments and CAPSTONE Trials MEDTRONIC SOFAMOR DANEK USA, INC Nicholas Tabrizi
K150291 02/06/2015 TYRX Neuro Absorbable Antibacterial Envelope MEDTRONIC TYRX, INC. Regina Novak
K150246 02/02/2015 Medtronic Model 5392 External Pulse Generator (EPG) Medtronic, Inc Becky Severson
K150422 02/19/2015 EOPA 3D Arterial Cannula MEDTRONIC, INC. Chelsea L Pioske
K150269 02/04/2015 Ballancer 505 System, Model 1201-AC Mego Afek AC Ltd. Aharon Cohen
K150257 02/03/2015 PreludeEASE Hydrophilic Sheath Introducer Merit Medical Systems, Inc. Michaela Rivkowich
K150316 02/09/2015 Polypectomy Snare MICRO- TECH (NANJING) CO., LTD. BECKY LI
K150434 02/19/2015 Injection Needle Micro-Tech (Nanjing) CO., Ltd. Becky Li
K150302 02/06/2015 PROFEMUR Preserve Classic Stem MICROPORT ORTHOPEDICS INC. MATT PAUL
K150366 02/12/2015 SOFIA 6F Catheter MICROVENTION, INC. NAOMI GONG
K150419 02/18/2015 miraDry System MD4000 MIRAMAR LABS, INC. KATHY O'SHAUGHNESSY
K150341 02/11/2015 Miromatrix Biological Mesh RS MIROMATRIX MEDICAL INC. JEFF ROSS
K150234 02/02/2015 Myriad Prostate Caddy? Immobilization Rectal Balloon Item #9901,3301 Myriad Medical, LLC Frank Bimbo
K150407 02/18/2015 BioFlo Midline Catheter NAVILYST MEDICAL, INC. Brandon M Brackett
K150448 02/20/2015 NMI PICC III and NMI PICC IV NAVILYST MEDICAL, INC. WANDA CARPINELLA
K150225 02/02/2015 NovaGold High Performance Guidewire NEOMETRICS, INC. Dave Liebl
K150313 02/09/2015 Ablation Confirmation NEUWAVE MEDICAL INC. DAN KOSEDNAR
K150378 02/13/2015 NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook NICO Corporation Sean Spence
K150281 02/05/2015 StatStrip Glucose Hospital Meter NOVA BIOMEDICAL CORPORATION Paul W. MacDonald
K150461 02/23/2015 StatStrip Xpress Glucose Hospital Meter System NOVA BIOMEDICAL CORPORATION Paul W. MacDonald
K150363 02/12/2015 NOVA Dental Implants System NOVA Implants Ltd. Dan Grimberg
K150370 02/13/2015 Nutra Light Advanced NUTRA LUXE MD, LLC GLORIA AVENDANO
K150362 02/12/2015 NuVasive CoRoent Small Interbody System NuVasive, Incorporated Martin Yahiro
K150472 02/23/2015 NxStage System One NXSTAGE MEDICAL, INC. Mary Lou Stroumbos
K150398 02/18/2015 EUM 100Pro OB TOOLS, LTD. GAL BEN DAVID
K150272 02/04/2015 Capnostream 35 Portable Respiratory Monitor ORIDION MEDICAL 1987 LTD. Dalia Givony
K150506 02/26/2015 ELIAN Digital Diagnostic X-ray System OSKO, INC. WANG CHOI
K150485 02/24/2015 AVERT Contrast Modulation System Osprey Medical, Inc. Melanie Hess
K150294 02/06/2015 DPZ Pedicular Fixation System Osteomed Implantes, LTDA J. D. Webb
K150322 02/09/2015 InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20mm) PAN MEDICAL LTD Jennie Budding
K150415 02/18/2015 NilRead Perceptive Software Claudio Gatti
K150454 02/20/2015 Acryfree Denture Base Material and Biosens Denture Base Material PERFLEX RAY KELLY
K150310 02/09/2015 IntelliVue Patient Monitor PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH JOHANNES SCHMID
K150227 02/02/2015 Disposable Blood Pressure Cuff Guard PINHU SAMA MEDICAL PACKING CO., LTD. MA JIANZHONG
K150254 02/03/2015 Streamline OCT Occipito-Cervico-Thoracic System Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) Sarah Pleaugh
K150380 02/13/2015 ProMIS Fixation System Premia Spine Ltd. Ron Sacher
K150423 02/19/2015 EXPAZEN PRODUITS DENTAIRES PIERRE ROLLAND (ACTEON GROUP) GENEVIEVE DE VILLEDON
K150392 02/18/2015 PROPEL device PROPEL ORTHODONTICS LLC. BRYCE WAY
K150494 02/25/2015 Proteus Digital Health Feedback Device PROTEUS DIGITAL HEALTH, INC. Jessie Duong
K150331 02/10/2015 18ch T/R Knee Coil Quality Electrodynamics, LLC Kathleen Aras
K150381 02/18/2015 AQUA CLEANSE QUALITY MEDICAL SUPPLY, INC JULIE SOLOMON
K150382 02/18/2015 Radio Therapy Treatment Chair RADIATION PRODUCTS DESIGN, INC. Howard Larson
K150226 02/02/2015 Hematocrit and Metabolite QUALICHECK RADIOMETER MEDICAL APS Mette Skytte Harpsoee
K150266 02/04/2015 Remington Medical Inc. Tuohy Epidural Needles REMINGTON MEDICAL, INC. CAITLIN SENTER
K150283 02/05/2015 Republic Spine Dark Star Spinal System REPUBLIC SPINE, LLC RUSTY MCCARVER
K150496 02/25/2015 Total Knee Arthroplasty System Responsive Orthopedics LLC Doug Kohrs
K150443 02/20/2015 ToeTac Hammertoe Fixation System RESTORE SURGICAL LLC dba Instratek JEFF SEAVEY
K150288 02/05/2015 PDO Absorbable Punctum Plug RIVERPOINT MEDICAL Edwin Anderson
K150478 02/24/2015 A35 Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD. KIM JIYOUNG
K150280 02/05/2015 PulmoVia Working Channel SANOVAS, INC. Roy Morgan
K150469 02/23/2015 Integra Laminoplasty System SEASPINE, INC. MICHELLE WILLIS
K150282 02/05/2015 Shaser Skin Beauty Intense Pulsed Light System Family for Acne SHASER, INC. Anthony Burns
K150352 02/11/2015 V Series Monitoring System (including V12 and V21 Monitors) SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD YANHONG BAI
K150403 02/18/2015 ADVIA Centaur TSH3-Ultra SIEMENS HEALTHCARE DIAGNOSTICS, INC. MATTHEW GEE
K150493 02/25/2015 Sensis Siemens Medical Solutions, Inc. Patricia D Jones
K150512 02/27/2015 STAR 90 SKANRAY TECHNOLOGIES PVT LTD. Hema ` Singh
K150369 02/13/2015 SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent G2 (Classic or Flex Retention) with DentiTrac Micro-recorder, Somn SOMNOMED INC. KIEN T. NGUYEN
K150376 02/13/2015 Sonoma Cancellous Bone Screw and Washer Sonoma Orthopedics Products, Inc Rick Epstein
K150377 02/13/2015 Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony LMD-X310NB LCD Monitor, Sony LMD-X550S LCD Monitor, Sony LMD-X550MD LCD, Sony LMD-X550NB LCD Monitor SONY ELECTRONICS, INC. Amarjit Andy Singh Jowandha
K150489 02/25/2015 EOS PMP, EOS PMP Integrated SORIN GROUP ITALIA S.R.L. LUIGI VECCHI
K150361 02/12/2015 ViSi Mobile Monitoring System Sotera Wireless, Inc. Carson Krupp
K150360 02/12/2015 TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath SPECTRANETICS, INC. Christopher S McLellan
K150285 02/05/2015 Leva(TM) Spacer System SPINE WAVE, INC. ROAIDA JOHNSON
K150417 02/18/2015 ASTRA SPINE SYSTEM SPINECRAFT LLC AMI AKALLAL-ASAAD
K150312 02/09/2015 Vdrive system, Vdrive Duo, Vdrive with V-Sono STEREOTAXIS, INC. JOHN NADELIN
K150357 02/12/2015 Reprocessed Electrophysiology Diagnostic Catheters STERILMED, INC. Nicole Boser
K150250 02/03/2015 SternSnap Angled Attachment Sterngold Dental, LLC MARIA RAO
K150449 02/20/2015 LITe Plate System STRYKER CORP. GARRY T. HAYECK
K150416 02/18/2015 ProCinch Adjustable Loop Device STRYKER ENDOSCOPY KELLY KUCHARCZYK
K150301 02/06/2015 NavSuite3 Kit Stryker Leibinger GmbH & Co. KG - Navigation Robin L Rowe
K150452 02/20/2015 ComboCath OTW PTA Dilatation Catheter Summa Therapeutics, LLC Richard Rush
K150511 02/27/2015 Coating Material SUN MEDICAL CO., LTD MR. YUKIHITO YUKIMUNE
K150253 02/03/2015 Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm TAIWAN SURGICAL CORPORATION HSIU-PING HUANG
K150438 02/19/2015 Force Fiber OrthoTape suture TELEFLEX MEDICAL, INC. VLADISLAVA ZAITSEVA
K150263 02/04/2015 K-Pack II Needle-21G x 2 TERUMO EUROPE N.V. M J Aerts
K150412 02/18/2015 Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator The Binding Site Group Ltd Marianne Sender
K150236 02/02/2015 Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Dalbavancin (0.0005 - 2ug/mL) THERMO FISHER SCIENTIFIC CYNTHIA KNAPP
K150427 02/19/2015 Vantage Titan 1.5T, V3.1, MRT-1510 TOSHIBA MEDICAL SYSTEMS CORPORATION Janine Reyes
K150292 02/06/2015 Chocolate PTCA Balloon Catheter TRIREME MEDICAL, LLC Shiva Ardakani
K150394 02/18/2015 Tyber Medical Wedge System TYBER MEDICAL LLC JEFF TYBER
K150505 02/25/2015 Cellfina System ULTHERA, INC. Suzon Lommel
K150432 02/19/2015 IDODENTINE DISC, IDODENTINE BLOCK UNION DENTAL S.A. JOSE LUIS RODRIGUEZ BLANCO
K150480 02/24/2015 JO H20 Water Based Personal Lubricant UNITED CONSORTIUM INC. Joe Mendoza
K150389 02/18/2015 Spiral Flow Peripheral Vascular Graft VASCULAR FLOW TECHNOLOGIES LTD Edwin Lindsay
K150385 02/18/2015 NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses Visioneering Technologies, Inc. Stephen Snowdy
K150258 02/03/2015 Vitrea, Version 7.0 Medical Image Processing Software Vital Images, Inc Parthiv Shah
K150262 02/04/2015 Crux Vena Cava Filter System, femoral; Crux Vena Cava Filter System, jugular Volcano Corporation Elaine Alan
K150441 02/20/2015 Volcano iFR Modality, iFR Scout feature VOLCANO CORPORATION NEETA SHARMA
K150442 02/20/2015 Volcano Visions PV .018 Digital IVUS Catheter Volcano Corporation Mary Stanners
K150336 02/10/2015 Photonica Professional Ward Photonics LLC Terry Ward
K150252 02/03/2015 PHALINX Hammertoe System WRIGHT MEDICAL TECHNOLOGY, INC. Val Myles
K150295 02/06/2015 LOCATOR RTx ZEST ANCHORS, INC. Annie Wrigth
K150224 02/02/2015 BLUE VINYL GLOVES POWDER FREE ZIBO SANYING TRADE CO., LTD Jing Li
K150501 02/26/2015 Zimmer Nexel Total Elbow Ulnar Cement Diverter ZIMMER, INC. Keith Proctor
K150249 02/03/2015 ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound System ZONARE MEDICAL SYSTEMS, INC. Steve Geerdes


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