FDA 510(k) Applications Received During December, 2015

FDA 510(k) Number Submission Date Device Name Applicant Contact
K153705 12/23/2015 PROcedure Rehearsal Studio 3DSYSTEMS, SIMBIONIX PRODUCTS KIM TORLUEMKE
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
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
K153754 12/29/2015 MicroMatrix ACELL, INC THOMAS GILBERT
K153613 12/17/2015 Cerafix Dura Substitute ACERA SURGICAL, INC. MATTHEW MACEWAN
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
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
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
K153561 12/14/2015 AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System ANDON HEALTH CO., LTD Yi Liu
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
K153675 12/21/2015 Paragon T2 Wand with Integrated Cable ARTHROCARE CORPORATION KRYSTLE DANUZ
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
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
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
K153573 12/15/2015 Converge BIOMEDICAL ENTERPRISES, INC Joe Soward
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
K153657 12/21/2015 Vanguard XP Knee System BIOMET, INC. JULIE GANTENBERG
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
K153742 12/28/2015 Apollo Balloon Dilatation Catheter BrosMed Medical Co., Ltd. Tina Yin
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
K153618 12/18/2015 Capillus202 CAPILLUS, LLC PATRICIA SCHNOOR
K153536 12/10/2015 Piccolo Composite« Nailing System CARBOFIX ORTHOPEDICS, LTD. YAEL RUBIN
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
K153519 12/08/2015 DReal CAREVATURE MEDICAL LTD Orly Maor
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
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
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
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
K153749 12/29/2015 3 Series Phototherapy Unit DAAVLIN DISTRIBUTING COMPANY MICHELE THIEL
K153549 12/11/2015 OSSIX VOLUMAX Datum Dental Ltd. Arie Goldlust
K153760 12/30/2015 Volumetric Infusion Controller DEKA RESEARCH & DEVELOPMENT Julie Perkins
K153490 12/04/2015 DD medical polymers DENTAL DIREKT GMBH UWE GREITENS
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
K153696 12/23/2015 Chattanooga Revolution Wireless DJO, LLC NATALIA SHIRINA
K153704 12/23/2015 Strive DJO, LLC Rand Daoud
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
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
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
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
K153583 12/15/2015 BioVision Plus FAXITRON BIOPTICS LLC CARLOS REYES
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
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
K153533 12/09/2015 Tearaway Introducer Sheath, MicroSlide Tearaway Introducer GALT MEDICAL CORP. DAVID DERRICK
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
K153716 12/24/2015 GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. GPC MEDICAL LTD VIKAS NARANG
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
K153597 12/16/2015 Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card HEALGEN SCIENTIFIC LLC Jianqiu Fang
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
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
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
K153538 12/10/2015 Dextramer CMV Kit Immudex Aps Liselotte Brix
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
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
K153758 12/30/2015 Straumann Bone Level Tapered Implants INSTITUT STRAUMANN AG Christopher Klaczyk
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
K153484 12/03/2015 Dillard Airway Dilatation System INTUIT MEDICAL PRODUCTS, LLC JACK GRIFFIS
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
K153753 12/29/2015 TelioCAD Multi IVOCLAR VIVADENT, INC. DONNA MARIE HARTNETT
K153605 12/17/2015 ivWatch Model 400 ivWatch, LLC Jaclyn Lautz
K153727 12/28/2015 INTRAcel Premium Fractional RF Micro Needle (FRM) System JEISYS MEDICAL, INC. HYOSEOK LEE
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
K153526 12/09/2015 Pyrenees Cervical Plate System K2M 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
K153469 12/01/2015 Cathtong I PICC Catheter L&Z US, INC. JENELLA COUTTS
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
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
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
K153461 12/01/2015 Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire for Edi Catheter 8 Fr, 125 cm MAQUET CRITICAL CARE AB Mirva Boothe
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
K153663 12/21/2015 Vario 8/18/ci MEDELA AG MARKUS BUTLER
K153667 12/21/2015 TRUESPAN Meniscal Repair System Medos International SARL Kristine Christo
K153598 12/16/2015 Medtronic Bio-Medicus Adult Cannula Kit MEDTRONIC INC. JENNIFER TANG
K153555 12/14/2015 EM ENT Navigated Suctions MEDTRONIC NAVIGATION, INC. Carey Brenner
K153660 12/21/2015 StealthStation System with Cranial Software MEDTRONIC NAVIGATION, INC. Augusta Henao
K153589 12/16/2015 CD HORIZON Spinal System MEDTRONIC SOFAMOR DANEK USA, INC. ANKIT K. SHAH
K153463 12/01/2015 CD HORIZON Spinal System, IPC POWEREASE System MEDTRONIC SOFAMOR DANEK USA, INC. Becky Ronner
K153501 12/07/2015 Bullfrog Micro-Infusion Device MERCATOR MEDSYSTEMS, INC. KIRK P. SEWARD
K153661 12/21/2015 ImmunoCard STAT! HpSA Meridian Bioscience, Inc Susan Rolih
K153672 12/21/2015 basixTOUCH40 Inflation Syringe MERIT MEDICAL SYSTEMS, INC. DAN W. LINDSAY
K153594 12/16/2015 MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) MICROVENTION, INC. Laraine Pangelina
K153739 12/28/2015 MRI Patient Monitor TeslaDUO MIPM MAMMENDORFER INSTITUT FUR PHYSIK UND MEDIZIN HANS SCHWAIGER
K153577 12/15/2015 FREND Testosterone Test System NanoEnTek USA Inc. Jimmy Chen
K153584 12/15/2015 NeoTract UroLift System UL500 NeoTract, Inc. Nancy E Isaac
K153707 12/23/2015 Nihon Kohden Vital Sign Telemeter NIHON KOHDEN CORPORATION TOM BENTO
K153479 12/02/2015 NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System NINEPOINT MEDICAL, INC EMAN NAMATI
K153665 12/21/2015 PROW FUSION-L NLT SPINE LTD Eti Zinger
K153786 12/31/2015 PROW FUSION-V NLT SPINE LTD Eti Zinger
K153534 12/09/2015 NobelProcera HT ML Full Contour Zirconia Crown NOBEL BIOCARE AB Charlemagne Chua
K153627 12/18/2015 NuVasive« TLX Interbody System NUVASIVE INCORPORATED CYNTHIA ADAMS
K153782 12/31/2015 NuVasive« Lumbar Interbody Implants NUVASIVE, INCORPORATED MARTIN YAHIRO
K153648 12/21/2015 Microcyn Plus Skin and Wound Hydrogel OCULUS INNOVATIVE SCIENCES Brian W. Martin
K153773 12/31/2015 Disposal Lens Cleaning Sheath OLYMPUS MEDICAL SYSTEMS CORP. TOSHIYUKI NAKAJIMA
K153625 12/18/2015 Single Use Injector NM600/610 OLYMPUS MEDICAL SYSTEMS CORP. TOSHIYUKI NAKAJIMA
K153620 12/18/2015 Enovare Ultrasound System OREON TECHNOLOGIES INC. Howard Fidel
K153608 12/17/2015 Vitoss BiModal Bone Graft Substitute Foam Strip ORTHOVITA, INC. LYNN LUNDY
K153550 12/11/2015 FTRD System Set OVESCO ENDOSCOPY AG MARC O. SCHURR
K153528 12/09/2015 PacEndo EDTA PAC-DENT INTERNATIONAL, INC. Wenying Zhu
K153678 12/21/2015 PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove PERMEADERM, INC. AUBREY WOODROOF
K153480 12/02/2015 ClearVue850 Diagnostic Ultrasound System PHILIPS HEALTHCARE Saraswathi Deora
K153702 12/23/2015 M3290B Philips IntelliVue Information Center iX PHILIPS MEDICAL SYSTEMS THERESA POOLE
K153593 12/16/2015 CliniscanSM MRI PICOFEMTO LLC Jessica Phillips
K153736 12/28/2015 3mensio Workstation Pie Medical Imaging B.V. Annemiek Bouts
K153735 12/28/2015 Release Laminoplasty Fixation System Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) Sarah Pleaugh
K153546 12/11/2015 PINK CAD/CAM disc POLIDENT D.O.O., DENTAL PRODUCTS INDUSTRY JANJA LIPUSCEK
K153655 12/21/2015 Accuryn Monitoring System POTRERO MEDICAL, INC. DEVYANI NANDURI
K153518 12/08/2015 Medipure Oxygen-LC System PRAXAIR DISTRIBUTION, INCORPORATED. Michael Skrjanc
K153514 12/07/2015 Premium Plus C01/C02 LED Curing Light PREMIUM PLUS INTERNATIONAL LIMITED Jessica Mao
K153732 12/28/2015 Powder Free Blue Nitrile Examination Glove QUBE MEDICAL PRODUCT SDN BHD TEO SIONG YAM
K153712 12/24/2015 VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit RADIOMETER AMERICA INC. Matt Ackerman
K153673 12/21/2015 AirFit N20 ResMed Ltd Kim Kuan Lee
K153563 12/14/2015 AirFit F20 RESMED LTD. Johanna Wright
K153628 12/18/2015 ROSC-U Mini Chest Compressor (RMCC) Resuscitation International, LLC HAYDEN FLEMING
DEN150057 12/09/2015 Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5 ROCHE DIAGNOSTICS Edie Eads
K153607 12/17/2015 ROMA Calculation Tool Using Elecsys Assays ROCHE DIAGNOSTICS Angelo Pereira
K153540 12/10/2015 Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators SAFE SECURE PACKAGING CO., LTD HOWARD JIA
K153646 12/21/2015 SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana SAFECARE BIOTECH (HANGZHOU)CO.,LTD. Alex Qiu
K153539 12/10/2015 RS80A Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD. Kyeong-Mi Park
K153529 12/09/2015 WS80A Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD. Kyeong-Mi Park
K153683 12/22/2015 Trak Male Fertility Testing System SANDSTONE DIAGNOSTICS, INC. Greg Sommer
K153525 12/09/2015 Seneka II Polyscrew Pedicle Fixation System Senecka Spine Khalid Sethi
K153521 12/08/2015 IH Implant System Sewon Medix Inc. Bum-keun Park
K153545 12/11/2015 Portable Slit Lamp SHANGHAI BOLAN OPTICAL-ELECTRIC CO.,LTD. Johnny Hu
K153767 12/30/2015 X-cera Zirconia Blanks SHENZHEN XIANGTONG PHOTOELECTRICITY TECHNOLOGY CO., LTD. YONGQING CHEN
K153759 12/30/2015 SIGN Compression Screw System SIGN FRACTURE CARE INTERNATIONAL ROB R. TEETER
K153485 12/03/2015 ENROUTE Transcarotid Neuroprotection System SILK ROAD MEDICAL, INC. KRISTIN ELLIS
K153553 12/11/2015 SiO2 Coated syringe 3 ml SiO2 Medical Products Sandra L True
K153606 12/17/2015 LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera Coupler, Tablet Application SMITH & NEPHEW JANICE HASELTON
K153723 12/28/2015 ACTICOAT Surgical Dressing Smith & Nephew Medical Limited Samantha Neilson
K153537 12/10/2015 Sol-M Insulin Syringe, Sol-M TB Syringe SOL-MILLENNIUM MEDICAL, INC. Jim Barley
K153636 12/18/2015 Liberator Powered Wheelchair with Solar Companion SOLAR MOBILITYLLC KURT SCHNEIDER
K153701 12/23/2015 ULYSS Multi View Sinuscope SOPRO-COMEG GMBH HAROLD LETTAU
K153530 12/09/2015 Bridge Occlusion Balloon SPECTRANETICS, INC. Christopher McLellan
K153621 12/18/2015 Juliet« Ti SPINEART FRANCK PENNESI
K153783 12/31/2015 SpaceVision« PLIF, SpaceVision« OLIF, SpaceVision« TLIF SpineVision S.A. Helene PLAS
K153686 12/23/2015 SPIWay Endonasal Access Guide SPIWAY LLC EUGENE CHEN
K153706 12/23/2015 Insulin Pen Needle STERILANCE MEDICAL (SUZHOU) INC. Juanjuan Sun
K153508 12/07/2015 Stryker CMF MEDPOR Customized Implant Stryker Jonathan Schell
K153679 12/21/2015 Stryker Neptune E-SEP Smoke Evacuation Pencil STRYKER CORPORATION MAIREAD TWOMEY
K153658 12/21/2015 Target Detachable Coils Stryker Neurovascular Kate Taylor
K153685 12/22/2015 Sunmed Haemostatic Valves SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD. James Qi Zhang
K153745 12/29/2015 Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider SURGICAL INSTRUMENT SERVICE AND SAVINGS INC (DBA MEDLINE REN BRANDI J. PANTELEON
K153714 12/24/2015 SynergEyes A&M (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes KC (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes PS (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes SiH (petr Synergeyes, Inc. Karen Kincade
K153527 12/09/2015 PicoWay Laser System SYNERON CANDELA CORPORATION Ruthie Amir
K153587 12/16/2015 Taps for Resorbable Screws SYNTHES (USA) PRODUCTS LLC Susan Lewandowski
K153690 12/23/2015 PriMatrix Dermal Repair Scaffold TEI BioSciences Inc. David D Cox
K153652 12/21/2015 ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set TELEFLEX INC. CHET JONES
K153470 12/02/2015 MADgic Laryngo-Tracheal Mucosal Atomization Device TELEFLEX MEDICAL Kristen Bisanz
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
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
K153560 12/14/2015 Optilite Low Level Albumin Kit THE BINDING SITE GROUP LTD JON LAUDER
K153647 12/21/2015 TSolution One w/ACG+ Surgical System THINK SURGICAL INC. IN K. MUN
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
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
K153677 12/21/2015 The Cellfina System ULTHERA, INC. Suzon Lommel
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
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
K153477 12/02/2015 EMMa Electronic Monitoring Management VITASYSTEMS GMBH Michael Rothhaar
K153493 12/04/2015 Clip Flow VOCO GmbH M. Th. Plaumann
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
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
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
K153631 12/18/2015 Zimmer Virage OCT Spinal Fixation System Zimmer Spine, Inc Ted Kuhn


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