FDA 510(k) Applications Received During October, 2016

FDA 510(k) Number Submission Date Device Name Applicant Contact
K162916 10/17/2016 3NT endoscopy system 3NT Medical Ltd. Ehud Bendory
K162925 10/19/2016 AcQGuide Steerable Sheath ACUTUS MEDICAL, INC. Brenda Clay
K163014 10/28/2016 AOS Small Bone Nailing System Advanced Orthopaedic Solutions, Inc. (AOS) Alex Bhaskarla
K162810 10/06/2016 InSeca ARC Stylus, Aerin Console Aerin Medical, Inc. Scott Wolf
K162815 10/06/2016 SterilContainer S System AESCULAP, INC Paul Amudala
K163000 10/28/2016 AMPLATZER TorqVue 45x45 Delivery Sheath AGA Medical Corporation (Wholly Owned by St. Jude Medical Co Mary Johnson
K162805 10/05/2016 Akros Fibulink Syndesmosis Repair Kit Akros Medical Charles Horrell
K162915 10/17/2016 Fully Automatic Electronic Blood Pressure Monitor Andon Health Co., Ltd. Liu Yi
K162914 10/17/2016 VenaCure EVLT NeverTouch Procedure Kit AngioDynamics, Inc. Robin Fuller
K162822 10/07/2016 ADAMS A1c HA-8180V, CALIBRATOR 80 Arkray Factory, Inc. Kazuya Yorimitsu
K162820 10/07/2016 AC3 Series IABP System ARROW INTERNATIONAL, INC. Alifiya Jagmag
K162842 10/11/2016 ASAHI PTCA Guide Wire ASAHI SUOH 03 ASAHI INTECC CO., LTD. YASUYUKI KAWAHARA
K163004 10/28/2016 Radifocus Glidewire Advantage Track Ashitaka Factory of Terumo Coporation Dina Justice
K162918 10/18/2016 Atlas Spine Expandable Interbody System Atlas Spine, Inc. Thomas Smith
K163025 10/31/2016 DORA Disposable A.V. Fistula Needle Sets Bain Medical Equipment (Guangzhou) Co., Ltd. Sophia Shao
K162887 10/17/2016 PrismaSATE Baxter Healthcare Corporation Kristen Bozzelli
DEN160047 10/03/2016 ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M Beckman Coulter Anthony Dennis
K162897 10/17/2016 Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser BECKMAN COULTER Suzana Otano
K163015 10/28/2016 Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak BIO-RAD LABORATORIES ELIZABETH PLATT
DEN160048 10/17/2016 FilmArray NGDS Warrior Panel BioFire Defense, LLC Cynthia Phillips
K162827 10/07/2016 VIDAS B.R.A.H.M.S. PCT (PCT) bioMerieux, Inc John Albright
K163042 10/31/2016 chromID Strepto B agar bioMerieux, Inc. Karen Russell
K163006 10/28/2016 VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL) bioMerieux, Inc. Jennifer Jines
K162950 10/24/2016 VITEK MS bioMerieux, Inc. Nathan Hardesty
K162974 10/25/2016 Biomet Microfixation RibFix Blu Thoracic Fixation System Biomet Microfixation Lauren Jasper
K163007 10/28/2016 Biomet Microfixation SternaLock 360 Sternal Closure System BIOMET MICROFIXATION LAUREN JASPER
K163029 10/31/2016 HydrisÖ Oral Rinse BIOPHARM CONSULT, L.L.C. DAVID S. JOHNSON
K162783 10/03/2016 EnFocus 2300, EnFocus 4400 Bioptigen, Inc. Ravi Kommineni
K162860 10/12/2016 MCS Bone Graft BIOVENTUS LLC John Brunelle
K162853 10/11/2016 Bonafix TWO - Dental Implant System BONAFIX SURGICAL AND DENTAL IMPLANTS Juan Tezak
K162856 10/12/2016 Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) Bonart Co., Ltd. Bankson Tsai
K162793 10/04/2016 RHYTHMIA HDx Mapping System Boston Scientific Corporation Regina Holmes
K162771 10/03/2016 EkoSonic Control Unit 4.0 BTG International, Inc. CURTIS JENSEN
K162769 10/03/2016 Pinpoint GT Introducer Needle C.R. BARD, INC. Jamie Howell
K163001 10/28/2016 PowerFlow Apheresis I.V. Port C.R. BARD, INC. Christoph Wagner von Hoff
K162900 10/17/2016 PowerMidline Catheter C.R. Bard, Inc. Casey Coombs
K162894 10/17/2016 AccuCath Intravascular Catheter C.R.BARD, INC. JACOB LEE
K162986 10/27/2016 SPIRA Open Matrix ALIF CAMBER SPINE TECHNOLOGIES Michael Black
K162909 10/17/2016 CSX-30 Flat Panel Detector Canon, Inc. û Medical Equipment Group Shinji Mori
K162994 10/27/2016 Capillus302, Capillus312, Capillus352 CAPILLUS, LLC PATRICIA SCHNOOR
K162858 10/12/2016 NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST Careplus (M) SDN BHD LIM KWEE SHYAN
K163019 10/31/2016 CareView 750Cw/750C X-ray Flat Panel Detectors CARERAY DIGITAL MEDICAL SYSTEM CO., LTD. Xu Wei
K162991 10/27/2016 YELLOW 560 Fluorescence Module Carl Zeiss Meditec AG Peter Schrutka-Rechtenstamm
K162952 10/24/2016 C.T.M. Mobility Scooter CHIEN TI ENTERPRISE CO., LTD. VIVIAN LO
K162947 10/21/2016 Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit; Linear Cutting Stapler and Single Use Loading Unit; Disposal Hemorrhoidal Circular Stapler CHONGQING QMI SURGICAL CO., LTD KANG LI
K162870 10/13/2016 CIMLRE F1 and CIMILRE S3 CIMILRE CO., LTD. Ko Bong Jae
K162905 10/17/2016 SleepWeaver 3D Nasal Mask Circadiance, LLC JAMES GIANOUTSOS
K162891 10/17/2016 Complete Control System COAPT, LLC Blair Lock
K162789 10/04/2016 Foresight Intracardiac Echocardiology (ICE) System Conavi Medical Inc. Sam Mostafavi
K162956 10/24/2016 NOWCARDIO SYSTEM CONTEX INTERNATIONAL TECHNOLOGIES (CANADA), INC. RICARDO RODRIGUEZ
K162906 10/17/2016 Flexi-Seal PROTECT Fecal Management System ConvaTec Karen Howes
K162934 10/20/2016 Biodesign Parastomal Hernia Repair Graft Cook Biotech Incorporated Perry W. Guinn
K163031 10/31/2016 Bunegin-Albin Air Aspiration Set COOK INCORPORATED JOHNATHAN LIU
K163018 10/31/2016 Zilver 635 Biliary Stent Cook Ireland Ltd. Nora O'Connor
K162942 10/21/2016 Corin MetaFix Hip Stem CORIN USA LIMITED RACHEL KING
K162979 10/26/2016 Veloxion System Corinth MedTech, Inc. Sandeep Saboo
K162941 10/21/2016 Ligasure Blunt Tip, Sealer/Divider, Nano-coated COVIDIEN CELSO DURAN
K163002 10/28/2016 Kangaroo Feeding Tube with IRIS Technology Covidien (dba Medtronic) Alexis Erazo
K162802 10/05/2016 Barrx Anorectal RFA Wand COVIDIEN LLC RACHEL SILVA
K162967 10/24/2016 nuance UNIVERSAL Den-Mat Holdings, LLC Helen Ragus
K163043 10/31/2016 Zeramex P6 Dental Implant System DENTALPOINT AG Viktor Lienhard
K162888 10/17/2016 Cercon Dentsply Sirona Karl Nittinger
K162969 10/24/2016 LIAISON« CMV IgG and LIAISON« CMV IgG Serum Control Set DiaSorin Inc. John Walter
K162959 10/24/2016 LIAISON« EA IgG and LIAISON« EA IgG Serum Control Set DIASORIN INC. JOHN WALTER
K162961 10/24/2016 LIAISON« VCA IgG and LIAISON« VCA IgG Serum Control Set; LIAISON« EBNA IgG and LIAISON« EBNA IgG Serum Control Set DIASORIN INC. JOHN WALTER
K162849 10/11/2016 Huvex Interspinous Fixation System DIO MEDICAL CO., LTD. LEE SUNG-HEE
K162951 10/24/2016 TUBETECH IV Administration Set Douglas Medical Products, Inc. Doug Johnson
K162821 10/07/2016 Babyleo TN500 Draegerwerk AG & Co. KGaA Bettina Moebius
K162886 10/17/2016 DEKA MOTUS AX EL.EN. ELECTRONIC ENGINEERING SPA PAOLO PERUZZI
K163035 10/31/2016 DilaCheck Nitrile Powder Free Examination Glove, (Sterile) Elm Tree Medical, Inc. Eva Martin
K162797 10/04/2016 SpringTMS eNeura Inc. Larry W. Getlin
K163038 10/31/2016 EPIC Extremity Snap-Off Screw EPIC EXTREMITY, LLC DAN SCHWARTZBAUER
K162811 10/06/2016 MR Conditional CGA 870 Essex Industries, Inc. Russ Jacobsmeyer
K162972 10/25/2016 ExactVu High Resolution Micro-Ultrasound System Exact Imaging Karina Torres
K162903 10/17/2016 Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies Exactech Inc Thomas McNamara
K162987 10/27/2016 FA100 SCCD (Sequential Continuous Contraction Device) FlowAid Medical Technologies, Corp Jacob Brezel
K162781 10/03/2016 Magma Spark Formatk Systems Ltd. Ahava Stein
K162836 10/11/2016 FUJIFILM Surgical System FUJIFILM New Development U.S.A., Inc. Stephen Mariano
K162990 10/27/2016 Optima XR240amx GE Medical Systems, LLC Chris Paulik
K162825 10/07/2016 CAPTIVATEÖ Compression Screws GLOBUS MEDICAL, INC. Kelly J. Baker
K163017 10/28/2016 Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs GMP MEDICARE SDN BHD EVA VINONI BT MUSTAFA
K162850 10/11/2016 GuideMia Ortho+ GUIDEMIA TECHNOLOGIES, LLC FEI GAO
K162930 10/19/2016 Aero Chrome* Select Breathable Performance Surgical Gowns Halyard Health, Inc. David M. Lee
K162923 10/18/2016 NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - AQUA BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - VIOLET BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DR HARTALEGA NGC SDN. BHD. KUAN MUN LEONG
K162924 10/18/2016 Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU) HARTALEGA SDB. BHD. KUAN KAM HON
K162819 10/06/2016 Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs HARTALEGA SDN. BHD. KUAN KAM HON
K162818 10/06/2016 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) HARTALEGA SDN. BHD. KUAN KAM HON
K162902 10/17/2016 ARIETTA Prologue Diagnostic Ultrasound system and Transducers HITACHI, LTD. ANGELA VAN ARSDALE
K162784 10/03/2016 Silk'n HST Home Skinovations Ltd. Amit Goren
K162788 10/03/2016 ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA IMMCO DIAGNOSTICS, INC. Kevin Lawson
K162970 10/24/2016 FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator Inari Medical Eben Gordon
K162848 10/11/2016 Straumann CARES Golden Ti/TiN Abutments INSTITUT STRAUMANN AG Christopher Klaczyk
K162851 10/11/2016 eLyx-PRO Intelligent Sensory Concept SA Joel Chanteraud
K162973 10/25/2016 EndoWrist Suction Irrigator Intuitive Surgical, Inc. Melissa S. Gonzalez
K162863 10/13/2016 dS Small Extremity 16CH 1.5T Coil INVIVO THERAPEUTICS CORPORATION Ken Revennaugh
K162817 10/06/2016 Noddle(TM) IOWA ADAPTIVE TECHNOLOGIES, INC. DBA VOXELLO, INC. R. RIVES BIRD
K162960 10/24/2016 TotalC-Ram ITENA CLINICAL Charles Peyre
K162868 10/13/2016 Exam Vue PACS JPI Healthcare Solutions, Inc Jang Won Lee
K162992 10/27/2016 Karl Storz UROMAT E.A.S.I. KARL STORZ ENDOSCOPY AMERICA, INC SERKAN SEZER
K162880 10/14/2016 TIPCAM 1S 3D System KARL STORZ Endoscopy America, Inc Winkie Wong
K162882 10/14/2016 KARL STORZ ICG Imaging System KARL STORZ ENDOSCOPY-AMERICA, INC. SUSIE S. CHEN
K162790 10/04/2016 V.A.C.ULTA Negative Pressure Wound Therapy System KCI USA, Inc. (Kinetic Concepts, Inc.) Margaret Marsh
K162948 10/21/2016 Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials KERR CORPORATION Jennifer Dzidrums
K162878 10/14/2016 Kitazato ET Catheters Kitazato Corporation Mari Yazaki
K162881 10/14/2016 Kitazato OPU Needles Kitazato Corporation Mari YAZAKI
K162801 10/05/2016 CastleLoc Spinal Fixation System L&K BIOMED CO., LTD. Yerim An
K162854 10/12/2016 Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml Liofilchem s.r.l. Fabio Brocco
K162852 10/11/2016 Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove Lucenxia Prescience AG Robert Hill
K162837 10/11/2016 Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532Ö Laser System LUMENIS LTD NAAMA JACOBY
K162772 10/03/2016 ARIES GBS Assay LUMINEX CORPORATION CHRISTIE HUGHES
K162935 10/20/2016 Rapid2 Therapy System MAGSTIM COMPANY LTD. Kevyn Beard
K162786 10/03/2016 PASS LP Spinal System MEDICREA INTERNATIONAL S.A DAVID RYAN
K162993 10/27/2016 Gemini Sterilization Wrap Medline Industries, Inc. Jennifer Mason
K162982 10/26/2016 Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) Medline Industries, Inc. Jennifer Mason
K162829 10/07/2016 Medline UNITE« Ankle Fracture Plating System MEDLINE, INDUSTRIES, INC. Jennifer Mason
K162912 10/17/2016 VIPER PRIMEÖ additions to the VIPER« System MEDOS INTERNATIONAL, SARL Karen Sylvia
K162892 10/17/2016 Achieve Advance Mapping Catheter MEDTRONIC INC. HEATHER TAYLOR
K163032 10/31/2016 Kyphon Xpede Bone Cement Medtronic Inc. Pamela Edwards
K162896 10/17/2016 Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface MEDTRONIC, INC. RENEE CVEYKUS
K163008 10/28/2016 CareLink SmartSync Device Manager - Pacing System Analyzer Medtronic, Inc. Laura Danielson
K162774 10/03/2016 MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System) Medtronic, Inc. Harsh Dharamshi
K162958 10/24/2016 MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge Medtronic, Inc. Harsh Dharamshi
K162855 10/12/2016 Reveal LINQ Medtronic, Inc. Syed Sumran Mohiuddin
K162988 10/27/2016 PreludeSYNC Radial Compression Device Merit Medical Systems, Inc. Ileana Davis
K162777 10/03/2016 Squirt Fluid Delivery System Merit Medical Systems, Inc. Angela Brady
K162898 10/17/2016 Olecranon Plating System MIAMI DEVICE SOLUTIONS, LLC Michelle Montesino
K162999 10/28/2016 V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System MICROVENTION, INC Laraine Pangelina
K162874 10/13/2016 Cannulated Screws Neoortho Neoortho Produtos Ortopedicos S/A Mariana de Oliveira Quinzani
K162869 10/13/2016 Contact Lens Case Ningbo Yinzhou Zonghai Artware Co., Ltd. Weng Changhai
K162885 10/17/2016 SPY Phi Open Field Handheld Fluorescence Imaging System NOVADAQ TECHNOLOGIES INC. JEN PENDLEBURY
K162875 10/14/2016 Sentry IVC filter NOVATE MEDICAL LTD. GORDON CROWLEY
K163005 10/28/2016 TIGR Matrix Surgical Mesh NOVUS SCIENTIFIC AB MATS NORBERG
K162927 10/19/2016 PRECICE UNYTE CoCr System NuVasive Specialized Orthopedics, Inc. Cora Sim
K163045 10/31/2016 Omron HEM-6400T-Z Wrist Blood Pressure Monitor Omron Healthcare, Inc. Renee Thornborough
K163021 10/31/2016 HAAG-STREIT FUNDUS MODULE 300 OPTOMED OY Jyri Leskela
K162862 10/12/2016 Raycast High Precision Lung Board Solution Orfit Industries NV Raymond Kelly
K162833 10/11/2016 VitriGuard ORIGIO A/S ROAIDA JOHNSON
K162962 10/24/2016 OrthAlign Plus System OrthAlign, Inc. David Vancelette
K162995 10/27/2016 Ibis« Pedicle Screw System Ortho Development Corporation Lindsay Martin
K162921 10/18/2016 Navigated Instrument System ORTHOFIX INC. JACKI KOCH
K162799 10/05/2016 Cliniview Palodex Group Oy Jouni Karkinen
K162785 10/03/2016 Velox Nebulizer System PARI Respiratory Equipment, Inc. Michael Judge
K163003 10/28/2016 Y3 Proximal Femoral Plate System PEGA MEDICAL INC. ARIEL R. DUJOVNE
K162901 10/17/2016 Penumbra 3D Revascularization Device Penumbra, Inc. Michaela Mahl
K163011 10/28/2016 PHA S1 Spinal System Phamedica, Inc. Henry Fam
K163026 10/31/2016 Ultra/Phonic Scanning Gel Pharmaceutical Innovations Inc. Shirley J. Bergman
K163023 10/31/2016 Other-Sonic Transmission Gel PHARMACEUTICAL INNOVATIONS, INC. SHIRLEY J. BERGMAN
K163024 10/31/2016 Ultra/Phonic Conductivity Gel PHARMACEUTICAL INNOVATIONS, INC. SHIRLEY J. BERGMAN
K163027 10/31/2016 Ultra/Phonic Free Conductivity Gel PHARMACEUTICAL INNOVATIONS, INC. SHIRLEY J. BERGMAN
K163020 10/31/2016 Xperius Ultrasound System PHILIPS HEALTHCARE SCOTT ZHANG
K162838 10/11/2016 Philips iCT CT System Philips Medical Systems (Cleveland), Inc. Christine Anderson
K162931 10/19/2016 Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Ruojuan Zhang
K162955 10/24/2016 Multi-Modality Tumor Tracking (MMTT) application Philips Medical Systems Nederland B.V. Yoram Levy
K162940 10/21/2016 MultiBand SENSE Philips Medical Systems Nederland B.V. Jan Van de Kerkhof
K162859 10/12/2016 Allura Xper FD series and Allura Xper OR Table series Philips Medical Systems Nederland BV Jeanette Becker
K162917 10/18/2016 Allerhope Allergy Skin Tester PROCARE INDUSTRIAL CO., LIMITED WANG YANHONG
K163041 10/31/2016 Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E PT. MEDISAFE TECHNOLOGIES DEEPAK BANG
K162946 10/21/2016 8ch Knee-Foot SPEEDER QUALITY ELECTRODYNAMICS, LLC KATHLEEN ARAS
K162966 10/24/2016 TxRx Knee 15 Flare MR Coil 1.5T Quality Electrodynamics, LLC Kathleen Aras
K163009 10/28/2016 Litho Quanta System SpA FRANCESCO DELL' ANTONIO
K163013 10/28/2016 Quantib Brain 1.2 Quantib BV Rudolf Scholte
K162804 10/05/2016 Q2 Low Pressure Power Injection Extension Set QUEST MEDICAL, INC. Amy Clendening-Wheeler
K162911 10/17/2016 Sofia RSV FIA on Sofia 2 analyzer Quidel Corporation Edward C. Brehm
K162954 10/24/2016 OARtrac System with Patient Specific Reusable Universal PSD Sensors RADIADYNE, LLC JOHN K. ISHAM
K162932 10/20/2016 Ranfac Fat Aspiration Cannula RANFAC CORP. CHRISTOPHER WHELAN
K162770 10/03/2016 Relign System Relign Corporation Nathan Nguyen
K162895 10/17/2016 Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5 Roche Diagnostics Jane Phillips
K162840 10/11/2016 Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 Roche Diagnostics Linda McCammack
K162826 10/07/2016 Encore Neutral RyMed Technologies, LLC Anna McCutchen
K162816 10/06/2016 SML-OSA2 Appliances SELANE PRODUCTS, INC. JOHN CHRISTIAN
K162845 10/11/2016 DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD ZHAI PEI
K162867 10/13/2016 MagDen Dental Implant System SHINHUNG MST Co., Ltd. Lee Sunbyung
K162977 10/26/2016 ADVIA 2120i, ADVIA 2120 SIEMENS HEALTHCARE DIAGNOSTICS Gerard Sadrakula
K162971 10/25/2016 Multix Fusion Max SIEMENS MEDICAL SOLUTIONS USA, INC. DENISE ADAMS
K162864 10/13/2016 OsteoVation Impact Skeletal Kinetics, LLC. Alicia Hemphill
K162782 10/03/2016 iHelmet Hair Growth System Slinph Technologies Co., LTD Zou Jian
K162996 10/27/2016 INVISIKNOT Ankle Syndesmosis Repair Kit SMITH & NEPHEW, INC. GREGORY NEAL
K162775 10/03/2016 Legion Cone System Smith & Nephew, Inc. Natalie Williams
K163034 10/31/2016 SUTUREFIX Curved Suture Anchor Smith and Nephew, Inc. Anne-Marie Keefe
K162884 10/14/2016 SpineGuard DSG Zavation Screw System SPINEGUARD,S.A. Stephane Bette
K162879 10/14/2016 Elite Expandable Interbody Fusion Device Spineology Inc. Jacqueline A. Hauge
K162945 10/21/2016 VERIFY ASSERT STEAM Process Challenge Device STERIS Corporation Ganga Kolli
K162890 10/17/2016 BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment STRAUMANN USA, LLC JENNIFER M. JACKSON
K162929 10/19/2016 Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker Stryker Corporation Brittney M. Larsen
K162937 10/20/2016 Stryker OrthoMap Versatile Hip System Stryker Corporation Brittney Larsen
K162841 10/11/2016 VariAx Distal Radius Plating System, VariAx 2 System Stryker GmbH Irene Bacalocostantis
K162830 10/07/2016 SIS Software Surgical Information Sciences, Inc. Mark Headrick
K163028 10/31/2016 Medline ReNewal Reprocessed Stryker External Fixation Devices SURGICAL INSTRUMENT SERVICE AND SAVINGS INC BRANDI J. PANTELEON
K162943 10/21/2016 SyMRI SyntheticMR AB Maria Almesaker
K162965 10/24/2016 SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction TEI Biosciences Inc. Kavita Amin
K162989 10/27/2016 Rusch Simplastic Foley Catheters TELEFLEX MEDICAL, INC. LORI PFOHL
K162922 10/18/2016 GalaFORM 3D TEPHA, INC. CONNIE H GARRISON
K162843 10/11/2016 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
K162873 10/13/2016 MEP Monitor TONICA ELEKTRONIK A/S LISE TERKELSEN
K162800 10/05/2016 BLUEPRINT Patient Specific Instrumentation TORNIER SAS Aymen AZAIEZ
K162957 10/24/2016 U2 Femoral Head UNITED ORTHOPEDIC CORPORATION GIMPEL CHIEN
K162812 10/06/2016 Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roc UNOMEDICAL A/S John M. Lindskog
K162803 10/05/2016 Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts VASCUTEK LTD. NEIL MCLACHLAN
K162794 10/04/2016 Gelweave Vascular Grafts VASCUTEK LTD. NEIL MCLACHLAN
K162877 10/14/2016 VOCSN Unified Respiratory System VENTEC LIFE SYSTEMS, INC Joseph Cipollone
K162968 10/24/2016 VORTRAN GO2VENT VORTRAN MEDICAL TECHNOLOGY 1, INC. James Lee
K162926 10/19/2016 Air-Powered Handpieces and Handpiece Attachments W&H DENTALWERK BURMOOS GMBH Anja Lindner
K163037 10/31/2016 Intra medullary endo-transilluminating device (iMET device) WEMED BIO-TECH INC. YIN-JIUN TSENG
K162828 10/07/2016 Winback Back 3SE WINBACK USA CORP CHEICK KONGO
K163044 10/31/2016 ORTHOLOC« 3Di Ankle Fracture Plating System WRIGHT MEDICAL TECHNOLOGY, INC. Val Myles
K163039 10/31/2016 ORTHOLOC« 3Di Small Bones Plating Wright Medical Technology, Inc. Michael Mullins
K162795 10/04/2016 PROPHECY INVISION Preoperative Navigation Alignment System Wright Medical Technology, Inc. Tara Conrad
K162944 10/21/2016 Irix-C Cervical Integrated Fusion System X-SPINE SYSTEMS, INC. KRISS ANDERSSON
K162824 10/07/2016 Z-Span Plate System Zavation, LLC Frankie Cummins
K162919 10/18/2016 Male Latex Condoms Zhejiang Xiangban Latex Products Co., Ltd. Huichao Lou
K162832 10/11/2016 731 Series Ventilators ZOLL MEDICAL CORPORATION CHUCK KOLIFRATH


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