FDA 510(k) Decisions During June, 2016  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K160546 06/09/2016 3M Attest Rapid Readout Biological Indicator 3M COMPANY Matt Mortensen
K161559 06/23/2016 Kuvia3D 4QIMAGING, LLC DBA QMETRICS EDWARD SCHREYER
K153436 06/06/2016 LATERAL Spine Truss System 4Web, Inc. Jessee Hunt
K153730 06/15/2016 ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control Abbott Laboratories Laura Yelvigi Joglekar
K153456 06/14/2016 Megapulse III Shortwave Diathermy Accelerated Care Plus Patrick Parker
K161144 06/24/2016 iDMS Data Management System ACCURAY INCORPORATED Elizabeth Osuna
K161136 06/24/2016 Precision Treatment Planning System ACCURAY INCORPORATED Shweta Kaushik
K161146 06/24/2016 Radixact Treatment Delivery System ACCURAY INCORPORATED Keith Picker
K160264 06/01/2016 Additive Orthopaedics Hammertoe Correction System Additive Orthopaedics, LLC Greg Kowalczyk
K153552 06/01/2016 AGE Automatic Upper Arm Blood Pressure Monitor Ageless Health Industrial Co., Ltd Victor Wan
K161061 06/22/2016 IMPAX Volume Viewing 4.0 AGFA HEALTHCARE N.V. Koen Cobbaert
K160364 06/10/2016 VersaWrap Tendon Protector Alafair Biosciences Inc Ben Walthall
K161247 06/30/2016 Relizorb Alcresta Therapeutics, Inc. Robert Gallotto
K161364 06/17/2016 BinaxNOW G6PD Test ALERE SCARBOROUGH, INC. Angela Drysdale
K152122 06/24/2016 Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) ALFA SCIENTIFIC DESIGNS, INC. MICHAEL CHANG-CHIEN
K152576 06/02/2016 Anker II Dental Implant System Alliance Global Technology Co., Ltd. YAYUAN CHANG
K161363 06/10/2016 Arsenal Spinal Fixation System ALPHATEC SPINE, INC RENEE MURPHY
K161342 06/15/2016 Sonic Window ANALOGIC CORPORATION MICHAEL J. DOYLE
K153288 06/01/2016 Voyant Open Fusion Device APPLIED MEDICAL RESOURCES JESSICA CHO
K153632 06/16/2016 Endoform Reconstructive Template Aroa Biosurgery Limited (Formerly Mesynthes Limited) Yasmin Rai
K160669 06/24/2016 ClariFix Device ARRINEX, INC. VAHID SAADAT
K160018 06/13/2016 Arrow Quickflash Arterial Catheterization Device ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.) TRACY LARISH
K161539 06/30/2016 Arthrosurface Bone Screws ARTHROSURFACE, INC. DAWN J. WILSON
K161362 06/14/2016 ASAHI Corsair Armet Asahi Intecc Co., Ltd. Carroll Councilman
K153106 06/21/2016 ASAHI Fielder XT-A, ASAHI Fielder XT-R ASAHI INTECC CO., LTD. Yoshihiko Fukui
K160430 06/24/2016 Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System Ascensia Diabetes Care US Inc. Jennifer L. Gregory
K153165 06/01/2016 NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit ASTUTE MEDICAL, INC Karin Hughes
K161297 06/07/2016 Beta-2-Microglobulin Beckman Coulter Ireland Inc. Eimear Carr
K160578 06/29/2016 Nustat XR Beeken Biomedical, LLC DAN O'HARA
K152984 06/03/2016 Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes BIO PROTECH, INC. DANIEL WOO
K160911 06/28/2016 VIDAS B.R.A.H.M.S. PCT (PCT) bioMerieux, Inc Thi My Lan Dang
K160071 06/16/2016 StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis Biomet, Inc. Carmen Albany
K160204 06/09/2016 BSD4343 Digital Flat Panel X-ray Detector BONTECH INC. Kwang S. Choi
K160751 06/14/2016 Symphion Endoscope and Symphion Cervical Sheath BOSTON SCIENTIFIC BROOKE CUDDY
DEN150040 06/03/2016 WallFlex Biliary RX Fully Covered Stent System RMV BOSTON SCIENTIFIC THOMAS HIRTE
K161003 06/17/2016 EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Fee BOSTON SCIENTIFIC CORPORATION VIRGINIA GARCIA
K160823 06/23/2016 NC Quantum Apex PTCA Dilatation Catheter BOSTON SCIENTIFIC CORPORATION JANE HORAN
K160514 06/22/2016 OptiCross 18, 30 MHz Peripheral Imaging Catheter BOSTON SCIENTIFIC CORPORATION Eric Elliott
K161134 06/20/2016 Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator BOVIE MEDICAL CORPORATION BRIAN KUNST
K161183 06/03/2016 Halo One Thin-Walled Guiding Sheath C.R. BARD, INC FIONA NI MHULLAIN
K153393 06/28/2016 PowerMidline Catheter C.R. BARD, INC Casey Coombs
K151985 06/14/2016 PowerPICC« EtOH Catheter and PowerPICC SOLO«2 EtOH Catheter C.R. Bard, Inc Bryan Stone
K153280 06/02/2016 PowerGlide Pro Midline Catheter C.R. BARD, INC. CASEY COOMBS
K161024 06/28/2016 Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape Canadian Technical Tape, Ltd. Howard Cohen
K153312 06/28/2016 SCATTER CORRECTION FOR CXDI SERIES CANON, INC SHINJI MORI
K161556 06/30/2016 CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit Centers for Disease Control and Prevention (CDC) Yon Yu
K153181 06/08/2016 MAIA CENTERVUE SPA ROBERTO GABRIOTTI
K160901 06/29/2016 Xpert Carba-R CEPHEID SCOTT A. CAMPBELL
K160775 06/03/2016 ThunderboltÖ Minimally Invasive and LancerÖ Open Pedicle Screw Systems CHOICE SPINE LP KIM FINCH
K152600 06/23/2016 Collagen Dental Wound Dressings COLLAGEN MATRIX, INC. GLORIA ZUCLICH
K161366 06/14/2016 ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) CONFORMIS, INC. AMITA SHAH
K151229 06/02/2016 ABC D-FLEX PROBE CONMED CORPORATION SANDY LECLAIR
K152863 06/22/2016 Portable ECG Monitor CONTEC MEDICAL SYSTEMS CO., LTD XUEYONG LI
K160891 06/24/2016 Ultrathane Endoureterotomy Stent Set Cook Incorporated Kara Kanorr
K152893 06/03/2016 Corin Optimized Positioning System (OPS) CORIN USA Kathy Trier
K160539 06/15/2016 BiZact Open Sealer/Divider COVIDIEN Sharon McDermott
K161045 06/17/2016 Monoject Covidien Sona Manickam
K153749 06/30/2016 3 Series Phototherapy Unit DAAVLIN DISTRIBUTING COMPANY MICHELE THIEL
K160005 06/07/2016 Contact Lens Case (multiple brand name) DANYANG CHANXIN GLASSES CASES FACTORY LEMON CHEN
K151987 06/01/2016 DCI Edge Dental Chair with Operative Unit DCI ROBERT BELLINGHAM
K152246 06/21/2016 Aquarius Stoma Measuring Device DEGANIA SILICONE LTD ZOYA LEE
K160926 06/28/2016 F1 MPS Modular Pedicle Screw System Degen Medical Craig Black
K160498 06/15/2016 Dentivera Milling Disc Dental Solutions, LLC Kendra Shoulders
K160213 06/21/2016 s-Clean Tapered II RBM Implant System Dentis Co., Ltd. Sun Chul Shin
K160232 06/07/2016 Disposable Barrier Sleeves and Covers DENTSPLY International Inc. Helen Lewis
K160700 06/10/2016 ATTUNE Revision Knee System Depuy (Ireland) Jaime Weeks
K161526 06/30/2016 LIAISON CMV IgM Serum Control Set DiaSorin Inc. JOHN WALTER
K161522 06/30/2016 LIAISON EBV IgM Serum Control Set DiaSorin Inc. John Walter
K152667 06/09/2016 ATOVEN-Reusable Laser Fiber DIOTECH CO LEE KYUNG YONG
K153704 06/03/2016 Strive DJO, LLC Rand Daoud
K161444 06/21/2016 DBSWIN and VistaEasy Imaging Software Duerr Dental AG Oliver Lange
K152937 06/23/2016 EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented ECO MEDI GLOVE SDN. BHD. SURESH KUMAR
K151137 06/07/2016 X-VIEW, IMAGEN EDLEN IMAGING LLC NICK RADACHI
K160552 06/01/2016 EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform EDWARDS LIFESCIENCES, LLC Tara Viviani
K160645 06/16/2016 PreSep Oligon Oximetry Catheter EDWARDS LIFESCIENCES, LLC Deana Boushell
K160668 06/03/2016 HumaPen Savvio Eli Lilly and Company, Inc. Christine A. Phliips
K153353 06/23/2016 SANDMAN ELITE EMBLA SYSTEMS SHANE T. SAWALL
K152918 06/02/2016 Gun Oil, Pink, Gun Oil H2O, Pink Water EMPOWERED PRODUCTS, INC. MATT CARR
K161482 06/27/2016 EndoChoice Water Bottle Cap Irrigation System ENDOCHOICE, INC. DAINEL HOEFER
K161147 06/07/2016 EndoCure Model EUR078A ENDOCURE TECHNOLOGIES, INC. CHARLES J. NEFF
K153164 06/03/2016 LunulaLaser ERCHONIA MEDICAL, INC. STEVE SHANKS
K160752 06/29/2016 HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length ETHICON ENDO-SUREGERY, LLC MARJORIE MEDINA
K153611 06/03/2016 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
K160697 06/28/2016 Gibralt« Spine System and Gibralt« Occipital Spine System Exactech, Inc. Dawn Davisson
K153057 06/23/2016 FitRiteÖ Total Hip Arthroplasty System EXCERA ORTHOPEDICS, INC. SCOTT COLERIDGE
K153372 06/30/2016 Repagyn vaginal suppositories FARMA-DERMA S.R.L. MARA CALZOLARI
K160573 06/01/2016 FirstSense Breast Exam First Sense Medical, LLC Paul G. Angott
K160540 06/23/2016 FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM FLEXICARE MEDICAL LIMITED JOEL BIDDLE
K152737 06/29/2016 Lite Touch FOCUS MEDICAL LLC JOHN B LEE
K161186 06/29/2016 Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter) FUJIFILM MEDICAL SYSTEMS U.S.A., INC. SHRADDHA MORE
K153136 06/30/2016 Initial LiSi Press GC AMERICA INC. MARK HEISS
K160131 06/21/2016 OEC Elite MiniView GE HANGWEI MEDICAL SYSTEMS CO., LTD. LIFENG WANG
K160618 06/09/2016 Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T GE MEDICAL SYSTEMS, LLC Jason Ma
K153713 06/07/2016 Getinge Series Warming Cabinet GETINGE SOURCING, LLC BARB SMITH
K153517 06/24/2016 AnyPlus« Cervical PEEK Cage System GS Medical Co., Ltd. Milan George
K153388 06/07/2016 IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection Set Pre-attached Holder, IMPROSAFE Blood Collection Set, IMPROVACUTER Blood Collection Set, IMPROSAFE Multi Sample Needle, IMPROSAFE Multi Sample Needle (Flashback), IM GUANGZHOU IMPROVE MEDICAL INSTRUMENTS CO., LTD. BANGFU SUN
K161214 06/27/2016 Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard) GUANGZHOU WONDFO BIOTECH CO., LTD. Bin Chen
K160763 06/29/2016 ally Liquid Personal Lubricant GUY & O'NEILL, INC. THOMAS MISGEN
K160717 06/14/2016 ally Warming Liquid Personal Lubricant GUY & O'NEILL, INC. THOMAS MISGEN
K152744 06/10/2016 DIEGO ELITE DRILL GYRUS ACMI, INC DOLAN MILLS
K161156 06/14/2016 Full Automatic (NIBP) Blood Pressure Monitor HEALTH & LIFE CO., LTD. SARAH SU
K153740 06/30/2016 RTHawk, HeartVista Cardiac Package HeartVista, Inc. James J Rogers
K152251 06/10/2016 Endobronchial Tube HENAN TUOREN MEDICAL DEVICE CO., LTD MEIZI ZHANG
K161188 06/09/2016 HEPATIQ 1.1 HEPATIQ LLC DIPU GHOSH
K153056 06/01/2016 Hermes Medical Imaging Suite v5.6 HERMES MEDICAL SOLUTIONS, AB JOAKIM ARWIDSON
K153719 06/03/2016 LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream HONEYWELL HOMMED, LLC Greg Lillegard
K160870 06/01/2016 Hospira Administration Sets HOSPIRA, INC. DAVID BLONSKI
K160265 06/17/2016 Image Navigator by Immuno Concepts Immuno Concepts, NA, Ltd. Eric S. Hoy
K160995 06/10/2016 NEOVIEW Plating System In2Bones SAS Morgane Grenier
K153692 06/24/2016 Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer INFRARED LABORATORY SYSTEMS, LLC (DBA SYNERMED) JULIE PASCHAL
K160496 06/10/2016 Reprocessed Inquiry Steerable Diagnostic EP Catheter Innovative Health, LLC. Rafal Chudzik
K152635 06/01/2016 QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls INOVA DIAGNOSTICS, INC. Gabriella Lakos
K160468 06/23/2016 Synthetic Vinyl Examination Gloves, Powder-Free, Yellow INPRO TECHNOLOGY DEVICE FACTORY WANG YANMEI
K160238 06/14/2016 Airborne Phototherapy Light INTERNATIONAL BIOMEDICAL Amy Pieper
K153472 06/23/2016 Quiver Laparoscopic Extendable ITL Corporation PTY LTD Emily Rossiter
K152606 06/28/2016 Jeesung Safety Syringe and Single Use Needles JEESUNG MEDICAL CO LTD Choi Yong Hyun
K161421 06/24/2016 Single Use Surgical Suction Irrigator JIANGSU HAIZE MEDICAL SCIENTIFIC DEVELOPMENT CO.,LTD. Vivian Sun
K160602 06/23/2016 JustRight Surgical Vessel Sealing System JustRight Surgical Jenifer Kennedy
K160451 06/20/2016 V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... KCI USA, INC. (KINETIC CONCEPTS, INC.) MELANIE AVILA
K160474 06/07/2016 DSM Biomedical Porcine Pericardium Dental Membrane Kensey Nash Corporation dba DSM Biomedical Brianna Schehr
K160334 06/21/2016 Advanced Medical Imaging Software Suite (KSWVWR) KEOSYS SAS Laurence BOY-MACHEFER
K160441 06/30/2016 Identic and KromaFaze Alginate Dental Impression Materials KERR CORPORATION Mohammad Saad Ansari
K152856 06/02/2016 Helios III LASEROPTEK CO. LTD. HONG CHU
K161101 06/22/2016 PolypVac Microdebrider (3.3mm and 4.0mm) LAURIMED LLC BRIAN R DUBOIS
K160644 06/30/2016 Lelo Hex Natural Rubber Latex Condom LELO Inc. Pavle Sedic
DEN150007 06/13/2016 Magnetic Surgical System Levita Magnetics International Corp. Cindy Domecus
K160169 06/23/2016 The Life Spine Subtalar Implant System Life Spine Randy Lewis
K160130 06/29/2016 BloodSTOP iX Battle Matrix LifeSciencePLUS Inc. Audrey Vitale
K152843 06/24/2016 Liger Medical HTU-110 LIGER MEDICAL, LLC STEVE SMITH
K160878 06/29/2016 OPTIS Metallic Stent Optimization E.4 SW LIGHTLAB IMAGING, INC. PADMINI SURAVARAM
K152688 06/15/2016 LightLas Multi-Wavelength Medical Laser System LIGHTMED CORPORATION Mollie Li
K161476 06/24/2016 SMR Shoulder System Limacorporate S.p.A. Sara Viel
K153569 06/22/2016 Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml LIOFILCHEM S.R.L Fabio Brocco
K161495 06/30/2016 ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD) LUMINEX CORPORATION CHRISTIE HUGHES
K152961 06/03/2016 VALIDATE D-Dimer Calibration Verification/Linearity Test Kit MAINE STANDARDS COMPANY LLC JAMES CHAMPLIN
K160526 06/09/2016 Masimo O3 Regional Oximeter System MASIMO CORPORATION MARGUERITE THOMLINSON
K153225 06/21/2016 Masimo Root Monitoring System and Accessories Masimo Corporation Marguerite Thomlinson
K153659 06/10/2016 MaxO2ME MAXTEC, LLC JERALD WILSON
K153273 06/29/2016 MySpine Pedicle Screw Placement Guides - LP Medacta International SA Michael G Loiterman
K152585 06/24/2016 Resmon PRO FULL MEDICAL GRAPHICS CORP. JIM PURDIE
K152519 06/02/2016 MTR550 (Tentative) Antimicrobial Silver Wound Gel MEDICAL TECHNOLOGY RESEARCH INC. Bhalchandra M. Karandikar
K152458 06/01/2016 Gemini Bonded Sterilization Wrap MEDLINE INDUSTRIES, INC. Jennifier Mason
K161035 06/13/2016 Medline Singe Patient Use Blood Pressure Cuff MEDLINE INDUSTRIES, INC. Matt Clausen
K161001 06/09/2016 MILAGRO ADVANCE PEEK Interference Screw MEDOS INTERNATIONAL SARL Kristine Christo
K160829 06/13/2016 illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 MERIDIAN BIOSCIENCE, INC. MICHELLE L. SMITH
K160625 06/14/2016 Disposable Hot Biopsy Forceps MICRO-TECH (NANJING) CO., LTD. BECKY LI
K153739 06/28/2016 MRI Patient Monitor TeslaDUO MIPM MAMMENDORFER INSTITUT FUR PHYSIK UND MEDIZIN HANS SCHWAIGER
K160400 06/08/2016 Miromatrix Biological Mesh MIROMATRIX MEDICAL INC. JEFF ROSS
K153078 06/28/2016 LED Curing Light GT-2000 MONITEX INDUSTRIAL CO., LTD. Shu-Lung Wang
K160427 06/03/2016 dynaMX(TM) Nitinol Compression Screw MX ORTHOPEDICS CORP. HOWARD L. SCHRAYER
K160874 06/28/2016 Nanovis Intervertebral Body Fusion System and FortiCore« NANOVIS LLC Matthew Hedrick
K160209 06/21/2016 Gold Anchor NASLUND MEDICAL AB Tomas Naslund
K152301 06/03/2016 Background Pattern Classification [BPc(TM)] Natus Medical Incorporated DBA Excel-Tech Ltd. (Xltek) Sanjay Mehta
K151239 06/06/2016 NMI DUAL PORT II NAVILYST MEDICAL, INC. ROBIN FULLER
K160511 06/24/2016 Naya Breast Pump System NAYA HEALTH INC. Janica B. Alvarez
K160350 06/16/2016 ECG CT Gating Device NEOCOIL, LLC MICHAEL LEIGH
K161039 06/17/2016 NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL) NeoMed, Inc. Tony Lair
K160739 06/12/2016 Cranial COVER Neos Surgery S.L. Eduard Garcia
K160703 06/10/2016 NeuroStar TMS Therapy System NEURONETICS, INC. Judy P. Ways
K152501 06/29/2016 Spinal Jaxx Interbody Fusion Device NEUROPRO SPINAL JAXX, INC. BENJAMIN J. REMINGTON
K161285 06/29/2016 Ablation Confirmation NEUWAVE MEDICAL, INC. DAN KOSEDNAR
K160617 06/03/2016 Large Screws Range NEWCLIP TECHNICS Gaelle LUSSORI
K160820 06/28/2016 PressON Pro Spinal Fixation System Nexus Spine, LLC Jared Crocker
K152729 06/06/2016 MICROPERIMETER MP-3 NIDEK CO., LTD. YONEJI MIZUNO
K152350 06/28/2016 Regular and Special Umbilical Cord Clamp and Cutter NINGBO FEITE MEDICAL DEVICE CO., LTD CHARLES SHEN
K153036 06/02/2016 NobelDesign Software NOBEL BIOCARE AB CHARLEMAGNE CHUA
K153534 06/06/2016 NobelProcera HT ML Full Contour Zirconia Crown NOBEL BIOCARE AB Charlemagne Chua
K160119 06/02/2016 NobelSpeedy Groovy NOBEL BIOCARE AB Charlemagne Chua
K161062 06/13/2016 NR Recorder Norav Medical GmbH David Seal
K161346 06/15/2016 NormaTec PCD-T and PCD-B NormaTec Industries, LP Peter Novello
K160156 06/23/2016 StatStrip Xpress Blood Glucose Monitoring System NOVA BIOMEDICAL CORPORATION Eliza Wang
K160598 06/20/2016 REBOA Balloon Catheter NUMED, INC. NICHELLE LAFLESH
K160916 06/28/2016 CoRoent« Ti-C System NUVASIVE, INCORPORATED Michelle Cheung
K160989 06/09/2016 NuVasive« Reline« System NuVasive, Incorporated Olga Lewis
K160510 06/09/2016 MAKO 7 nVision Medical Corporation Surbhi Sarna
K161180 06/09/2016 Oak Ridge Products Sharps Containers OAK RIDGE PRODUCTS, LLC Tibor Kovari
K151976 06/27/2016 Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode OMNITECH SYSTEMS, INC. JON D. BARRETT
K160115 06/03/2016 Heat Pain Pro OMRON HEALTHCARE, INC. RENEE Thornborough
K161479 06/28/2016 hipEOS ONEFIT MEDICAL Julien SIMON
K153374 06/17/2016 CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System ORTHOCARE RAJEEV CHHABRA
K161280 06/17/2016 Cervical Stand Alone System Orthofix Inc. Natalia Volosen
K152339 06/24/2016 Unifine Pentips/ Unifine Pentips Plus OWEN MUMFORD LTD Patty Cronan
K153434 06/10/2016 Pall-Aquasafe Water Filter PALL INTERNATIONAL, SARL KAREN D PETERSON-DOYLE
K161064 06/12/2016 Penumbra System ACE 68 Reperfusion Catheter Penumbra, Inc. Charles DeNault
K161164 06/24/2016 CareEvent inclusive of the CareEvent Mobile Application accessory PHILIPS MEDICAL SYSTEMS Theresa Poole
K153702 06/13/2016 M3290B Philips IntelliVue Information Center iX PHILIPS MEDICAL SYSTEMS THERESA POOLE
K153518 06/03/2016 Medipure Oxygen-LC System PRAXAIR DISTRIBUTION, INCORPORATED. Michael Skrjanc
K160012 06/02/2016 O-pel Laser and families of probe delivery devices PRECISE LIGHT SURGICAL KEN ARNOLD
K152884 06/20/2016 DermaTherapy Bed Linens PRECISION FABRICS GROUP, INC. Terry Montgomery
K152561 06/03/2016 Communicator Surgical Facemask with Clear Window Prestige Ameritech, Ltd Rex Reese
K160627 06/14/2016 Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solution QFIX Nadia Sookdeo Harhen
K161193 06/02/2016 16ch Tx/Rx Knee SPEEDER Quality Electrodynamics, LLC Kathleen Aras
K150404 06/23/2016 QiF Blood and Fluid Warmer Quality in Flow Ltd. Neta Sherman
K153351 06/17/2016 Quantib Brain 1 QUANTIB BV FLOOR VAN LEEUWEN
K160458 06/20/2016 BI IMAGE-X EVOLUTION RADIOTECNOLOGIA INDUSTRIAL S.A. DE C.V. Marcelo Mojica
K160525 06/20/2016 RCT700 RAY CO.,LTD Changhwan Lee
DEN130051 06/08/2016 PEDIATRIC VISION SCANNER REBISCAN, INC. JUSTIN G SHAKA
K160655 06/03/2016 OrthoButton CL RIVERPOINT MEDICAL EDWIN ANDERSON
K160795 06/16/2016 United Urologics Intermittent Catheter ROBLING MEDICAL Diane Peper
K160729 06/13/2016 Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 Roche Diagnostics Adam Clark
K153607 06/15/2016 ROMA Calculation Tool Using Elecsys Assays ROCHE DIAGNOSTICS Angelo Pereira
K160681 06/17/2016 CenterCross Ultra Catheter ROXWOOD MEDICAL, INC Grace Li
K153201 06/24/2016 SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System SD BIOSENSOR Yeon Park
K153545 06/22/2016 Portable Slit Lamp SHANGHAI BOLAN OPTICAL-ELECTRIC CO.,LTD. Johnny Hu
K160853 06/27/2016 Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD (SIUI) Flower Cai
K160370 06/09/2016 BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD Zeng Zhe
K152244 06/20/2016 RADspeed Pro SHIMADZU CORPORATION Toshio Kadowaki
K152877 06/07/2016 SureFine Pen Needle SHINA MED CORPORATION SUNG-SOON PARK
K160652 06/03/2016 iFUSE Implant System SI-BONE, INC. ROXANNE DUBOIS
K151986 06/29/2016 ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material SIEMENS HEALTHCARE DIAGNOSTICS INC. MATTHEW GEE
K153360 06/29/2016 ADMIRE SIEMENS MEDICAL SOLUTIONS, INC. JOHN URTZ
K153131 06/03/2016 Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20? Hooded Acetabular Liner SIGNATURE ORTHOPAEDICS PTY LTD. DECLAN BRAZIL
K160095 06/10/2016 Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial Wound & Skin Cleanser 8oz, Simple Science Antimicrobial Wound & Skin Cleanser 16oz, Simple Science Antimicrobial Wound & Skin Cleanser 23oz Simple Science, LLC Eoin Croke
K160770 06/29/2016 Vent-Os Sinus Dilation family SINUSYS CORPORATION Lloyd H. Griese
K160099 06/02/2016 CEREC SpeedGlaze Sirona Dental Systems GmbH Thomas Diesch
K153606 06/02/2016 LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera Coupler, Tablet Application SMITH & NEPHEW JANICE HASELTON
K160738 06/15/2016 ZUK Select Knee System SMITH & NEPHEW, INC. BRAD SHEALS
K160235 06/30/2016 ViaValve Safety I.V. Catheter SMITHS MEDICAL ASD, INC. BRIAN FARIAS
K153537 06/17/2016 Sol-M Insulin Syringe, Sol-M TB Syringe SOL-MILLENNIUM MEDICAL, INC. Jim Barley
K160905 06/03/2016 Sonendo GentleWave System SONENDO, INC. DAN W. MILLER
K161122 06/08/2016 Sony IP Converter NU-IP40S SONY ELECTRONICS INC. AMARJIT 'ANDY' JOWANDHA
K153391 06/16/2016 Sophono Bone Conduction Systems (S) Configuration and (M) Configuration SOPHONO INC. Rozanne Paciej
K153367 06/17/2016 S698 Symbioz flow SOPRO - ACTEON GROUP Philippe BOYER
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