| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K053256 |
12/16/2005 |
3M TEGADERM SILVER (AG) MESH |
3M COMPANY |
AMY E SHORT |
| K051041 |
12/23/2005 |
INSULIN PUMP |
ABBOTT DIABETES CARE INC. |
MARY ROSE |
| K053330 |
12/16/2005 |
ARCHITECT B12 CALIBRATORS |
ABBOTT LABORATORIES |
MARGARET PROCHNIAK |
| K052744 |
12/16/2005 |
C2000 AUTOMATED MANIFOLD KIT |
ACIST MEDICAL SYSTEMS, INC. |
A; SAALABI |
| K053250 |
12/15/2005 |
ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT |
ADVANCED NEUROMODULATION SYSTEMS |
DANIELLE ALARCON |
| K052087 |
12/14/2005 |
BREATHING FILTER BACTERIAL/VIRAL, MODEL AG7178 |
AG INDUSTRIES |
IAN GORDON |
| K053440 |
12/30/2005 |
AMPLATZER SIZING BALLOON II |
AGA MEDICAL CORP. |
AMANDA JOHNSON |
| K053458 |
12/22/2005 |
WEB1000 |
AGFA CORP. |
PHIL CUSCUNA |
| K052023 |
12/08/2005 |
CADIMAS VERSION 1.0 |
ALAN PENN & ASSOCIATES., INC. |
ROGER H SCHNEIDER |
| K051101 |
12/06/2005 |
VERIFY FLASH INTEGRATOR |
ALBERT BROWNE LTD. |
CYNTHIA J M. NOLTE |
| K052340 |
12/09/2005 |
DU857 DUAL FREQUENCY ULTRASOUND THERAPY AND MUSCLE STIMULATOR SYSTEM |
ALFA TECH MEDICAL SYSTEMS, LTD. |
SUSAN D GOLDSTEIN-FALK |
| K051275 |
12/09/2005 |
LAGUNA MONOAXIAL PEDICLE SCREW SYSTEM |
ALLEZ SPINE, LLC |
HARTMUT LOCH |
| K052733 |
12/22/2005 |
ALMITECH INC. DENTAL IMPLANT SYSTEM |
ALMITECH INC. |
ALEX BREYTMAN |
| K053142 |
12/20/2005 |
AMBU MARK IV BABY RESUSCITATOR |
AMBU A/S |
SANJAY PARIKH |
| K053140 |
12/23/2005 |
AMBU MARK IV RESUSCITATOR |
AMBU A/S |
SANJAY PARIKH |
| K053175 |
12/08/2005 |
AMEDITECH DRUGSMARTCUP |
AMEDITECH, INC. |
JOHN WU |
| K051903 |
12/27/2005 |
FETALGARD LITE-NIBP, MODEL FGL-NIBP |
ANALOGIC CORPORATION |
JANET KWIATKOWSKI |
| K053119 |
12/07/2005 |
DISTAL RADIO-ULNAR JOINT IMPLANT |
APTIS MEDICAL, LLC. |
BRYAN BABB |
| K052901 |
12/12/2005 |
ARTHREX TENSIONLOK |
ARTHREX, INC. |
ANN WATERHOUSE |
| K052776 |
12/13/2005 |
TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS AR-2257, AR-TBD |
ARTHREX, INC. |
SALLY FOUST |
| K053297 |
12/06/2005 |
ARTHROCARE 8000S COBLATOR SURGERY SYSTEM |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K053447 |
12/27/2005 |
ARTHROCARE PERC-D SPINEWAND |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K052845 |
12/16/2005 |
B-CARE POWDERED LATEX EXAMINATION GLOVES |
B-CARE INDUSTRIES CO., LTD. |
Kevin Walls |
| K052772 |
12/20/2005 |
BARRIERPLUS GOLD ORTHO POWDER-FREE SYNTHETIC POLYISOPRENE ORTHOPEDIC SURGICAL GLOVES |
BARRIERMED GLOVE CO. |
VICTOR J RAGUCCI |
| K051693 |
12/07/2005 |
MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM |
BAYER HEALTHCARE, LLC |
ANDREA HOLLE |
| K053020 |
12/30/2005 |
TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM |
BAYER HEALTHCARE, LLC |
ANDRES HOLLE |
| K052503 |
12/14/2005 |
TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM |
BAYER HEALTHCARE, LLC |
ANDRES HOLLE |
| K052307 |
12/16/2005 |
BEAMER PAINLOW INFRARED LIGHT TREATMENT SYSTEM |
BEAMLINE CORPORATION |
DAVID R BALZER |
| K053090 |
12/16/2005 |
DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR |
BECKMAN COULTER, INC. |
ERI HIRUMI |
| K053241 |
12/22/2005 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN GP 1-32 G/ML |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
| K053011 |
12/14/2005 |
PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20 |
BIO PROTECH, INC. |
E.J. Smith |
| K053152 |
12/02/2005 |
BIOHORIZONS SINGLE-STAGE IMPLANT |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
WINSTON GREER |
| K051030 |
12/23/2005 |
COAG-A-MATE MTX III |
BIOMERIEUX, INC. |
JOHN CUSACK |
| K053097 |
12/14/2005 |
VITEK 2 GRAM POSITIVE CEFOXITIN SCREEN |
BIOMERIEUX, INC. |
Nancy Weaver |
| K053186 |
12/01/2005 |
VITEK 2 GRAM POSITIVE TELITHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE |
BIOMERIEUX, INC. |
Nancy Weaver |
| K052888 |
12/06/2005 |
POROUS TITANIUM ACETABULAR AUGMENTS |
BIOMET MANUFACTURING CORP. |
ALLISON KOSKEY |
| K052990 |
12/16/2005 |
STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEM |
BIOMET, INC. |
LESTER F PADILLA |
| K043598 |
12/16/2005 |
FC 1400 FETAL MONITOR |
BIONET CO., LTD. |
SUN-YOUNG JEONG |
| K043597 |
12/16/2005 |
FC 700 FETAL MONITOR |
BIONET CO., LTD. |
SUN-YOUNG JEONG |
| K052625 |
12/05/2005 |
BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 |
BIONICARE MEDICAL TECHNOLOGIES, INC. |
KENT HOFFMAN |
| K052646 |
12/16/2005 |
BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20 |
BIOSPACE CORPORATION LIMITED |
DANIEL KAMM |
| K052289 |
12/13/2005 |
DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE |
BIOWAVE CORPORATION |
MARY MCNAMARA-CULLINANE |
| K051513 |
12/07/2005 |
BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER |
BIPORE, INC. |
KEITH PALUCH |
| K052799 |
12/16/2005 |
MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEM |
BONUTTI RESEARCH, INC. |
PATRICK BALSMANN |
| K053118 |
12/16/2005 |
STERLING MONORAIL PTA BALLOON DILATATION CATHETER, MODEL H74939031-XXXXXX |
BOSTON SCIENTIFIC CORP. |
MAUREEN MARY MONTBRIAND |
| K053116 |
12/16/2005 |
STERLING OTW PTA BALLOON DILATATION CATHETER, MODEL H74939032-XXXXXX |
BOSTON SCIENTIFIC CORP. |
MAUREEN MARY MONTBRIAND |
| K052779 |
12/20/2005 |
BRECOMP |
BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT |
MARKUS DENK |
| K052781 |
12/09/2005 |
BREFORMANCE |
BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT |
MARKUS DENK |
| K052780 |
12/21/2005 |
DENTAPLAST HOT, MODEL 16-XXX |
BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT |
MARKUS DENK |
| K052862 |
12/30/2005 |
FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE) |
BRYAN KEROPIAN DDS |
BRYAN KEROPIAN |
| K053031 |
12/07/2005 |
EXTENDSURE HBFASC CONTROL |
CANTEBURY SCIENTIFIC LTD. |
MAURICE OWEN |
| K053089 |
12/20/2005 |
ASCENT PIT & FISSURE SEALANT |
CAO GROUP, INC. |
ROBERT K LARSEN |
| K053395 |
12/23/2005 |
BP PRO BLOOD PRESSURE MONITOR |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
ALEX GONOROVSKY |
| K052790 |
12/23/2005 |
SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD |
CARDINAL HEALTH, ALARIS PRODUCTS |
STACY L LEWIS |
| K053303 |
12/30/2005 |
CARDIOCOM COMMANDER III |
CARDIOCOM LLC |
DANIEL KAMM |
| K053304 |
12/30/2005 |
COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM |
CARDIOCOM LLC |
DANIEL KAMM |
| K051257 |
12/22/2005 |
ADULT CEREBRAL OXIMETER, MODEL 2040 |
CAS MEDICAL SYSTEMS, INC. |
RON JEFFREY |
| K051896 |
12/16/2005 |
MODEL 750E SERIES MONITOR |
CAS MEDICAL SYSTEMS, INC. |
RON JEFFREY |
| K052725 |
12/28/2005 |
PROTECTOR NEEDLE SHEATH PROP |
CERTOL INTERNATIONAL, LLC |
LEWIS WARD |
| K050758 |
12/22/2005 |
CHEMPAQ XBC ANALYZER |
CHEMPAQ A/S |
JONATHAN S KAHAN |
| K052963 |
12/05/2005 |
MEDIQ VERSION 1.0 |
CLARIO MEDICAL IMAGING, INC. |
PATRICIA A MILBANK |
| K051964 |
12/01/2005 |
POWERNEB |
COMEDICA , INC. |
KRISTA OAKES |
| K052539 |
12/09/2005 |
COOK FORMULA 418 BILIARY STENT SYSTEM |
COOK, INC. |
KAREN BRADBURN |
| K052841 |
12/08/2005 |
MIRA-FLEX 18 MICROCATHETER |
COOK, INC. |
THALIA BRINE |
| K052560 |
12/06/2005 |
BIOFINITY (COMFILCON A) SOFT CONTACT LENS |
COOPERVISION, INC. |
JACK P DOUGLAS |
| K053197 |
12/15/2005 |
TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION |
CORDIS NEUROVASCULAR, INC. |
Amarilys Machado |
| K052263 |
12/16/2005 |
MULTIPLE (TOOTH DESENSITIZER) |
COSMEDENT, INC. |
JAMES L SANDRIK |
| K053201 |
12/09/2005 |
CURAE'LASE CL1000 IR LASER SYSTEM |
CURAE'LASE INC. |
M. JOYCE HEINRICH |
| K051911 |
12/06/2005 |
GELITA-SPON |
CURAMEDICAL, BV |
WILLIAM GREENROSE |
| K052135 |
12/20/2005 |
CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER |
CYBERSONICS, INC. |
WILLIAM A STOLL |
| K053157 |
12/09/2005 |
AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A |
DADE BEHRING, INC. |
VICTOR M CARRIO |
| K053104 |
12/23/2005 |
DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR |
DADE BEHRING, INC. |
ANDREA M TASKER |
| K053109 |
12/23/2005 |
DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
ANDREA M TASKER |
| K052303 |
12/16/2005 |
READMYHEART, MODEL RMH2.0 |
DAILYCARE BIOMEDICAL INC |
DANIEL J. H. CHANG |
| K052688 |
12/12/2005 |
ELLIPSE FLEX PPT, MODEL 9ESF7255 |
DANISH DERMATOLOGIC DEVELOPMENT A/S |
OLE KOFOD |
| K053167 |
12/08/2005 |
BIOPURE MTAD ROOT CANAL CLEANSER |
DENTSPLY INTL., INC. |
HELEN LEWIS |
| K052840 |
12/16/2005 |
IGI-SYSTEM |
DENX ADVANCED DENTAL SYSTEMS |
RACHEL WEISSBROD |
| K051714 |
12/07/2005 |
TOTAL BILE ACIDS ASSAY, MODEL DZ042A |
DIAZYME LABORATORIES |
HUAN TRAN |
| K051487 |
12/22/2005 |
DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE |
DOCTOR'S RESEARCH GROUP, INC. |
MAHMUD AHMED |
| K051733 |
12/07/2005 |
ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL |
DRG INTL., INC. |
Gary Lehnus |
| K052445 |
12/05/2005 |
DUOPROSS NEEDLE |
DUOPROSS MEDITECH CORPORATION |
FRANK FERGUSON |
| K052743 |
12/22/2005 |
DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921 |
DYNAREX CORP. |
JAMES HURLMAN |
| K052343 |
12/07/2005 |
E-SAN BLUETOOTH CRADLE |
E-SAN LIMITED |
KRISTIN M ZIELINSKI |
| K053008 |
12/27/2005 |
E-Z-EM ENDOSCOPIC CO2 REGULATOR |
E-Z-EM, INC. |
ROBERT WILLIAMS |
| K050921 |
12/12/2005 |
EASYSTIM NMS-28 |
EASYMED INSTRUMENT CO., LTD. |
JEFFERY WU |
| K053404 |
12/21/2005 |
LIFESTENT FLEXSTART BILIARY STENT SYSTEM |
EDWARDS LIFESCIENCES, LLC. |
KEVIN DRISKO |
| K053016 |
12/30/2005 |
WIRELESS PHYSIOLOGIC MONITORING SYSTEM |
EDWARDS LIFESCIENCES, LLC. |
DIANE PETERSON |
| K053432 |
12/30/2005 |
EKOS MICRO-INFUSION SYSTEM |
EKOS CORP. |
JOCELYN KERSTEN |
| K053248 |
12/01/2005 |
SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL |
ELECTROMED, INC. |
CHET SIEVERT |
| K053281 |
12/07/2005 |
EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE) |
EMAGEON INC. |
INGER L HANSON |
| K052320 |
12/30/2005 |
ENCORE CLP OFFSET TOTAL HIP SYSTEM |
ENCORE MEDICAL CORPORATION |
SAM SON |
| K053100 |
12/19/2005 |
ESTECH COBRA BIPOLAR SYSTEM |
ENDOSCOPIC TECHNOLOGIES, INC. |
CRAIG COOMBS |
| K052081 |
12/16/2005 |
REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULA |
ESTECH, INC. |
CRAIG COOMBS |
| K052233 |
12/13/2005 |
TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM |
ETVIEW LTD. |
YORAM LEVY |
| K052133 |
12/12/2005 |
IMMUNOSCAN RA ANTI-CCP TEST SYSTEM |
EURODIAGNOSTICA |
WILLIAM L BOTELER JR. |
| K052787 |
12/27/2005 |
ACUMATCH 12/14 C-SERIES CEMENTED FEMORAL STEMS (SIZE 1-6), ACUMATCH 12/14 L-SERIES CEMENTED FEMORAL STEMS (SIZE 1-5) |
EXACTECH, INC. |
MARITZA ELIAS |
| K051858 |
12/01/2005 |
ACUMATCH M-SERIES LPB 12/14 FEMORAL STEM |
EXACTECH, INC. |
Lisa Simpson |
| K053120 |
12/09/2005 |
STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES |
EXCELSIOR MEDICAL CORP. |
RUBEN MARTINEZ |
| K051294 |
12/21/2005 |
FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1 |
FEMSPEC L.L.C. |
CARL YOUNGMANN |
| K052115 |
12/29/2005 |
FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY |
FIRST CHECK DIAGNOSTICS LLC |
KEVIN J GADAWSKI |
| K052531 |
12/14/2005 |
FU HONG INDUSTRIES LIMITED SOOTHER TEETHER |
FU HONG INDUSTRIES LTD. |
Kevin Walls |
| K052889 |
12/20/2005 |
VITROS CA 19-9 |
FUJIREBIO DIAGNOSTICS, INC. |
DIANA L WOLANIUK |
| K051520 |
12/09/2005 |
GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H |
GAMBRO RENAL PRODUCTS |
THOMAS B DOWELL |
| K052972 |
12/29/2005 |
DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3 |
GE HEALTHCARE |
JOEL KENT |
| K053435 |
12/16/2005 |
GE VOLUSON I |
GENERAL ELECTRIC CO. |
ALLEN SMITH |
| K053066 |
12/19/2005 |
SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH |
GENZYME CORPORATION |
LISA D CROCKETT |
| K053055 |
12/22/2005 |
ORTHODONTIC POLYMER COMPOSITE BRACKET |
GESTENCO INTERNATIONAL AB |
GORAN STEEN |
| K052184 |
12/01/2005 |
GIVEN DIAGNOSTIC SYSTEM |
GIVEN IMAGING LTD. |
SHOSHANA FRIEDMAN |
| K052923 |
12/21/2005 |
GREAT GLOVE POWDER FREE VINYL EXAMINATION GLOVES |
GREAT GLOVE (CHINA), INC. |
K.M. LEE |
| K052922 |
12/20/2005 |
GREAT GLOVE POWDERED VINYL EXAMINATION GLOVES |
GREAT GLOVE (CHINA), INC. |
K.M. LEE |
| K052956 |
12/21/2005 |
NITRILE BLUE POWDER FREE EXAMINATION GLOVE |
GREAT GLOVE SDN BHD |
LIM WEE-CHAI |
| K052177 |
12/09/2005 |
POWDER FREE STERILE LATEX SURGICAL GLOVES |
HARTALEGA SDN BHD |
NURUL AISYAH KONG |
| K052471 |
12/23/2005 |
HDC SPIDER SCREW |
HDC S.R.L. |
MILLIE LYNN BENTLEY |
| K052120 |
12/16/2005 |
LUMIMED MONOCHROME LCD MONITOR, MODELS MM 20, MM 30 AND MM50 |
HEEYOUNG CO., LTD. |
DANIEL KAMM |
| K053258 |
12/09/2005 |
EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER |
HITACHI MEDICAL CORP. |
DOUG THISTLETHWAITE |
| K052597 |
12/16/2005 |
BREATHEX OMEGA CPAP DEVICE, MODEL 322 |
HOFFMAN LABORATORIES, LLC |
KEITH BOSECKER |
| K053308 |
12/29/2005 |
ABX MICROS CRP 200, OPTION IM |
HORIBA ABX |
TIM LAWTON |
| K052007 |
12/16/2005 |
ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE) |
HORIBA ABX |
TIM LAWTON |
| K053349 |
12/09/2005 |
HOFFMANN II ROD TO WIRE COUPLING |
HOWMEDICA OSTEONICS CORP |
FRANCISCO HARO |
| K052917 |
12/27/2005 |
STRYKER COMPARTMENTAL KNEE SYSTEM |
HOWMEDICA OSTEONICS CORP |
VIVIAN KELLY |
| K052748 |
12/02/2005 |
SYSTEM 12 X3 ACETABULAR INSERTS; SERIES II X3 ACETABULAR INSERTS |
HOWMEDICA OSTEONICS CORP |
KAREN ARIEMMA |
| K052811 |
12/21/2005 |
HSINER JET NEBULIZER, MODEL HS-31100 |
HSINER CO., LTD. |
TOM SHANKS |
| K053369 |
12/22/2005 |
MEDILOG DARWIN HOLTER ANALYSIS |
HUNTLEIGH HEALTHCARE |
JAMES PARDEY |
| K051472 |
12/23/2005 |
BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR |
HYPHEN BIOMED |
OLA ANDERSON |
| K050365 |
12/27/2005 |
BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202 |
HYPHEN BIOMED |
OLA ANDERSON |
| K051433 |
12/15/2005 |
I-STAT CREATINE KINASE MB (CK-MB) |
I-STAT CORPORATION |
SUE KENT |
| K052865 |
12/22/2005 |
HOSPIRA CATH LAB CONVENIENCE KITS |
ICU MEDICAL, INC. |
TOM KOZMA |
| K052694 |
12/16/2005 |
ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES. |
IND DIAGNOSTIC INC. |
JASON PENG |
| K053276 |
12/27/2005 |
IST PEDICLE SCREW SYSTEM |
INNOVATIVE SPINAL TECHNOLOGIES INC |
STEPHEN PALUMBO |
| K052562 |
12/23/2005 |
ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS. |
INTERACOUSTICS AS |
DANIEL EGGAN |
| K051371 |
12/06/2005 |
INTERBODY INNOVATIONS CEMENT RESTRICTOR |
INTERBODY INNOVATIONS LLP |
IAN GORDON |
| K053196 |
12/16/2005 |
ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) |
INVERNESS MEDICAL INNOVATIONS, INC. |
JAMES M DELANEY |
| K050642 |
12/05/2005 |
ORTHOBLAST II PUTTY AND PASTE |
ISOTIS ORTHOBIOLOGICS, INC |
PAUL DONER |
| K052587 |
12/27/2005 |
3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1 EXF |
J. MORITA USA, INC. |
KEITH A BARRITT |
| K052398 |
12/07/2005 |
MESA SPINAL SYSTEM |
K2M, LLC |
RICHARD W WOODS |
| K051300 |
12/08/2005 |
ROBIN HOOD VEST |
KAMBER CORPORATION |
DAVID J BLOCH |
| K050944 |
12/23/2005 |
K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET |
KAMIYA BIOMEDICAL CO. |
BRIAN SCHLIESMAN |
| K053262 |
12/19/2005 |
KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
YVONNE FERNANDEZ |
| K053173 |
12/15/2005 |
DS CASSETTE |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
SHINICHI YAMANAKA |
| K052467 |
12/20/2005 |
BRAIN VIEWRX VIEWER, VERSION 1.0 |
KYRON CLINICAL IMAGING, INC. |
JAMES L REUSS |
| K052604 |
12/16/2005 |
STARLITE 2006 |
LASER DENTAL INNOVATIONS |
HOWARD FEINBERG |
| K053149 |
12/13/2005 |
SPIRO-BALL |
LEVENTON, S.A. |
ORIOL VERNIS |
| K052397 |
12/22/2005 |
CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML) |
LIFE-SHIELD PRODUCTS, INC |
Ke-Min Jen |
| K052735 |
12/28/2005 |
ALLOCRAFT DBM |
LIFECELL CORP. |
HOWARD M HOLSTEIN |
| K052678 |
12/27/2005 |
AQ-830 SLIM BODY, BODY FAT MONITOR |
LIMAX ELECTRONICS CO., LTD. |
JENNIFER REICH |
| K051926 |
12/12/2005 |
LIMERICK PJ'S COMFORT JR PORTABLE ELECTRIC BREAST PUMP |
LIMERICK, INC. |
PAUL KRUMM |
| K052715 |
12/22/2005 |
CALM CURVE, VERSION 01.00 |
LMS MEDICAL SYSTEMS (CANADA), LTD. |
PAMELA HASWELL |
| K052728 |
12/05/2005 |
POWDER FREE LATEX STERILE PATIENT EXAMINATION GLOVES |
M/S. KANAM LATEX INDUSTRIES PVT. LTD. |
RAVI ABRAHAM |
| K052846 |
12/22/2005 |
TEWA CJ-TYPE, PJ-TYPE, CB-TYPE AND PB-TYPE ACUPUNCTURE NEEDLES FOR SINGLE USE |
MAANSHAN MEDICAL INSTRUMENTS CO., LTD. |
Kevin Walls |
| K052622 |
12/09/2005 |
MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT |
MACAN ENGINEERING CO. |
MICKEY ALBERGO |
| K050150 |
12/05/2005 |
MANI NEEDLE & SUTURE PACK |
MANI, INC. |
DAVID J BLOCH |
| K052606 |
12/15/2005 |
MARIETTA CONTACT LENS (POLYMACON), TINTED DAILY WEAR CONTACT LENS |
MARIETTA VISION |
MARTIN DALSING |
| K053269 |
12/21/2005 |
MASIMO SET RAD-8 PULSE OXIMETER |
MASIMO CORPORATION |
JIM CRONIN |
| K051324 |
12/05/2005 |
MEDI BUTLER |
MEDI USA, LP |
GARY L YINGLING |
| K051694 |
12/21/2005 |
CLICKZIP NEEDLE RETRACTABLE SAFETY SYRINGE |
MEDICAL DEVICE MANUFACTURER (THAILAND) LTD. |
OYTIP KUNWUNLOP |
| K052338 |
12/15/2005 |
SOLAR GI |
MEDICAL MEASUREMENT SYSTEMS,B.V. |
KARIN OGINK-SOMHORST |
| K052751 |
12/23/2005 |
VENTLINK SYSTEM |
MEDISERVE INFORMATION SYSTEMS, INC. |
MARK OFORI-KYEI |
| K052615 |
12/09/2005 |
MEDISIZE GOLD |
MEDISIZE BV |
SOPIHA LAM |
| K050933 |
12/09/2005 |
FUGO BLADE FOR PERIPHERAL IRIDOTOMY, MODEL M300 |
MEDISURG LTD. |
RICHARD J FUGO |
| K053325 |
12/07/2005 |
MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY); MULTISCAN ULTRASOUND SYSTEM, MODEL M0001 |
MEDIWATCH LTD |
ANDREW HOPKINS |
| K042404 |
12/22/2005 |
LIFEPAK, MODEL 1000 |
MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. |
SHERRI POCOCK |
| K052386 |
12/16/2005 |
MEDTRONIC M2 MAGNET ADJUSTMENT TOOL |
MEDTRONIC NEUROSURGERY |
JEFFREY HENDERSON |
| K051386 |
12/16/2005 |
MASTERGRAFT PUTTY BONE VOID FILLER |
MEDTRONIC VASCULAR |
RICHARD TREHARNE |
| K053252 |
12/16/2005 |
U-CLIP DEVICE, MODELS B140, B160 AND B180 |
MEDTRONIC VASCULAR |
DAVID D COX |
| K052288 |
12/20/2005 |
VITALOGIK |
MENNEN MEDICAL LTD. |
MICHA OESTEREICH |
| K053414 |
12/27/2005 |
MENTOR NOVASILK MESH |
MENTOR CORP. |
DONNA A CRAWFORD |
| K053296 |
12/15/2005 |
MENTOR ARIS SUPRAPUBIC SURGICAL KIT |
MENTOR CORPORATION |
DONNA A CRAWFORD |
| K053160 |
12/07/2005 |
MICRUS MODIFIED MICROCOIL 18-SYSTEM, CERECYTE, MODEL CSP & CHE |
MICRUS ENDOVASCULAR CORPORATION |
MARGARET WEBBER |
| K053192 |
12/05/2005 |
MODEL 418 SERIES WALKERS |
MJM INTERNATIONAL CORPORATION |
MELLY MOROLES |
| K052451 |
12/08/2005 |
MPS ACACIA MEDFLO ELASTOMERIC PUMP |
MPS ACACIA |
FERGIE FERGUSON |
| K052946 |
12/08/2005 |
MPS ACACIA NERVE BLOCK NEEDLE |
MPS ACACIA |
FERGIE F FERGUSON |
| K052942 |
12/27/2005 |
21.3INCH MONOCHROME LCD MONITOR |
NEC-MITSUBISHI ELECTRIC VISUAL SYSTEMS CORP. |
SHUICHI KINO |
| K053214 |
12/20/2005 |
THERAKNIT GARMENT ELECTRODE |
NEUROTRON MEDICAL |
JACK GULDALIAN |
| K053093 |
12/07/2005 |
KALIX II IMPLANT, MODEL 141 0XX WITH XX |
NEWDEAL S.A. |
JUDITH E O'GRADY |
| K053408 |
12/22/2005 |
NEXA BONE PLATE AND SCREW SYSTEM |
NEXA ORTHOPEDICS, INC. |
LOUISE M FOCHT |
| K053394 |
12/14/2005 |
NEXA BONE SCREW SYSTEM |
NEXA ORTHOPEDICS, INC. |
LOUISE M FOCHT |
| K053129 |
12/08/2005 |
NEXUSTKO NEEDLELESS ACCESS DEVICE, MODEL NIS-5 |
NEXUS MEDICAL, LLC |
AL BOEDEKER |
| K051828 |
12/15/2005 |
NIPRO SUREFUSER AMBULATORY INFUSION PUMP |
NIPRO MEDICAL CORPORATION |
KAELYN HADLEY |
| K052885 |
12/23/2005 |
ZYGOMA 17 ABUTMENT MULTI-UNIT RP 2MM, MODEL 29314; ZYGOMA 17 ABUTMENT MULTI-UNIT RP 3MM, MODEL 29315 |
NOBEL BIOCARE USA LLC |
HERBERT CRANE |
| K050726 |
12/05/2005 |
SILVERSEAL SILVERAID WITH X-STATIC |
NOBLE FIBER TECHNOLOGIES, INC. |
PATRICIA DAVIDSON |
| K052669 |
12/23/2005 |
AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODEL 4000, 4100 |
NONIN MEDICAL, INC. |
LORI M ROTH |
| K052490 |
12/08/2005 |
ENDOSSEOUS DENTAL IMPLANT SYSTEM |
NORTHERN IMPLANTS, LLC |
GRETA M HOLS |
| K053470 |
12/21/2005 |
NOVOFINE 32G TIP |
NOVO NORDISK INC. |
JOHN SIGNORIN |
| K052700 |
12/20/2005 |
PANA-SPRAY |
NSK AMERICA CORP. |
HIROHIKO MURASE |
| K052210 |
12/12/2005 |
NUVASIVE COROENT EXTENSURE SYSTEM |
NUVASIVE, INC. |
LAETITIA COUSIN |
| K053286 |
12/22/2005 |
MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION |
NXSTAGE MEDICAL, INC. |
NORMA LEMAY |
| K052804 |
12/09/2005 |
BREATHKEY MODEL G10/BREATHKEY MODEL G30X |
OMEGAPOINT SYSTEMS, LLC |
BARBARA S FANT |
| K052428 |
12/08/2005 |
RESOLUTION ENDOVASCULAR SYSTEM |
OMNISONICS MEDICAL TECHNOLOGIES |
ANNE M KULIS |
| K052645 |
12/14/2005 |
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873; |
ORTHO-CLINICAL DIAGNOSTICS |
MICHAEL M BYRNE |
| K052819 |
12/23/2005 |
VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III |
Ortho-Clinical Diagnostics, Inc. |
Darlene J Phillips |
| K052867 |
12/23/2005 |
VITROS CHEMISTRY PRODUCTS DTIBC REAGENT |
Ortho-Clinical Diagnostics, Inc. |
Darlene J Phillips |
| K053261 |
12/12/2005 |
ORTHOFIX TITANIUM NAILING SYSTEMS |
ORTHOFIX SRL |
CANDACE F CEDERMAN |
| K053080 |
12/01/2005 |
GRAFTCAGE ACX |
OSTEOTECH, INC. |
CHRISTOPHER TALBOT |
| K051781 |
12/16/2005 |
GRAFTCAGE TLX |
OSTEOTECH, INC. |
CHRISTOPHER TALBOT |
| K051195 |
12/16/2005 |
GRAFTON DBM |
OSTEOTECH, INC. |
CHRISTOPHER W TALBOT |
| K043209 |
12/05/2005 |
VIAGRAF DBM PASTE |
OSTEOTECH, INC. |
CHRISTOPHER TALBOT |
| K052706 |
12/27/2005 |
A-200 POWERED WHEELCHAIR |
OTTO BOCK HEALTHCARE, LP |
BOB CLARKE |
| K052866 |
12/13/2005 |
OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER |
OXYHEAL HEALTH GROUP |
DAVE HEANY |
| K052396 |
12/09/2005 |
OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 615 |
OXYSURE SYSTEMS, INC. |
JULIAN T ROSS |
| K053282 |
12/13/2005 |
ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIP |
PAJUNK GMBH |
CHRISTIAN QUASS |
| K053279 |
12/22/2005 |
UROVANTAGE |
PCK ELECTRONIC INDUSTRY & TRADE CO., LTD. |
JONATHAN S KAHAN |
| K052701 |
12/13/2005 |
COROLENE |
PETERS SURGICAL |
ANNIE LASSERRE |
| K052974 |
12/16/2005 |
WARMING LIQUID PERSONAL LUBRICANT |
PHARMAPAC LLC |
TOM OTTO |
| K052795 |
12/30/2005 |
PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30 |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH |
MARKUS STACHA |
| K053154 |
12/16/2005 |
MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM |
PIE MEDICAL |
CARRI GRAHAM |
| K052988 |
12/30/2005 |
CAAS |
PIE MEDICAL IMAGING B.V. |
CARLA DE VRIES |
| K051691 |
12/09/2005 |
MINIMATE COMPRESSOR |
PRECISION MEDICAL, INC. |
JAMES PARKER |
| K053063 |
12/13/2005 |
PRO-FLOW MULTIPURPOSE CANNULA |
PRO-TECH SERVICES, INC. |
NEIL SHELLER |
| K051290 |
12/27/2005 |
TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, ULTRA ABSORBENCY (UNSCENTED AND SCENTED) |
PROCTER & GAMBLE CO. |
MARK M ANDERSON |
| K052941 |
12/09/2005 |
I-NEB INSIGHT AAD SYSTEM |
PROFILE THERAPEUTICS PLC |
BARBARA CAMPBELL |
| K053146 |
12/14/2005 |
QUICKVUE INFLUENZA A + B TEST |
QUIDEL CORP. |
JOHN D TAMERIUS |
| K050817 |
12/12/2005 |
T-TEK |
R2 DIAGNOSTICS, INC. |
PEGGY S CARTER |
| K052249 |
12/07/2005 |
UTOPIA |
RESPCARE INC. |
FRANK PELC |
| K053203 |
12/20/2005 |
MYNEB NEBULIZER, MODEL RDD100 |
RESPIRONICS NEW JERSEY, INC. |
Lauren Ziegler |
| K052573 |
12/13/2005 |
STARDUST II |
RESPIRONICS, INC. |
ZITA A YURKO |
| K051382 |
12/05/2005 |
ELECSYS PROBNP IMMUNOASSAY |
ROCHE DIAGNOSTICS CORP. |
THERESA M AMBROSE |
| K053165 |
12/14/2005 |
ISE INDIRECT NA, K, CL FOR GEN.2 |
ROCHE DIAGNOSTICS CORP. |
KERWIN KAUFMAN |
| K052727 |
12/16/2005 |
ROSSMAX NON-INVASIVE BLOOD PRESSURE MONITORS, MODELS S380, K350 |
ROSSMAX INTERNATIONAL LTD. |
YOLANDA LIN |
| K052553 |
12/22/2005 |
NITOM LOCKING FACEBOW |
RUSSELL SAMUELS ORTHODONTIC DESIGN |
RUSSELL HENRY ASHLEIGH SAMUELS |
| K052810 |
12/20/2005 |
SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM |
SCANDIUS BIOMEDICAL, INC. |
ERIC BANNON |
| K052259 |
12/14/2005 |
DR. SCHOLL'S DUAL ACTION FREEZE AWAY WART REMOVER, MODEL 40406 |
SCHERING-PLOUGH HEALTHCARE PRODUCTS, INC. |
DOREEN FRANK |
| K052170 |
12/21/2005 |
SEASPINE VBR SYSTEM |
SEASPINE, INC. |
DIANA SMITH |
| K052108 |
12/07/2005 |
SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100 |
SEIN ELECTRONICS CO., LTD. |
JAY MANSOUR |
| K052826 |
12/23/2005 |
QMS QUINIDINE. QMS QUINIDINE CALIBRATORS |
SERADYN INC. |
JACK ROGERS |
| K052388 |
12/01/2005 |
SERIM PERACETIC ACID CHEMICAL INDICATOR |
SERIM RESEARCH CORP. |
PATRICIA A RUPCHOCK |
| K053346 |
12/09/2005 |
MODIFICATION TO: DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-9900 |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLSTEIN-FALK |
| K051736 |
12/02/2005 |
FOX PULSE OXIMETER |
SHUNSUKE NAKANISHI |
YINGCHAO XIAO |
| K053133 |
12/05/2005 |
SYNGO DYNAMICS, VERSION 5.0 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JUDITH CAMPBELL |
| K053007 |
12/05/2005 |
SKYLARK URO PROBE |
SKYLARK DEVICE & SYSTEMS CO., LTD |
GEORGE CHIANG |
| K052265 |
12/27/2005 |
SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL |
SMITH & NEPHEW, INC. |
GINO J ROUSS |
| K052426 |
12/07/2005 |
SMITH & NEPHEW MODULAR HIP |
SMITH & NEPHEW, INC. |
JASON SELLS |
| K052275 |
12/07/2005 |
SMITH & NEPHEW PLATFORM HIP STEM |
SMITH & NEPHEW, INC. |
GINO ROUSS |
| K052221 |
12/08/2005 |
AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP |
SORENSON MEDICAL, INC. |
Douglas Bueschel |
| K052848 |
12/27/2005 |
SPECTRA HAIR REMOVAL LASER |
SPECTRAGENICS, INC. |
ROBERT E GROVE |
| K050526 |
12/06/2005 |
POLYMER COATED ONLINE CHLORINATED POWDER FREE EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR |
SPI GLOVES SDN. BHD. |
CHOOI FONG CHUN |
| K052644 |
12/05/2005 |
SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER |
ST. JUDE MEDICAL |
GLENN JACQUES |
| K052522 |
12/13/2005 |
STAYHEALTHY BODY COMPOSITION ANALYZER, MODELS BC1 AND BC2 |
STAYHEALTHY, INC. |
COLIN K HILL |
| K051373 |
12/09/2005 |
CRONUS GUIDEWIRE, MODEL 001-001470-1 |
STEREOTAXIS, INC. |
KELLY ROWLAND |
| K052283 |
12/23/2005 |
HEART STG SYSTEM AND SOFTWARE |
STETHOGRAPHICS, INC. |
ROZANNE PACIEJ |
| K052871 |
12/16/2005 |
STRYKER CUSTOM TI IMPLANT |
STRYKER LEIBINGER |
WADE T RUTKOSKIE |
| K051603 |
12/30/2005 |
STRYKER INJECTABLE CEMENT |
STRYKER LEIBINGER MICRO IMPLANTS |
WADE T RUTKOSKIE |
| K053115 |
12/06/2005 |
XIA SPINAL SYSTEM |
STRYKER SPINE |
SIMONA VOIC |
| K052875 |
12/27/2005 |
PROSTIM REUSABLE NEUROSTIMULATION ELECTRODES |
SUMMIT MANUFACTURING, L.L.C. |
SUSAN D GOLDSTEIN-FALK |
| K052962 |
12/06/2005 |
OPTIMIZED BARB DESIGN |
SURGICAL SPECIALTIES CORP. |
ELIZABETH LAZARO |
| K053482 |
12/27/2005 |
SUPERSTITCH GW, MODELS 06-15-04-GW, 08-15-04-GW |
SUTURA, INC. |
GERARD J PRUD'HOMME |
| K052943 |
12/15/2005 |
DDRFORMULA AND DDRFORMULA PLUS |
SWISSRAY MEDICAL AG |
JOHN MONAHAN |
| K053105 |
12/02/2005 |
SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP |
SYNTHES (USA) |
LISA M BOYLE |
| K052683 |
12/05/2005 |
SYNTHES (USA) STERNAL FIXATION SYSTEM |
SYNTHES (USA) |
Lisa Boyle |
| K053199 |
12/14/2005 |
SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT |
SYNTHES (USA) |
Lisa Boyle |
| K052151 |
12/07/2005 |
SYNTHES PANGEA MONOAXIAL SYSTEM |
SYNTHES SPINE CO.LP |
ANGELA MIKROULIS |
| K052586 |
12/09/2005 |
A & I PEDIATRIC WHEELCHAIRS, MODELS RWAL2006-12, LT3207-12. A & I BARIATRIC WHEELCHAIRS, MODEL NO. WCDE2611P, WCDE2811P |
TAIWAN AN I CO.,LTD. |
Kevin Walls |
| K052724 |
12/14/2005 |
TECO ISE REAGENT SET FOR CX SYSTEM |
TECO DIAGNOSTICS |
JIAN VAECHES |
| K052635 |
12/13/2005 |
TEH LOONG POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW |
TEH LOONG CORP. |
CHIEN LIN |
| K052887 |
12/08/2005 |
SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD), MODEL SV-S23BL35VS |
TERUMO EUROPE N.V. |
M.J. AERTS |
| K052572 |
12/05/2005 |
ANSPACH KNOTLESS ANCHOR |
THE ANSPACH EFFORT, INC. |
WILLIAM CONETY |
| K051993 |
12/13/2005 |
LMA FASTRACH ETT SINGLE USE |
THE LARYNGEAL MASK CO.,LTD. |
FOSTER BOOP |
| K051864 |
12/21/2005 |
MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00 |
THE MAGSTIM COMPANY LTD. |
ANTHONY THOMAS |
| K053141 |
12/14/2005 |
NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800 |
THE MAGSTIM COMPANY LTD. |
CHRIS LEWIS |
| K053365 |
12/13/2005 |
MODIFICATION TO THERMAGE THERMACOOL SYSTEM |
THERMAGE, INC. |
PAMELA M BUCKMAN |
| K053266 |
12/29/2005 |
MYOTRAC INFINITI |
THOUGHT TECHNOLOGY LTD. |
SURESH SUGIRTHARAJA |
| K052208 |
12/09/2005 |
GLUCOSE PILOT |
Tianjin New Bay Bioresearch Co., Ltd. |
RODBRIGO BERLIE |
| K053457 |
12/21/2005 |
VAPORMAX II |
TRIMEDYNE, INC. |
GLENN D YEIK |
| K052864 |
12/22/2005 |
TYRX SURGICAL MESH, MODEL SMPC-0501 |
TYRX PHARMA INC |
MASON W DIAMOND |
| K052385 |
12/27/2005 |
TANGORS POLYAXIAL SYSTEM |
ULRICH GMBH & CO. KG |
CHRISTOPH ULRICH |
| K051638 |
12/06/2005 |
INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC |
UNIPATH LTD. |
Louise Roberts |
| K053245 |
12/20/2005 |
GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIG DRAINAGE CATHETER; NEPHROSTOMY CATHETER; BILIARY CATHETER |
URESIL, LLC |
MATTHEW MAHON |
| K053051 |
12/22/2005 |
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES |
VANGUARD MEDICAL CONCEPTS, INC. |
TRISH STEPHENS |
| K052258 |
12/13/2005 |
VASCULAR SOLUTIONS SKYWAY SUPPORT CATHETER |
VASCULAR SOLUTIONS, INC. |
SARA L COON |
| K053503 |
12/28/2005 |
VAX-D GENESIS SYSTEM (THERAPEUTIC TABLE) |
VAX-D MEDICAL TECHNOLOGIES USA, L.C. |
LAWRENCE DYER |
| K052738 |
12/06/2005 |
INFUSIONCATH PERIPHERAL INFUSION CATHETER, MODELS VF0012, VF0016, VF0024, VF0028, VF0032, VF0036, VF0040, VF0044 |
VEINRX INC. |
GREGORY J MATHISON |
| K052632 |
12/15/2005 |
VITREA2 VERSION 3.8 MEDICAL IMAGE PROCESSING SOFTWARE |
VITAL IMAGES, INC. |
TIMOTHY J KAPPERS |
| K053392 |
12/15/2005 |
FUTURABOND NR SINGLE DOSE |
VOCO GMBH |
MICHAEL SUS |
| K052348 |
12/02/2005 |
IN VISION GOLD WITH SPIN VISION, MODEL 891 SV |
VOLCANO CORPORATION |
JENNIFER M MOTTO |
| K052395 |
12/01/2005 |
STERILE EQUIPMENT COVERS |
VOLCANO CORPORATION |
Michelle J Badal |
| K053162 |
12/09/2005 |
DEXTROSCOPE & DEXTROBEAM |
VOLUME INTERACTIONS PTE LTD |
R. FAREETH |
| K053202 |
12/07/2005 |
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL |
W.L. GORE & ASSOCIATES |
Michael Ivey |
| K053200 |
12/07/2005 |
GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL |
W.L. GORE & ASSOCIATES,INC |
Michael Ivey |
| K053132 |
12/30/2005 |
WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791 |
WAKO CHEMICALS, USA, INC. |
LORI CREASY |
| K053131 |
12/30/2005 |
WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191 |
WAKO CHEMICALS, USA, INC. |
LORI CREASY |
| K052160 |
12/16/2005 |
ACUITY CENTRAL STATION, MODEL 020XXXXX (NOTE: XXXXX = VARIOUS CONFIG.) |
WELCH ALLYN, INC. |
JOHN E SAWYER |
| K051242 |
12/13/2005 |
WINNER SELF SEAL STERILIZATION POUCH |
WINNER MEDICAL (USA), INC. |
MING XIE |
| K052026 |
12/05/2005 |
LINEAGE A-CLASS POLY LINER |
WRIGHT MEDICAL TECHNOLOGY, INC. |
THERESA LEISTER |
| K052847 |
12/12/2005 |
CAPLESS PEDICLE SCREW SYSTEM |
X-SPINE SYSTEMS, INC. |
FLOYD G LARSON |
| K050843 |
12/22/2005 |
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM |
XOFT, INC. |
Kathy O'Shaughnessy |
| K052328 |
12/22/2005 |
ZAN LUNG-FUNCTION LAB |
ZAN MESSGERATE GMBH |
JIM LEWIS |
| K051484 |
12/05/2005 |
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM. |
ZEUS SCIENTIFIC, INC. |
MARK K KOPNITSKY |
| K052912 |
12/15/2005 |
YUSHENG DISPOSABLE VAGINAL SPECULUM |
ZHEJIANG YUSHENG MEDICAL INSTRUMENT CO. LTD. |
PEIFANG XING |
| K053189 |
12/09/2005 |
COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES |
ZIMMER, INC. |
LAURA D WILLIAMS |
| K052425 |
12/28/2005 |
ZIMMER COMPUTER ASSISTED SOLUTIONS-ELECTROMAGNETIC AND IMAGELESS KNEE INSTRUMENTATION |
ZIMMER, INC. |
STEPHEN H MCKELVEY |
| K052906 |
12/19/2005 |
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM |
ZIMMER, INC. |
DALENE T BINKLEY |
