FDA 510(k) Applications Received During February, 2015

FDA 510(k) Number Submission Date Device Name Applicant Contact
K153705 12/23/2015 PROcedure Rehearsal Studio 3DSYSTEMS, SIMBIONIX PRODUCTS KIM TORLUEMKE
K150477 02/24/2015 3M Comply Indicator Tape for Ethylene Oxide (EO) Sterilization 3M COMPANY MATT MORTENSEN
K153571 12/15/2015 Cavilon Advanced High Endurance Skin Protectant 3M HEALTH CARE MARIA RUIZ
K153731 12/28/2015 LifeFlow Rapid Infusion Device (LifeFlow Device) 410 Medical Innovation, LLC Galen Robertson
K153744 12/28/2015 A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) A1 GLOVE SDN BHD CONNIE YUNG
K153730 12/28/2015 ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control Abbott Laboratories Laura Yelvigi Joglekar
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
K153674 12/21/2015 Sorbact Foam Gentle Border, Sorbact Superabsorbent ABIGO Medical AB Annica Corbe
K153456 12/01/2015 Megapulse III Shortwave Diathermy Accelerated Care Plus Patrick Parker
K153559 12/14/2015 OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System Accelerated Care Plus (ACP) Patrick Parker
DEN150056 12/07/2015 Acclarent Aera Eustachian Tube Balloon Dilation System ACCLARENT, INC. JAMES PATRICK GARVEY
K150453 02/20/2015 TULA Iontophoresis System with Earset ACCLARENT, INC. PAVAN SETHI
K153754 12/29/2015 MicroMatrix ACELL, INC THOMAS GILBERT
K153613 12/17/2015 Cerafix Dura Substitute ACERA SURGICAL, INC. MATTHEW MACEWAN
K150330 02/10/2015 Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) ACON Laboratories, Inc. Qiyi Xie
K153718 12/28/2015 Spirit Hair Removal laser Family ACTIVE OPTICAL SYSTEMS , LTD. GIL Bidas
K153488 12/04/2015 Occlusion Perfusion Catheter Advanced Catheter Therapies, Inc. Paul Joseph Fitzpatrick
K150233 02/02/2015 NIOX VERO Airway Inflammation Monitor AEROCRINE AB Kathleen Rickard
K153629 12/18/2015 ArcadiusXP C Spinal System Aesculap Implant Systems, Inc. Lisa M Boyle
K153700 12/23/2015 Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments AESCULAP IMPLANT SYSTEMS, LLC Paul Amudala
K153552 12/11/2015 AGE Automatic Upper Arm Blood Pressure Monitor Ageless Health Industrial Co., Ltd Victor Wan
K153564 12/14/2015 PURE CRYOGEN AIR LIQUIDE HEALTHCARE AMERICA CORPORATION STEVE MILLER
DEN150055 12/07/2015 AeroForm Tissue Expander System AIRXPANDERS, INC Robin` Bush
K153642 12/21/2015 DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal ALCON LABORATORIES, INC. SHERRI LAKOTA
K153643 12/21/2015 Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives ALCON LABORATORIES, INC. SHERRI LAKOTA
K150457 02/20/2015 AlfaSight 9000 Thermographic System ALFA THERMODIAGNOSTICS, INC. Daniel Beilin
K153603 12/17/2015 Alphatec Navigation Instruments ALPHATEC SPINE, INC. RENEE MURPHY
K153494 12/04/2015 HQS Introducer (Model 2064-HQS) ALSEAL Jean-Francois M Delforge
K153779 12/31/2015 Abutment for Bridges ALTATEC GmbH Colleen Boswell
K150395 02/18/2015 Omega LIF System AMENDIA, INC. Bruce Hooper
K153561 12/14/2015 AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System ANDON HEALTH CO., LTD Yi Liu
K150396 02/18/2015 Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips APEX BIOTECHNOLOGY CORP. Hsue-mei Lee
K150256 02/03/2015 SILVERLON BURN CONTACT DRESSINGS ARGENTUM MEDICAL C.Richard Foster
K153596 12/16/2015 ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control ARK DIAGNOSTICS, INC. KENNETH C. KASPER
K153632 12/18/2015 Endoform Reconstructive Template Aroa Biosurgery Limited (Formerly Mesynthes Limited) Yasmin Rai
K153633 12/18/2015 Endoform Reconstructive Template Aroa Biosurgery Limited (Formerly Mesynthes Limited) Yasmin Rai
K153487 12/04/2015 CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS ARROW INTERNATIONAL, INC. (Subsidiary of Teleflex Inc.) Elizabeth Duncan
K153669 12/21/2015 MultiFIX S Ultra Knotless Fixation System ArthoCare Corporation Laura Kasperowicz
K153586 12/16/2015 Arthrex iBalance TKA System Arthrex, Inc. Leon Brown
K150456 02/20/2015 Arthrex Plates, Screws, and Staples Arthrex, Inc. David L Rogers
K153675 12/21/2015 Paragon T2 Wand with Integrated Cable ARTHROCARE CORPORATION KRYSTLE DANUZ
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
K150232 02/02/2015 Radifocus Optitorque Angiographic Catheter ASHITAKA FACTORY OF TERUMO CORP. Monika McDole-Russell
K153465 12/01/2015 AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup) Assure Tech (Hangzhou) Co., Ltd. Shisheng Ling
K153459 12/01/2015 TACVAC ATHENA GTX SEAN MAHONEY
K153500 12/07/2015 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip Atricure, Inc. Jonathan McElwee
K153460 12/01/2015 Pantheris Catheter (8Fr), Pantheris Catheter (7Fr) AVINGER, INC. Patty Hevey
K153551 12/11/2015 ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. Axis-Shield Diagnostics Limited. Claire I Dora
K153542 12/11/2015 Pelican Sling Retractor Beacon Surgical, Inc. Allan Alward
K153651 12/21/2015 Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems BECKMAN COULTER, INC. MICHAEL ROBERT LORENZ
K153481 12/03/2015 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe BECTON, DICKINSON AND COMPANY John Blewitt
K150388 02/18/2015 Dental Implant System BIO CONCEPT CO., LTD HUA CAO
DEN150058 12/16/2015 Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak Bio-Rad Laboratories Elizabeth Platt
K150300 02/06/2015 Liquichek Cardiac Markers Plus Control LT Bio-Rad Laboratories Elizabeth Platt
K153474 12/02/2015 Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series BIOCHEMICAL DIAGNOSTICS, INC ALLEN PANETZ
K150296 02/06/2015 Biodenta Customized Abutment-Hybrid BIODENTA SWISS AG David Elier
K153573 12/15/2015 Converge BIOMEDICAL ENTERPRISES, INC Joe Soward
K150424 02/19/2015 JuggerStitch Meniscal Repair Device BIOMET MANUFACTURING CORP. Patricia S. Beres
K153558 12/14/2015 Ventix Suture Anchor BIOMET MANUFACTURING CORP. Adam Cargill
K153695 12/23/2015 Biomet Spine Fusion System Biomet Spine LLC. Kyle Hoefling
K150503 02/26/2015 Echo Bi-Metric Microplasty Line Extension BIOMET, INC. AMY WALRIVEN
K153657 12/21/2015 Vanguard XP Knee System BIOMET, INC. JULIE GANTENBERG
K150492 02/25/2015 Ora-GUARD Dental Grind Guard Bite Tech Inc. Jeff Padovan
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
K153617 12/18/2015 OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution) BOSTON SCIENTIFIC CORPORATION Eric Elliott
K153473 12/02/2015 Braemar Telemetry Patch System Braemar Manufacturing, LLC Kent Sayler
K153653 12/21/2015 DICOM Viewer Brainlab AG Rainer Birkenbach
K150498 02/26/2015 Discovery 24 BRAINMASTER TECHNOLOGIES, INC. Mr. Tom Collura
K153742 12/28/2015 Apollo Balloon Dilatation Catheter BrosMed Medical Co., Ltd. Tina Yin
K150353 02/11/2015 BTL-4000 BTL INDUSTRIES, INC Jan Zarsky
K150345 02/11/2015 Magic3 Go Intermittent Urinary Catheter C.R. BARD, INC. WILLIAM HEARD
K150514 02/27/2015 Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters C.R. Bard, Inc. James R. Davis
K153541 12/10/2015 Coldplay CryoBalloon« Ablation System C2 THERAPEUTICS, INC. THERESA BRANDNER-ALLEN
K153720 12/28/2015 ENZA Zero-Profile Anterior Interbody Fusion Camber Spine Technologies Michael Black
K150326 02/09/2015 PicoWay Laser System Candela Corporation Ruthie Amir
K153618 12/18/2015 Capillus202 CAPILLUS, LLC PATRICIA SCHNOOR
K153536 12/10/2015 Piccolo Composite« Nailing System CARBOFIX ORTHOPEDICS, LTD. YAEL RUBIN
K150289 02/05/2015 CARDIOLINE HD+ CARDIOLINE S.p.A Emanuele Ercoli
K153748 12/29/2015 AirLife Misty Finity Nebulizer CareFusion Erika Fernandez
K153554 12/14/2015 Genesis Low Temperature Reusable Rigid Container System CareFusion 2200 Inc Jane Weber
K153654 12/21/2015 Sentry WEB SmartInterp CareFusion Germany 234 GmbH Elmar Niedermeyer
K153492 12/04/2015 CareView 1800L CARERAY DIGITAL MEDICAL SYSTEM CO., LTD. Leilei Li
K153581 12/15/2015 Bladder Scanner Caresono Technology Co., Ltd. Yuzhong Ma
K150342 02/11/2015 Touch Ultrasound CARESTREAM HEALTH, INC. CAROLYN L WAGNER
K153519 12/08/2015 DReal CAREVATURE MEDICAL LTD Orly Maor
K150467 02/23/2015 Retina Workplace CARL ZEISS MEDITEC AG MICHAEL HAISCH
K150397 02/18/2015 Divine 9 CarraShield Labs, Inc. Dean Fresonke
K150320 02/09/2015 COMPASS CENTERVUE SPA ROBERTO GABRIOTTI
K153681 12/22/2015 PleuraFlow System CLEARFLOW, INC. DOV GAL
DEN150059 12/24/2015 APAS Compact with Urine Analysis Module CLEVER CULTURE SYSTEMS AG Lusia Guthrie
K153591 12/16/2015 ebb Complete Tamponade System CLINICAL INNOVATIONS, LLC TOM HAUETER
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
K153729 12/28/2015 8F FlowGate2 Balloon Guide Catheter CONCENTRIC MEDICAL SHAZIA HAKIM
K153599 12/16/2015 Concert Medical Hands-Free Syringe (HFS) Concert Medical, LLC Timothy S Powers
K153721 12/28/2015 iTotal Cruciate Retaining (CR) Knee Replacement System CONFORMIS, INC. Amita Shah
K153499 12/07/2015 EDGE Arthroscopic Energy System, Arthroscopic Energy System Probes, Arthroscopic Energy System Wireless Footswitch, Arthroscopic Energy System Corded Footswitch, Arthroscopic Energy System Foot Control, Extension ConMed Corporation Dionne Sanders
K153506 12/07/2015 Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit CONSURE MEDICAL PVT LTD. Nishith Chasmawala
K150350 02/11/2015 Flexi-Seal Signal Fecal Management System ConvaTec Ltd. Clare Williamson
K153761 12/30/2015 Emergency Transtracheal Airway Catheter COOK INCORPORATED KOTEI AOKI
K153778 12/31/2015 Nester Embolization Coils, Tornado Embolization Coils COOK INCORPORATED David Lehr
K153725 12/28/2015 Corin TaperFit Hip Stem CORIN USA LIMITED DIANA L. NADER-MARTONE
K153772 12/31/2015 Corin TriFit TS Hip CORIN USA LIMITED Diana L. Nader-Martone
K150277 02/05/2015 Pain Therapy System, Model PTS-II COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD Eagle Eagle
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
K153612 12/17/2015 ArthrexVIP Web Portal CUSTOM ORTHOPAEDIC SOLUTIONS, INC. Keith Grafmeyer
K153671 12/21/2015 Family of CoolGlide Aesthetic Lasers CUTERA, INC. Julia Brown
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
K153749 12/29/2015 3 Series Phototherapy Unit DAAVLIN DISTRIBUTING COMPANY MICHELE THIEL
K150359 02/12/2015 Tensyn Plug DALLEN MEDICAL, INC. Al Memmolo
K153549 12/11/2015 OSSIX VOLUMAX Datum Dental Ltd. Arie Goldlust
K153760 12/30/2015 Volumetric Infusion Controller DEKA RESEARCH & DEVELOPMENT Julie Perkins
K150347 02/11/2015 Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+ DELTEX MEDICAL LIMITED Paul Dwane
K153490 12/04/2015 DD medical polymers DENTAL DIREKT GMBH UWE GREITENS
K150344 02/11/2015 Dentis Dental Implant System DENTIS CO., LTD. JINJU LEE
K153639 12/21/2015 OneQ-SL s-Clean Implant System DENTIS CO., LTD. SUN CHUL SHIN
K153709 12/23/2015 Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer Stylet DEVICOR MEDICAL PRODUCTS, INC. SHAWNA ROSE
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
K153696 12/23/2015 Chattanooga Revolution Wireless DJO, LLC NATALIA SHIRINA
K153704 12/23/2015 Strive DJO, LLC Rand Daoud
K150327 02/10/2015 Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2 Dunamis LLC Prithviraj Chavan
K153746 12/29/2015 Dunamis Force DFX Tensile Tape Dunamis LLC Prithvi Raj Chavan
K153634 12/18/2015 Wireless Earlens Light Driven Hearing Aid EARLENS CORPORATION Deborah Arthur
K150239 02/02/2015 FibroScan Echosens Celine Fournier
K153475 12/02/2015 SD5 & SD6 Ultrasonic Tabletop Doppler EDAN INSTRUMENTS, INC. QUEENA CHEN
K153644 12/21/2015 ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II ELITechGroup Valerie Gourdon
K153588 12/16/2015 EndoChoice Water Bottle Cap System ENDOCHOICE, INC. Daniel Hoefer
K150271 02/04/2015 Prime Adaptive Ultrasonic Scalpel System ENDOPRIME, INC. RICHARD GRANT
K150364 02/12/2015 ERBE ESU Model VIO dV with Accessories ERBE ELEKTROMEDIZIN GMBH Axel Retzlaff
K150446 02/20/2015 Erchonia Zerona 6 headed scanner EZ6 ERCHONIA CORPORATION Steve Shanks
K153611 12/17/2015 Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device Ethicon, LLC Marjorie Medina
K150491 02/25/2015 ER36 Series OAE Test System ETYMOTIC RESEARCH, INC. Steve Iseberg
K153784 12/31/2015 NOSOGARD FILTERS Evoqua Water Technologies, LLC Robert Dudek
K153649 12/21/2015 Exactech« Novation« Element Press-fit Femoral Stem EXACTECH INC Thomas McNamara
K153595 12/16/2015 Optetrak Logic Metaphyseal Cones EXACTECH INC PATRICK HUGHES
K153776 12/31/2015 Optetrak One Logic Femoral Components Exactech Inc Patrick Hughes
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
K153583 12/15/2015 BioVision Plus FAXITRON BIOPTICS LLC CARLOS REYES
K150473 02/23/2015 FlexPointer 1.5 mm FIAGON GMBH DR. DIRK MUCHA
K153638 12/18/2015 Bicortical Fixation Screw & Washer Nut System FIRST RAY LLC ROBERT HOY
K153622 12/18/2015 First Ray Internal Bone Staple System FIRST RAY LLC Robert Hoy
K153585 12/16/2015 Flip Button Suture Anchor FIRST RAY LLC Robert Hoy
K153505 12/07/2015 F&P Eson 2 Nasal Mask FISHER & PAYKEL HEALTHCARE LIMITED SUE CHO
K153566 12/14/2015 Magma System FORMATK SYSTEMS LTD. AHAVA STEIN
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
K153483 12/03/2015 Balloon controller PB-30 FUJIFILM MEDICAL SYSTEMS U.S.A., INC. Aaron Ge
K153464 12/01/2015 FDR D-EVO flat Panel Detector System FUJIFILM MEDICAL SYSTEMS U.S.A., INC. Katherine Y. Choi
K153626 12/18/2015 SonoSite Edge II Ultrasound System FUJIFILM SONOSITE,INC. Patricia Liau
K150349 02/11/2015 Rapid Hair Removal Pads FULL POWER AED Jahn Power
K150488 02/25/2015 Humelock II Reversible Shoulder System FX SOLUTIONS Jean-Jacques Martin
K150408 02/18/2015 V-STEADY, V-FAST G21 S.R.L. MAURIZIO FORONI
K153533 12/09/2015 Tearaway Introducer Sheath, MicroSlide Tearaway Introducer GALT MEDICAL CORP. DAVID DERRICK
K150420 02/18/2015 Centricity Universal Viewer GE HEALTHCARE CHERYL BORK
K150298 02/06/2015 Entropy Module, E-ENTROPY-01 GE HEALTHCARE FILAND OY JOEL KENT
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
K150354 02/11/2015 PAPAYA 3D Plus GENORAY CO., LTD. Kyoung-hwa Kim
K153676 12/21/2015 OSTEON III GENOSS CO., LTD. EUNSANG LEE
K153670 12/21/2015 Genteel Lancing Device Genteel, LLC Christopher Jacobs
K153713 12/24/2015 Getinge Series Warming Cabinet GETINGE SOURCING, LLC BARB SMITH
K153466 12/01/2015 PillCam COLON 2 Capsule Endoscopy System GIVEN IMAGING LTD. HILLA DEBBY
K153590 12/16/2015 AvaDent Denture Base Material Global Dental Science Chuck Johnson
K150358 02/12/2015 Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System GOLD STANDARD DIAGNOSTICS NAPOLEON MONCE
K153716 12/24/2015 GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. GPC MEDICAL LTD VIKAS NARANG
K150373 02/13/2015 Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model No.: MD25x0/ MD26x0] GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED Patrick Chow
K153517 12/08/2015 AnyPlus« Cervical PEEK Cage System GS Medical Co., Ltd. Milan George
K153580 12/15/2015 Central Monitoring System GUANGDONG BIOLIGHT MEDITECH CO., LTD. Jin Liang
K153600 12/16/2015 Consult Station TS H4D SAS MARTA RIVAS
K153708 12/23/2015 Halyard Black-Orange Powder-Free Nitrile Exam Glove Halyard Health Christine L Macauley
K153741 12/28/2015 CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test HANGZHOU CLONGENE BIOTECH CO., LTD. ZHENG SHUJIAN
K150356 02/12/2015 Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card HEALGEN SCIENTIFIC LLC JIANQIU FANG
K153597 12/16/2015 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
K153489 12/04/2015 Cryocare CS Surgical System Health Tronics Maritza Ward
K153740 12/28/2015 RTHawk, HeartVista Cardiac Package HeartVista, Inc. James J Rogers
K150308 02/09/2015 Palm TENS HEAT IN A CLICK LLC GUY LEVI
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
K153582 12/15/2015 Prometheus ChitoGauze XR PRO HEMCON MEDICAL TECHNOLOGIES, INC. Maire Ni Beilliu
K153737 12/28/2015 OSTEOPAL plus HERAEUS MEDICAL GMBH ASTRID MARX
K153547 12/11/2015 ECHELON Oval V 5.1 MRI System Hitachi Medical Systems America, Inc. Doug Thistlethwaite
K153614 12/17/2015 PROBEAT-V and accessories HITACHI, LTD., HEALTH CARE COMPANY NAOYA NISHIMURA
K153486 12/04/2015 Affirm Prone Biopsy System Hologic Inc Sarah Fairfield
K153719 12/28/2015 LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream HONEYWELL HOMMED, LLC Greg Lillegard
K153615 12/17/2015 NeoFuse HA Enhanced PLIF/TLIF HT MEDICAL, LLC ROBERT COMPTON
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
K153557 12/14/2015 ABPM 7100, Hypertension Management Software I.E.M. GMBH Hella Witt
K153570 12/14/2015 Axxent Electronic Brachytherapy System Model 110 XP 1200 ICAD INC. John DeLucia
K153694 12/23/2015 Icare ic100 Icare Finland Oy Matti Tulikoura
K153756 12/30/2015 Microlyte Ag IMBED BIOSCIENCES, INC. ANKIT AGARWA
K150513 02/27/2015 Imed Technology Intravascular Administration Set, Imed Technology Extension Set IMED TECHNOLOGY, INC. KYLE ADAMS
K153538 12/10/2015 Dextramer CMV Kit Immudex Aps Liselotte Brix
K150275 02/04/2015 Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls Immunalysis Corporation Joseph Ginete
K153693 12/23/2015 Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators IMMUNALYSIS CORPORATION JOSEPH GINETE
K153509 12/07/2015 GPS Angled Abutment IMPLANT DIRECT SYBRON MANUFACTURING LLC DEBLEENA SINHA
K153650 12/21/2015 Microdent Ektos Implant System IMPLANTS MICRODENT SYSTEM S.L JORDI CLAPES DONADEU
K153770 12/30/2015 OS2(R)-VP Varisation Staple IN2BONES SAS MORGANE GRENIER
K153609 12/17/2015 RTS Flexible 1 MPJ Implant w/Grommets In2BonesUSA, LLC Joe Clift
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
K153692 12/23/2015 Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer INFRARED LABORATORY SYSTEMS, LLC (DBA SYNERMED) JULIE PASCHAL
K153568 12/14/2015 InMode Plus System InMode MD Ltd. Ahava Stein
K150500 02/26/2015 Px PEEK IBF System INNOVASIS, INC. Marshall McCarty
K150365 02/12/2015 Cloud9 System inSleep Technologies, LLC Marty Kerber
K153758 12/30/2015 Straumann Bone Level Tapered Implants INSTITUT STRAUMANN AG Christopher Klaczyk
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
K153766 12/30/2015 Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens for Daily Wear Interojo Inc. Si-Chul Rho
K150343 02/11/2015 V8 Transluminal BAV Catheter InterValve, Inc. Mark Ungs
K153484 12/03/2015 Dillard Airway Dilatation System INTUIT MEDICAL PRODUCTS, LLC JACK GRIFFIS
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
DEN150008 02/23/2015 INVOcell INVO BIOSCIENCE Kathleen Karloff
K153544 12/11/2015 cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System IQuum, Inc. Lingjun Chen
K153472 12/02/2015 Quiver Laparoscopic Extendable ITL Corporation PTY LTD Emily Rossiter
K150393 02/18/2015 TETRIC EVOFLOW BULK FILL IVOCLAR VIVADENT AG SANDRA CAKEBREAD
K153753 12/29/2015 TelioCAD Multi IVOCLAR VIVADENT, INC. DONNA MARIE HARTNETT
K153605 12/17/2015 ivWatch Model 400 ivWatch, LLC Jaclyn Lautz
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
K153727 12/28/2015 INTRAcel Premium Fractional RF Micro Needle (FRM) System JEISYS MEDICAL, INC. HYOSEOK LEE
K150367 02/12/2015 Neodent Implant System JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S Jacson Cambruzzi
K153624 12/18/2015 Neodent Implant System JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S Jacson Cambruzzi
K153520 12/08/2015 Electronic Pulse Stimulator JKH HEALTH CO.,LTD. Pu Jiang
K150468 02/23/2015 Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs K2 Medical GmbH & Co. KG Harald Jung
K153526 12/09/2015 Pyrenees Cervical Plate System K2M Nancy Giezen
K150325 02/09/2015 Range/Denali/Mesa Spinal System K2M, Inc Nancy Giezen
K150481 02/24/2015 Cascadia Interbody System K2M, Inc. Nancy Giezen
K153482 12/03/2015 KLS Martin Thoracic Plating System KLS-MARTIN L.P. Jennifer Damato
K153762 12/30/2015 Smartdop XT6 KOVEN TECHNOLOGY, INC. Heather Bell
K153476 12/02/2015 KATANA AVENCIA Block Kuraray Noritake Dental, Inc. Michio Takigawa
K153656 12/21/2015 PathLoc-SI Joint Fusion System L&K BIOMED Co., Ltd. Yerim An
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K153495 12/07/2015 Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System LDR Spine USA Brad Strasser
K153710 12/24/2015 Tuxedo Digital Dental Sensor LED DENTAL INC Wesley Newsom
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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
K153722 12/28/2015 SMR 3-Pegs Glenoids Limacorporate S.p.A. Emmanuele Buttazzoni
K153569 12/15/2015 Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml LIOFILCHEM S.R.L Fabio Brocco
K153687 12/23/2015 Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL Liofilchem s.r.l Fabio Brocci
K153698 12/23/2015 LumenR Tissue Retractor System LumenR, LLC GREGORY PISKUN
K153769 12/30/2015 R:GEN Laser System Lutronic Corporation Jhung Won Vojir
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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
K153523 12/09/2015 FUSION Vascular Graft MAQUET CARDIOVASCULAR, LLC Mark Dinger
K153688 12/23/2015 Edi Catheter ENFit MAQUET CRITICAL CARE AB MIRVA BOOTHE
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K150314 02/09/2015 Masimo MightySat Rx Fingertip Pulse Oximeter MASIMO CORPORATION Marguerite Thomlinson
K153602 12/17/2015 Materialise Glenoid Positioning System MATERIALISE NV OLIVER CLEMENS
K153659 12/21/2015 MaxO2ME MAXTEC, LLC JERALD WILSON
K153743 12/28/2015 PIEZOSURGERY PLUS MECTRON SPA ZUNINO FRANCO
K153664 12/21/2015 M.U.S.T. Pedicle Screw System MEDACTA INTERNATIONAL MICHAEL G. LOITERMAN
K150499 02/26/2015 Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty MEDELA AG ORLANDO ANTUNES
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K150487 02/25/2015 X-Suit NIR Biliary Metallic Stent MEDINOL LTD. Michal Hershkovitz
K150286 02/05/2015 Medline Enteral Feeding Sets MEDLINE INDUSTRIES, INC. Stephanie Blair
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K150333 02/10/2015 MedSource Sharps Dart MedSource International, LLC Laura Riggen
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K153598 12/16/2015 Medtronic Bio-Medicus Adult Cannula Kit MEDTRONIC INC. JENNIFER TANG
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K153589 12/16/2015 CD HORIZON Spinal System MEDTRONIC SOFAMOR DANEK USA, INC. ANKIT K. SHAH
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K150250 02/03/2015 SternSnap Angled Attachment Sterngold Dental, LLC MARIA RAO
K153508 12/07/2015 Stryker CMF MEDPOR Customized Implant Stryker Jonathan Schell
K150449 02/20/2015 LITe Plate System STRYKER CORP. GARRY T. HAYECK
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K153685 12/22/2015 Sunmed Haemostatic Valves SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD. James Qi Zhang
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K150253 02/03/2015 Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm TAIWAN SURGICAL CORPORATION HSIU-PING HUANG
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K153510 12/07/2015 Powder Free Polychloroprene Examination Glove Green TERANG NUSA SDN BHD ROBERT HILL
K153601 12/16/2015 Spectra Optia Apheresis System Terumo BCT, Inc Nicholas Wong
K150263 02/04/2015 K-Pack II Needle-21G x 2 TERUMO EUROPE N.V. M J Aerts
K153703 12/23/2015 Guiding Catheter Texas Medical Technologies, Inc. Aaron Chiu
K153771 12/30/2015 TXM Guiding Sheath Texas Medical Technologies, Inc. Aaron Chiu
K150412 02/18/2015 Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator The Binding Site Group Ltd Marianne Sender
K153560 12/14/2015 Optilite Low Level Albumin Kit THE BINDING SITE GROUP LTD JON LAUDER
K150236 02/02/2015 Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Dalbavancin (0.0005 - 2ug/mL) THERMO FISHER SCIENTIFIC CYNTHIA KNAPP
K153647 12/21/2015 TSolution One w/ACG+ Surgical System THINK SURGICAL INC. IN K. MUN
K150427 02/19/2015 Vantage Titan 1.5T, V3.1, MRT-1510 TOSHIBA MEDICAL SYSTEMS CORPORATION Janine Reyes
K150270 02/04/2015 ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment Set TOSOH BIOSCIENCE, INC. Robert L Wick
K153498 12/07/2015 Operio TOUL MEDITECH AB Tomas Hansson
K153531 12/09/2015 Treace Medical Concepts (TMC) Plating System TREACE MEDICAL CONCEPTS, INC. JOE FERGUSON
K150292 02/06/2015 Chocolate PTCA Balloon Catheter TRIREME MEDICAL, LLC Shiva Ardakani
K153682 12/22/2015 Chocolate XD PTCA Balloon Catheter TriReme Medical, LLC Shiva Ardakani
K153689 12/23/2015 STERIZONE Sterilizer TSO3 INC NATHALIE RACETTE
K153575 12/15/2015 Tyber Medical Trauma Screw TYBER MEDICAL LLC Mark F Schenk
K150394 02/18/2015 Tyber Medical Wedge System TYBER MEDICAL LLC JEFF TYBER
K150386 02/18/2015 Tyece OTC TENS Device TYECE LTD Parshid Falahati
K150505 02/25/2015 Cellfina System ULTHERA, INC. Suzon Lommel
K153677 12/21/2015 The 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
K150476 02/24/2015 Spectra S1Plus and Spectra S2 Plus UZINMEDICARE CO. Ho Jun Kang
K150389 02/18/2015 Spiral Flow Peripheral Vascular Graft VASCULAR FLOW TECHNOLOGIES LTD Edwin Lindsay
K153502 12/07/2015 ClariVein IC VASCULAR INSIGHTS, LLC LORRAINE M. HANLEY
K153717 12/24/2015 Venus Versa System Venus Concept Ltd. Tal Bresler-Stramer
K153562 12/14/2015 Powder Free Blue Nitrile Examination Glove Viet Glove Corporation Pham Ngoc Thanh
K153565 12/14/2015 DONASORB SILVER WOUND DRESSING VIRCHOW BIOTECH PVT. LTD. BRUCE GIBBINS
K150385 02/18/2015 NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses Visioneering Technologies, Inc. Stephen Snowdy
K153548 12/11/2015 VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM VISIONSENSE LTD ALEX CHANIN
K153645 12/21/2015 VITA ENAMIC Implant Solutions (IS) VITA ZAHNFABRIK H. RAUTER GMBH CO. BERND WALKER
K150258 02/03/2015 Vitrea, Version 7.0 Medical Image Processing Software Vital Images, Inc Parthiv Shah
K153477 12/02/2015 EMMa Electronic Monitoring Management VITASYSTEMS GMBH Michael Rothhaar
K153493 12/04/2015 Clip Flow VOCO GmbH M. Th. Plaumann
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
K153733 12/28/2015 VORTRAN Manometer VORTRAN MEDICAL TECHNOLOGY 1, INC. JAMES LEE
K153513 12/07/2015 Insufflator 50L FM134 W.O.M WORLD OF MEDICINE GMBH Soeren Markworth
K150336 02/10/2015 Photonica Professional Ward Photonics LLC Terry Ward
K153543 12/11/2015 WHILL Model M WHILL, INC. TERESE BOGUCKI
K153478 12/02/2015 Sydney IVF Gamete Buffer WILLIAM A. COOK AUSTRALIA PTY LTD Gordana Pozvek
K153763 12/30/2015 Howell Biliary Aspiration Needle WILSON-COOK MEDICAL, INC. Jennifer McMahan
K150252 02/03/2015 PHALINX Hammertoe System WRIGHT MEDICAL TECHNOLOGY, INC. Val Myles
K153635 12/18/2015 SALVATION(R) External Fixation System WRIGHT MEDICAL TECHNOLOGY, INC. Leslie Fitch
K153496 12/07/2015 Disposable Surgical Face Mask XIANTAO RAYXIN MEDICAL PRODUCTS CO., LTD. Liang Zhang
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
K153631 12/18/2015 Zimmer Virage OCT Spinal Fixation System Zimmer Spine, Inc Ted Kuhn
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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