| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K151369 |
08/07/2015 |
.decimal p.d |
.DECIMAL, LLC |
KEVIN ERHART |
| K151687 |
08/03/2015 |
QuantorView |
3DISC AMERICAS |
SIGRID SMITT-JEPPESEN |
| K143613 |
08/14/2015 |
PaxWire Occlusion Balloon System |
ACCESSCLOSURE, INC. |
Kelly Jabbal |
| K151056 |
08/13/2015 |
Aesculap T-Space PEEK and XP Spinal System |
AESCULAP IMPLANT SYSTEMS, LLC |
LISA M. BOYLE |
| K143729 |
08/18/2015 |
SterilContainer S |
AESCULAP, INC. |
Denise R Adams |
| K151935 |
08/12/2015 |
Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori Whole Blood, Serum, Plasma; Alere Clearview H. pylori Whole Blood Only |
ALERE SAN DIEGO, INCORPORATED |
JOSEPH DE LA ROSA |
| K143354 |
08/20/2015 |
Natrelle 133 Plus Tissue Expander |
ALLERGAN, INC. |
Bruce Krattenmaker |
| K150395 |
08/10/2015 |
Omega LIF System |
AMENDIA, INC. |
Bruce Hooper |
| K150043 |
08/14/2015 |
Transcutaneous Electrical Nerve Stimulators (TENS) |
ANDON HEALTH CO.,LTD |
Liu Yi |
| K142689 |
08/06/2015 |
GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System |
Apex BioTechnology Corp. |
Hsue-mei Lee |
| K151153 |
08/20/2015 |
Pirouette 018 |
ARRAVASC LIMITED |
MAIREAD MCCAFFREY |
| K151877 |
08/07/2015 |
MicroTract Access System |
ARSTASIS, INC. |
Debra Cogan |
| K151256 |
08/12/2015 |
Arthrex BioSync« Bone Wedge |
Arthex, Inc |
Laura Medlin |
| K150648 |
08/20/2015 |
Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm |
ARTHREX, INC. |
Laura Medlin |
| K151732 |
08/28/2015 |
Arthrex Fracture Plates |
ARTHREX, INC. |
COURTNEY SMITH |
| K151897 |
08/06/2015 |
MultiFIX« P Knotless Fixation Device |
ArthroCare Corporation |
Laura Kasperowicz |
| K151459 |
08/31/2015 |
Integra Total Ankle Replacement System |
Ascension Orthopedics |
Frederic Testa |
| K151437 |
08/27/2015 |
ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug |
ATRIUM MEDICAL CORPORATION |
TIMOTHY J. TALCOTT |
| K151998 |
08/19/2015 |
TraceIT Tissue Marker - 3mL |
AUGMENIX, INC. |
NOEL ROLON |
| K150621 |
08/18/2015 |
OsteoSelect PLUS Demineralized Bone Matrix Putty |
BACTERIN INTERNATIONAL INC. |
Howard L Schrayer |
| K143538 |
08/14/2015 |
MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit |
BAYER MEDICAL CARE INC. |
LISA A. EWING |
| K151009 |
08/18/2015 |
Nexus Suture |
BAYLIS MEDICAL COMPANY INC. |
Meghal Khakhar |
| K143648 |
08/25/2015 |
BD MAX Enteric Parasite Panel, BD MAX Instrument |
BECTON, DICKINSON AND COMPANY |
PAUL SWIFT |
| K151206 |
08/28/2015 |
Fingertip Pulse Oximeter |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
LEI CHEN |
| K151219 |
08/04/2015 |
Models 2200DR and 1600DR Digital Stationary Radiographic Systems |
BEIJING POLYCON MEDICAL ENGINEERING COMPANY |
XIANGCHEN LIU |
| K151064 |
08/12/2015 |
Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System |
BIOMET SPINE |
Alexandra Beck |
| K151409 |
08/07/2015 |
Selectra Catheters and Selectra Accessory Kit |
BIOTRONIK, INC. |
JON BRUMBAUGH |
| K143292 |
08/04/2015 |
TheraCal DC |
Bisco Inc |
Michelle Schiltz-Taing |
| K151801 |
08/13/2015 |
Arc Endocuff Vision |
BODDINGTONS PLASTICS LTD |
PAUL BLACKMORE |
| K150692 |
08/05/2015 |
AXIOS Stent with Electrocautery Enhanced Delivery System |
BOSTON SCIENTIFIC CORP. |
Carole Sykes |
| K151802 |
08/06/2015 |
Resolution Clip |
BOSTON SCIENTIFIC CORPORATION |
ELENA NIEVES |
| K151325 |
08/04/2015 |
Bovie J-Plasma Handpiece |
BOVIE MEDICAL CORPORATION |
Brian Kunst |
| K142943 |
08/03/2015 |
Metallic Locking Bone Plate and Screw |
Canwell Medical Co., Ltd |
Chen Hui |
| K151516 |
08/21/2015 |
Capillus82 |
Capillus, LLC |
PATRICIA SCHNOOR |
| K150289 |
08/27/2015 |
CARDIOLINE HD+ |
CARDIOLINE S.p.A |
Emanuele Ercoli |
| K150810 |
08/14/2015 |
Vyntus / SentrySuite Product Line |
CareFusion Germany 234 GmbH |
Elmar Niedermeyer |
| K150929 |
08/04/2015 |
CareView 1500Cw X-ray Flat Panel Detectors |
CARERAY DIGITAL MEDICAL SYSTEM CO., LTD. |
YULING DING |
| K140907 |
08/07/2015 |
LEECH, MEDICINAL |
CAROLINA BIOLOGICAL SUPPLY CO. |
KEITH E BARKER |
| K151057 |
08/10/2015 |
WASTON Metallic Bone Plate and Screw Systems |
CHANGZHOU WASTON MEDICAL APPLIANCE CO. LTD |
Jack Lu |
| K143758 |
08/07/2015 |
PerioType Rapid |
CLINICAL HOUSE EUROPE GMBH |
Judi Weissinger |
| K151379 |
08/13/2015 |
Conventus PRS System |
Conventus Orthopaedics, Inc |
Kent R Lind |
| K152033 |
08/19/2015 |
Cook ECM Powder |
Cook Biotech Incorporated |
Perry W Guinn |
| K152044 |
08/14/2015 |
Flexor Radial Hydrophilic Introducer Access Set |
COOK INCORPORATED |
SARAH REEVES |
| K150847 |
08/13/2015 |
Foundation Interbody Devices |
CORELINK LLC |
Sharon Gregory |
| K150735 |
08/04/2015 |
Force TriVerse Electrosugical Device, Holster, 10-foot, Force TriVerse Electrosurgical Device, Holster, 15-foot |
COVIDIEN |
NANCY SAUER |
| K151088 |
08/28/2015 |
DMRC Bulk Fill |
DANVILLE MATERIALS, LLC |
DONG HUA |
| K150040 |
08/27/2015 |
Implanova |
DENTAL EVOLUTIONS INC. |
PARSA T ZADEH |
| K140432 |
08/03/2015 |
HI-LIGHT, HI-LIGHT PLUS |
DENTALL CORPORATION |
Priscilla Chung |
| K151867 |
08/07/2015 |
STA R MAX |
DIAGNOSTICA STAGO S.A.S. |
ARNAUD COLLIN |
| K151006 |
08/31/2015 |
EarlySense Central Display Station (CDS) |
EARLYSENSE LTD. |
DALIA ARGAMAN |
| K150220 |
08/19/2015 |
STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast |
EB NEURO, S.P.A. |
Christiano Pineider |
| K150823 |
08/26/2015 |
EDLENi Intra-Oral Sensor |
EDLEN IMAGING LLC |
Nick Radachi |
| K143325 |
08/20/2015 |
OC-Light S FIT |
EIKEN CHEMICAL CO. LTD |
Yoshinori Ota |
| K151319 |
08/28/2015 |
Eko Electronic Stethoscope System |
Eko Devices, Inc. |
Connor Landgraf |
| K151561 |
08/04/2015 |
Leksell Gamma Knife Icon |
ELEKTA INSTRUMENT AB |
MATILDA FORSBERG |
| K151200 |
08/13/2015 |
STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device |
ETHICON, INC. |
DONNA MARSHALL |
| K151061 |
08/06/2015 |
Cornea Cold |
EUROBIO |
Marie-Claude Amoureux |
| K152070 |
08/26/2015 |
BioZorb LP Marker |
FOCAL THERAPEUTICS |
George Hermann |
| K150962 |
08/28/2015 |
Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack |
FOCUS DIAGNOSTICS |
SHARON YOUNG |
| K151346 |
08/20/2015 |
Frontier Medical Devices Posterior Cable Screw System |
FRONTIER MEDICAL DEVICES, INC. |
BETHANY BYMAN |
| K143556 |
08/20/2015 |
Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
MARY MOORE |
| K151859 |
08/12/2015 |
Synapse Cardiovascular |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
JYH-SHYAN LIN |
| K152209 |
08/19/2015 |
FUJIFILM SonoSite X-Porte Ultrasound System |
FUJIFILM SONOSITE,INC. |
PATRICIA LIAU |
| K143721 |
08/27/2015 |
PRCT2 |
FX SOLUTIONS |
JEAN JACQUES MARTIN |
| K152133 |
08/28/2015 |
IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE 2.1 CX Cryoablation Needle, IceFORCE 2.1 CX Prostate Cryoablation Kit Visual-ICE System |
GALIL MEDICAL LTD |
LYNNE DAVIES |
| K151372 |
08/14/2015 |
Low Dose CT Lung Cancer Screening Option for Qualified GE Systems |
GE Medical Systems, LLC |
John Jaeckle |
| K151587 |
08/07/2015 |
Digital Automatic Wrist Blood Pressure Monitor MD3200 |
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
Patrick Chow |
| K151583 |
08/07/2015 |
Digital Automatic Wrist Blood Pressure Monitor MD3900 |
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
PATRICK CHOW |
| K150767 |
08/17/2015 |
EDOSE |
GUANGZHOU RAYDOSE SOFTWARE TECHNOLOGY., LLC |
DENNIS DONG |
| K150022 |
08/07/2015 |
Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream |
Guangzhou Wondfo Biotech Co., Ltd. |
Ben Chen |
| K150519 |
08/19/2015 |
ManipulatOR PRO, ManipulatOR |
GYNETECH PTY. LTD. |
Brett Telford |
| K143539 |
08/31/2015 |
Dental Implant OKTAGON Bone Level |
Hager & Meisinger GmbH |
Wiebke Stolten |
| K150857 |
08/14/2015 |
Banana Gold |
HANKOOK LATEX GONGUP CO., LTD. |
KWON DUKEE |
| K151463 |
08/18/2015 |
Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components |
HANSEN MEDICAL, INC. |
Elisa Aldridge |
| K151343 |
08/24/2015 |
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (white, blue, orange) |
HARTALEGA NGC SDN BHD |
KUAN MUN LEONG |
| K151642 |
08/13/2015 |
Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card |
HEALGEN SCIENTIFIC LLC |
JIANQIU FANG |
| K151348 |
08/18/2015 |
Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card) |
HEALGEN SCIENTIFIC LLC |
JIANQIU FANG |
| K150311 |
08/18/2015 |
Full Automatic (NIBP)Blood Pressure Monitor |
Health & Life Co., Ltd. |
Sarah Su |
| K152186 |
08/20/2015 |
HealthMyne PACS |
HEALTHMYNE, INC. |
SIGRID SCHOEPEL |
| K150695 |
08/13/2015 |
Modpod |
HOLLYWOG, LLC |
MICHAEL TREAS |
| K150169 |
08/14/2015 |
Sertera Biopsy Device |
Hologic, INC |
Brenda Geary |
| K151164 |
08/07/2015 |
Assure Prism multi Blood Glucose Monitoring System |
i-Sens, Inc. |
JOON HO JUNG |
| K151232 |
08/06/2015 |
VIKINI Diode Laser System |
ILOODA CO., LTD |
Suhee Nam |
| K142351 |
08/25/2015 |
25-Hydroxy Vitamin Ds EIA |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
Mick Henderson |
| K151740 |
08/27/2015 |
JAZZ System |
Implanet, S.A. |
Regis Le Couedic |
| K152097 |
08/25/2015 |
Retraction Aspirator |
INARI MEDICAL |
EBEN GORDON |
| K150274 |
08/26/2015 |
GDH Professional Blood Glucose Monitoring System and GDH Professional LED Blood Glucose Monitoring System |
Infopia Co., Ltd. |
NA YUN KIM |
| K143738 |
08/27/2015 |
DSS Sinusplasty Balloon Catheter |
Intuit Medical Products, LLC |
Jack Griffis |
| K150971 |
08/25/2015 |
Zekang Self-adhesive Electrode |
Jiangsu Zekang Medical Technology Co., Ltd |
Doris Dong |
| K142760 |
08/25/2015 |
Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles |
K.S. Choi Corporation |
Kak Soo Choi |
| K151216 |
08/10/2015 |
Everest Spinal System |
K2M, Inc |
Nancy Giezen |
| K150481 |
08/20/2015 |
Cascadia Interbody System |
K2M, Inc. |
Nancy Giezen |
| K150865 |
08/03/2015 |
Metacross RX PTA Balloon Dilitation Catheter |
Kaneka Corporation |
Toshihiko Motomine |
| K141017 |
08/20/2015 |
PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
MARGARET MARSH |
| K150771 |
08/27/2015 |
RxG Distraction System |
KLS MARTIN L.P. |
JENNIFER DAMATO |
| K150703 |
08/13/2015 |
CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial) |
KURARAY NORITAKE DENTAL INC. |
MICHIO TAKIGAWA |
| K150704 |
08/21/2015 |
PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Pa |
KURARAY NORITAKE DENTAL, INC. |
MICHIO TAKIGAWA |
| K143487 |
08/21/2015 |
Lifelines iEEG |
KVIKNA EHF |
Gardar Thorvardsson |
| K151140 |
08/18/2015 |
LnK Lumbar Interbody Fusion Cage System |
L&K BIOMED Co., Ltd |
Yerim An |
| K143017 |
08/07/2015 |
Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver |
LABORATOIRES URGO |
SOPHIE FORTIN |
| K151702 |
08/13/2015 |
Reusable Full Silicone Cover |
LAERDAL MEDICAL AS |
MARI KAADA |
| K151333 |
08/21/2015 |
LightStim for Pain LED Belt |
LED INTELLECTUAL PROPERTIES, LLC |
Steve Marchese |
| K143454 |
08/27/2015 |
Pruitt F3-S Carotid Shunt |
LeMaitre Vascular, Inc |
Xiang Zhang |
| K151286 |
08/05/2015 |
OPTIS Integrated System Mobile Workstation |
LIGHTLAB IMAGING, INC. |
Padmini Suravaram |
| K151947 |
08/12/2015 |
LightSheer Desire Light Laser System |
LUMENIS LTD |
ELISSA BURG |
| K143752 |
08/06/2015 |
Total Knee Application (TKA) |
MAKO SURGICAL CORP. |
JONATHAN REEVES |
| K150928 |
08/10/2015 |
Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides |
MATERIALISE N.V. |
Laurel Berzanskis |
| K151850 |
08/11/2015 |
McKesson Cardiology |
MCKESSON ISRAEL LTD. |
GILBERT WONG |
| K151023 |
08/05/2015 |
COMPACT PIEZO LED |
MECTRON SPA |
FRANCO ZUNINO |
| K150986 |
08/17/2015 |
Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants |
MEDDEV CORPORATION |
PATRICK GREY |
| K151117 |
08/20/2015 |
Laparoscope Lens Shield Device |
Medeon Biodesign, Inc |
Greta Chang |
| K151235 |
08/06/2015 |
Medline Foot Plates and Screws |
MEDLINE INDUSTRIES, INC. |
Jennifer Mason |
| K143529 |
08/21/2015 |
UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer |
MEDLINE INDUSTRIES, INC. |
JENNIFER MASON |
| K150465 |
08/03/2015 |
Medtronic Confida Brecker Guidewire |
Medtronic CoreValve, LLC. |
Genevieve Balutowski Dunbar |
| K151000 |
08/06/2015 |
O-Arm O2 Imaging System |
MEDTRONIC INC. |
RISHI SINHA |
| K150614 |
08/06/2015 |
Reveal LINQ |
MEDTRONIC INC. |
DIANNA L. JOHANNSON |
| K151128 |
08/06/2015 |
CAPSTONE Spinal System, CLYDESDALE Spinal System |
MEDTRONIC SOFAMOR DANEK USA, INC |
LEE GRANT |
| K151172 |
08/14/2015 |
MASTERGRAFT Contain |
MEDTRONIC SOFAMOR DANEK USA, INC |
Gregory K Maschek |
| K150728 |
08/14/2015 |
XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole |
MEDTRONIC XOMED, INC. |
Gabriela Anchonda |
| K152054 |
08/07/2015 |
Confida Adaptive Sheath |
Medtronic, Inc. |
Matthew Lobeck |
| K143203 |
08/26/2015 |
AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe, AveCure Microwave Medium Antenna-Probe, AveCure Microwave Small Antenna-Probe, AveCure Microwave Mini Antenna-Probe |
MEDWAVES INCORPORATED |
TED ORMSBY |
| K151768 |
08/28/2015 |
Menicon Saline Rinse Solution |
MENICON CO.,LTD. |
TOHRU KAWAGUCHI |
| K143583 |
08/11/2015 |
Cathivex ┐GV filter units |
MERCK MILLIPORE LTD. |
CHRIS PARR |
| K152116 |
08/27/2015 |
5.5 F Worley Advanced LVI Lateral Vein Introducer |
MERIT MEDICAL SYSTEMS, INC. |
ALINA STUBBS |
| K151373 |
08/07/2015 |
Corvocet Coaxial Introducer |
Merit Medical Systems, Inc. |
Ileana Garcia |
| K151776 |
08/12/2015 |
Central Venous Pressure System |
Mespere LifeSciences Inc. |
Helen Tan |
| K143348 |
08/21/2015 |
BC-3600 Auto Hematology Analyzer |
MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
Tan Chuanbin |
| K143233 |
08/13/2015 |
Mitsar-EEG |
MITSAR CO., LTD |
Semchenkov Ales |
| K150146 |
08/31/2015 |
Biogel PI Micro Indicator Underglove |
MOLNLYCKE HEALTH CARE US, LLC |
Megan Bevill |
| K150205 |
08/24/2015 |
LED Curing Light |
MONITEX INDUSTRIAL CO., LTD. |
SHU-LUNG WANG |
| K143433 |
08/28/2015 |
Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm |
Natus Manufacturing Limited |
Michael Galvin |
| K143458 |
08/13/2015 |
Neurosplint |
Neurospectrum LLC |
David Kernan |
| K151797 |
08/25/2015 |
Nuocande Plastic Manual Wheelchair Model NKD L07 |
NINGBO LECOUNT MEDICAL TECHNOLOGY CO., LTD. |
CHARLES SHEN |
| K151305 |
08/27/2015 |
SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg) |
NONIN MEDICAL INC. |
LAURA J. LIND |
| K151341 |
08/20/2015 |
Turbo High-Flow Non-coring Needle |
NORFOLK MEDICAL |
NATAN PHEIL |
| K151407 |
08/12/2015 |
RECON system |
NORMED MEDIZIN-TECHNIK GMBH |
ARNE BRIEST |
| K152071 |
08/26/2015 |
NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only) |
NOVABONE PRODUCTS, LLC |
RICHARD A. DAVIS |
| K151277 |
08/13/2015 |
Airlock« osteosynthesis plate system |
NOVASTEP |
GILLES AUDIC |
| K150143 |
08/31/2015 |
Normal Saline Flush |
NURSE ASSIST, INC. |
Brian Cox |
| K151374 |
08/06/2015 |
NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable XLIF System |
NuVasive, Incorporated |
Olga Lewis |
| K143579 |
08/28/2015 |
NuVasive Sterilization Trays |
NuVasive, Incorporated |
Olga Lewis |
| K150786 |
08/27/2015 |
Rezum System |
NxThera, Inc. |
J. Robert Paulson, JD |
| K150398 |
08/06/2015 |
EUM 100Pro |
OB TOOLS, LTD. |
GAL BEN DAVID |
| K151623 |
08/06/2015 |
Penumbra System 110 Aspiration Tubing |
Penumbra, Inc. |
Michaela Mahl |
| K151929 |
08/12/2015 |
PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE |
PERSYST DEVELOPMENT CORPORATION |
DARI DARABBEIGI |
| K151598 |
08/17/2015 |
VesselNavigator Rel. 1.0 |
PHILIPS MEDICAL SYSTEMS NEDERLAND BV |
LISELOTTE KORNMANN |
| K150665 |
08/07/2015 |
Philips Spectral CT Applications |
PHILIPS MEDICAL SYSTEMS NETHRLANDS BV |
NONE PROVIDED |
| K151863 |
08/07/2015 |
Precision Spine Interspinous Plate System |
PRECISION SPINE, INC. |
MICHAEL C. DAWSON |
| K151422 |
08/21/2015 |
Reform Pedicle Screw System |
Precision Spine, Inc. |
Michael C. Dawson |
| K151753 |
08/27/2015 |
16 ch Tx/Rx Knee SPEEDER |
Quality Electrodynamics, LLC |
Kathleen Aras |
| K151924 |
08/07/2015 |
Q-Rad Radiographic System with Auto-Tracker Option |
QUANTUM MEDICAL IMAGING DIVISON OF CARESTREAM |
MARK CAMIRAND |
| K150819 |
08/06/2015 |
Triglycerides |
Randox Laboratories Limited |
Pauline Armstrong |
| K151880 |
08/07/2015 |
Wingman Crossing Catheter |
REFLOW MEDICAL |
REBECCA K PINE |
| K143623 |
08/13/2015 |
Narval Brux |
RESMED SAS |
Larissa D'Andrea |
| K150572 |
08/27/2015 |
Respire Pink Series-Herbst-EF |
Respire Medical Holding |
David Walton |
| K150288 |
08/28/2015 |
PDO Absorbable Punctum Plug |
RIVERPOINT MEDICAL |
Edwin Anderson |
| K143446 |
08/13/2015 |
Accu-Chek FlexLink Plus infusion set |
Roche Diagnostics GmbH |
Alexander Ruegner |
| K143534 |
08/06/2015 |
Elecsys CA-125 II assay |
ROCHE PROFESSIONAL DIAGNOSTICS |
LINDA MCCAMMACK |
| K151756 |
08/21/2015 |
STERISPINE LC CAGE |
SAFE ORTHOPAEDICS |
Pierre Dumouchel |
| K143700 |
08/05/2015 |
CPAP Cannulaide |
Salter Labs |
Aurelia Brownridge |
| K151663 |
08/12/2015 |
RS80A Diagnostic Ultrasound System |
SAMSUNG MEDISON CO., LTD. |
KYEONG-MI PAK |
| K151180 |
08/19/2015 |
ScandiDos Delta4 Phantom+ |
SCANDIDOS AB |
THOMAS MATZEN |
| K132929 |
08/05/2015 |
SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVII MENTOR NFC BLOOD GLUCOSE MONITORING SYSTEM |
SD BIOSENSOR, INC. |
Feng-Yu Lee |
| K151856 |
08/06/2015 |
ABL80 FLEX CO-OX with AQURE connectivity |
SENDX MEDICAL INC. |
Vibeke Agerlin |
| K150095 |
08/06/2015 |
ReDs Wearable System |
SENSIBLE MEDICAL INNOVATIONS LTD. |
Inbal Ben-Tzvi |
| K150894 |
08/28/2015 |
VIA 21 Microcatheter |
SEQUENT MEDICAL, INC |
Bethany Barrett |
| K142976 |
08/26/2015 |
UltraTENS |
Shenzhen Dongdixin Technology Co., Ltd |
Qilian Liu |
| K151653 |
08/07/2015 |
8ch Foot Ankle Coil |
SHENZHEN RFTECH CO., LTD. |
KE XI |
| K151462 |
08/12/2015 |
SI-TECHNOLOGY« SI-DESIS« SCREWS |
SI-TECHNOLOGY, LLC |
CHRIS DONNER |
| K150757 |
08/11/2015 |
syngo.CT Dual Energy |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
Kimberly Mangum |
| K150745 |
08/11/2015 |
syngo.CT Single Source Dual Energy |
Siemens Medical Solutions USA, Inc. |
Kimberly Mangum |
| K151353 |
08/07/2015 |
syngo.MR Neurology, syngo.MR Oncology |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CORDELL L. FIELDS |
| K151380 |
08/13/2015 |
syngo.via RT Image Suite |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
EVE DAVIS |
| K150685 |
08/24/2015 |
Skynector CPAP Mask |
SKY WISE MEDICAL INSTRUMENT (SHEN ZHEN) CO., LTD. |
Field Fu |
| K143512 |
08/26/2015 |
ActiSpec Activity Monitor |
SLEEP MODUS, INC. |
STANFORD P HUDSON |
| K152164 |
08/28/2015 |
S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System |
SONOSCAPE MEDICAL CORP. |
Toki Wu |
| K152165 |
08/26/2015 |
S9 Portable Digital Color Doppler Ultrasound System |
SONOSCAPE MEDICAL CORP. |
Toki Wu |
| K142995 |
08/17/2015 |
SOPIX |
SOPRO - ACTEON GROUP |
PHILIPPE BOYER |
| K150564 |
08/12/2015 |
Spaulding Electrocardiograph 2100iQ |
Spaulding Clinical Research, LLC |
Andre Leak |
| K151741 |
08/20/2015 |
HA Minuteman G3 MIS Fusion Plate |
SPINAL SIMPLICITY LLC |
JULIE MCKEE |
| K152174 |
08/31/2015 |
Sniper Spine System |
SPINE WAVE, INC. |
Sanja Jahr |
| K150357 |
08/27/2015 |
Reprocessed Electrophysiology Diagnostic Catheters |
STERILMED, INC. |
Nicole Boser |
| K151247 |
08/10/2015 |
NC Straumann Screw Retained Abutments |
STRAUMANN USA, LLC |
CHRISTOPHER KLACZYK |
| K151157 |
08/05/2015 |
NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for Bars/Bridges, NNC Straumann Variobase Abutment for Bars/Bridges, RN Straumann Variobase Abutment for Bars/Bridges, WN Straumann Variobase Abutment for Bars/Bridges |
STRAUMANN USA, LLC |
CHRISTOPHER KLACZYK |
| K150814 |
08/10/2015 |
Straumann Screw-Retained Abutment |
STRAUMANN USA, LLC |
Manuela Ventur |
| K152076 |
08/26/2015 |
PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority |
Stryker |
Jonathan Schell |
| K150584 |
08/13/2015 |
Stryker Suture Tape |
Stryker |
Taylor White |
| K151243 |
08/20/2015 |
STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit] |
Stryker Endoscopy |
GOLNAZ MOEINI |
| K151879 |
08/06/2015 |
VariAx 2 One-Third Tubular Plating System |
STRYKER GMBH |
HEIKE GUSTKE |
| K151264 |
08/10/2015 |
Restoration Anatomic Shell |
STRYKER ORTHOPAEDICS |
Allison M Ling |
| K150452 |
08/13/2015 |
ComboCath OTW PTA Dilatation Catheter |
Summa Therapeutics, LLC |
Richard Rush |
| K151166 |
08/18/2015 |
Instru-Safe Instrument Protection System |
Summit Medical Inc. |
Nicole Dove |
| K151332 |
08/17/2015 |
Nexus Universal, Nexus Universal Chroma |
SYBRON DENTAL SPECIALTIES |
COURTNEY CLARK |
| K151241 |
08/07/2015 |
Synchro-Medical TIGER TRACK Screw System |
Synchro Medical |
Danilo Campani |
| K143444 |
08/21/2015 |
SynePure Wound Cleanser |
Synedgen Inc. |
Shenda Baker |
| K150673 |
08/21/2015 |
SYNFIX Evolution Secured Spacer System |
SYNTHES (USA) PRODUCTS LLC |
EUGENE BANG |
| K143692 |
08/21/2015 |
GranOSTM - beta tricalcium phosphate synthetic bone granules |
TCM ASSOCIATES LTD |
IAIN ALLIGAN |
| K152081 |
08/26/2015 |
Weck Auto Endo5 Hem-o-lok Ligating Clip Applier |
Teleflex Medical, Inc. |
Ashlea Ricci |
| K150973 |
08/04/2015 |
NUZONE X2G Polychloroprene Synthetic Green Surgical Gloves Powder Free, Tested for Use with Chemotherapy Drugs |
TERANG NUSA SND BHD |
ROBERT HILL |
| K151349 |
08/27/2015 |
Advanced Perfusion System 1 |
Terumo Cardiovascular Systems Corporation |
John Chesney |
| K150412 |
08/28/2015 |
Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator |
The Binding Site Group Ltd |
Marianne Sender |
| K150658 |
08/26/2015 |
Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit |
THE BINDING SITE GROUP LTD |
Andrea Thomas |
| K150556 |
08/28/2015 |
Sensititre 18-24 hours MIC or BP Susceptibility System with Ceftolozane/tazobactam (0.03/4- 64/4ug/mL) |
THERMO FISHER SCIENTIFIC |
CYNTHIA KNAPP |
| K142765 |
08/11/2015 |
TM SAFETY NEEDLE |
ThinkMed Medical Technology Co., Ltd. |
Garfield Wang |
| K150871 |
08/04/2015 |
ForeFoot STP System |
TORNIER, INC. |
BRIAN HOCKETT |
| K151837 |
08/19/2015 |
CS 3D Imaging |
TROPHY |
MARIE-PIERRE LABAT-CAMY |
| K151087 |
08/21/2015 |
CS 8100SC, CS8100SC Access |
TROPHY |
MARIE-PIERRE LABAT-CAMY |
| K150086 |
08/05/2015 |
Titan |
TZORA ACTIVE SYSTEMS LTD. |
Adi Shemer |
| K151371 |
08/19/2015 |
Corporate Dental Imaging (CDI) Application |
U.S. ARMY DENTAL COMMAND (DENCOM) |
WILLIAM K. PORTER |
| K151213 |
08/21/2015 |
UCP Drug Test Mini Cups |
UCP BIOSCIENCES, INC |
NANCY CHEN |
| K141594 |
08/10/2015 |
Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless Trocar |
UNIMICRO MEDICAL SYSTEMS (SHENZHEN) CO., LTD. |
LONG YANG |
| K150432 |
08/14/2015 |
IDODENTINE DISC, IDODENTINE BLOCK |
UNION DENTAL S.A. |
JOSE LUIS RODRIGUEZ BLANCO |
| K151316 |
08/13/2015 |
U2 Hip Stem, Ti Porous Coated, Matrix |
United Orthopedic Corporation |
Karen Ho |
| K151345 |
08/25/2015 |
BioGuard Air/Water Valve, BioGuard Suction Valve |
UNITED STATES ENDOSCOPY GROUP, INC. |
CARROLL L. MARTIN |
| K143424 |
08/28/2015 |
UTAH CVX-RIPE |
UTAH MEDICAL PRODUCTS, INC. |
Ben Shirley |
| K151533 |
08/13/2015 |
Respiratory Gating for Scanners |
VARIAN MEDICAL SYSTEMS, INC |
PETER J. CORONADO |
| K151657 |
08/07/2015 |
Shielded Applicator Set, Cervical Stop |
VARIAN MEDICAL SYSTEMS, INC |
PETER J. CORONADO |
| K151981 |
08/13/2015 |
Turnpike catheter |
VASCULAR SOLUTION, INC. |
BEKA VITE |
| K143554 |
08/04/2015 |
Venus Legacy CX |
Venus Concept Ltd. |
Orit Ron Edoute |
| K150154 |
08/28/2015 |
ANAM Test System: Military Battery |
Vista LifeSciences, Inc. |
Lori White |
| K143701 |
08/26/2015 |
EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUM |
VOLCANO CORPORATION |
MARCUS GARCIA |
| K151961 |
08/18/2015 |
Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens |
Volk Optical Inc. |
Meghan M Leonard |
| K151008 |
08/26/2015 |
LINK« MEGASYSTEM-C« |
Waldemar Link GmbH & Co. KG |
Helmut D Link |
| K143148 |
08/11/2015 |
Disposable Pressure Manometer (DPM) |
Westmed, Inc. |
DIANA UPP |
| K151142 |
08/13/2015 |
IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
BETINA KISTNER |
| K143724 |
08/27/2015 |
COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit |
WILLIAM A. COOK AUSTRALIA PTY, LTD. |
Gordana Pozvek |
| K152045 |
08/21/2015 |
SALVATION« External Fixation System |
WRIGHT MEDICAL TECHNOLOGY, INC. |
JEANINE REDDEN |
| K151309 |
08/14/2015 |
Wartie Advanced Wart Remover or other proprietary name |
YOUMEDICAL CORP BV |
FRANCESCA MAPPA |
| K143289 |
08/18/2015 |
NON-STERILE, POWER FREE NITRILE EXAMINATION GLOVES-ORANGE, GREEN, BLUE AND VIOLET COLOR |
YTY INDUSTRY (MANJUNG) SDN. BHD. |
Arivagalan Subramaniam |
| K151586 |
08/10/2015 |
Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens |
YUNG SHENG OPTICAL CO., LTD. |
WEN-HAN CHEN |
| K150896 |
08/31/2015 |
Vitality Spinal Fixation System |
ZIMMER SPINE, INC. |
DONNA M. SEMLAK |
| K151448 |
08/13/2015 |
Continuum and Trilogy Integrated Taper (IT) Acetabular Systems |
ZIMMER, INC. |
KEITH PROCTOR |
| K151818 |
08/05/2015 |
SImmetry Sacroiliac Joint Fusion System |
Zyga Technology, Inc. |
Diane Brinza |
