| 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 |
