FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
K141770 |
07/01/2014 |
LUNA CPAP AND AUTO-CPAP SYSTEM |
3B MEDICAL, INC |
ALEX LUCIO |
K142034 |
07/28/2014 |
3M STERI-VAC STERILIZER/AERATOR |
3M COMPANY |
MATT MORTENSEN |
K141823 |
07/07/2014 |
AAP LOQTEC CLAVICLE PLATES 2.7/3.5 |
AAP IMPLANTATE AG |
CHRISTIAN ZIETSCH |
K141949 |
07/18/2014 |
CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25, SELF TAPPING, TITANIUM |
AAP IMPLANTATE AG |
CHRISTIAN ZIETSCH |
K141782 |
07/02/2014 |
HI-TORQUE VERSATURN GUIDE WIRE |
Abbott Vascular |
VIVEK THAKKAR |
K141919 |
07/15/2014 |
VEINOPLUS SPORT NEUROMUSCULAR STIMULATOR |
AD REM TECHNOLOGY SARL |
NORMAN F ESTRIN |
K141912 |
07/15/2014 |
AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BON |
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
ANNA HWANG |
K141993 |
07/22/2014 |
NAKOMA ACP |
ALLIANCE PARTNERS, LLC |
KELLEN HILLS |
K141945 |
07/17/2014 |
ECHOSTAR COMFORT 1.5T MRI |
ALLTECH MEDICAL SYSTEMS AMERICA, INC. |
MICHAELEEN DOM |
K141852 |
07/09/2014 |
IFS ADVANCED FEMTOSECOND LASER SYSTEM |
AMO MANUFACTURING USA, LLC |
RODNEY HUANG |
K141984 |
07/21/2014 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
ANDON HEALTH CO., LTD |
LIU YI |
K141865 |
07/10/2014 |
DANA |
ANTHROTRONIX, INC |
CORINA E LATHAN, PHD, PE |
K141969 |
07/21/2014 |
FIRSTSTIC N INTRODUCER |
ARGON MEDICAL DEVICES, INC |
SUZANNE CHEANG |
K142035 |
07/28/2014 |
GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, RELION MICRO BLOOD GLUCOSE MONITORING SYSTEM |
ARKRAY FACTORY INC. |
LONNA M DENDOOVEN |
K141920 |
07/16/2014 |
Wrist Hemiarthroplasty System |
ARTHROSURFACE, INC. |
DAWN J WILSON |
K141981 |
07/21/2014 |
ASAHI FUBUKI 043 / ASAHI FUBUKI |
ASAHI INTECC CO., LTD. |
CANDACE CEDERMAN |
K142078 |
07/31/2014 |
VELASII THERAPY LASER SYSTEM |
ASPEN LASER SYSTEMS, LLC |
A. BRAUN HENDERSON |
K142056 |
07/29/2014 |
LIOLI IOL DELIVERY SYSTEM |
AST PRODUCTS, INC. |
William Lee |
K142036 |
07/28/2014 |
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS |
B. BRAUN MEDICAL, INC. |
TRACY MADDOCK |
K142011 |
07/24/2014 |
SOLUTION SET/EXTENSION SET |
BAXTER HEALTHCARE CORPORATION |
TIFFANY LIN |
K141932 |
07/16/2014 |
AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS |
BECKMAN COULTER, INC. |
ANTHONY DENNIS |
K141810 |
07/07/2014 |
BD BACTEC PLUS ANAEROBIC/F (PLASTIC) |
Becton, Dickinson and Company |
Paul Swift |
K141973 |
07/21/2014 |
DIODE LASER HAIR REMOVAL SYSTEM |
BEIJING ANCHORFREE TECHNOLOGY CO., LTD |
Diana Hong |
K142023 |
07/25/2014 |
LUNA INTERBODY SYSTEM |
BENVENUE MEDICAL, INC. |
CINDY DOMECUS, R.A.C. (US & EU) |
K141924 |
07/16/2014 |
HD BLOOD PRESSURE MONITOR |
BIOCARE ASIA CORPORATION LTD. |
Ke-Min Jen |
K141830 |
07/07/2014 |
STIMULAN KIT, STIMULAN RAPID CURE |
BIOCOMPOSITES LTD. |
MARIE WHALLEY |
K141798 |
07/03/2014 |
SYPHER SPACER SYSTEM |
BIOGENNIX, LLC |
MEREDITH MAY, MS, RAC |
K141893 |
07/14/2014 |
VIBRANCE KEGEL DEVICE (VKD) |
BIOINFINITY (M)SDN.BHD. |
Carrie Hetrick |
K141975 |
07/21/2014 |
WATERLASE IPLUS S |
BIOLASE, INC. |
COLLEEN BOSWELL |
K141910 |
07/15/2014 |
Intraosseous Cannula System Bio-MAC? and Bio-CORE |
BIOLOGIC THERAPIES INC |
AL LIPPINCOTT |
K141791 |
07/02/2014 |
BIOMET FUSION SYSTEM |
BIOMET SPINE |
TED KUHN |
K141804 |
07/03/2014 |
POLARIS SPINAL SYSTEM - HA COATED |
BIOMET SPINE LLC, |
KIMBERLY MCCOY |
K141762 |
07/01/2014 |
PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM |
BIOMET, INC. |
LONNIE WITHAM |
K142020 |
07/25/2014 |
LARVAL DEBRIDEMENT THERAPY PRODUCTS - LARVAE 100/200/300 AND BIOBAG 50/100/200/300/400 |
BIOMONDE |
ROSINA ROBINSON, RN, MED, RAC |
K141820 |
07/07/2014 |
JAGWIRE HIGH PERFORMANCE GUIDWIRE |
BOSTON SCIENTIFIC CORP. |
ALLISON BAILLIE |
K141943 |
07/17/2014 |
BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM |
BREATHE TECHNOLOGIES |
Samir Ahmad |
K141831 |
07/07/2014 |
HYDRAVIEW GUIDEWIRE |
BRIVANT LIMITED |
KENNETH WALSH |
K141785 |
07/02/2014 |
MICRO THERMX MICROWAVE ABLATION SYSTEM AND ACCESSORIES |
BSD MEDICAL CORP. |
DIXIE TOOLSON SELLS |
K141985 |
07/22/2014 |
TRUE BA V BALLOON VALVULOPLASTY CATHETER |
C.R. BARD, INC. |
AARON CONOVALOFF |
K142083 |
07/31/2014 |
TRUE FLOW VALVULOPLASTY PERFUSION CATHETER |
C.R. BARD, INC. |
AARON CONOVALOFF |
K142030 |
07/25/2014 |
STGC-LORDOTIC |
CARDINAL SPINE, LLC |
KEVIN A. THOMAS |
K141965 |
07/21/2014 |
PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT |
CAREFUSION |
JOY GREIDANUS |
K141936 |
07/17/2014 |
MICROBLAB, MICROLOOP |
CAREFUSION GERMANY 234 GMBH |
ELMAR NIEDERMEYER |
K141837 |
07/07/2014 |
DRX-EVOLUTION |
CARESTREAM HEALTH,INC. |
CAROLYN L WAGNER |
K141844 |
07/08/2014 |
RESCAN 700, CALLISTO EYE |
CARL ZEISS MEDITEC AG |
MANDY AMBRECHT |
K141859 |
07/10/2014 |
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/H5 SUBTYPING |
CENTERS FOR DISEASE CONTROL AND PREVENTION |
Yon Yu, Pharm.D. |
K142047 |
07/28/2014 |
EIDON |
CENTERVUE SPA |
ROGER GRAY |
K141942 |
07/17/2014 |
MIDLINE II TI |
CENTINEL SPINE, INC. |
JUSTIN EGGLETON |
K142079 |
07/31/2014 |
STALIF CTI, STALIF C |
CENTINEL SPINE, INC. |
JUSTIN EGGLETON |
K142045 |
07/28/2014 |
XPERT FLU/RSV XC ASSAY |
CEPHEID |
SCOTT A CAMPBELL,PH.D.,MBA |
K141829 |
07/07/2014 |
GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM |
CERAGEM MEDISYS INC. |
Hak-Sung Kim |
K141880 |
07/11/2014 |
BIOPOR AOC POROUS POLYETHYLENE, CEREPOR |
CEREMED, INC. |
CHELSEA MITCHELL |
K141806 |
07/03/2014 |
CLEAR GUIDE ONE |
CLEAR GUIDE MEDICAL |
JACK KENT |
K141909 |
07/15/2014 |
COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP |
COLLAGEN MATRIX, INC. |
PEGGY HANSEN |
K141818 |
07/07/2014 |
TURBO-JECT PICC SETS |
COOK CORPORATED |
SEAN SPENE |
K142012 |
07/24/2014 |
FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS |
CORPAK MEDSYSTEMS |
STEPHANIE WASIELEWKI |
K141858 |
07/10/2014 |
CLOSURERFG RADIOFREQUENCY GENERATOR |
COVIDIEN |
Laura Moen-Ftacek |
K142048 |
07/28/2014 |
EMPRINT PROCEDURE PLANNING APPLICATION |
Covidien LLC |
HEATHER V NIGRO |
K141894 |
07/14/2014 |
SHARKCORE FINE NEEDLE BIOPSY SYSTEM |
COVIDIEN LLC (FORMERLY BEACON ENDOSCOPIC CORP) |
Saket Bhatt |
K141801 |
07/03/2014 |
HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM |
COVIDIEN, LLC |
JULIE UNDERDAHL |
K142000 |
07/23/2014 |
ESOFLIP ES |
CROSPON, LTD. |
PAUL DRYDEN |
K142072 |
07/23/2014 |
GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS) |
CUSTOM ORTHOPAEDIC SOLUTIONS, INC. |
JUSTIN J BAKER,PHD |
K141809 |
07/07/2014 |
RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM |
DEFIBTECH, LLC |
Ed Horton |
K142076 |
07/31/2014 |
CLAVEGUARD FREEDOM SURGICAL LIGHT |
DICKSON & DICKSON HEALTHCARE (US), INC |
RAGUNATH MUNIANDY |
K141970 |
07/21/2014 |
DIGITEK TITANIUM ABUTMENT |
DIGITEK DENTAL SOLUTIONS LIMITED |
ALWIN NGAI |
K142064 |
07/30/2014 |
GALILEO NT |
EB NEURO, S.P.A. |
ALLISON SCOTT, RAC |
K141900 |
07/14/2014 |
SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE |
ECKERT & ZIEGLER BEBIG GMBH |
HUB VAN DE BERGH |
K142080 |
07/31/2014 |
NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED |
ECOLAB, INC. |
JENNIFER WILLNER |
K141958 |
07/18/2014 |
ERB ENDORECTAL BALLOON |
EDGE MEDICAL LLC |
GREGORY MATHISON |
K141855 |
07/09/2014 |
CLARITY |
ELEKTA LTD. |
|
K141990 |
07/22/2014 |
ENCORE HUMERAL SHOULDER STEM |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
K141916 |
07/15/2014 |
PATHASSIST LED LIGHT FIBER |
Entellus Medical, Inc. |
GARRETT P AHLBORG |
K141986 |
07/22/2014 |
ELUX 810 LASER |
EQUIPMED NORTH AMERICA, INC. |
JIM BARLEY |
K142042 |
07/28/2014 |
ERCHONIA SHL |
ERCHONIA CORPORATION |
Kevin Walls |
K142008 |
07/23/2014 |
MYLABSEVEN, MYLABALPHA |
ESAOTE S.P.A. |
Allison Scott |
K142077 |
07/31/2014 |
MYLABGAMMA |
ESAOTE, S.P.A. |
Allison Scott |
K141952 |
07/18/2014 |
ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED |
ETHICON ENDO-SURGERY, INC. |
LINDA HILL |
K141776 |
07/02/2014 |
STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES |
ETHICON, INC. |
PETER CECCHINI |
K141827 |
07/07/2014 |
EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE |
EUROIMMUN U.S., Inc. |
MICHAEL A LOCKE |
K142038 |
07/28/2014 |
EUROIMMUN LYME ELISA(IgG/IgM) |
EUROIMMUN US |
MICHAEL LOCKE |
K141797 |
07/02/2014 |
ALTEON 6.5MM BONE SCREWS |
EXACTECH, INC. |
THOMAS MCNAMARA |
K141821 |
07/07/2014 |
ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7; ALTEON NECK PRESERVING FEMORAL STEM, EXTENDED OFFSET |
EXACTECH, INC. |
THOMAS MCNAMARA |
K141960 |
07/18/2014 |
Exactech« Novation« Crown Cup« |
EXACTECH, INC. |
THOMAS MCNAMARA |
K141850 |
07/09/2014 |
FLOSPINE PEDICLE SCREW SYSTEM |
FLOSPINE |
RICH JANSEN |
K141997 |
07/23/2014 |
CRIT-LINE IV SYSTEM |
FRESENIUS MEDICAL CARE |
DENISE OPPERMANN |
K142003 |
07/23/2014 |
FDR D-EVO II FLAT PANEL DETECTOR SYSTEM |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
KATHERINE Y CHOI |
K141765 |
07/01/2014 |
FDR D-EVO FLAT PANEL DETECTOR SYSTEM |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
KATHERINE Y CHOI |
K142017 |
07/25/2014 |
X-PORTE ULTRASOUND SYSTEM |
FUJIFILM SonoSite, Inc. |
Patricia Liau |
K141768 |
07/01/2014 |
LOGIQ V5/LOGIQ V3 |
GE HEALTHCARE |
BRYAN BEHN |
K141963 |
07/18/2014 |
12SL ECG ANALYSIS PROGRAM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
KRISTIN PABST |
K142085 |
07/31/2014 |
DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T |
GE MEDICAL SYSTEMS, LLC |
JENNY WONG |
K141961 |
07/18/2014 |
GENADYNE SPIRO FOAM DRESSING KIT |
GENADYNE BIOTECHNOLOGIES, INC. |
CHIEN MING GOH |
K142044 |
07/28/2014 |
CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE |
Guangzhou Wondfo Biotech Co., Ltd. |
Joe Shia |
K141862 |
07/10/2014 |
HEALTH2SYNC MOBILE APPLICATION, HEALTH2SYNC SMART CABLE |
H2 Inc. |
Feng-Yu Lee |
K142063 |
07/30/2014 |
#8C RENEGADE DENTAL HANDPIECE |
HANDPIECE CLUB, LLC |
TINA WU |
K141822 |
07/07/2014 |
SENSEI X ROBOTIC CATHETER SYSTEM |
HANSON MEDICAL, INC. |
TODD MILHOLLAND |
K141892 |
07/14/2014 |
QK-SYSTEMIC THERAPEUTIC APPARATUS |
HARBIN QUANKE MEDI-TECHNICAL DEVELOPMENT CO., LTD. |
WANG XIANGLIN |
K141869 |
07/11/2014 |
QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT |
HEMEDEX INCORPORATED |
DEAN HONKONEN |
K141921 |
07/16/2014 |
HIVOX SPOPAD EMS |
HIVOX BIOTEK, INC. |
Ke-Min Jen |
K142029 |
07/25/2014 |
MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM |
HOLOGIC, INC. |
SARAH FAIRFIELD |
K142037 |
07/28/2014 |
QUANTRA |
HOLOGIC, INC. |
CATHERINE WILLIAMS |
K141944 |
07/17/2014 |
HOME ACCESS AIC TEST |
HOME ACCESS HEALTH CORP. |
Sandra D White |
K141792 |
07/02/2014 |
GENESIS TOUCH SYSTEM |
HONEYWELL HOMMED |
CLAUDIA JACKSON |
K141789 |
07/02/2014 |
PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE |
HOSPIRA, INC. |
Yuliya Matlin |
K142054 |
07/29/2014 |
IMACOR ZURA EVO IMAGING SYSTEM |
IMACOR INC. |
JAMES W MONROE |
K141803 |
07/03/2014 |
IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY |
Immunalysis Corporation |
joseph Ginete |
K141872 |
07/11/2014 |
SUDOSCAN |
IMPETO MEDICAL INC |
Calley Herzog |
K141764 |
07/01/2014 |
TRISTAR BONE GRAFT FIXATION SYSTEM |
IMPLADENT, LTD. |
MAURICE VALEN |
K141950 |
07/18/2014 |
HFD100 ROCKER ARM ACCESSORY |
IMRIS, INC. |
KARISSA HOLCOMB |
K142057 |
07/29/2014 |
INFIX CANNULATED SCREW SYSTEM |
INFIX MEDICAL LLC |
JAMES C HOLLEY |
DEN140022 |
07/18/2014 |
GLAUCOMA COMPANION |
INNOVATEX, INC. |
STEPHEN C CHEN |
K141967 |
07/21/2014 |
PUREFILL OXYGEN COMPRESSOR |
INOVO, INC. |
PAUL DRYDEN |
K141841 |
07/08/2014 |
INTEGRA MOZAIK OSTEOCONDUCTIVE SCAFFOLD - STRIP |
INTEGRA LIFESCIENCE CORPORTATION |
NICOLE C HARLAN |
K141922 |
07/16/2014 |
IRIS INTELLIGENT RETINAL IMAGING SYSTEM |
INTELLIGENT RETINAL IMAGING SYSTEMS, LLC |
RYAN BOUCHARD |
K141783 |
07/02/2014 |
TDX SP2 POWER WHEECHAIR |
INVACARE CORPORATION |
DOUG UELMEN |
K141848 |
07/09/2014 |
IOGYN SYSTEM |
IOGYN, INC. |
RICH CHRISTENSEN |
K141861 |
07/10/2014 |
HILTHERA 4.0 |
JEISYS MEDICAL, INC. |
Priscilla Chung |
K142043 |
07/28/2014 |
INSYNC ZR HIGH TRANSLUCENCY ZIRCONIA |
JENSEN INDUSTRIES, INC. |
JORDAN SCHRECK |
K141825 |
07/07/2014 |
IDEAL Locking Plate System |
JIANGSU IDEAL MEDICAL SCIENCE & TECHNOLOGY CO., LT |
ALICE GONG |
K141777 |
07/02/2014 |
NEODENT IMPLANT SYSTEM |
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S |
KEVIN A THOMAS |
K142016 |
07/25/2014 |
CAPRI |
K2M, INC. |
NANCY GIEZEN |
K141873 |
07/11/2014 |
RANGE/MESA/DENALI SPINAL SYSTEM |
K2M, INC. |
NANCY GLEZEN |
K141781 |
07/02/2014 |
KOGENT SPETZLER LIGHTED SUCTION TUBES |
KATALYST SURGICAL, LLC |
MERYL KOCH |
K141891 |
07/14/2014 |
MEDICAL LCD MONITOR |
KOSTEC CO., LTD |
Priscilla Chung |
K141902 |
07/14/2014 |
LAGIS ENDOSCOPIC INSTRUMENTS DISPOSABLE GRASPER |
LAGIS ENTERPRISES CO, LTD. |
CORA CHEN |
K141908 |
07/15/2014 |
DUAL SWITCH |
LASER ENGINEERING, INC. |
LAURIE DOBBS |
K141877 |
07/11/2014 |
LEAF PATIENT MONITORING SYSTEM |
LEAF HEALTHCARE, INC. |
RONALD S WARREN |
K141905 |
07/15/2014 |
PRO-LINK WEDGE SYSTEM |
LIFE SPINE |
RANDY LEWIS |
K141769 |
07/01/2014 |
OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER |
LIGHTLAB IMAGING, INC. |
JEFFREY ROBERTS |
K141934 |
07/17/2014 |
PHYSICA KR KNEE SYSTEM |
LIMACORPORATE S.P.A. |
EMANUELE BUTTAZZONI |
K141989 |
07/22/2014 |
MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM |
MAKO SURGICAL CORPORATION |
JONATHAN REEVES |
K142069 |
07/30/2014 |
GMK EXTENSION |
MEDACTA INTERNATIONAL |
ADAM GROSS |
K141988 |
07/22/2014 |
M.U.S.T PEDICLE SCREW SYSTEM |
MEDACTA INTERNATIONAL |
ADAM GROSS |
K141926 |
07/16/2014 |
INVIA ENDURE NEGATIVE PRESSURE WOUND THERAPY SYSTEM |
MEDELA AG |
ADRIENNE LENZ |
K142022 |
07/25/2014 |
MEDLINE RENEWAL REPROCESSED GYRUS-DIEGO SINUS APPLICATION BLADES |
MEDLINE RENEWAL |
RICHARD D WYNKOOP |
K142068 |
07/30/2014 |
BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON;PENTAX COMPATIBLE;DISPOSABLE RRIGATING ADAPTOR, STERILE AND NON-STERILE |
MEDOVATIONS, INC. |
LAURA BOLL |
K141951 |
07/18/2014 |
DLP SILICONE CORONARY ARTERY OSTIAL CANNULAE |
MEDTRONIC INC. |
KEVIN T LAM |
K141833 |
07/07/2014 |
STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION |
MEDTRONIC NAVIGATION, INC. |
CHRISTOPHER PERMAN |
K141824 |
07/07/2014 |
MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIP |
MEDTRONIC SOFAMOR DANEK, INC. |
COURTNEY N LONG |
K142051 |
07/28/2014 |
PRELUDE PLASTIC JACKETED GUIDE WIRE |
MERIT MEDICAL SYSTEMS INC. |
MICHAEL O'SULLIVAN |
K141870 |
07/11/2014 |
BREAST VOLUME NAVIGATOR |
METRITRACK LLC |
MIRELA WOHLFORD |
K142014 |
07/24/2014 |
SOFIA DISTAL ACCESS CATHETER |
MICROVENTION, INC. |
Naomi Gong |
K141885 |
07/11/2014 |
CMDR-2ST & CMDR-2SLWT DIGITAL PORTABLE X-RAY |
MINXRAY, INC. |
DANIEL KAMM |
K142032 |
07/25/2014 |
MRI PATIENT MONITORING SYSTEM TESLA M3 |
MIPM MAMMENDORFER INSTITUT FUR PHYSIK UND MEDIZIN |
ANDRE KINDSVATER |
K141886 |
07/14/2014 |
MDK HANDPIECES |
MODERN KOREA CO., LTD. |
Priscilla Chung |
K141847 |
07/09/2014 |
AVANCE FOAM DRESSING KITS |
MOLNLYCKE HEALTH CARE US, LLC |
ANGELA L BUNN, RAC |
K141983 |
07/21/2014 |
NEUROBLATE SYSTEM |
MONTERIS MEDICAL CORP |
CRAIG COOMBS |
K141811 |
07/07/2014 |
MORTARA MONITORING WAVEFORM VIEWER |
MORTARA INSTRUMENT, INC. |
AMY YANG |
K142033 |
07/25/2014 |
VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP) |
NANOSPERE,INC. |
NOAH LERMER |
K141771 |
07/01/2014 |
PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY |
NANOSTRING TECHNOLOGIES INC. |
SYLVA KRIZAN |
K141933 |
07/16/2014 |
FILAO NC RX PTCA DILATATION CATHETER |
NATEC MEDICAL LTD |
JUDITH DANIELSON |
K142084 |
07/31/2014 |
EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX |
NCONTACT SURGICAL, INC. |
JANE RICUPERO |
K141832 |
07/07/2014 |
3T 16CH FLEX SPEEDER, MEDIUM , 3T 16CH FLEX SPEEDER, LARGE |
NEOCOIL, LLC |
MICHAEL LEIGH |
K142025 |
07/25/2014 |
NEUROLUMEN PN-1000 |
NEUROLUMEN, LLC |
Doug Durning |
K142060 |
07/29/2014 |
TRANSOM ANTERIOR CERVICAL PLATE |
NEUROSTRUCTURES, INC. |
MEREDITH MAY |
K142040 |
07/28/2014 |
OCS-B COLLAGEN |
NIBEC CO LTD |
DANIEL NAM |
K141907 |
07/15/2014 |
STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG/CCS, STAT PROFILE PRIME CALIBRTOR CARTRIDGE CCS/CCS COMP, NOVA LINEARITY STANDARD SET A |
NOVA BIOMEDICAL CORPORATION |
PAUL W MACDONALD |
K141994 |
07/22/2014 |
BULK FILL FLOWABLE COMPOSITE |
NOVOCOL, INC. |
CORA BRACHO-TROCONIS |
K141968 |
07/21/2014 |
NUVASIVE NVM5 SYSTEM |
NUVASIVE, INC. |
JEREMY MARKOVICH |
K141896 |
07/14/2014 |
COROENT SYSTEM |
NUVASIVE, INCORPORATED |
OLGA LEWIS |
K142050 |
07/28/2014 |
NUVASIVE COROENT SMALL CONTOURED INTERBODY SYSTEM |
NUVASIVE, INCORPORATED |
MICHELLE CHEUNG |
K141759 |
07/01/2014 |
OAK RIDGE PRODUCTS MULTI-PURPOSE SHARPS CONTAINERS |
OAK RIDGE PRODUCTS, LLC |
CONOR J O'MALLEY |
K141851 |
07/09/2014 |
NAVILAS LASER SYSTEM |
OD -OS GMBH |
JUDY F GORDON |
K141914 |
07/15/2014 |
PRODIGY AUTOCODE EJECT BLOOD GLUCOSE MONITORING SYSTEM |
OK BIOTECH CO., LTD. |
Ke-Min Jen |
K141991 |
07/22/2014 |
SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED); SINGLE USE SP |
OLYMPUS MEDICAL SYSTEMS COPR. |
DAPHNEY GERMAIN-KOLAWOLE |
K141978 |
07/21/2014 |
MAXPOWER RELIEF |
OMRON HEALTHCARE, INC. |
PAUL DRYDEN |
K141787 |
07/02/2014 |
SAGITTILT |
ORFIT INDUSTRIES NV |
Lee Leichter |
K141784 |
07/02/2014 |
ORTHO SOLUTIONS ULTOS PLATING SYSTEM |
ORTHO SOLUTIONS LIMITED |
AL LIPPINCOTT |
K141857 |
07/10/2014 |
CrossTie Intraosseous Fixation System |
ORTHODISCOVERY GROUP LLC (D.B.A. CROSSROADS EXTREM |
VERNON HARTDEGEN |
K142052 |
07/28/2014 |
ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT |
ORTHOFIX SRL |
CHERYL WAGONER |
K141760 |
07/01/2014 |
ORTHOFIX GALAXY WRIST |
ORTHOFIX SRL |
CHERYL WAGONER |
K141842 |
07/08/2014 |
STARBAND, STARLIGHT |
ORTHOMERICA PRODUCTS, INC. |
DAVID C KERR |
K142081 |
07/31/2014 |
CONTRAST MONITORING SYSTEM DISPLAY, CONTRAST MONITORING SYSTEM SYRINGES |
OSPREY MEDICAL, INC. |
MELANIE HESS |
K141930 |
07/16/2014 |
OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML |
OSSEON LLC |
KEITH BURGER |
K141911 |
07/15/2014 |
OPTIMUS NEURO SYSTEM |
OSTEONIC CO., LTD. |
Priscilla Chung |
K141854 |
07/09/2014 |
INSTRUMENT CASSETTE (EFCCL1-F) |
OSUNG MND CO., LTD |
KIRAN SHEIKH |
K141812 |
07/07/2014 |
MYGAIT STIMULATION SYSTEM |
OTTO BOCK HEALTHCARE PRODUCTS GMBH |
RENE URTZ |
K141790 |
07/02/2014 |
AQANIFE |
OVESCO ENDOSCOPY AG |
TANJA R LINZER |
K141794 |
07/02/2014 |
ENDO-MARYLAND DISSECTOR |
OVESCO ENDOSCOPY AG |
TANJA R LINZER |
K142005 |
07/23/2014 |
SpineFab Vertebral Body Replacement (VBR) System |
OXFORD PERFORMANCE MATERIALS |
LEIGH AYRES |
K141875 |
07/11/2014 |
Pasture 60S Surgical Mask |
PASTURE PHARMA PTE LTD |
SARAH HASSAN |
K141876 |
07/11/2014 |
Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture A520S Surgical N95 Respirator, Pasture A520CS Surgical N95 Respirator, Pasture E520S Surgical N95 Respirator, Pasture E520CS Surgical N95 Respirator |
PASTURE PHARMA PTE LTD |
SARAH HASSAN |
K141979 |
07/21/2014 |
ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES |
PHILIPS MEDICAL SYSTEMS NETHERLAND, B.V. |
JEANETTE BECKER |
K141883 |
07/11/2014 |
CLINISCANSM EEG |
PICOFEMTO LLC |
SRIKANT KRISHNA |
K142027 |
07/25/2014 |
888 WNLE POWERED WHEELCHAIR |
PIHSIANG MACHINERY MFG. CO., LTD. |
DAVID LIN |
K141998 |
07/23/2014 |
SAMA DISPOSABLE BLOOD PRESSURE CUFF BARRIERS |
PINGHU SAMA MEDICAL PACKING CO., LTD. |
CHARLES SHEN |
K141913 |
07/15/2014 |
PJUR SILICONE BASED LUBRICANT: PJUR BACKDOOR ANAL GLIDE AND ANALYSE ME! |
PJUR GROUP LUXEMBOURG SA |
CANDACE F CEDERMAN |
K141816 |
07/07/2014 |
HEMOPORE |
Polyganics BV |
BETTY IJMKER |
K142041 |
07/28/2014 |
POROSTEON PHUSION METAL CERVICAL CAGE |
POROSTEON, INC. |
ROBERT A POGGIE, PHD |
K141839 |
07/08/2014 |
PREMIER ETCH |
PREMIER DENTAL PRODUCTS CO. |
VINCENT D'ALESSANDRO |
K141923 |
07/16/2014 |
INCLUSIVE TITANIUM ABUTMENTS, COMPATIBLE WITH DENTSPLY IMPLANTS ANKYLOS C/X |
PRISMATIK DENTALCRAFT, INC. |
Marilyn Pourazar |
K141788 |
07/02/2014 |
OBSIDIAN MILLING BLOCKS |
PRISMATIK DENTALCRAFT, INC. |
ARMIN ZEHTABCHI |
K141887 |
07/14/2014 |
OBSIDIAN PRESS (ALL CERAMIC AND POM) |
PRISMATIK DENTALCRAFT, INC. |
ARMIN ZEHTABCHI |
K141956 |
07/18/2014 |
FIBERGRAFT BG MORSELS |
PROSIDYAN, INC |
JANICE M HOGAN |
K141793 |
07/02/2014 |
PULMONE MINIBOXPFT 2.0 |
PULMONE ADVANCED MEDICAL DEVICES, LTD. |
SUSAN ALPERT |
K141863 |
07/10/2014 |
PURICORE WOUND HYDROGEL SPRAY DRESSING |
PURICORE INC. |
ART MORSE |
K141834 |
07/07/2014 |
SAPPHIRE ADMINISTRATION SET |
Q CORE MEDICAL LTD |
Rhona Shanker |
K142002 |
07/23/2014 |
BREAST SPEEDER CX, GRID HOLDER CX |
QUALITY ELECTRODYNAMICS, LLC. |
Kathleen Aras |
K141931 |
07/16/2014 |
LYRA ADENOVIRUS ASSAY |
QUIDEL CORPORATION |
Ronald H Lollar |
K141927 |
07/16/2014 |
LYRA PARAINFLUENZA VIRUS ASSAY |
QUIDEL CORPORATION |
Ronald H Lollar |
K141775 |
07/01/2014 |
SOFIA (R) STREP A+ FIA |
QUIDEL CORPORATION |
JOHN D TAMERIUS |
K141795 |
07/03/2014 |
BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500 |
R & D BATTERIES, INC. |
KAREN MANLEY |
K141881 |
07/11/2014 |
RAPIDRESULTS |
RAMSOFT, INC. |
LELY LAM-HONG |
K142058 |
07/29/2014 |
RAYSCAN A-EXPERT |
RAY CO., LTD |
ANDEW PAENG |
K142247 |
07/29/2014 |
RAYSCAN A-EXPERT 3D |
RAY CO., LTD |
KYUNGHA SEO |
K141860 |
07/10/2014 |
RAYSTATION |
RAYSEARCH LABORATORIES AB |
DAVID HEDFORS |
K141838 |
07/08/2014 |
SOL PORTABLE DIODE LASER UNIT (WITH WIRELESS FOOT CONTROL) |
REGULATORY TECHNOLOGY SERVICES, LLC |
MARK JOB |
K141954 |
07/18/2014 |
XCEL 455 SLIT LAMP |
REICHERT, INC. |
THOMAS M HECKMANN |
K141813 |
07/07/2014 |
RHYTHMSTAR SYSTEM |
RHYTHMEDIX, LLC |
M.W.(ANDY) ANDERSON |
K141867 |
07/10/2014 |
ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM |
Roche Diagnostics |
KHONE SAYSANA |
K142021 |
07/25/2014 |
Elecsys Estradiol III CalSet |
Roche Diagnostics |
KELLI TURNER |
K141929 |
07/16/2014 |
ACCU-CHEK CONNECT DIABETES MANAGEMENT APP |
ROCHE DIAGNOSTICS CORPORATION |
CHUNHONG(EMMA) TAO |
K141928 |
07/16/2014 |
COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR |
Roche Diagnostics Operations (RDO) |
NOEL K MENCIAS |
K141925 |
07/16/2014 |
TOTAL PROTEIN URINE/CSF GEN.3 |
Roche Diagnostics Operations (RDO) |
PATRICK STIMART |
K142070 |
07/30/2014 |
FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS |
RTI SURGICAL, INC. |
KRISTINA HALL |
K141879 |
07/11/2014 |
BELIMED STEAM STERILIZER MST-H |
SAUTER AG |
MICHAEL HARI |
K141895 |
07/14/2014 |
MOBILEDIAGNOST WDR |
SEDECAL SA |
JENNIFER CARTLEDGE |
K141946 |
07/17/2014 |
DIGITAL ELECTROCARDIOGRAPH |
SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD. |
Diana Hong |
K141999 |
07/23/2014 |
ADVIA CENTAUR TSH |
Siemens Healthcare Diagnostics Inc. |
Alex Hsu |
K141772 |
07/01/2014 |
IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL |
Siemens Healthcare Diagnostics Inc. |
Asha Gartland |
K141846 |
07/09/2014 |
ACUSON X700 ULTRASOUND SYSTEM, ACUSON X600 ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SHELLY PEARCE |
K141971 |
07/21/2014 |
BIOGRAPH TRUE PET/CT FAMILY SOFTWARE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ALAINE MEDIO |
K141977 |
07/21/2014 |
MAGNETOM AERA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH 24 RF CHANNEL |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
NADIA SOOKDEO |
K142049 |
07/28/2014 |
MULTIX FUSION VA30 & VA40 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PATRICIA D JONES |
K142006 |
07/23/2014 |
SYMBIA 6.0 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CYNTHIA BUSCH |
K142061 |
07/30/2014 |
SILHOUETTE INSTALIFT |
SILHOUETTE LIFT, INC. |
Juan Carlos Serna |
K141835 |
07/07/2014 |
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS; PREBENT RODS |
SPINE ART |
FRANCK PENNESI |
K141980 |
07/21/2014 |
LEVA (TM) SPACER SYSTEM |
SPINE WAVE, INC. |
ROALDA RIZKALLAH |
K142026 |
07/25/2014 |
SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICE |
SPINEFRONTIER, INC. |
MEREDITH l MAY |
K141871 |
07/11/2014 |
Straumann Bone Level NC Angled Screw Retained Abutments |
STRAUMANN USA, LLC |
CHRISTOPHER KLACZYK |
K141962 |
07/18/2014 |
XN CAL |
Streck |
Deborah Kipp |
K141955 |
07/18/2014 |
XN CAL PF |
Streck |
Deborah Kipp |
K141964 |
07/18/2014 |
XN CHECK |
Streck |
Deborah Kipp |
K141957 |
07/18/2014 |
XN CHECK BF |
Streck |
Deborah Kipp |
K141941 |
07/17/2014 |
SPINEMASK TRACKER, SPINEMAP 3D 3.0-SOFTWARE,SPINEMAP 3D 3.0-UPGREADE, SPINEMAP 3D 3.0-ENABLE, SPINEMAP 3D 3.0-SALES D |
STRYKER CORPORATE |
LILIAN ECKERT |
K142066 |
07/30/2014 |
AERO-LL LUMBAR CAGE SYSTEM |
STRYKER CORPORATION |
Alan Traettino |
K141935 |
07/17/2014 |
STRYKER S2 DRILL |
STRYKER CORPORATION |
VISHAL KANANI |
K141992 |
07/22/2014 |
VARIAX 2 SYSTEM |
Stryker Trauma AG |
ESTELA CELI |
K141800 |
07/03/2014 |
PERFRACTION |
SUN NUCLEAR CORPORATION |
JEFF KAPATOES |
K141778 |
07/02/2014 |
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN |
SURGICAL SPECIALTIES CORPORATION |
KIRSTEN STOWELL FRANCO |
K141826 |
07/07/2014 |
FLASHPAK STERILIZATION CONTAINER SYSTEM |
SYMMETRY MEDICAL INC- MANCHESTER |
ROBERT JOHNSON |
K142024 |
07/25/2014 |
BRIGHTMATTER NAVIGATION SYSTEM |
SYNAPTIVE MEDICAL INC. |
CAMERON PIRON |
K142001 |
07/23/2014 |
SYNTEC WETALI ORTHODONTIC MINI SCREWS |
SYNTEC SCIENTIFIC CORPORATION - TAIPEI OFFICE |
KAVIN CHU |
K141796 |
07/03/2014 |
DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM |
SYNTHES (USA) PRODUCTS LLC |
KARA ELKIN |
K141897 |
07/14/2014 |
SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM |
SYNTHES USA PRODUCTS, LLC |
MITCH OHIWA |
K141878 |
07/11/2014 |
HONGYUN POWDER-FREE YELLOW VINYL PATIENT EXAMINATION GLOVES |
TANGSHAN HONGYUN PLASTIC PRODUCTS CO., LTD. |
CHU XIAOAN |
K141888 |
07/14/2014 |
RUSCH ENDOBRONCHIAL TUBES |
Teleflex Medical, Inc. |
LORI PFOHL |
K141939 |
07/17/2014 |
TELEFELX ISIS HVT TRACHEAL TUBE, CUFFED WITH SUBGLOTTIC SECRETION SUCTION PORT; WITH STYLET |
Teleflex Medical, Inc. |
JAMES A COCHIE |
K141940 |
07/17/2014 |
CONCHASMART COLUMN |
TELEFLEX, INC. |
Amanda Webb |
K141938 |
07/17/2014 |
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET) |
TERUMO BCT, INC.. |
PATTI ARNDT |
K142073 |
07/31/2014 |
ST'RIM |
THIEBAUD SAS |
PATSY J TRISLER, JD, RAC |
K141953 |
07/18/2014 |
ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL |
TITAN SPINE, LLC |
CHRISTINE SCIFERT |
K142087 |
07/30/2014 |
COVA MONITORING SYSTEM |
toSense, Inc. |
NANDINI MIRTHY |
K141972 |
07/21/2014 |
KLASSIC HD ACETABULAR INSERT WITH E-LINK POLY |
TOTAL JOINT ORTHOPEDICS, INC. |
CHRIS WEABER |
K141868 |
07/10/2014 |
TRIA FANP |
TRIA BEAUTY, INC. |
JONATHAN KAHAN |
K141917 |
07/15/2014 |
UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR DAILY WEAR |
UNICON OPTICAL CO., LTD. |
MICHAEL LEE |
K142062 |
07/30/2014 |
SPIRAL FLOW PERIPHERAL VASCULAR GRAFT |
VASCULAR FLOW TECHNOLOGIES LTD |
EDWIN LINDSAY |
K142065 |
07/30/2014 |
TURNPIKE CATHETER |
VASCULAR SOLUTIONS, INC. |
ELLIE GILLESPIE |
K142059 |
07/29/2014 |
FOX MOBILE |
VECTURA GMBH |
PAUL DRYDEN |
K141937 |
07/17/2014 |
TRIDENT FUSION IMPLANT |
VILEX IN TENNESSEE, INC. |
ABRAHAM LAVI |
K141904 |
07/14/2014 |
VIORA V-TOUCH |
VIORA LTD. |
YORAM LEVY |
K142086 |
07/31/2014 |
NIO -INTRAOSSEOUS DEVICE |
WAISMED LTD. |
JONATHAN S KAHAN |
K142055 |
07/29/2014 |
GYMFORM ABS & CORE |
WELL BRAIN INTERNATIONAL, LTD. |
VICTOR K WAI |
K141767 |
07/01/2014 |
ID MILLENNIUM, ID MOMENTS SILICONE |
WESTRIDGE LABORATORIES, INC. |
ALBERT REGO |
K141982 |
07/21/2014 |
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS |
WRP ASIA PACIFIC SDN. BHD. |
SARALA DEVI JAYARAMAN |
K142075 |
07/31/2014 |
BI-FUNNEL GASTROSTOMY FEEDING TUBE, TRI-FUNNEL GASTROSTOMY FEEDING TUBE |
XERIDIEM (FORMERLY MRI) |
JESUS VALENCIA |
K141874 |
07/11/2014 |
URISCAN OPTIMA |
YD DIAGNOSTICS CORP. |
YANG HO DONG |
K142082 |
07/31/2014 |
ZIMMER 3.1MM DENTAL IMPLANT;2.9MM ANGLED ABUTMENT;STRAIGHT HEX, 2.9MM CONTOUR ABUTEMENT |
ZIMMER DENTAL INC. |
CHRISTINA BOYDSON |
K142053 |
07/29/2014 |
UNIVERSAL CLAMP SPINAL FIXATION SYSTEM |
ZIMMER SPINE, INC. |
HOLLY SEPPANEN |
K142166 |
07/30/2014 |
TOTAL SHIELD SURGICAL;TOGA(REGULAR, LARGE,X-LARGE);HOOD; HELMET ADVANCED HELMET W/LED LIGHTING, TOTAL SHIELD ACCESSORIES |
ZIMMER, INC. |
ANGELA ESTRADA |
K141840 |
07/08/2014 |
TRABECULAR METAL TIBIAL CONE BROACH, TRABECULAR METAL COUPLED TIBIAL CONE BROACH |
ZIMMER, INC. |
DIANA TAYLOR |
K141774 |
07/02/2014 |
ZOLL X SERIES |
ZOLL MEDICAL CORPORATION |
TAMMAY SHUKLA |