| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K121075 |
04/09/2012 |
NERVEVISION SOFTWARE SYSTEMS |
3D IMAGING PARTNERS INC. |
CAROLYN PRIMUS |
| K121069 |
04/09/2012 |
3M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK |
3M COMPANY |
JIZHONG JIN |
| K121003 |
04/02/2012 |
ABBOTT PLEX-ID FLU ASSAY |
ABBOTT LABORATORIES |
DARREN CLARKE |
| K121015 |
04/04/2012 |
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM |
Abbott Vascular |
Ivalee Cohen |
| K121222 |
04/23/2012 |
TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETER |
Abbott Vascular |
SUZANNE REDMAN |
| K121136 |
04/13/2012 |
RENOIR POSTERIOR CERVIAL FIXATION SYSTEM |
ACCEL SPINE |
DANIEL CHON |
| K121078 |
04/09/2012 |
VAN GOGH ANTERIOR CERVICAL PLATE SYSTEM |
ACCEL SPINE |
DANIEL CHON |
| K121161 |
04/17/2012 |
EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER |
ACTA MEDICAL LLC |
AARON COMPTON |
| K121282 |
04/30/2012 |
MICROLUX/DL MICROLUX/BLU BIO/SCREEN |
ADDENT, INC. |
JOSHUA FRIEDMAN |
| K121253 |
04/25/2012 |
MERIDIAN CRANIAL PERFORATOR |
ADEOR MEDICAL TECHNOLOGIES GMBH |
FABIO VON ZEPPELIN |
| K121288 |
04/30/2012 |
FUSE CAGE |
ADVANCED MEDICAL TECHNOLOGIES AG |
J.D. WEBB |
| K121095 |
04/11/2012 |
DX-D IMAGING PACKAGE |
AGFA HEALTHCARE N.V. |
DAVID LEDWIG |
| K121272 |
04/27/2012 |
PROTECH DENT |
AKERVALL TECHNOLOGIES INC |
SASSA AKERVALL |
| K121031 |
04/05/2012 |
WAVELIGHT FS200 PATIENT INTERFACE 1505 |
ALCON RESEARCH, LTD. |
MICHAEL BUENGER |
| K121181 |
04/18/2012 |
SWANNSHIDI BONE MARROW ASPIRATION NEEDLE |
ALLIANCE PARTNERS, LLC |
JENNIFER PALINCHIK |
| K121150 |
04/16/2012 |
ALMA LASERS FAMILY OF PIXEL RF TIPS |
ALMA LASERS INC. |
KATHY MAYNOR |
| K121022 |
04/04/2012 |
AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV |
AMERIWATER |
BRIAN BOWMAN |
| K121218 |
04/23/2012 |
HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE CANNULA, 4MM DIA, 26 CM LENGTH, 3 APERTURE REUSABLE CANNULA, 4MM DIA, |
ANDREW TECHNOLOGIES, LLC |
HERBERT CRANE |
| K121004 |
04/03/2012 |
APEX KIRSCHNER WIRES AND STEINMANN PINS |
APEX TOOLS & ORTHOPEDICS CO. |
HOLLACE SAAS RHODES |
| K121168 |
04/17/2012 |
APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH |
APTUS ENDOSYSTEMS, INC. |
BURT GOODSON |
| K121124 |
04/13/2012 |
ARTHREX MIXING AND DELIVERY SYSTEM |
ARTHREX, INC. |
CHRISTINA FLORES |
| K121261 |
04/26/2012 |
ASAP MUITISCOPE |
ASAP ENDOSCOPIC PRODUCTS GMBH |
ANGELIKA SCHERP |
| K121101 |
04/11/2012 |
SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT |
ASTORIA-PACIFIC,INC. |
CHARLES A PETERSON |
| K121070 |
04/09/2012 |
C-QUR RPM MESH |
ATRIUM MEDICAL CORP. |
JOSEPH DEPAOLO |
| K121177 |
04/18/2012 |
BOND APATITE |
AUGMA BIOMATERIALS, LTD. |
KEVIN A THOMAS |
| K120971 |
04/02/2012 |
ATLAS PTA BALLOON DILATATION CATHETER |
BARD PERIPHERAL VASCULAR, INC. |
MEGAN BROWN |
| K121092 |
04/10/2012 |
FLOWEASE [SUBCUTANEOUS] INFUSION SET |
BAXTER HEALTHCARE CORP. |
NIEDRE M HECKMAN |
| K121087 |
04/10/2012 |
CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM |
BAYER HEALTHCARE |
ROGER SONNENBURG |
| K121190 |
04/19/2012 |
CONTOUR NEXT BLOOD GLUCOSE METER |
BAYER HEALTHCARE LLC |
CHARLES RYAN |
| K121165 |
04/17/2012 |
BEAM BRUSH/BEAM APP |
BEAM TECHNOLOGIES, LLC |
ALEX CURRY |
| K121214 |
04/23/2012 |
ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM |
BECKMAN COULTER, INC. |
KERRIE OETTER |
| K121050 |
04/06/2012 |
0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE |
BECTON DICKINSON & CO. |
JOHN ROBERTS |
| K120994 |
04/02/2012 |
BD BACTEC PLUS PRIME AEROBIC/F |
Becton, Dickinson and Company |
Paul Swift |
| K121283 |
04/30/2012 |
BD EMERALD SAF-T SINGLE USE, HYPODERMIC |
Becton, Dickinson and Company |
KIMBERLY LANE |
| K121284 |
04/30/2012 |
CHABNER XRT GARMENTS |
BFFL CO. INC |
EVAN P PHELPS |
| K121198 |
04/19/2012 |
BW685, BW685S |
BIEGLER GMBH |
PAUL DRYDEN |
| K121268 |
04/26/2012 |
WANDY DISPERSVIE ELECTRODE |
BIO-MED USA INC. |
YOUNG CHI |
| K121143 |
04/16/2012 |
LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3) |
Bio-Rad Laboratories |
SUZSNNE PARSONS |
| K121122 |
04/13/2012 |
DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL |
BIOCHEMICAL DIAGNOSTIC, INC. |
ALLEN PANETZ |
| K121270 |
04/26/2012 |
BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM |
BIOJECT MEDICAL TECHNOLOGIES INC. |
CHRISTINE BREITBACH |
| K121286 |
04/30/2012 |
EPIC 10 |
BIOLASE TECHNOLOGY, INC. |
ROBERT YANG |
| K121002 |
04/02/2012 |
ETEST CEFTAROLINE |
BIOMERIEUX, INC. |
JENNIFER CHIA-HSUAN LIN |
| K121100 |
04/11/2012 |
VITEK 2 AST STREPTOCOCUS VANCOMYCIN |
BIOMERIEUX, INC. |
JOCELYN JENNINGS |
| K121183 |
04/18/2012 |
COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMS |
BIOMET CORPORATION |
PATRICIA SANDBORN BERES |
| K121149 |
04/16/2012 |
VANGUARD SSK 360 REVISION KNEE SYSTEM |
BIOMET MANUFACTURING CORP. |
GARY BAKER, M.S. RAC |
| K121130 |
04/13/2012 |
POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS |
BIOMET SPINE |
VIVIAN KELLY |
| K121113 |
04/12/2012 |
BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER |
BIOPSY SCIENCES, LLC |
SHARON ROCKWELL |
| K121267 |
04/26/2012 |
BT-200V VASCULAR DOPPLER |
BISTOS CO., LTD. |
YOUNG CHI |
| K121196 |
04/19/2012 |
EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) |
BOSTON SCIENTIFIC CORP. |
VICKY L HAGENS |
| K121186 |
04/18/2012 |
RADIAL JAW 4 PULMONARY BIOPSY FORCEPS |
BOSTON SCIENTIFIC CORP. |
CORRIE GOODING |
| K121048 |
04/06/2012 |
ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED |
BOSTON SCIENTIFIC CORP. |
JANIS F TARANTO |
| K120983 |
04/02/2012 |
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM |
Boston Scientific Corporation |
JANIS F TARANTO |
| K121073 |
04/09/2012 |
POWERGLIDE MIDLINE CATHETER |
C.R. BARD, INC. |
JESSICA AGNELLO |
| K121167 |
04/17/2012 |
CAIRE COMPANION 5 OXYGEN CONCENTRATOR |
CAIRE INC. |
BEN KADRLIK |
| K121254 |
04/25/2012 |
CAMBER SPINE TECHNOLOGIES TLS 5.0 INERBODY CAGE |
CAMBER SPINE TECHNOLOGIES |
DAN PONTECORVO |
| K121176 |
04/18/2012 |
STGC |
CARDINAL SPINE, LLC |
KEVIN A THOMAS |
| K121009 |
04/03/2012 |
HEARTCHECK ECG PEN WITH GEMS HOME |
CARDIO COMM SOLUTIONS, INC. |
JONATHAN WARD |
| K120979 |
04/02/2012 |
CAREFUSION NICOLET EDX |
CAREFUSION 209, INC. |
CURTIS TRUESDALE |
| K121247 |
04/25/2012 |
ALCO-SCREEN |
CHEMATICS, INC. |
CARL REYNOLDS |
| K121256 |
04/25/2012 |
ALCO-SCREEN 02 |
CHEMATICS, INC. |
CARL REYNOLDS |
| K121208 |
04/20/2012 |
OBIX PERINATAL DATA SYSTEM 7.0 |
CLINICAL COMPUTER SYSTEMS, INC. |
CYNTHIA BELL |
| K121237 |
04/24/2012 |
BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE |
CLINIQA CORPORATION |
DAWN GAST |
| K121263 |
04/26/2012 |
TAPER SET HIP SYSTEM RDP STEM |
CONSENSUS ORTHOPEDICS, INC. |
|
| K121275 |
04/27/2012 |
AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER |
CONVATEC INC |
KATRINA FIEDLER |
| K121039 |
04/05/2012 |
COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM |
COPAN FLOCK TECHNOLOGIES |
CYNTHIA SINCLAIR |
| K121037 |
04/05/2012 |
LOSPA TIBIAL BASE PLATE |
CORENTEC CO., LTD |
J.S. DANIEL |
| K121194 |
04/19/2012 |
ENDO CLIP III 5MM CLIP APPLIER |
COVIDIEN |
ANGELA VAN ARSDALE |
| K121139 |
04/16/2012 |
ACCUMESH DEPLOYMENT SYSTEM |
Covidien LLC |
JAMES MCMAHON |
| K120997 |
04/02/2012 |
BAROSTAT SOFTWARE OPTION |
CROSPON, LTD. |
PAUL DRYDEN |
| K121127 |
04/13/2012 |
SIDELAZE LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440NM WAVELENGTH LASERS |
CYNOSURE, INC. |
IRINA KULINETS |
| K121287 |
04/30/2012 |
HT-WEDGE |
D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INT'L |
SUSAN PAVELKO |
| K121215 |
04/23/2012 |
DEKA ARM SYSTEM |
DEKA INTEGRATED SOLUTIONS CORPORATION |
ROGER LEROUX |
| K121007 |
04/03/2012 |
NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1 |
DELTA MED SRL |
HARRY BONTRAGER |
| K121020 |
04/04/2012 |
VIPER SYSTEM |
DEPUY SPINE, INC. |
KIRSTEN LEHMULLER |
| K121027 |
04/04/2012 |
DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH |
DIAMOND DIAGNOSTICS, INC |
KATHY CRUZ |
| K121140 |
04/16/2012 |
PROLYTE ELECTROLYTE ANALYZER |
DIAMOND DIAGNOSTICS, INC |
KATHY CRUZ |
| K121040 |
04/05/2012 |
SMARTLYTE ELECTROLYTE ANALYZER |
DIAMOND DIAGNOSTICS, INC. |
KATHY CRUZ |
| K121053 |
04/06/2012 |
DIAZYME HOMOCYSTEINE POC TEST KIT |
DIAZYME LABORATORIES |
Abhijit Datta |
| K121093 |
04/10/2012 |
D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000 |
DXM CO., LTD. |
JIGAR SHAH |
| K121185 |
04/18/2012 |
EDWARDS PERCUTANEOUS SHEATH INTRODUCER |
EDWARDS LIFESCIENCES, LLC. |
SPENCER WALKER |
| K121119 |
04/12/2012 |
BNA ANALYSIS SYSTEM |
EIMINDA LTD. |
DALIA DICKMAN |
| K121024 |
04/04/2012 |
LINEAR POROUS COATED HIP STEM, SIZE 5; REVELATION HIP STEM, SIZE 8; FOUNDATION POROUS PRESS FIT STEM, SIZE 8; |
ENCORE MEDICAL, L.P. |
WILLIAM GARZON |
| K121174 |
04/17/2012 |
XPRESS MULTI-SINUS DILATION TOOL |
Entellus Medical, Inc. |
KAREN E PETERSON |
| K121207 |
04/20/2012 |
EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM |
EPS BIO TECHNOLOGY CORP. |
Cynthia Hung |
| K120995 |
04/02/2012 |
ERAD PACS/ERAD RIS/PACS/ERAD EPVLITE VIEWER SOFTWARE PRODUCT |
ERAD, INC. |
JILLIAN M REED |
| K121028 |
04/05/2012 |
ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM)) |
ETVIEW LTD. |
YORAM LEVY |
| K121220 |
04/23/2012 |
EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT |
EXACTECH, INC. |
LINDY KNISELY |
| K121067 |
04/06/2012 |
EXACTECH EQUINOXE SHOULDER SYSTEM TORQUE DEFINING SCREW AND SHORT REPLICATOR PLATE |
EXACTECH, INC. |
LINDY KNISELY |
| K121142 |
04/16/2012 |
CRAWFORD BIOCANALICULUS INTUBATION |
FCI SAS (FRANCE CHIRURGIE INSTRUMENTATION) |
BARBARA FANT |
| K121125 |
04/13/2012 |
FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM |
FLEXIBLE STENTING SOLUTIONS, INC. |
JOSEPH C GRIFFIN III |
| K120986 |
04/02/2012 |
STRATIFY JCV DXSELECT |
FOCUS DIAGNOSTICS, INC. |
TARA VIVIANI |
| K121118 |
04/12/2012 |
FORA COMFORTSCAN EAR THERMOMETER |
FORA CARE INC. |
PINJUNG CHEN |
| K121206 |
04/20/2012 |
DETECT |
FORUM ENGINEERING TECHNOLOGIES LTD |
YULIYA YUKEVICH |
| K121154 |
04/16/2012 |
ULTRASONIC NEBULIZER |
FOSHAN GAUNYING ELECTRONICS CO., LTD. |
GUENTER GINSBERG |
| K121035 |
04/05/2012 |
FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
GINA WALLJASPER |
| K121251 |
04/25/2012 |
ICEROD CX CRYOABLATION NEEDLE ICEROD CX CRYOABLATION NEEDLE MULTIPACK |
GALIL MEDICAL LTD. |
LYNNE DAVIES |
| K121274 |
04/27/2012 |
PIXEL APP |
GAUSS SURGICAL, INC. |
PEGGY MCLAUGHLIN |
| K121200 |
04/19/2012 |
FLIGHTPLAN FOR LIVER |
GE HEALTHCARE |
CAROL ALLOIAN |
| K121019 |
04/04/2012 |
OPTIMA NM/CT 640 |
GE HEALTHCARE |
ELI WERNER |
| K121062 |
04/06/2012 |
VIVID I DIAGNOSTIC ULTRASOUND SYSTEM, VIVID Q DIAGNOSTIC ULTRASOUND SYSTEM |
GE MEDICAL SYSTEM ISRAEL LTD. |
BRYAN BEHN |
| K121063 |
04/06/2012 |
VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEM |
GE MEDICAL SYSTEM ISRAEL LTD. |
BRYAN BEHN |
| K121049 |
04/06/2012 |
UNIFY DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM |
GLOBUS MEDICAL INC. |
MERIAM YOUSSEF |
| K121107 |
04/12/2012 |
FORTIFY INTEGRATED CORPECTOMY SPACERS, (FORTIFY I AND FORTIFY I-R) |
GLOBUS MEDICAL, INC. |
SARAH M FITZGERALD |
| K121166 |
04/17/2012 |
WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL |
Guangzhou Wondfo Biotech Co., Ltd. |
Joe Shia |
| K121225 |
04/23/2012 |
HAMILTON-C2 |
HAMILTON MEDICAL AG |
RALPH AGUILA |
| K121005 |
04/03/2012 |
ADIPREP ADIPOSE TRANSFER SYSTEM |
HARVEST TECHNOLOGIES, CORP. |
GABRIEL J MURACA, JR. |
| K121278 |
04/30/2012 |
HERMES MEDICAL IMAGING SUITE V5.2 |
HERMES MEDICAL SOLUTIONS, AB |
JOAKIM ARWIDSON |
| K121085 |
04/10/2012 |
HET BIPOLAR LIGATOR SYSTEM |
HET SYSTEMS, LLC |
SHELLEY TRIMM |
| K121280 |
04/30/2012 |
MYOSURE INTRUMENT TRAY |
HOLOGIC, INC. |
DANIEL F PHELAN |
| K121032 |
04/05/2012 |
PRIMARY SYMBIQ SET, DITAL MICROBORE TUBING, 0.2 MICRON FILTER, NON-DEHP |
HOSPIRA, INC. |
Yuliya Matlin |
| K121132 |
04/13/2012 |
EZSENSOR P DIGITAL INTRAORAL SENSOR |
HUMANRAY CO,LTD |
DAVE KIM |
| K121108 |
04/12/2012 |
DOPPLEX ABILITY |
HUNTLEIGH HEALTHCARE |
DAVID MOYNHAM |
| K121133 |
04/13/2012 |
CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM |
i-SENS, Inc. |
HYUN JOON OH |
| K121034 |
04/05/2012 |
IOI TOTAL HIP |
ICONACY ORTHOPEDIC IMPLANTS, LLC |
ROY Y HORI, PHD |
| K121077 |
04/09/2012 |
NHANCER |
IMDS OPERATIONS B.V. |
E SCHULTING |
| K121231 |
04/24/2012 |
IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST |
IND NDIAGNOSTIC INC. |
KAI LOU |
| K121021 |
04/04/2012 |
INOMAX DS (DELIVERY SYSTEM) |
INO THERAPEUTICS |
DAVID TRUEBLOOD |
| K121012 |
04/03/2012 |
FLEXLAB 3.6, ACCELERATOR A3600 |
INPECO S.P.A. |
ROBERTO TAMBORRA |
| K121159 |
04/16/2012 |
INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER |
INTEGRA LIFESCIENCE CORPORTATION |
STEVEN PELTIER |
| K120977 |
04/02/2012 |
DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC |
INTERNATIONAL TECHNIDYNE CORP. |
LAWRENCE PICCIANO |
| K121026 |
04/04/2012 |
FLO-GUARD BREATHING FILTER |
INTERSURGICAL, INC. |
MICHAEL ZALEWSKI |
| K121023 |
04/04/2012 |
SPECTRUM V.0 |
INTRINSIC MEDICAL IMAGING |
STEPHEN J GOLDNER, JD, RAC |
| K121128 |
04/13/2012 |
MULTIPURPOSE HANDLING MEDIUM |
IRVINE SCIENTIFIC SALES CO., INC. |
JAYME YAMAGUCHI-OWENS |
| K121171 |
04/17/2012 |
CUROS TIP |
IVERA MEDICAL, INC. |
DON CANAL |
| K121230 |
04/24/2012 |
IPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUE |
IVOCLAR VIVADENT AG |
SANDRA CAKEBREAD |
| K121152 |
04/16/2012 |
SURGICAL GOWN, SMS |
JIANGSU GUANGDA MEDICAL MATERIAL, CO., LTD |
DARREN REEVES |
| K121016 |
04/04/2012 |
RANGE SPINAL SYSTEM (MESA AND DENALI) |
K2M, INC. |
NANCY GIEZEN |
| K121232 |
04/24/2012 |
K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR |
KAMIYA BIOMEDICAL COMPANY |
SHAWN KAPLAN |
| K121187 |
04/19/2012 |
KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES |
KATALYST SURGICAL, LLC |
MICHELLE MCDONOUGH |
| K120985 |
04/02/2012 |
KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING |
KIMBERLY-CLARK CORP. |
MARCIA JOHNSON |
| K121098 |
04/11/2012 |
HERO I DENTAL IMPLANT SYSTEM |
KJ MEDITECH CO., LTD |
Priscilla Chung |
| K121047 |
04/06/2012 |
HERO II DENTAL IMPLANT SYSTEM, IS DENTAL IMPLANT SYSTEM |
KJ MEDITECH CO., LTD |
Priscilla Chung |
| K121109 |
04/12/2012 |
AERODR X70 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
SHIGEYUKI KOJIMA |
| K121046 |
04/06/2012 |
STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT |
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. |
HEATHER VIELE |
| K121096 |
04/11/2012 |
VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM |
L & K BIOMED CO., LTD |
KI HYANG KIM |
| K121103 |
04/11/2012 |
LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT S |
LDR SPINE USA INC. |
BRADLEY W STRASSER |
| K121116 |
04/12/2012 |
PLATEAU SPACER SYSTEM |
LIFE SPINE |
RANDY LEWIS |
| K120998 |
04/02/2012 |
SOLSTICE CROSS CONNECTOR |
LIFE SPINE |
RANDY LEWIS |
| K121151 |
04/16/2012 |
PRO-LINK CERVICAL SPACER SYSTEM |
LIFE SPINE, INC |
RANDY LEWIS |
| K121289 |
04/30/2012 |
LTM-LABAROSCOPIC SURGICAL MESH |
LIFECELL CORP. |
MARK R JAKUBOWSKI |
| K121227 |
04/23/2012 |
MANUKA FILL |
LINKS MEDICAL PRODUCTS, INC. |
James Smith |
| K120976 |
04/02/2012 |
MANUKA IG |
LINKS MEDICAL PRODUCTS, INC. |
James Smith |
| K121083 |
04/10/2012 |
TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA |
LOMA VISTA MEDICAL |
TIFFINI DIAGE |
| K121064 |
04/06/2012 |
MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM |
MAKO SURGICAL CORPORATION |
DIONNE SANDERS |
| K120984 |
04/02/2012 |
MASIMO RAS-125C ACOUSTIC RESPIRATION SENSOR |
MASIMO CORPORATION |
PATRICIA MILBANK |
| K121203 |
04/20/2012 |
BOSTON KERATOPROSTHESIS OR BOSTON KPRO |
MASSACHUSETTS EYE & EAR INFIRMARY |
BRIAN J EDWARDS |
| K121243 |
04/25/2012 |
ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER |
MEDA CO. LTD. |
KAI CHEN |
| K121011 |
04/03/2012 |
AMISTEM AND QUADRA - LINE EXTENSION |
MEDACTA INTERNATIONAL |
ADAM GROSS |
| K121115 |
04/12/2012 |
M.U.S.T PEDICLE SCREW SYSTEM |
MEDACTA INTERNATIONAL |
ADAM GROSS |
| K121262 |
04/26/2012 |
MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY |
MEDEFIL, INC. |
PRADEEP AGGARWAL |
| K120980 |
04/02/2012 |
1.9F X 20CM VASCU-PICC 1.9F X 50CM VASCU-PICC |
MEDICAL COMPONENTS INC |
JEAN CALLOW |
| K120981 |
04/02/2012 |
2.6F X 20CM VASCU-PICC 2.6F X 50CM VASCU-PICC |
MEDICAL COMPONENTS INC |
JEAN CALLOW |
| K121094 |
04/10/2012 |
MEDCOMP VASCU-PICC & MIDLINE CATHETERS |
MEDICAL COMPONENTS INC |
JEAN CALLOW |
| K121148 |
04/16/2012 |
SAMBA SCREW, 9MM DIA., 25MM LONG, SAMBIA SCREW, 9MM DIA., 30MM LONG, SAMBA SCREW 9MM DIA., 35MM LONG, SAMBA SCREW, 9MM D |
MEDICAL DESIGN LLC. |
KRISTI VONDRA |
| K121014 |
04/03/2012 |
SOLAR GI |
MEDICAL MEASUREMENT SYSTEMS,B.V. |
K. OGINK SOMHORST |
| K120982 |
04/02/2012 |
DIGITAL EYE-FUNDUS CAMERA |
MEDIMAGING INTEGRATED SOLUTIONS, INC. (MIIS) |
CHIH-LU HSU |
| K121265 |
04/26/2012 |
AMPHIRION PLUS PTA CATHETER |
MEDTRONIC INC. |
NAINESH SUREJA |
| K121290 |
04/30/2012 |
AQUAMANTRYS3 BSC 9.1S |
MEDTRONIC INC. |
TARA N TURNEY |
| K121219 |
04/23/2012 |
ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETER |
MEDTRONIC INC. |
WENDY SAUNDERS |
| K120987 |
04/02/2012 |
DLP SINGLE STAGE VENOUS CANNULA INFLATABLE CUFF |
MEDTRONIC INC. |
EMILY BLUS |
| K120988 |
04/02/2012 |
DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA, DLP SINGLE STAGE VENOUS CANNULA WITH RIGHT |
MEDTRONIC INC. |
JACQUELINE HAUGE |
| K121191 |
04/19/2012 |
VERTEX RCCONSTRUCTION SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
CLAIRE EVANS |
| K121264 |
04/26/2012 |
TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE |
MEDTRONIC SURGICAL TECHNOLOGIES |
RISHI SINHA |
| K121246 |
04/25/2012 |
MEDYSSY LT CAGE SYSTEM |
MEDYSSEY CO., LTD. |
MICHAEL KVITNISKY |
| K120978 |
04/02/2012 |
OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR |
MERETE MEDICAL GMBH |
EMMANUEL ANAPLIOTIS |
| K121044 |
04/06/2012 |
ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM |
MERIDIAN BIOSCIENCE, INC. |
Michelle L Smith |
| K121051 |
04/06/2012 |
CONCIERGE GUIDING CATHETER |
MERIT MEDICAL SYSTEMS, INC. |
MICHAELA RIVKOWICH |
| K121269 |
04/26/2012 |
TBA |
MIGADA PLANT |
YOSSI SHACHAR |
| K121248 |
04/25/2012 |
LIQUOGUARD CSF LIQUOGUARD CSF TUBING SET (1500MM) LIQUOGUARD CSF TUBING SET (2000MM) SAFETY CUSHION FOR TUBING SET ATTAC |
MOLLER MEDICAL GMBH |
GRANT GECKELER |
| K121117 |
04/12/2012 |
NDX ABUTMENTS |
NATIONAL DENTEX CORP |
LINDA K SCHULZ |
| K121089 |
04/10/2012 |
NMI PICC III |
NAVILYST MEDICAL, INC. |
Lorraine M Hanley |
| K121184 |
04/18/2012 |
SENSUS |
NEUROMETRIX, INC. |
RAINER MAAS |
| K121276 |
04/27/2012 |
NEURO VENTION LAMINPLASTY PLATING SYSTEM |
NEUROVENTION LLC |
MEREDITH MAY |
| K121285 |
04/30/2012 |
ORAVAN OSA |
NEW JERSEY SNORING SOLUTIONS |
DEBORAH STEIN |
| K121195 |
04/19/2012 |
NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER |
NINEPOINT MEDICAL, INC |
CINDY DOMECUS |
| K120989 |
04/02/2012 |
TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM |
NIPRO DIAGNOSTICS, INC. |
KAREN DEVINCENT |
| K121001 |
04/02/2012 |
COPRESSION SYSTEMS (MODELS CMP-001 AND CMP-002) |
NOVITAS MEDICAL, LLC |
MARSHAL FRYMAN |
| K121241 |
04/25/2012 |
MALE LATEX CONDOM |
NULATEX SDN. BHD. |
TEO AI SIANG |
| K121293 |
04/30/2012 |
CS-SERIES-FP WITH 3030+OPTION |
OMEGA MEDICAL IMAGING, LLC |
BRIAN J FLEMING |
| K121173 |
04/17/2012 |
CHORD-X EPTFE SUTURE |
ON-XLIFETECHNOLOGIES |
JOHN ELY |
| K121091 |
04/10/2012 |
CATALYS PRECISION LASER SYSTEM |
OPTIMEDICA CORPORATION |
ALAN MARQUARDT |
| K121239 |
04/24/2012 |
MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVE |
OPTOACOUSTICS LTD |
PAUL DRYDEN |
| K121043 |
04/05/2012 |
OPTOS OCT/SLO MICROPERIMETER |
OPTOS PLC |
RANDY J PREBULA |
| K121250 |
04/25/2012 |
OP SPINE SYSTEM |
ORTHOPEDIATRICS, CORP. |
MARK FOX |
| K121102 |
04/11/2012 |
OSTEOSYMBIONICS PEEK CRANIAL IMPLANT |
OSTEOSYMBIONICS, LLC |
ELAINE DUNCAN |
| K121175 |
04/18/2012 |
FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM |
OSTIAL CORPORATION |
KAITLIN VON HOFFMANN |
| K121228 |
04/23/2012 |
PONTO BONE ANCHORED HEARING SYSTEM |
OTICON MEDICAL AB |
KAROLIN ISBERG JERNBY |
| K120996 |
04/02/2012 |
FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN |
PARAGON VISION SCIENCES |
WILLIAM E MEYERS |
| K121249 |
04/25/2012 |
MULTIARRAY KIT |
PARAMED SRL |
LUISELLA DE BENEDETTI |
| K121156 |
04/16/2012 |
AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES |
PHADIA AB |
MARTIN MANN |
| K121296 |
04/30/2012 |
INTERVENTIONAL WORKSPOT |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
FRANS JACOBS |
| K121223 |
04/23/2012 |
QLAB WITH FHN AND VPQ PLUG-IN |
PHILIPS ULTRASOUND, INC. |
PENNY GRECO |
| K121065 |
04/06/2012 |
POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE |
POLYMED THERAPEUTICS, INC |
JJ XIA |
| K121197 |
04/19/2012 |
BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT |
PREVENTICE, INC. |
DREW PALIN |
| K121266 |
04/26/2012 |
CARDIOSCOPE |
PULSECOR LIMITED |
E.J. Smith |
| K121603 |
04/06/2012 |
RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3 |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
| K121145 |
04/16/2012 |
RENU MEDICAL REPROCESSED AIRCAST VENAFLOW CALF GARMENTS/ALL SIZES, RENU MEDICAL REPROCESSED AIRCAST VENAFLOW THIGH GARME |
RENU MEDICAL, INC. |
BRUCE PIERSON |
| K121170 |
04/17/2012 |
RESIN 11 |
RESPINNOVATION SAS |
PAUL DRYDEN |
| K121279 |
04/30/2012 |
ELECSYS LH CALCHECK 5 |
Roche Diagnostics |
K. Colleen Adams |
| K121291 |
04/30/2012 |
TINA-QUANT HBA1C GEN. 2 TEST SYSTEM |
ROCHE DIAGNOSTICS |
SUSAN HOLLANDBECK |
| K121123 |
04/13/2012 |
BIOFUSIONARY BEBE |
ROCKY MOUNTAIN BIOSYSTEMS, INC. |
AMY BENEDICT |
| K121030 |
04/05/2012 |
SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE |
SACKS HOLDINGS, INC. |
DEVIN CHODOROW |
| K121299 |
04/30/2012 |
STERISPINEPS PEDICLE SCREW, STERISPINEPS ROD |
SAFE ORTHOPAEDICS |
PIERRE DUMOUCHEL |
| K121162 |
04/17/2012 |
POLARIS Q-SWITCH RUBY SYSTEM |
SANDSTONE MEDICAL TECHNOLOGIES, LLC |
MARK ROHRER |
| K121144 |
04/16/2012 |
ELECTRONIC STETHOSCOPE |
SHARP CORPORATION |
DIANE RUTHERFORD |
| K121010 |
04/03/2012 |
M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
YANG ZHAOHUI |
| K121157 |
04/16/2012 |
POWDER-FREE VIVYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
SHIJAZHUANG JIUYUAN PLASTIC CO., LTD |
CHU XIAOAN |
| K121084 |
04/10/2012 |
LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L |
Siemens Healthcare Diagnostics Inc. |
FRANCES A DILLON |
| K121138 |
04/13/2012 |
ACUSON S3000 DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTION |
SHELLY PEARCE |
| K121160 |
04/16/2012 |
MAGNETOM SPECTRA |
SIEMENS MEDICAL SOLUTIONS USA INC. |
NADIA SOOKDEO |
| K121295 |
04/30/2012 |
ARTISTETM SOLUTION WITH SYS VCIO |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CHRISTINE DUNBAR |
| K121292 |
04/30/2012 |
DYNAPBV BODY SOFTWARE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PATRICIA D JONES |
| K121074 |
04/09/2012 |
SCENIUM 2.0 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ELAINE CHANG |
| K121072 |
04/09/2012 |
SOMATOM DEFINITION FLASH |
SIEMENS MEDICAL SYSTEMS, INC. |
KIMBERLY MANGUM |
| K121297 |
04/30/2012 |
ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULAR |
SIGNATURE ORTHOPAEDICS, PTY, LTD |
DECLAN BRAZIL |
| K121281 |
04/30/2012 |
SIMPLI SIMPLER IMPLANT SYSTEM |
SIMPLER IMPLANT SOLUTIONS |
HAROLD BERGMAN |
| K121018 |
04/04/2012 |
BIORAPTOR 2.9, BIORAPTOR 2.3 PK, OSTEORAPTOR, & BIORAPTOR KNOTLESS SUTURE AN |
SMITH & NEPHEW, INC. |
JOHN CONNOR |
| K121216 |
04/23/2012 |
STR GRAFT |
SOFT TISSUE REGENERATION, INC. |
ROBERT A POGGIE |
| K121229 |
04/24/2012 |
INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR WITH WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY |
SORIN GROUP ITALIA S.R.L. |
BARRY SALL |
| K121017 |
04/04/2012 |
CAPNOGRAPHY PAD (92516) |
SPACELABS HEALTHCARE |
THOMAS KROENKE |
| K121172 |
04/17/2012 |
REFORM PEDICLE SCREW SYSTEM |
SPINAL USA |
J.D. WEBB |
| K121060 |
04/06/2012 |
SPINE FRONTIER INDUS ACP SYSTEM |
SPINEFRONTIER, INC. |
FREDY H VARELA |
| K121129 |
04/13/2012 |
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE |
SPINEOLOGY, INC. |
BRYAN BECKER |
| K121006 |
04/03/2012 |
ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER |
ST. JUDE MEDICAL |
NICOLE MARWICK |
| K121201 |
04/19/2012 |
SAVIE-AQUA 55UV (METHAFILCON A) TINNTED BLUE SOFT (HYDROPHILIC) CONTACT LENS |
ST. SHINE OPTICAL CO., LTD. |
ELLA LEE |
| K121029 |
04/05/2012 |
METS MODULAR DISTAL FEMUR |
STANMORE IMPLANTS WORLDWIDE LTD |
NANCY C MACDONALD |
| K120992 |
04/02/2012 |
METS SMILES TOTAL KNEE REPLACEMENT |
STANMORE IMPLANTS WORLDWIDE LTD |
NANCY C MACDONALD |
| K121056 |
04/06/2012 |
METS MODULAR PROXIMAL FEMUR |
STANMORE IMPLANTS WORLDWIDE LTD. |
NANCY C MACDONALD |
| K121055 |
04/06/2012 |
METS MODULAR TOTAL FEMUR |
STANMORE IMPLANTS WORLDWIDE LTD. |
NANCY C MACDONALD |
| K121158 |
04/16/2012 |
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS |
STERILMED, INC. |
JASON SKRAMSTED |
| K121240 |
04/24/2012 |
REPROCESSED ENDOSCOPIC TROCARS |
STERILMED, INC. |
JASON SKRAMSTED, RAC |
| K121131 |
04/13/2012 |
BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM |
STRAUMANN USA |
ELAINE ALAN |
| K121235 |
04/24/2012 |
LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM |
Stryker |
JAMSHED BADARPURA |
| K121153 |
04/16/2012 |
PEEK CUSTOMIZED CRAIAL IMPLANT KIT |
Stryker |
Manish Patel |
| K121252 |
04/25/2012 |
HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM |
STRYKER CORP. |
ESTELA CELI |
| K121112 |
04/12/2012 |
STRYKER VIDEO URETEROSCOPE |
Stryker Endoscopy |
KEVIN POTGIETER, RAC |
| K121106 |
04/12/2012 |
TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET |
SURGICAL APPLIANCE INDUSTRIES, INC. |
GARY PARSONS |
| K120972 |
04/02/2012 |
FLEXITOUCH SYSTEM |
TACTILE SYSTEMS TECHNOLOGY INC |
PHILLIP ROSE |
| K121224 |
04/20/2012 |
GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
LINDA KO |
| K121257 |
04/26/2012 |
LARYNGEAL ELECTRODE |
TECHNOMED EUROPE |
PIERRE VREULS |
| K121192 |
04/19/2012 |
NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK) |
TEKMEDIC (M) SDN BHD |
PATRICK LEONG |
| K121141 |
04/16/2012 |
TL-200 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM |
TENSYS MEDICAL SYSTEMS, INC |
Jamie Sulley |
| K121209 |
04/20/2012 |
TERUMO PALL AL20X ARTERIAL FILTER |
Terumo Cardiovascular Systems Corporation |
SUZANNE GRENIER |
| K121135 |
04/13/2012 |
THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE |
THD SPA |
GUIDO BONAPACE |
| K121045 |
04/06/2012 |
HUMAN ALBUMIN CSF KIT |
THE BINDING SITE GROUP, LTD. |
JILL CONSTANTINE |
| K121211 |
04/20/2012 |
VU APOD INTERVERTEBRAL BODY FUSION DEVICE |
THEKEN SPINE, LLC |
DALE DAVISON |
| K121114 |
04/12/2012 |
TIGRAN PERIBRUSH |
TIGRAN TECHNOLOGIES AB |
ULF LUNDGREN |
| K121076 |
04/09/2012 |
ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
CHARLEMAGNE CHUA |
| K120991 |
04/02/2012 |
TRANS1 INTERBODY FUSION SYSTEM |
TRANS1 INCORPORATED |
CHERYL L WAGONER |
| K121178 |
04/18/2012 |
TRANSCORP ACIF SYSTEM |
TRANSCORP, INC. |
ANDREW RODENHOUSE |
| K121134 |
04/13/2012 |
TL TRISEB CREAM |
TRIGEN LABORATORIES, INC. |
MELISSA GOODHEAD |
| K121008 |
04/03/2012 |
TRILLIANT SURGICAL K-WIRES |
TRILLIANT SURGICAL LTD |
J.D. WEBB |
| K120975 |
04/02/2012 |
CS 8100 CS 8100 ACCESS |
TROPHY |
MARIE-PIERRE LABAT-CAMY |
| K120993 |
04/02/2012 |
GAMMAMEDPLUS IX BRACHYTHERAPY AFTERLOADER, GAMMAMEDPLUS 3/24 IX BRACHYTHERAPY AFTERLOADER |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K121236 |
04/24/2012 |
PAX-DUO3D PLUS, PCT-5000 |
VATECH CO., LTD. |
DAVE KIM |
| K121260 |
04/26/2012 |
TROOPER OXYGEN CONCENTRATOR |
VBOX, INC. |
THEODORE JAGGER |
| K121033 |
04/05/2012 |
VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) |
VENTANA MEDICAL SYSTEMS, INC. |
ERIKA AMMIRATI |
| K121213 |
04/20/2012 |
VITREAADVANCED |
VITAL IMAGES, INC. |
Daniel Biank |
| K121273 |
04/27/2012 |
VISIONS PV .035 DITITAL IVUS CATHETER |
VOLCANO CORPORATION |
MARILYN POURAZAR |
| K121105 |
04/12/2012 |
NUTRISAFE 2 FEEDING TUBE |
VYGON CORP. |
JILLIAN MIKOVICH |
| K121234 |
04/24/2012 |
GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING |
W. L. GORE & ASSOCIATES, INC. |
ALICIA L HEMPHILL |
| K121013 |
04/03/2012 |
CONNEX VITAL SIGNS MONITOR 6000 SERIES |
WELCH ALLYN, INC. |
KEVIN CROSSEN |
| K121057 |
04/06/2012 |
COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS |
WILLIAM COOK EUROPE APS |
Jennifer Brown |
| K121221 |
04/23/2012 |
PROFEMUR Z REVISION HIP STEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
YUAN LI |
| K121025 |
04/04/2012 |
YA HORNG BLOOD PRESSURE MONITOR, YA HORNG BLOOD PRESSURE MONITOR, BLUETOOTH TRANSMISSION |
YA HORNG ELECTRONIC CO., LTD. |
JEN KE-MIN |
| K121182 |
04/18/2012 |
VIALOK NON-VENTED |
YUKON MEDICAL, LLC |
CARL DUPPER |
| K121277 |
04/27/2012 |
Z-SNAP OFF SCREW, Z-DOUBLE THREAD COMPRESSION SCREW, Z-GUIDE WIRE, Z-STAPLE |
Z-MEDICAL GMBH & CO. KG |
ALEXANDER HENNINGER |
| K121059 |
04/06/2012 |
SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM |
ZIMMER MEDIZINSYSTEMS GMBH |
ARMIN PETRASCHKA |
| K120990 |
04/02/2012 |
NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL |
ZIMMER TRABECULAR METAL TECHNOLOGY |
JUDITH ROSEN |
