FDA 510(k) Decisions During November, 2016  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K160127 11/10/2016 iCodeConnect 3B MEDICAL, INC. ALEX LUCIO
K163207 11/28/2016 Filtek One Bulk Fill Restorative 3M Company Scott Erickson
K161696 11/23/2016 aap LOQTEQ« Distal Lateral Humerus Plate 2.7/3.5 AAP IMPLANTATE AG RENI SCHALLER
K161703 11/04/2016 LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer AAP IMPLANTATE AG RENI SCHALLER
K161747 11/22/2016 LOQTEQ« VA Distal Tibia Plate System: LOQTEQ« VA Distal Medial Tibia Plate 3.5; LOQTEQ« VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ« VA Distal Fibula Plate 2.7/3.5 aap Implantate AG Reni Schaller
K162322 11/17/2016 the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model ACCESS SCIENTIFIC, LLC WALTER CORDIGLIA
K163092 11/30/2016 TubeClear Control Box and Clearing Stem Actuated Medical, Inc. Thomas L. Cronin
K161011 11/08/2016 SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive Adhezion Biomedical, LLC Richard Jones
K162230 11/18/2016 Fully Automatic Electronic Blood Pressure Monitor ADON HEALTH CO., LTD. Liu Yi
K161913 11/04/2016 AOS Small Fragment Plating System ADVANCED ORTHOPAEDIC SOLUTIONS, INC. (AOS) ALEX BHASKARLA
K161834 11/30/2016 One Drop Blood Glucose Monitoring System AgaMatrix, Inc. David Olsen
K161391 11/30/2016 DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives ALCON LABORATORIES, INC. Sherri Lakota
K161288 11/16/2016 LenSX Laser System ALCON LABORATORIES, INC. JAMES ARGANDA
K161457 11/21/2016 XEN Glaucoma Treatment System Allergan, Inc. Barbara A. Niksch
K162160 11/18/2016 Preference Elite Pedicle Screw System AMEDICA CORPORATION Shanna Ryan
K153021 11/22/2016 Fingertip Pulse Oximeter A310 AMEMO INC HUA XIE
K160924 11/08/2016 Amendia Interbody Fusion Devices AMENDIA, INC. Bruce Hooper
K160791 11/15/2016 AmorChem Titanium Porous Fixation Device AmorChem Holdings, Inc. KEVIN MCBRIDE
K162914 11/16/2016 VenaCure EVLT NeverTouch Procedure Kit AngioDynamics, Inc. Robin Fuller
K162316 11/22/2016 Pirouette 014 ArraVasc Ltd Aoife Donoghue
K161782 11/21/2016 Arthrex Univers Revers Shoulder Prosthesis System ARTHREX, INC. David L Rogers
K160682 11/17/2016 CONTOUR NEXT ONE Blood Glucose Monitoring System ASCENSIA DIABETES CARE Roger Sonnenburg
K161623 11/10/2016 Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL B. Braun Medical Inc. Nancy Skocypec
K161819 11/25/2016 NNR06 Multi-Purpose Solution Bausch & Lomb Incorporated Glenn Davies
K161323 11/30/2016 Solution Set for Epidural Use BAXTER HEALTHCARE CORPORATION Tiffany Lin
K162414 11/29/2016 UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System BECKMAN COULTER, INC. NANCY NADLER
K161692 11/16/2016 Diode Laser Therapy Machine BEIJING ADSS DEVELOPMENT CO., LTD GAO YURONG
K160508 11/21/2016 Electronic Pulse Stimulator BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. Lei Chen
K160558 11/18/2016 RAPIDO HOLLOW-FIBRE DIALYZERS BELLCO Srl Giuseppe Tomasini
K162431 11/17/2016 Luna 3D Interbody Fusion System Benvenue Medical, Inc. Jeff Emery
K162232 11/17/2016 MOSS 100 Pedicle Screw System Biedermann Motech GmbH & Co. KG Gerd Federle
K161974 11/01/2016 SLENDERTONE« Connect Abs, Type 570 Bio-Medical Research Ltd. Anne-Marie Keenan
K163007 11/23/2016 Biomet Microfixation SternaLock 360 Sternal Closure System BIOMET MICROFIXATION LAUREN JASPER
K161592 11/03/2016 Persona Partial Knee System BIOMET, INC. Nicole J. Meredith
K160446 11/07/2016 MCP Bone Putty BioStructures, LLC John Brunelle
K161670 11/02/2016 Lucid Q-PTP / HWA 55 BISON MEDICAL CO., LTD SUN WO
K161628 11/10/2016 JAS Pulse(TM) Ultrasonic Therapy Bonutti Research, Inc. Patrick G. Balsmann
K162350 11/04/2016 Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Boston Scientific Corporation Ka Zoua Xiong
K160481 11/09/2016 Vivo 60 BREAS MEDICAL AB Albert Cefalo
K161277 11/22/2016 ConvertX Nephroureteral Stent System BRIGHTWATER MEDICAL BOB SMOUSE
K162769 11/04/2016 Pinpoint GT Introducer Needle C.R. BARD, INC. Jamie Howell
K162894 11/15/2016 AccuCath Intravascular Catheter C.R.BARD, INC. JACOB LEE
K161027 11/08/2016 Cadwell AmpliScan Cadwell Industries, Inc. John Cadwell
K162994 11/18/2016 Capillus302, Capillus312, Capillus352 CAPILLUS, LLC PATRICIA SCHNOOR
K162214 11/30/2016 Protek Solo 24 Fr Venous Cannula Set CARDIAC ASSIST, INC. GREG JOHNSON
K162440 11/04/2016 CardioInsight Cardiac Mapping System CARDIOINSIGHT TECHNOLOGIES, INC LAURIE LEWANDOWSKI
K160746 11/02/2016 CARDIOLINE touchECG CARDIOLINE S.p.A Emanuele Ercoli
K160437 11/03/2016 PleurX Peritoneal Catheter System CareFusion Tamara Brey
K161408 11/22/2016 Compass Cast and MAP CENTURION MEDICAL PRODUCTS CORPORATION MATTHEW K. PRICE
K162444 11/23/2016 Xpert MRSA NxG CEPHEID SCOTT A. CAMPBELL
K161905 11/17/2016 Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge CHANGZHOU XIN NENG YUAN MEDICAL STAPLER CO.,LTD. Boping Ma
K162103 11/23/2016 Choice Spine Lumbar Spacer System (SabreÖ, SharkÖ, HornetÖ, HarpoonÖ), Choice Spine Interbody Fusion System (HarrierÖ), Choice Spine Vertebral Body Replacement System (HawkeyeÖ) CHOICE SPINE, LP KIM FINCH
K163138 11/30/2016 Clarius Ultrasound System Clarius Mobile Health Corp. Abhijit Ahir
K163139 11/30/2016 PleuraFlow System with FlowGlide CLEARFLOW, INC. DOV GAL
K161515 11/15/2016 eUnity Client Outlook Inc. Christie Eby
K160800 11/16/2016 DuoCem COLTENE/WHALEDENT AG Silke Wallaschek
K160884 11/22/2016 CXI Support Catheter COOK INCORPORATED Daniel J. Corbin
K160656 11/21/2016 CorSens CorSens Medical Ltd. Yoram Levy
K162941 11/14/2016 Ligasure Blunt Tip, Sealer/Divider, Nano-coated COVIDIEN CELSO DURAN
K163102 11/30/2016 ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mm COVIDIEN KATIE BROWN
K160718 11/14/2016 Vital Sync Informatics Manager & Virtual Patient Monitoring Platform COVIDIEN Timothy Holwick
K160921 11/03/2016 CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant CS Medical LLC Kendall Ashe
K162231 11/16/2016 iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert CYDEN LIMITED MIKE KIERNAN
K160180 11/03/2016 Intermittent Pneumatic Compression system DaeSung Maref Co., Ltd Jae-wha Lee
K160166 11/15/2016 X-MIND trium DE GOTZEN S.R.L. Olivier Balouka
K163043 11/30/2016 Zeramex P6 Dental Implant System DENTALPOINT AG Viktor Lienhard
K160762 11/21/2016 Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set DIAZYME LABORATORIES ABHIJIT DATTA
K161646 11/04/2016 Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set DIAZYME LABORATORIES ABHIJIT DATTA
K153394 11/18/2016 Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain Calibrator Diazyme Laboratories Abhijit Datta
K162220 11/21/2016 DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage DIO MEDICAL CO., LTD SUNG HEE-LEE
K160761 11/22/2016 DW-1C DONGWON MEDICAL CO., LTD. Gil Haeng Lee
K161962 11/28/2016 VAMP Venous/Arterial Blood Management Protection System Edwards Lifesciences LLC Jennifer Wilbur
K162024 11/21/2016 AltiVate Anatomic Shoulder System ENCORE MEDICAL, L.P DESIREE WELLS
K161610 11/09/2016 EXPRT Revision Hip System Encore Medical, L.P. TEFFANY HUTTO
K161472 11/18/2016 Walk-O2-Bout ESSEX INDUSTRIES, INC. RUSS JACOBSMEYER
K160447 11/10/2016 Calprest NG EUROSPITAL S.P.A. Claudia Brandolin
K160663 11/16/2016 Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF) EVOLUTION SPINE, LLC Ashton Kouzbari
K161373 11/03/2016 Nunchaku FCI (FRANCE CHIRURGIE INSTRUMENTATION) THIERRY FETICK
K161131 11/03/2016 FONA Pan/Ceph FONA SRL ELISA GUSBERTI
K162450 11/30/2016 ESPADA Acne-Clearing Blue Light Pen FOREO INC. Davor Soldo
K162781 11/09/2016 Magma Spark Formatk Systems Ltd. Ahava Stein
K162462 11/23/2016 AMICUS Separator System, AMICUS Separator System; Refurbished FRESENIUS KABI USA LLC KIM FORCH
K160933 11/18/2016 Discovery NM 750b Bopsy GE Healthcare Efrat Hartog-David
K162268 11/03/2016 Senographe Pristina GE HEALTHCARE Gregory Pessato
K162743 11/22/2016 ViewPoint 6 GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS TRACEY ORTIZ
K163077 11/17/2016 LOGIQ E9, LOGIQ E9 XDClear 2.0 GE Medical Systems Ultrasound and Primary Care Diagnostics, Bryan Behn
K162403 11/18/2016 HyperBand GE Medical Systems, LLC Jason Ma
K162990 11/15/2016 Optima XR240amx GE Medical Systems, LLC Chris Paulik
K161438 11/08/2016 Genesys Spine Apache« Anterior Lumbar Interbody Fusion System GENESYS SPINE BRIAN BERGERON
K160079 11/10/2016 rainbow Shine GENOSS Co. Ltd. Byungsun Kim
K160872 11/23/2016 PolyPlex Wound Dressing GLOBAL HEALTH SOLUTIONS, LLC Bradley Burnam
K160564 11/17/2016 TroClose1200 GORDIAN SURGICAL LTD. ZVI PEER
K160532 11/03/2016 Greiner Holdex GREINER BIO-ONE NA INC. MANFRED ABEL
K160349 11/03/2016 Electronic Sphygmomanometer Guangdong Biolight Meditech Co., Ltd. Liang Jin
K160132 11/21/2016 Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC HAGER & MEISINGER GMBH Melanie May
K160512 11/15/2016 HardyCHROM ESBL HARDY DIAGNOSTICS ANDRE HSIUNG
K160049 11/15/2016 Charisma Heraeus Kulzer, LLC (Mitsui Chemicals Group) Jamie Cleveland
K162583 11/17/2016 ALOKA LISENDO 880 HITACHI, LTD. ANGELA VAN ARSDALE
K162085 11/10/2016 i-CAT FLX V series / KaVo 3D eXam+ V series IMAGING SCIENCES INTERNATIONAL Ruth Pui
K161831 11/15/2016 IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set Immunodiagnostic Systems Ltd Mick Henderson
K162970 11/22/2016 FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator Inari Medical Eben Gordon
K161013 11/29/2016 InnoSEAL Hemostatic Pad InnoTherapy Inc. Moon Sue Lee
K160421 11/02/2016 Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter Innovative Health, LLC. Rafal Chudzik
K162863 11/07/2016 dS Small Extremity 16CH 1.5T Coil INVIVO THERAPEUTICS CORPORATION Ken Revennaugh
K163185 11/21/2016 OptiLux LED Illuminator ISOLUX LLC NIKOLAOS ANDREOULAKIS
K162265 11/15/2016 CushionCast Moldable Cushions IZI Medical Products LLC Qiang Cao
K161378 11/02/2016 joimax Electrosurgical Instruments JOIMAX GMBH WOLFGANG RIES
K161768 11/09/2016 LUCAS 3 Chest Compression System Jolife AB Malin Melander
K162257 11/07/2016 P1145 Dental Restorative Kerr Corporation Mohammad Saad Ansari
K160895 11/01/2016 Initia Total Hip System & BIOCERAM AZUL(R) HEAD KYOCERA Medical Corporation Cheryl Hastings
K162801 11/03/2016 CastleLoc Spinal Fixation System L&K BIOMED CO., LTD. Yerim An
K153656 11/14/2016 PathLoc-SI Joint Fusion System L&K BIOMED Co., Ltd. Yerim An
K162136 11/03/2016 CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System L&K BIOMED CO.,LTD. Yerim An
K161673 11/18/2016 LacriPro Punctum Plug LACRIMEDICS, INC. REBECCA C. DUTTON
K161776 11/29/2016 Lenstec LC Injection system LENSTEC INC. JIMMY CHACKO
K161636 11/04/2016 Lipogems System Lipogems International SpA CARLO RUSSO
K162210 11/16/2016 touchTymp MAICO DIAGNOSTICS GMBH UWE LEDWORUSKI
K160940 11/23/2016 Masimo Disposable Transflectance Forehead Sensor Masimo Corporation Marguerite Thomlinson
K162273 11/07/2016 Materialise TKA Guide System MATERIALISE NV OLIVER CLEMENS
K162577 11/18/2016 Dosimetry Check Version 5 Release 1 MATH RESOLUTIONS, LLC WENDEL DEAN RENNER
K161493 11/08/2016 YO Home Sperm Test MEDICAL ELECTRONIC SYSTEMS, LTD MARCIA DEUTSCH
K160642 11/29/2016 Medline ENFit Syringe Medline Industries, Inc. Stephanie Blair
K161638 11/07/2016 SPEEDTRAP Graft Preparation System MEDOS INTERNATIONAL SARL Jeffrey Dzialo
K161779 11/03/2016 MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter MedSource International, LLC Laura Riggen
K162892 11/15/2016 Achieve Advance Mapping Catheter MEDTRONIC INC. HEATHER TAYLOR
K161370 11/02/2016 Durepair Dura Regeneration Matrix Medtronic Neurosurgery Manas Lele
K162379 11/16/2016 CD HORIZON« Spinal System MEDTRONIC SOFAMOR DANEK USA, INC. Nathaniel Hendricks
K162097 11/17/2016 InTRAkit Medtronic Vascular Nisarg Shah
K161921 11/04/2016 SwiftNINJA Microcatheter MERIT MEDICAL SYSTEMS, INC. LUKE MEIDELL
K161649 11/09/2016 Virtu C Spinal Implant System Met 1 Technologies, LLC Dan Gerbec
K162539 11/10/2016 Solitaire 2 Revascularization Device MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR JENNIFER CORREA
K162466 11/29/2016 LuminScan (TM) Imaging System MICRO-TECH (NANJING) CO.,LTD. Becky Li
K161624 11/07/2016 MicrO2 OSA Device with Micro-Recorder MICRODENTAL, Inc. David Kuhns
K161909 11/17/2016 IQvitals Zone Midmark Corporation Asad Abu-Tarif
K161939 11/17/2016 Avance Abdominal Dressing Kit Molnlycke Health Care US, LLC Megan Bevill
K161935 11/04/2016 Avance Foam Dressing Kit - XL MOLNLYCKE HEALTH CARE, US LLC MEGAN BEVILL
K161948 11/03/2016 Avance Gauze Dressing Kits MOLNLYCKE HEALTH CARE, US LLC MEGAN BEVILL
K162113 11/07/2016 Powder Free Nitrile Examination Gloves (Blue) NAM VIET GLOVE JOINT STOCK COMPANY OOI LOON SENG
K160594 11/22/2016 MRWire Guide Wire NANO4IMAGING GMBH CHRISTOPH R. MANEGOLD
K161174 11/03/2016 Nanova Interference Screw NANOVA BIOMATERIALS INC. ANDREW RITTS
K161431 11/30/2016 SimplECG Nanowear Inc. Venkatesh Varadan
K162595 11/04/2016 Trex_HD Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) Sanjay Mehta
K161634 11/10/2016 IPS CaseDesigner NOBEL BIOCARE AB CHARLEMAGNE CHUA
K162043 11/22/2016 NobelProcera HT ML FCZ Bridge Nobel Biocare AB Charlemagne Chua
K161435 11/22/2016 Temporary Snap Abutment Nobel Biocare AB Charlemagne Chua
K161856 11/15/2016 StatStrip Xpress Glucose Hospital Meter System Nova Biomedical Corporation Paul W. MacDonald
K162218 11/22/2016 Pain FreezeÖ, Medium Stream Spray, Model #2101; Pain FreezeÖ, Mist Spray, Model #2102 NUANCE MEDICAL, LLC MARC LIEBERMAN
K162191 11/22/2016 NAVILAS Laser System OD-OS GMBH WINFRIED TEIWES
K153773 11/22/2016 Disposal Lens Cleaning Sheath OLYMPUS MEDICAL SYSTEMS CORP. TOSHIYUKI NAKAJIMA
K162092 11/22/2016 Evolv Model BP7000 Upper Arm Blood Pressure Monitor OMRON HEALTHCARE, INC. RENEE THORNBOROUGH
K162862 11/09/2016 Raycast High Precision Lung Board Solution Orfit Industries NV Raymond Kelly
K162355 11/22/2016 Raycast MammoRx Carbon Fibre Breast Board Orfit Industries NV Eddy Marivoet
K160720 11/28/2016 Carriere Motion Clear Class II ORTHO ORGANIZERS, INC. COLLEEN BOSWELL
K153317 11/30/2016 HEMASORBPLUS Resorbable Hemostatic Bone Putty ORTHOCON, INC. HOWARD L. SCHRAYER
K162576 11/10/2016 FORTEZZA Spinal Stabilization System OSSO SURGICAL Basheer Hassan
K160881 11/15/2016 Tablo Console OUTSET MEDICAL, INC. LESLIE TRIGG
K162453 11/01/2016 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) Pan Medical Ltd. Jennie Budding
K162198 11/18/2016 GFS Ultimate PARCUS MEDICAL, LLC PAUL VAGTS
K160545 11/23/2016 GAP ENDO-EXO MEDULLARY SYSTEM PEGA MEDICAL INC. Ariel R. Dujovne
K163020 11/16/2016 Xperius Ultrasound System PHILIPS HEALTHCARE SCOTT ZHANG
K162148 11/23/2016 Allura Xper R9 PHILIPS MEDICAL SYSTEMS NETHRLANDS BV Jeanette Becker
K160595 11/18/2016 PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator PMS Medikal Ambalaj Sanayi ve Ticaret LTD STI Derya Dikici
K162211 11/28/2016 AccuFit Lateral Plate System PRECISION SPINE, INC. Michael C. Dawson
K162300 11/22/2016 Reform« POCT System PRECISION SPINE, INC. MICHAEL C. DAWSON
K160361 11/04/2016 PRIMAGARD Isolation Gown (AAMI PB70 Level 3) PRIMED MEDICAL PRODUCTS INC. RICHARD R ROY
K162537 11/16/2016 CAD/CAMouflage Milling Block PRISMATIK DENTALCRAFT, INC. ALIVA DAS
K160979 11/04/2016 Inclusive Abutments PRISMATIK DENTALCRAFT, INC. SHELLY HARRIS
K162240 11/17/2016 ProMedTek Model C1400 Shortwave Diathermy Device PROMEDTEK INC. Dan Puchek
K153409 11/15/2016 Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) PROTECT U GUARD, LLC Brent W. Laartz
K162284 11/04/2016 Puritan Fecal Opti-Swab Collection and Transport System PURITAN MEDICAL PRODUCTS LLC MEHDI KARAMCHI
K162966 11/30/2016 TxRx Knee 15 Flare MR Coil 1.5T Quality Electrodynamics, LLC Kathleen Aras
K163066 11/29/2016 TxRx Knee 15 Flare MR Coil 3.0T QUALITY ELECTRODYNAMICS, LLC Kathleen Aras
K152232 11/18/2016 Quest Diagnostics HairCheck-DT (Cocaine) Quest Diagnostics Incorporated Lisa Christo
K162451 11/28/2016 Solana HSV 1+2/VZV Assay QUIDEL CORPORATION Ronald H. Lollar
K160561 11/02/2016 Boosting Catheter QXMEDICAL, LLC FERNANDO DI CAPRIO
K160153 11/04/2016 ABL90 FLEX PLUS RADIOMETER MEDICAL APS SOEREN BOEGESTRAND
K161454 11/01/2016 Propeller Sensor Model 2015-E Reciprocal Labs Corporation Taylor Mahan-Rudolph
K161254 11/07/2016 Renovo Life Small Bone IM Nail System Renovo Life LLC Harold Crowder
K161978 11/17/2016 AirFit N20 ResMed Ltd Kim Kuan Lee
K161778 11/22/2016 ToeTacÖ 10? Hammertoe Fixation System RESTORE SURGICAL LLC DBA INSTRATEK JEFF SEAVEY
K162457 11/14/2016 Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit Rocket Medical Plc Tracy Charlton
K160786 11/21/2016 RODO Abutment System RODO MEDICAL, INC Michael Parsons
K162278 11/15/2016 Digital Diagnostic Mobile X-ray System SAMSUNG ELECTRONICS CO., LTD. CHULSIN KIM
K161944 11/21/2016 Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs SHANDONG BAISHENG MEDICAL PRODUCTS CO., LTD. CECILY SHENG
K161074 11/17/2016 Powder Free Nitrile Examination Gloves Flock-Lined, Black Color SHEN WEI (USA), INC. CHERYL BAILEY-KROLL
K161735 11/17/2016 Non-contact Forehead Thermometer Shenzhen Dongdixin Technology Co., Ltd. Siping Yuan
K160530 11/28/2016 Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD. Mina Cheng
K161708 11/22/2016 Arm automatic blood pressure monitor SHENZHEN PUMP MEDICAL SYSTEM CO., LTD XIE QIONGYU
K161891 11/21/2016 HC Primer Shofu Dental Corporation Mauro Malzyner
K162538 11/17/2016 ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator SIEMENS HEALTHCARE DIAGNOSTICS SUSAN FERRIN
K161494 11/15/2016 Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) Siemens Healthcare Diagnostics, Inc. Laura J. Duggan
K162541 11/16/2016 syngo Application Software SIEMENS MEDICAL SOLUTIONS USA, INC PATRICIA D. JONES
K161795 11/18/2016 MAGNETOM ESSENZA Siemens Medical Solutions USA, Inc. Cordell L. Fields
K162971 11/22/2016 Multix Fusion Max SIEMENS MEDICAL SOLUTIONS USA, INC. DENISE ADAMS
K162102 11/22/2016 MAGNETOM Avantofit, MAGNETOM Skyrafit SIEMENS MEDICAL SOLUTIONS, INC. JOHN URTZ
K162078 11/18/2016 EVOS Small Fragment Plating System SMITH & NEPHEW, INC. SAMANTHA STAUBACH
K160923 11/17/2016 REDAPT Anteverted Cemented Liner SMITH & NEPHEW, INC. KIM PHAN
K161763 11/22/2016 Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device Smith & Nephew, Inc. Bradley Heil
K161264 11/23/2016 TRIGEN Low Profile Bone Screws SMITH & NEPHEW, INC. ALLISON CHAN
K161665 11/15/2016 VLP Wrist Fracture System SMITH & NEPHEW, INC. SAMANTHA STAUBACH
K152660 11/09/2016 HYPNOSPAD Somnics Inc. TSUNG-MIN HSIEH
K162573 11/04/2016 Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source SOURCE PRODUCTION AND EQUIPMENT CO., INC. KELLEY RICHARDT
K161740 11/04/2016 D-SPECT Scanner, D-SPECT L Scanner Spectrum Dynamics Medical Ltd Igor Naroditsky
K160278 11/04/2016 VSTAAR AdjusteR SPINAL ACOUSTICS, LLC ALBERT A. TORRENCE
K161993 11/22/2016 Leva« Anterior Interbody System Spine Wave, Inc. Sanja Jahr
K161873 11/22/2016 Pacel Flow Directed Pacing Catheter St. Jude Medical Blair Schwartz
K162162 11/04/2016 Barrier Supreme Sterilization Wrapper Standard Textile Co., Inc. Bradley J. Bushman
K161700 11/21/2016 SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters STERILMED, INC. Reuben Lawson
K162262 11/09/2016 Tritanium« PL Cage STRYKER Deirdre Jayko
K162310 11/10/2016 XBraid TT Suture Tape Stryker Taylor White
K162062 11/01/2016 AVAmax Vertebral Balloon, AVAflex Vertebral Balloon STRYKER CORPORATION BECKY DITTY
K161753 11/15/2016 Hoffman LRF System STRYKER GMBH PAUL NELSON
K161863 11/23/2016 ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA) Stryker GmbH Saad Attiyah
K162585 11/04/2016 SuniIQ Digital Radiography System Suni Medical Imaging, Inc Al Bettencourt
K160190 11/10/2016 Sunmed Control Syringes Sunny Medical Device (Shenzhen) Co.,Ltd. James Qi Zhang
K161999 11/16/2016 Aixplorer SUPERSONIC IMAGINE LAURENCE HERMITTE
K153714 11/15/2016 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
K162163 11/17/2016 UltraShape System SYNERON MEDICAL LTD Ruthie Amir
K161952 11/07/2016 UltraShape System Syneron Medical Ltd. Ruthie Amir
K161590 11/03/2016 MatrixRIB Fixation System SYNTHES (USA) PRODUCTS LLC THOMAS SHEA
K162358 11/01/2016 T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System SYNTHES USA PRODUCTS LLC Eugene Bang
K161417 11/10/2016 DePuy Synthes MAXFRAME Multi-Axial Correction System SYNTHES USA, LLC STACEY BONNELL
K161738 11/10/2016 FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ?-Ketone Monitoring Systems TAIDOC TECHNOLOGY CORPORATION PAUL LIU
K161357 11/04/2016 LipiFlow Thermal Pulsation System TEARSCIENCE, INC. Christy Coleman
K162396 11/23/2016 SILK Surgical Suture TELEFLEX MEDICAL, INC NATALIE HICHAK
K161968 11/03/2016 MicrUs TELEMED Yury Sokolov
K161932 11/28/2016 Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink Terang Nusa Sdn Bhd Robert Hill
K162843 11/17/2016 Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1 Terumo Cardiovascular Systems Corporation Bryan Hann
K161742 11/15/2016 Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid Tornier, Inc. Laurie Lewandowski
K162183 11/25/2016 Vantage Galan 3T, MRT-3020, V4.0 TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K162155 11/01/2016 Xario 200 Diagnostic Ultrasound System V5.0 TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K162619 11/04/2016 I View and Imagen Sensor TRIDENT S.R.L. GIORGIO RIZZO
K162656 11/10/2016 ESU-1 Electrosurgical Generator TVA Medical, Inc. Katherine Kumar
K161597 11/16/2016 Tyber Medical BioTy« Nanotopography Trauma Screw TYBER MEDICAL LLC MARK F. SCHENK
K160855 11/22/2016 U&U Enteral Syringe U&U MEDICAL TECHNOLOGY CO.,LTD BLACK WANG
K160045 11/17/2016 Heyman Packing Applicator Set VARIAN MEDICAL SYSTEMS, INC PETER J. CORONADO
K152615 11/03/2016 Vonflex S VERICOM CO., LTD. Myung-Hwan Oh
K162252 11/14/2016 FasTouch Fixation System VIA SURGICAL LTD. OFEK LEVIN
K162175 11/21/2016 Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less Viet Glove Corporation PHAM NGOC THANH
K162363 11/18/2016 V30 system, V-Form Handpiece BC Medium applicator Viora Ltd. Stella Raizelman Perry
K161157 11/03/2016 Vitrea CT Dual Energy Image View VITAL IMAGES, INC. Alexis Erazo
K161433 11/09/2016 Insulia Diabetes Management Companion VOLUNTIS S.A. RAFFI KRIKORIAN
K161957 11/23/2016 W&H Implantmed SI-1015 incl. Accessories W&H DENTALWERK BURMOOS GMBH ANJA LINDNER
K160801 11/29/2016 Well Lead Extraction Bag WELL LEAD MEDICAL CO., LTD. HAN GUANG YUAN
K162225 11/22/2016 WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System WellDoc, Inc Michele Livingston
K152906 11/22/2016 Disposable High Pressure Injector Syringe WUXI YUSHOU MEDICAL APPLICANCES CO., LTD Wu Feng
K162944 11/07/2016 Irix-C Cervical Integrated Fusion System X-SPINE SYSTEMS, INC. KRISS ANDERSSON
K160959 11/17/2016 Xsert Lumbar Expandable Interbody System X-SPINE SYSTEMS, INC. KRISS ANDERSON
K160705 11/23/2016 Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture, Y. JACOBS MEDICAL, INC HUI JUN PARK
K162095 11/02/2016 Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue) YTY INDUSTRY (MANJUNG) SDN. BHD., Punitha Samy
K162002 11/01/2016 Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay ZDi, Solutions, LLC Zachary A. Dutton
K162050 11/21/2016 ZELTIQ CoolSculpting System ZELTIQ Aesthetics, Inc Shruti Jayakumar
K161620 11/01/2016 Anatomical Shoulder Domelock Dome centric ZIMMER GMBH ROBERTO TOMMASINI
K161862 11/14/2016 ThermoPro Zimmer MedizinSysteme GmbH Armin Petraschka


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