| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K142112 |
09/23/2014 |
4WEB SPINAL IMPLANT PRODUCTS |
4WEB, INC. |
RICH JANSEN |
| K141949 |
09/12/2014 |
CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25, SELF TAPPING, TITANIUM |
AAP IMPLANTATE AG |
CHRISTIAN ZIETSCH |
| K140371 |
09/30/2014 |
FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT), TEST STRIPS (100CT) |
ABBOTT DIABETES CARE INC. |
MICHELLE RICAFORT |
| K142527 |
09/19/2014 |
Extension Set with BD Q-Syte Luer Access Split Septum |
ACACIA, INC. |
DAN HYUN |
| K133963 |
09/09/2014 |
SURGISEAL TWIST (TM) TOPICAL SKIN ADHESIVE |
Adhezion Biomedical, LLC |
Caridad Smith |
| K141602 |
09/12/2014 |
DX-D IMAGING PACKAGE |
AGFA HEALTHCARE N.V. |
SHAEANN CAVANAGH |
| K140077 |
09/22/2014 |
ALBAAD PLASTIC APPLICATOR TAMPONS UNSCENTED |
ALBAAD LTD. |
ROBERT J STAAB, PH.D. |
| K141476 |
09/30/2014 |
WAVELIGHT FS200 LASER SYSTEM |
ALCON RESEARCH, LTD. DBA ALCON LABORATORIES, INC. |
Bob Lundberg |
| K133851 |
09/03/2014 |
ALERE PBP2A SA/CONS CULTURE COLONY TEST |
ALERE SCARBOROUGH, INC |
DANIELLE A BRIGGEMAN |
| K141450 |
09/17/2014 |
AXIOM 2.8 |
ANTHOGYR SAS |
THERESE CANDAU |
| K140097 |
09/24/2014 |
AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM |
APPLIED MEDICAL TECHNOLOGY, INC. |
JOSHUA MEINKE |
| K141033 |
09/12/2014 |
SILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRESSINGS, SILVERLON EASY AG ANTIMICROBIAL WOUND CONTACT NEGATIV |
ARGENTUM MEDICAL, LLC |
C. RICHARD FOSTER |
| K142336 |
09/17/2014 |
GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System |
ARKRAY FACTORY INC. |
Kazuya Yorimitsu |
| K142035 |
09/05/2014 |
GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE MONITORING SYSTEM |
ARKRAY FACTORY INC. |
LONNA M DENDOOVEN |
| K141635 |
09/03/2014 |
ARTHREX IBALANCE TKA SYSTEM |
ARTHREX, INC. |
LEON BROWN II |
| DEN130031 |
09/05/2014 |
NEPHROCHECK TEST SYSTEM |
ASTUTE MEDICAL, INC |
KARIN HUGHES |
| K141380 |
09/26/2014 |
PROVOX FREEHANDS FLEXIVOICE |
ATOS MEDICAL AB |
FERENC DAHNER |
| K140039 |
09/15/2014 |
POLYCRYL |
AUROLAB |
KRISHNA KUMAR.R |
| K142261 |
09/24/2014 |
Ultraverse 035 PTA Balloon Dilatation Catheter |
Bard Peripheral Vascular, Inc. |
Mario Thomas |
| K140496 |
09/16/2014 |
Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents |
BECKMAN COULTER, INC. |
NANETTE CANEPA |
| K140911 |
09/05/2014 |
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM |
BECKMAN COULTER, INC. |
BRENT LEMBERG |
| K141355 |
09/03/2014 |
VOLUMETRIC INCENTIVE SPIROMETER |
BESMED HEALTH BUSINESS CORPORATION |
PAUL DRYDEN |
| K140837 |
09/24/2014 |
LUCID LY |
BIO-MED USA INC. |
YOUNG CHI |
| K141924 |
09/08/2014 |
HD BLOOD PRESSURE MONITOR |
BIOCARE ASIA CORPORATION LTD. |
Ke-Min Jen |
| K140390 |
09/10/2014 |
TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS |
BIOMET MANUFACTURING CORP. |
BRIAN KINCAID |
| K140710 |
09/04/2014 |
BIOMET GRAFT DELIVERY SYRINGES |
BIOMET SPINE (AKA EBI, LLC) |
DEBRA L BING |
| K141804 |
09/25/2014 |
POLARIS SPINAL SYSTEM - HA COATED |
BIOMET SPINE LLC, |
KIMBERLY MCCOY |
| K142295 |
09/15/2014 |
Sirius Femoral Stem, Size 30A |
Biomet, Inc. |
Jason Dugger |
| K141483 |
09/23/2014 |
BIOSPACE BODY COMPOSITION ANALYZER |
BIOSPACE CORPORATION LIMITED |
DANIEL KAMM |
| K141439 |
09/12/2014 |
ORTHODONTIC ACRYLIC (NOT FINALIZED) |
BISCO, INC. |
Michelle Schiltz-Taing |
| K142259 |
09/10/2014 |
Direxion Torqueable Microcatheter |
BOSTON SCIENTIFIC CORP. |
Mark Lanz |
| K141150 |
09/25/2014 |
PTA BALLOON DILATATION CATHETER |
BOSTON SCIENTIFIC CORP. |
Carol Tiffany |
| K141831 |
09/04/2014 |
HYDRAVIEW GUIDEWIRE |
BRIVANT LIMITED |
KENNETH WALSH |
| K133852 |
09/19/2014 |
APOLLO BALLOON DILATATION CATHETER |
BROSMED MEDICAL |
STEPHEN LEE |
| K141025 |
09/12/2014 |
ARTIMES BALLOON DILATATION CATHETER |
BROSMED MEDICAL |
STEPHEN LEE |
| K134040 |
09/10/2014 |
BTL-9000; BTL-9000 RADIOFREQUENCY MODULE |
BTL INDUSTRIES LTD |
MICHAIL M PANKRATOV |
| K133456 |
09/24/2014 |
POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER |
C.R. BARD, INC. |
ELIZABETH PETERSON |
| K141985 |
09/18/2014 |
TRUE BA V BALLOON VALVULOPLASTY CATHETER |
C.R. BARD, INC. |
AARON CONOVALOFF |
| K133223 |
09/19/2014 |
XENMATRIX AB SURGICAL GRAFT |
C.R. BARD, INC. |
Tony John |
| K142225 |
09/12/2014 |
Pilot Elite Diode Laser |
CAO Group, Inc. |
Robert K Larsen |
| K142223 |
09/12/2014 |
Pilot Pro Diode Laser |
CAO GROUP, INC. |
ROBERT K. LARSEN |
| K142226 |
09/12/2014 |
Pilot Ultra Diode Laser |
CAO GROUP, INC. |
ROBERT K. LARSEN |
| K141552 |
09/05/2014 |
ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS |
CAREFUSION |
JOY GREIDANUS |
| K141068 |
09/09/2014 |
ZEISS CATARACT SUITE MARKERLESS |
CARL ZEISS MEDITEC AG |
SARAH HARRINGTON |
| K141829 |
09/24/2014 |
GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM |
CERAGEM MEDISYS INC. |
Hak-Sung Kim |
| K134011 |
09/03/2014 |
GENERAL SPINAL SYSTEM |
CHANGZHOU DEAN MEDICAL INSTRUMENT CO, LTD |
Diana Hong |
| K141806 |
09/19/2014 |
CLEAR GUIDE ONE |
CLEAR GUIDE MEDICAL |
JACK KENT |
| K142325 |
09/18/2014 |
Veenstra Instruments VDC-506 Dose Calibrator |
Comecer Netherlands b.v. |
Gert Jan Klok |
| K142134 |
09/12/2014 |
C-WIRE DOUBLE ENDED ORTHOPEDIC WIRES |
CONMED CORPORATION, LARGO |
JOY LOVETT |
| K140416 |
09/17/2014 |
TREKKER, TREKKER TRANSIT |
CONVAID PRODUCTS, INC. |
DONALD GRIGGS |
| K133889 |
09/04/2014 |
PREMIUM |
COUSIN BIOTECH S.A.S. |
FRANCK PELLETIER |
| K142048 |
09/17/2014 |
EMPRINT PROCEDURE PLANNING APPLICATION |
Covidien LLC |
HEATHER V NIGRO |
| K140429 |
09/11/2014 |
CRANE ACRYLIC HERBST APPLIANCE |
CRANE DENTAL LABORATORY, INC. |
KATE YOUNG |
| K142000 |
09/25/2014 |
ESOFLIP ES |
CROSPON, LTD. |
PAUL DRYDEN |
| K133739 |
09/05/2014 |
TRUSCULPT |
CUTERA, INC. |
BRADLEY RENTON |
| K141425 |
09/11/2014 |
ELITE + LASER SYSTEM |
CYNOSURE, INC. |
KELLI MCMILLAN |
| K142376 |
09/24/2014 |
Palomar Icon Aesthetic System |
CYNOSURE, INC. |
Allyson Connor |
| K140719 |
09/22/2014 |
PICOSURE WORKSTATION |
CYNOSURE, INC. |
KEVIN O'CONNELL |
| K130742 |
09/10/2014 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
DAHOON PLASTIC CO., LTD. |
CHU XIAOAN |
| K141007 |
09/25/2014 |
DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE |
DEMETECH CORP. |
ANTHONY DIMERCURIO |
| K140634 |
09/19/2014 |
extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam Dressing Kit |
Devon Medical, Inc. |
Steve XU |
| K141144 |
09/03/2014 |
STA LIATEST D-DI |
DIAGNOSTICA STAGO |
CARLO D'ALESSANDRO |
| K142076 |
09/30/2014 |
CLAVEGUARD FREEDOM SURGICAL LIGHT |
DICKSON & DICKSON HEALTHCARE (US), INC |
RAGUNATH MUNIANDY |
| K141565 |
09/10/2014 |
GLOBE-TROTTER GT5400 |
Draeger Medical Systems, Inc. |
GALE WINARSKY |
| K140399 |
09/18/2014 |
EBM IDO VIEWER |
EBM TECHNOLOGIES USA, LLC |
JOHN SU |
| K141590 |
09/03/2014 |
EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE |
ECO MEDI GLOVE SDN. BHD |
SURESH KUMAR |
| K141696 |
09/18/2014 |
EDWARDS ESHEATH INTRODUCER SET |
EDWARDS LIFESCIENCES |
NEIL DELANEY |
| K141495 |
09/03/2014 |
TRUWAVE DISPOSABLE PRESSURE TRANSDUCER |
EDWARDS LIFESCIENCES, LLC. |
ANDREW S MAZURKIEWICZ, JR |
| K133895 |
09/05/2014 |
DEKA SMARTXIDE LASER SYSTEM |
EL.EN. S.P.A |
GEORGE CHO |
| K140670 |
09/25/2014 |
ELLIPSE I2PL+/ELLIPSE MULTIFLEX+ |
ELLIPSE A/S |
OLE KOFOD |
| K140613 |
09/18/2014 |
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM |
ELLIPSE TECHNOLOGIES INC. |
John McIntyre |
| K141598 |
09/30/2014 |
FUSE COLONOSCOPY SYSTEM |
ENDOCHOICE, INC. |
TAMAR FUERST |
| K142113 |
09/30/2014 |
ESOPHYX2 HD |
ENDOGASTRIC SOLUTIONS, INC. |
MICHAEL A DANIEL |
| K141137 |
09/15/2014 |
STEREOS WORKSTATION |
EOS IMAGING |
JOHN J SMITH |
| K133584 |
09/08/2014 |
IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM |
EOSHEALTH, INC. |
Carrie Hetrick |
| K142008 |
09/12/2014 |
MYLABSEVEN, MYLABALPHA |
ESAOTE S.P.A. |
Allison Scott |
| K142077 |
09/12/2014 |
MYLABGAMMA |
ESAOTE, S.P.A. |
Allison Scott |
| K141122 |
09/15/2014 |
HARMONIC SCALLOP BLADE, GENERATOR G11 |
ETHICON ENDO-SURGERY, LLC |
EMILY KRUETZKAMP |
| K142306 |
09/15/2014 |
Flower Upper Extremity Plating Set |
Flower Orthopedics Corporation |
Gary Barnett |
| K133976 |
09/09/2014 |
FUJIFILM ENDOSCOPIC CO2 REGULATOR |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
GINA WALLJASPER |
| K141514 |
09/03/2014 |
SYNAPSE 3D TENSOR ANALYSIS |
FUJIFILM MEIDCAL SYSTEMS U.S.A..,INC. |
JYH-SHYAN LIN |
| K141562 |
09/05/2014 |
MSN-006 |
GC AMERICA, INC. |
MARK HEISS |
| K141074 |
09/18/2014 |
CORTEX ID SUITE |
GE MEDICAL SYSTEMS, LLC |
DAVID DUERSTELER |
| K141477 |
09/18/2014 |
DISCOVERY IQ |
GE MEDICAL SYSTEMS, LLC |
HUY DOAN |
| K142085 |
09/26/2014 |
DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T |
GE MEDICAL SYSTEMS, LLC |
JENNY WONG |
| K142383 |
09/25/2014 |
Optima XR200amx, Optima XR220amx |
GE Medical Systems, LLC |
Chris Paulik |
| K141437 |
09/19/2014 |
XLR8 PLUS (XLR8+) |
GENADYNE BIOTECHNOLOGIES, INC. |
CHIEN MING, GOH |
| K140380 |
09/26/2014 |
OPERA SWING |
GENERAL MEDICAL MERATE S.P.A. |
BERTHOIN CLAUDE |
| K133911 |
09/03/2014 |
GENESYS SPINE ANTERIOR BUTTRESS PLATE SYSTEM |
GENESYS SPINE |
BRIAN J BERGERON |
| K141286 |
09/30/2014 |
AER-O-SCOPE COLONOSCOPE SYSTEM |
GI VIEW LTD. |
MARK HELLER |
| K140195 |
09/10/2014 |
SURGICAL DRAPE |
GRIFFITH-LUCAS LLC |
MIKE GU |
| K142423 |
09/10/2014 |
EyeSuite Imaging |
HAAG-STREIT AG |
Oscar Banz |
| K140367 |
09/12/2014 |
ARCHITECT PX EXTRACELLULAR COLLAGEN MATRIX |
HARBOR MEDTECH, INC. |
JERRY MEZGER |
| K140050 |
09/12/2014 |
NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE |
HARTALEGA SDN BHD |
NURUL AISHYAH KONG |
| K142157 |
09/05/2014 |
PALACOS R+G PRO |
HERAEUS MEDICAL GMBH |
ASTRID MARX |
| K131173 |
09/18/2014 |
FIA Blood Glucose Monitoring System (G2) |
HMD BIOMEDICAL, INC. |
AXEL LIN |
| K140841 |
09/11/2014 |
TABLO CARTRIDGE |
HOME DIALYSIS PLUS |
NANCY GALLO |
| K140866 |
09/10/2014 |
TABLO CONSOLE |
HOME DIALYSIS PLUS |
NANCY GALLO |
| K142300 |
09/17/2014 |
Arrow GPSCath Balloon Dialation Catheter (150 cm) |
HOTSPUR TECHNOLOGIES, INC., |
ERICK ANKERUD |
| K140928 |
09/15/2014 |
ABPM7100 |
I.E.M. GMBH |
ARNE BRIEST |
| K142418 |
09/26/2014 |
I.T.S. Hand Locking Plates System - HLS |
I.T.S. GmbH |
Al Lippincott |
| K141343 |
09/05/2014 |
AXXENT CERVICAL APPLICATOR |
ICAD, INC. |
John DeLucia |
| K142054 |
09/29/2014 |
IMACOR ZURA EVO IMAGING SYSTEM |
IMACOR INC. |
JAMES W MONROE |
| K141069 |
09/17/2014 |
Lung Density Analysis |
IMBIO LLC |
JASON SHEARD |
| K141572 |
09/05/2014 |
MOSAIQ ONCOLOGY INFORMATION SYSTEM |
IMPAC MEDICAL SYSTEMS, INC. |
KATHRYN STINSON |
| K141950 |
09/04/2014 |
HFD100 ROCKER ARM ACCESSORY |
IMRIS, INC. |
KARISSA HOLCOMB |
| K133753 |
09/19/2014 |
MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR |
INFOBIONIC, INC. |
CARRIE NEUBERGER |
| K141591 |
09/24/2014 |
SMARTGRAFT 30 SYSTEM |
INGENERON, INC. |
ANITA KADALA |
| K130312 |
09/18/2014 |
IROOT FM |
INNOVATIVE BIOCERAMIX INC. |
QUANZU YANG |
| K141075 |
09/26/2014 |
SINGLE-SITE WRISTED NEEDLE DRIVER |
INTUITIVE SURGICAL |
EINAV YEMINI |
| K123329 |
09/17/2014 |
DA VINVI SURGICAL SYSTEM |
INTUITIVE SURGICAL, INC. |
CINDY DOMECUS |
| K141670 |
09/18/2014 |
ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA |
JOHNSON & JOHNSON VISION CARE, INC. |
SCOTT DURLAND |
| K141873 |
09/08/2014 |
RANGE/MESA/DENALI SPINAL SYSTEM |
K2M, INC. |
NANCY GLEZEN |
| K140964 |
09/04/2014 |
CALCULASE II |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
WINKIE WONG |
| K140362 |
09/15/2014 |
KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES |
KATALYST SURGICAL, LLC |
MERYL KOCH |
| K142179 |
09/17/2014 |
D-KAT Z-YPE |
KEELER LTD. |
EUGENE R VAN ARSDALE |
| K141271 |
09/26/2014 |
AERODR SYSTEM 2 |
KONICA MINOLTA, INC. |
RUSSELL D MUNVES |
| K142397 |
09/19/2014 |
Predicate III Guidewire |
Lake Region Medical |
Mathew Pexa |
| K133717 |
09/19/2014 |
LONGBOW SPACER SYSTEM |
LIFE SPINE |
RANDY LEWIS |
| K141905 |
09/26/2014 |
PRO-LINK WEDGE SYSTEM |
LIFE SPINE |
RANDY LEWIS |
| K141453 |
09/19/2014 |
ILUMIEN OPTIS, DRAGONFLY OPTIS IMAGING CATHETER |
LIGHTLAB IMAGING, INC. |
JEFFREY ROBERTS |
| K142386 |
09/29/2014 |
Operating Room Light Handle Adapter |
Litex Manufacturing, Inc. |
Noel Gharibian |
| K131968 |
09/05/2014 |
LONGFIAN OXYGEN CONCENTRATOR |
LONGFIAN SCITECH CO., LTD. |
JUN PENG |
| K140377 |
09/16/2014 |
XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
Tina Ip |
| K140488 |
09/10/2014 |
CONTACT LENS CASE |
MACA PLASTICS, INC. |
CORRINA CULBERTSON |
| K131340 |
09/09/2014 |
POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES |
MADE PLASTIC CO., LTD. |
CHU XIAOAN |
| K141358 |
09/25/2014 |
CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES |
MAUNA KEA TECHNOLOGIES |
MICHAEL A DANIEL |
| K140167 |
09/10/2014 |
RENAISSANCE X SYSTEM |
MAZOR ROBOTICS LTD |
AHAVA STEIN |
| K142258 |
09/30/2014 |
PolyCatch Retrieval Device |
Medi-Globe Corporation |
Scott Karler |
| K141633 |
09/29/2014 |
PRO-PICC WITH VALVE TECHNOLOGY |
MEDICAL COMPONENTS INC |
JONATHAN SCHELL |
| K141321 |
09/15/2014 |
GLUCOSTABILIZER INSULIN DOSING CALCULATOR |
MEDICAL DECISION NETWORK |
JANE KEATHLEY |
| K140369 |
09/26/2014 |
MEDLINE NEURO SPONGE |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
| K141290 |
09/29/2014 |
HELICAL RIDGE PEEK INTERFERENCE SCREW |
MEDSHAPE, INC |
JACK GRIFFIS |
| K133577 |
09/26/2014 |
CLYDESDALE(R) SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC |
LEE GRANT |
| K141824 |
09/05/2014 |
MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIP |
MEDTRONIC SOFAMOR DANEK, INC. |
COURTNEY N LONG |
| K140608 |
09/12/2014 |
MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIRE |
MERIT MEDICAL SYSTEMS, INC. |
SIOBHAN KING |
| K140758 |
09/15/2014 |
M-PM-DISC (PINK) |
MERZ DENTAL GMBH |
RICHARD G HUNTER |
| K133298 |
09/19/2014 |
ENDO SMART |
META BIOMED, INC. |
BLIX WINSTON |
| K141235 |
09/12/2014 |
PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS |
MICROPORT ORTHOPEDICS INC. |
BYRON LEDBETTER |
| K141272 |
09/04/2014 |
FLOSHIELD 10MM ENDOSCOPIC CANNULA AND BLUNT OBTURATOR, FLOSHIELD 10MM ENDOSCOPIC CANNULA, FLOSHIELD 10MM BLUNT OBTURATOR |
MINIMMALLY INVASIVE DEVICES |
TRUDIE L SEEGER, PH.D. |
| K141885 |
09/18/2014 |
CMDR-2ST & CMDR-2SLWT DIGITAL PORTABLE X-RAY |
MINXRAY, INC. |
DANIEL KAMM |
| K140557 |
09/18/2014 |
MIVI 6F GUIDE CATHETER |
MIVI, LLC |
MICHELLE STRAIGHT |
| K141719 |
09/04/2014 |
BIOGEL PL MICRO SURGICAL GLOVE |
MOLNLYCKE HEALTH CARE, US LLC |
CURTIS TRUESDALE |
| K142105 |
09/05/2014 |
ELI 380 ELECTROCARDIOGRAPH |
MORTARA INSTRUMENT, INC |
AMY YANG |
| K140349 |
09/22/2014 |
STARBRIGHT 5% SODIUM FLUORIDE VARNISH |
NANOVA BIOMATERIALS, INC. |
ANDREW RITTS |
| K140280 |
09/05/2014 |
FORTICORE |
NANOVIS, LLC |
KAREN E WARDEN PHD |
| K141669 |
09/19/2014 |
SURGIMAP |
NEMARIS INC |
KEITH BARRITT |
| K141103 |
09/23/2014 |
INTRAMEDULLARY NAIL AND SCREWS-NEONAIL |
NEOORTHO PRODUTOS ORTOPEDICOS S/A |
KEVIN A THOMAS |
| K140947 |
09/04/2014 |
COMPAT ENTERAL DELIVERY PUMP SETS |
NESTLE HEALTHCARE NUTRITION, INC. |
M.W.(ANDY) ANDERSON |
| K141244 |
09/09/2014 |
NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (DUAL SPECIES) NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (SINGLE SPECIES) |
NORTH AMERICAN SCIENCE ASSOC., INC. |
JULIE WHEELER |
| K132121 |
09/24/2014 |
STATSTRIP GLUCOSE HOSPITAL METER SYSTEM |
NOVA BIOMEDICAL CORPORATION |
PAUL W MACDONALD, PHD |
| K134019 |
09/11/2014 |
MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO |
NXSTAGE MEDICAL, INC. |
LAURA F PLATH |
| K140378 |
09/25/2014 |
FLEXGUIDE ULTRA BEAMPATH ROBOTIC FIBER CONDUIT |
OMNIGUIDE, INC. |
NICOLE RASMUSSEN |
| K141140 |
09/30/2014 |
COMP A-I-R |
OMRON HEALTHCARE, INC. |
PAUL DRYDEN |
| K141079 |
09/11/2014 |
OPTIMEDICA CATALYS PRECISION LASER SYSTEM |
OPTIMEDICA CORPORATION |
STEVE JWANOUSKOS |
| K142339 |
09/26/2014 |
HEMASORB Resorbable Hemostatic Bone Putty |
ORTHOCON, LLC |
Howard L Schrayer |
| K141078 |
09/02/2014 |
ORTHOFIX TL-HEX TRUE LOK HEXALOBE SYSTEM (TL-HEX) |
ORTHOFIX SRL |
CHERYL WAGONER |
| K131817 |
09/26/2014 |
EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER |
OSMUNDA MEDICAL DEVICE CONSULTING CO., LTD. |
MIKE GU |
| K133050 |
09/19/2014 |
ONE PLUS IMPLANT SYSTEM |
OSSEOFUSE, INC. |
Priscilla Chung |
| K141616 |
09/23/2014 |
STERILIZATION CASSETTE |
OTICON MEDICAL AB |
CAROL A WESSLING |
| K141422 |
09/30/2014 |
PROFLUORO FLUORIDE VARNISH |
PAC-DENT INTERNATIONAL, INC. |
WENYING ZHU |
| K133603 |
09/25/2014 |
PHILIPS CT DYNAMIC MYOCARDIAL PERFUSION (DMP) APPLICATION |
PHILIPS MEDICAL SYSTEMS |
SUSAN QUICK |
| K141998 |
09/19/2014 |
SAMA DISPOSABLE BLOOD PRESSURE CUFF BARRIERS |
PINGHU SAMA MEDICAL PACKING CO., LTD. |
CHARLES SHEN |
| K131983 |
09/10/2014 |
ITRAC CERVICAL TRACTION SYSTEM |
PIVOTAL HEALTH SOLUTIONS |
AARON TVEDT |
| K142408 |
09/25/2014 |
FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) |
POLYMED THERAPEUTICS, INC |
FRANK LUO |
| K132245 |
09/05/2014 |
AJAX DENTAL UNIT |
PRO DENTAL SERVICES LLC. |
JOHN NEACSU |
| K140865 |
09/03/2014 |
INFRARED HEATING DEVICE |
PRO MEDICAL SUPPLIES, INC. |
DORIS DONG |
| K141018 |
09/15/2014 |
ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT |
PROCTER & GAMBLE CO. |
MICHAEL KAMINSKI, PH.D. |
| K141638 |
09/17/2014 |
PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE |
PROPPER MANUFACTURING CO.,INC. |
ANDREW SHARAVARA |
| K130450 |
09/30/2014 |
SURGTEX POWDERED SURGICAL GLOVE, SURGTEX POWDERFREE POLYMER COATED SURGICAL GLOVE |
PURNA BINA SDN BHD |
ROBERT HILL |
| K142181 |
09/18/2014 |
RANDOX ALDOLASE CALIBRATION SERUM |
RANDOX LABORATORIES LIMITED |
PAULINE ARMSTRONG |
| K140991 |
09/11/2014 |
RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE |
RANFAC CORP. |
CHRISTOPHER P WHELAN |
| K142123 |
09/24/2014 |
REACH ACCESS TELEMEDICINE DOSE CALCULATOR |
REACH HEALTH, INC. |
BETH DESTASIO |
| K141547 |
09/30/2014 |
WINGMAN EXTENDABLE TIP SUPPORT CATHETER |
REFLOW MEDICAL |
Rebecca K Pine |
| K140780 |
09/10/2014 |
KEGEL SMART, KEGELSMART PEARL |
REGULATORY INSIGHT, INC. |
Kevin Walls |
| K141370 |
09/02/2014 |
RENOVIS CEMENTED HIP SYSTEM |
Renovis Surgical Technologies, Inc. |
Sharyn Orton |
| K134003 |
09/04/2014 |
RHINIX NASAL FILTER |
RHINIX APS |
METTE MUNCH |
| K142127 |
09/05/2014 |
ELECSYS ESTRADIOL III CALCHECK 5 |
Roche Diagnostics |
KELLI TURNER |
| K141384 |
09/12/2014 |
WHISPERJECT AUTOINJECTOR |
SCANDINAVIAN HEALTH LIMITED |
James Haynes |
| K141895 |
09/18/2014 |
MOBILEDIAGNOST WDR |
SEDECAL SA |
JENNIFER CARTLEDGE |
| K142241 |
09/12/2014 |
LARIAT sulture Delivery Device |
SENTREHEART INC. |
Kit Cariquitan |
| K140874 |
09/02/2014 |
GH DISPOSABLE AND GH REUSABLE BLOOD PRESSURE CUFF |
SHANGHAI GOAHUI RUBBER AND PLASTIC COMPANY |
RHONDA ALEXANDER, MS, MPA |
| K141260 |
09/17/2014 |
ELECTRONIC PULSE STIMULATOR |
SHENZHEN JINGKEHUI ELECTRONIC CO., LTD |
BILL QUANQIN DAI |
| K140690 |
09/02/2014 |
BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN-FALK |
| K141574 |
09/05/2014 |
ARTIS ZEE/ZEEGO SW VC21 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PATRICIA D JONES |
| K141971 |
09/12/2014 |
BIOGRAPH TRUE PET/CT FAMILY SOFTWARE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ALAINE MEDIO |
| K142395 |
09/09/2014 |
SC2000 and ACUSON X300 Diagnostic Ultrasound Systems |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
Shelly Pearce |
| K140912 |
09/15/2014 |
SOMATOM SCOPE/SOMATOM SCOPE POWER |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
EVE DAVIS |
| K141405 |
09/16/2014 |
MOBIS II ST SPINAL IMPLANT |
SIGNUS MEDIZINTECHNIK GMBH |
J.D. WEBB |
| K141255 |
09/22/2014 |
SIMEX SUBGLOTTIC ASPIRATION SYSTEM |
SIMEX MEDIZINTECHNIK GMBH |
HAMID KHOSROWSHAHI |
| K140013 |
09/05/2014 |
SOPIX INSIDE, SOPIX2 INSIDE |
SOPRO - ACTEON GROUP |
RICK ROSATI |
| K141156 |
09/09/2014 |
SPACELABS HEALTHCARE TELEMETRY RECEIVER |
SPACELABS HEALTHCARE |
THOMAS KROENKE |
| K141113 |
09/26/2014 |
SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE |
SPACELABS HEALTHCARE LTD. |
AL VAN HOUDT |
| K142546 |
09/25/2014 |
TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath |
SPECTRANETICS, INC. |
Christopher McLellan |
| K141835 |
09/10/2014 |
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS; PREBENT RODS |
SPINE ART |
FRANCK PENNESI |
| K141314 |
09/29/2014 |
SCARLET AC-T SECURED ANTERIOR CERVICAL CAGE AND ASSOCIATED INSTRUMENTATION |
SPINEART |
Franck Pennesi |
| K141337 |
09/08/2014 |
ARENA-C |
SPINEFRONTIER, INC. |
MEREDITH MAY MS, RAC |
| K142213 |
09/10/2014 |
VIA SPINOUS PROCESS FIXATION SYSTEM |
SPINEOLOGY, INC. |
TIM CRABTREE |
| K140804 |
09/03/2014 |
VDRIVE WITH V-LOOP/ VDRIVE DUO |
STEREOTAXIS, INC. |
DIANE HORWITZ, PH.D., RAC |
| K141551 |
09/08/2014 |
PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 90 (DEGREES) |
STRYKER CORPORATE |
BECKY DITTY |
| K141673 |
09/04/2014 |
IVAS 8 GAUGE BONE BIOPSY KIT |
STRYKER CORPORATION |
BRITTNEY L LARSEN |
| K141935 |
09/26/2014 |
STRYKER S2 DRILL |
STRYKER CORPORATION |
VISHAL KANANI |
| K141800 |
09/26/2014 |
PERFRACTION |
SUN NUCLEAR CORPORATION |
JEFF KAPATOES |
| K142309 |
09/16/2014 |
GEM Flow COUPLER Device and System |
Synovis Life Technologies, Inc. |
Troy Thome |
| K141897 |
09/25/2014 |
SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM |
SYNTHES USA PRODUCTS, LLC |
MITCH OHIWA |
| DEN140019 |
09/22/2014 |
T2CANDIDA AND T2DX INSTRUMENT |
T2 BIOSYSTEMS, INC |
Sarah Kalil |
| K141293 |
09/03/2014 |
PHOT-X IIS MODEL 505 |
TAKARA BELMONT CORPORATION |
ROBERT SCHIFF |
| K140088 |
09/25/2014 |
PHANTOM XL INSULATED DILATORS |
TEDAN SURGICAL INNOVATIONS, LLC |
JOANN(DIONICIA) REBLANDO |
| K140556 |
09/24/2014 |
CONCHASMART BREATHING CIRCUIT |
TELEFLEX, INC. |
Amanda Webb |
| K133797 |
09/04/2014 |
QMASTER-H/REVO |
TELESYSTEMS CO., LTD. |
Claude Berthoin |
| K141481 |
09/17/2014 |
TRC-NW400 NON-MYDRIATIC RETINAL CAMERA |
TOPCON CORPORATION |
MAUREEN O'CONNELL |
| K142182 |
09/09/2014 |
FRIMAP ADAPTER CONNECTOR (MAC) |
TOPERA, INC. |
DENNIS POZZO |
| K141472 |
09/19/2014 |
VANTAGE ELAN |
TOSHIBA AMERICA MEDICAL SYSTEMS INC |
PAUL BIGGINS |
| K134025 |
09/05/2014 |
AQUILION ONE VISION SELF-PROPELLED SCAN BASE KIT FOR IVR-CT |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K141541 |
09/08/2014 |
XIDF-AWS801, ANGIO WORKSTATION, V5.31 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K133324 |
09/05/2014 |
SURESUBTRACTION LUNG |
TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN |
PAUL BIGGINS |
| K141097 |
09/26/2014 |
CSC SERIES INTRALUMINAL STAPLER FOR SINGLE USE |
TOUCHSTONE INTERNATIONAL MEDICAL SCIENCE CO., LTD. |
JO QIAO |
| K140017 |
09/16/2014 |
TRANSONIC HCM 102 SYSTEM |
TRANSONIC SYSTEMS, INC. |
NAVEEN THURAMALLA |
| K134035 |
09/17/2014 |
TRANSONIC HCM 103 SYSTEM |
TRANSONIC SYSTEMS, INC. |
NAVEEN THURAMALLA |
| K141607 |
09/18/2014 |
DENTAL IMAGING SOFTWARE |
TROPHY |
MARIE-PIERRE LABAT-CAMY |
| K142230 |
09/10/2014 |
Apollo Suture Anchor System and Titan Screws |
Valeris Medical |
Daniel Lanois |
| K140528 |
09/05/2014 |
TRUE BEAM, TRUE BEAM STX, EDGE |
VARIAN MEDICAL SYSTEMS, INC. |
PETER J CORONADO |
| K141248 |
09/05/2014 |
SMART SEGMENTATION KNOWLEDGE BASED CONTOURING |
VARIAN MEDICAL SYSTEMS, INC. |
PETER J CORONADO |
| K141490 |
09/26/2014 |
UNIVERSAL SEGMENTED CYLINDER APPLICATOR SET AND UNIVERSAL STUMP APPLICATOR SET |
VARIAN MEDICAL SYSTEMS, INC. |
PETER J CORONADO |
| K141937 |
09/10/2014 |
TRIDENT FUSION IMPLANT |
VILEX IN TENNESSEE, INC. |
ABRAHAM LAVI |
| K133983 |
09/12/2014 |
INTRA. OX HANDHELD TISSUE OXIMETER |
VIOPTIX INC. |
GREG HOLLAND |
| K141706 |
09/09/2014 |
ECARE COORDINATOR (ECC) |
VISICU, INC. |
CHRIS FERGUSON |
| K141546 |
09/03/2014 |
VITALOGRAPH MODEL 7000 SPIROTRAC |
VITALOGRAPH(IRELAND) LTD. |
TOM J HEALY |
| K141464 |
09/10/2014 |
NOVAGUARD S A SAFETY SYSTEM |
WEST PHARMACEUTICAL SERVICES |
KEVIN LENTZ |
| K140877 |
09/03/2014 |
VERICORE ZIRCONIA BLANKS |
WHIP MIX CORP. |
JOHN WATERS |
| K140418 |
09/03/2014 |
POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE |
WRP RUBBER PRODUCTS SDN BHD |
LIM CHIN YIT |
| K140786 |
09/03/2014 |
XENCO MEDICAL CERVICAL INTERBODY SYSTEM |
XENCO MEDICAL, LLC |
GUSTAVO R PRADO |
| K141419 |
09/12/2014 |
ZVPLASTY |
ZAVATION LLC |
JOHN WALKER |
| K141108 |
09/16/2014 |
YUSHENG |
ZIBO YUSHENG PLASTIC PRODUCTS CO., LTD. |
CHU XIAOAN |
| K141601 |
09/11/2014 |
IASSIST KNEE SYSTEM |
ZIMMER CAS |
CHRISTOPHER MCLEAN |
| K141500 |
09/23/2014 |
OPTIO-C ANTERIOR CERVICAL SYSTEM |
ZIMMER SPINE, INC. |
DONNA M SEMLAK |
| K141840 |
09/03/2014 |
TRABECULAR METAL TIBIAL CONE BROACH, TRABECULAR METAL COUPLED TIBIAL CONE BROACH |
ZIMMER, INC. |
DIANA TAYLOR |
| K141697 |
09/18/2014 |
XTRAFIX EXTERNAL FIXATION SYSTEM, XTRAFIX SMALL EXTERNAL FIXATION SYSTEM |
ZIMMER, INC. |
ROMIL SHETH |
