| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K043189 |
02/09/2005 |
SONALIS, MODEL 2000 |
3G ULTRASOUND, INC. |
PAUL SCHNEIDER |
| K053256 |
12/16/2005 |
3M TEGADERM SILVER (AG) MESH |
3M COMPANY |
AMY E SHORT |
| K050159 |
02/22/2005 |
MODIFICATION TO: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000 |
3M COMPANY |
GINGER CANTOR |
| K051041 |
12/23/2005 |
INSULIN PUMP |
ABBOTT DIABETES CARE INC. |
MARY ROSE |
| K053330 |
12/16/2005 |
ARCHITECT B12 CALIBRATORS |
ABBOTT LABORATORIES |
MARGARET PROCHNIAK |
| K050103 |
02/16/2005 |
XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM |
ABBOTT LABORATORIES |
ANN E LEONARD |
| K052744 |
12/16/2005 |
C2000 AUTOMATED MANIFOLD KIT |
ACIST MEDICAL SYSTEMS, INC. |
A; SAALABI |
| K042272 |
02/28/2005 |
ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA) |
ACON LABORATORIES, INC. |
EDWARD TUNG, PH.D. |
| K043507 |
02/25/2005 |
ACON OXY II ONE STEP OXYCODONE TEST STRIP; TEST DEVICE |
ACON LABORATORIES, INC. |
EDWARD TUNG |
| K050015 |
02/03/2005 |
MODIFIED ACUMEN SHEATH, MODEL TTWO767 |
ACUMEN MEDICAL, INC. |
Marybeth Gamber |
| 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 |
| K043126 |
02/03/2005 |
ASSIST HEADER CLEANER |
ALCAVIS INTERNATIONAL, INC. |
GARY J MISHKIN |
| 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 |
| K050078 |
02/18/2005 |
ROC LUMBAR PLATING SYSTEM |
ALPHATEC/NEXMED |
ELLEN A YARNALL |
| 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 |
| K050025 |
02/03/2005 |
NANOSS BONE VOID FILLER |
ANGSTROM MEDICA, INC. |
FLOYD G LARSON |
| K050104 |
02/16/2005 |
APEX MEDICAL MININEB & MINIPLUS |
APEX MEDICAL CORP. |
ANAN CHANG |
| K043123 |
02/10/2005 |
APEX MODULAR HA HIP STEM |
APEX SURGICAL, LLC. |
EDWARD J CHEAL |
| K053119 |
12/07/2005 |
DISTAL RADIO-ULNAR JOINT IMPLANT |
APTIS MEDICAL, LLC. |
BRYAN BABB |
| K050077 |
02/15/2005 |
SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS |
ARKRAY, INC. |
HELEN LANDICHO |
| K043284 |
02/25/2005 |
ENDOASSIST |
ARMSTRONG HEALTHCARE LIMITED |
PATRICK A FINLAY |
| K052901 |
12/12/2005 |
ARTHREX TENSIONLOK |
ARTHREX, INC. |
ANN WATERHOUSE |
| K043145 |
02/18/2005 |
BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B |
ARTHREX, INC. |
SALLY FOUST |
| K052776 |
12/13/2005 |
TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS AR-2257, AR-TBD |
ARTHREX, INC. |
SALLY FOUST |
| K043248 |
02/16/2005 |
TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS; STAINLESS STEEL. MODEL AR-8921DS |
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 |
| K050313 |
02/24/2005 |
BIS SRS (SEMI-RESUABLE SENSOR) |
ASPECT MEDICAL SYSTEMS, INC. |
CHRISTINE VOZELLA |
| K050063 |
02/09/2005 |
PROSTATE-63 CANCER DIAGNOSTIC TEST |
ASYMMETRX |
MARIA MCKEON |
| K052845 |
12/16/2005 |
B-CARE POWDERED LATEX EXAMINATION GLOVES |
B-CARE INDUSTRIES CO., LTD. |
Kevin Walls |
| K050147 |
02/03/2005 |
TRELLIS-8 PERIPHERAL INFUSION SYSTEM |
BACCHUS VASCULAR, INC. |
MAUREEN BENSING |
| K052772 |
12/20/2005 |
BARRIERPLUS GOLD ORTHO POWDER-FREE SYNTHETIC POLYISOPRENE ORTHOPEDIC SURGICAL GLOVES |
BARRIERMED GLOVE CO. |
VICTOR J RAGUCCI |
| K042808 |
02/08/2005 |
ADVIA IMS CARBAMAZEPINE METHOD |
BAYER HEALTHCARE, LLC |
ANDRES HOLLE |
| K042807 |
02/08/2005 |
ADVIA IMS VALPROIC ACID METHOD |
BAYER HEALTHCARE, LLC |
ANDRES HOLLE |
| 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 |
| K042110 |
02/25/2005 |
BEAMCATH |
BEAMPOINT AB |
CONSTANCE BUNDY |
| K050202 |
02/09/2005 |
CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS |
BECKMAN COULTER, INC. |
BRENT TABER |
| K050057 |
02/10/2005 |
COULTER LH 750 HEMATOLOGY ANALYZER |
BECKMAN COULTER, INC. |
STAN SUGRUE |
| K053090 |
12/16/2005 |
DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR |
BECKMAN COULTER, INC. |
ERI HIRUMI |
| K050062 |
02/10/2005 |
GEMIFLOXACIN, 5UG BBL SENSI-DISC |
BECTON DICKINSON & CO. |
BRADFORD SPRING |
| K050191 |
02/22/2005 |
MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE |
BECTON DICKINSON & CO. |
CARTER NAVARRO |
| K050089 |
02/28/2005 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN-SULBACTAM (GP) 2-32 UG/ML |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
| K053241 |
12/22/2005 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN GP 1-32 G/ML |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
| K043423 |
02/01/2005 |
MODEL SC-3008 SEQUENTIAL CIRCULATOR |
BIO COMPRESSION SYSTEMS, INC. |
RON MOTHERWELL |
| K053011 |
12/14/2005 |
PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20 |
BIO PROTECH, INC. |
E.J. Smith |
| K043584 |
02/08/2005 |
LIQUICHEK BNP CONTROL |
BIO-RAD LABORATORIES, INC. |
SUZANNE S PARSONS |
| K042553 |
02/17/2005 |
BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER |
BIOCARDIA, INC. |
DANIEL C ROSENMAN |
| 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 |
| K050002 |
02/17/2005 |
VITEK 2 COMPACT |
BIOMERIEUX, INC. |
Nancy Weaver |
| K053097 |
12/14/2005 |
VITEK 2 GRAM POSITIVE CEFOXITIN SCREEN |
BIOMERIEUX, INC. |
Nancy Weaver |
| K050075 |
02/28/2005 |
VITEK 2 GRAM POSITIVE DAPTOMYCIN |
BIOMERIEUX, INC. |
JOLYN TENLLADO |
| K050076 |
02/18/2005 |
VITEK 2 GRAM POSITIVE ERTAPENEM |
BIOMERIEUX, INC. |
JOLYN TENLLADO |
| K053186 |
12/01/2005 |
VITEK 2 GRAM POSITIVE TELITHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE |
BIOMERIEUX, INC. |
Nancy Weaver |
| K043371 |
02/03/2005 |
BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER |
BIOMERIX CORPORATION |
CHRISTINA L KICHULA |
| K052888 |
12/06/2005 |
POROUS TITANIUM ACETABULAR AUGMENTS |
BIOMET MANUFACTURING CORP. |
ALLISON KOSKEY |
| K043100 |
02/17/2005 |
BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS |
BIOMET, INC. |
GARY BAKER |
| K043505 |
02/09/2005 |
DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM |
BIOMET, INC. |
GARY BAKER |
| K052990 |
12/16/2005 |
STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEM |
BIOMET, INC. |
LESTER F PADILLA |
| K042757 |
02/11/2005 |
VANGUARD SSK KNEE SYSTEM |
BIOMET, INC. |
GARY BAKER |
| 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 |
| K050100 |
02/25/2005 |
RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER |
BIONOSTICS, INC. |
KATHY STORRO |
| K043242 |
02/28/2005 |
TRIAGE TOX DRUG SCREEN |
BIOSITE INCORPORATED |
JEFFREY R DAHLEN |
| K052646 |
12/16/2005 |
BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20 |
BIOSPACE CORPORATION LIMITED |
DANIEL KAMM |
| K033862 |
02/14/2005 |
BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK |
BIOTEQUE CORP. |
WILLIAM LEE |
| 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 |
| K043168 |
02/01/2005 |
BISCOVER LV |
BISCO, INC. |
BENJAMIN LICHTENWALNER |
| K042804 |
02/01/2005 |
TESCERA OPAQUER POWDER/SCULPTING RESIN |
BISCO, INC. |
BENJAMIN LICHTENWALNER |
| K043338 |
02/18/2005 |
BLAKSTONE LAMINOPLASTY FIXATION SYSTEM |
BLACKSTONE MEDICAL, INC. |
DEAN CIPORKIN |
| K052799 |
12/16/2005 |
MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEM |
BONUTTI RESEARCH, INC. |
PATRICK BALSMANN |
| K050120 |
02/08/2005 |
EASY CORE BIOPSY SYSTEM II |
BOSTON SCIENTIFIC CORP. |
MICHELLE M BERRY |
| 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 |
| K042513 |
02/10/2005 |
VECTORVISION OSTEOTOMY |
BRAINLAB AG |
RAINER BIRKENBACH |
| 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 |
| K043246 |
02/02/2005 |
BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS |
C.R. BARD, INC. |
JOHN C KNORPP |
| K043251 |
02/09/2005 |
CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B |
CANDELA CORP. |
LORRAINE CALZETTA |
| 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 |
| K050230 |
02/16/2005 |
TURBO TEMP TRIO |
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 |
| K043575 |
02/24/2005 |
DERMILLUME, MODEL PRO1000 |
CARE ELECTRONICS, INC. |
THOMAS MOODY |
| K043222 |
02/14/2005 |
VISCUCAM C DIGITAL CAMERA |
CARL ZEISS MEDITEC AG |
R. MICHAEL CROMPTON |
| 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 |
| K050167 |
02/08/2005 |
CHISON 600M WITH C60 CONVEX PROBE, L700 LINEAR PROBE |
CHISON MEDICAL IMAGING CO., LTD. |
MO RUOLI |
| K052963 |
12/05/2005 |
MEDIQ VERSION 1.0 |
CLARIO MEDICAL IMAGING, INC. |
PATRICIA A MILBANK |
| K050013 |
02/09/2005 |
RETRACTOFOAM |
COLTENE/WHALEDENT AG |
HENRY J VOGELSTEIN |
| K051964 |
12/01/2005 |
POWERNEB |
COMEDICA , INC. |
KRISTA OAKES |
| K050161 |
02/03/2005 |
SYSTEM 7500-B ELECTROSURGICAL UNIT; ABCFLEX PROBE FOR FLEXIBLE ENDOSCOPY |
CONMED ELECTROSURGERY |
PAMELA VETTER |
| 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 |
| K043605 |
02/04/2005 |
INSCOPE 3-STAGE BALLOON DILATOR |
CORDIS EUROPA, N.V. |
HARM HOVINGA |
| 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 |
| K043545 |
02/17/2005 |
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH DAPTOMYCIN (0.03 - 16 MCG/ML) |
DADE BEHRING, INC. |
CYNTHIA VAN DUKER |
| K042735 |
02/15/2005 |
N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) |
DADE BEHRING, INC. |
KATHLEEN A DRAY-LYONS |
| K043476 |
02/15/2005 |
STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT |
DADE BEHRING, INC. |
GEORGE M PLUMMER |
| K043589 |
02/14/2005 |
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM |
DADE MICROSCAN, INC. |
CYNTHIA VAN DUKER |
| K052303 |
12/16/2005 |
READMYHEART, MODEL RMH2.0 |
DAILYCARE BIOMEDICAL INC |
DANIEL J. H. CHANG |
| K042884 |
02/15/2005 |
DAKOCYTOMATION ER/PR PHARMDX KIT |
DAKOCYTOMATION CALIFORNIA, INC. |
TIFFANY D ALMEROTH |
| K052688 |
12/12/2005 |
ELLIPSE FLEX PPT, MODEL 9ESF7255 |
DANISH DERMATOLOGIC DEVELOPMENT A/S |
OLE KOFOD |
| K043255 |
02/24/2005 |
ELLIPSE LIGHT SPT |
DANISH DERMATOLOGIC DEVELOPMENT A/S |
OLE KOFOD |
| K043572 |
02/22/2005 |
COMPATIBILITY ECG TRUNK CABLES |
DATEX-OHMEDA |
JOEL C KENT |
| K043551 |
02/18/2005 |
DATEX-OHMEDA S/5 PSM MODULE, (CONSISTING OF E-PSM AND E-PSMP MODULES) AND ACCESSORIES |
DATEX-OHMEDA |
JOEL KENT |
| K050055 |
02/04/2005 |
GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM |
DATEX-OHMEDA, INC. |
DAN KOSEDNAR |
| K050386 |
02/23/2005 |
PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM |
DENTSPLY INTERNATIONAL |
HELEN LEWIS |
| 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 |
| K042992 |
02/11/2005 |
CORAIL AMT HIP PROSTHESIS |
DEPUY ORTHOPAEDICS, INC. |
NANCY S FRIDDLE |
| K043308 |
02/16/2005 |
MODIFICATION TO: HEALOS BONE GRAFT MATERIAL |
DEPUY SPINE, INC. |
SHARON STAROWICZ |
| K041390 |
02/09/2005 |
DIAMOND MEDISTIM |
DIAMOND SYSTEMS USA, INC. |
DONNA LOPE |
| K051714 |
12/07/2005 |
TOTAL BILE ACIDS ASSAY, MODEL DZ042A |
DIAZYME LABORATORIES |
HUAN TRAN |
| K043323 |
02/01/2005 |
D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR |
DIDECO S.R.L. |
BARRY SALL |
| K050152 |
02/07/2005 |
PALM PRO PREMIUM, MODEL 6PF1 & PALM PRO, MODEL 6PF2, LATEX EXAM GLOVE |
DIPPED PRODUCTS (THAILAND) LTD |
IAN P GORDON |
| K051487 |
12/22/2005 |
DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE |
DOCTOR'S RESEARCH GROUP, INC. |
MAHMUD AHMED |
| K043461 |
02/28/2005 |
CUSTODIOL |
DR. FRANZ KOHLER CHEMIE GMBH |
T. WHIT ATHEY |
| K042904 |
02/18/2005 |
INFINITY KAPPA XLT |
Draeger Medical Systems, Inc. |
PENELOPE H GRECO |
| K043439 |
02/18/2005 |
INFINITY MODULAR MONITORS WITH VF5 MODIFICATIONS (DELTA/KAPPA/DELTA XL/VISTA XL/GAMMA X XL AND SC 7000/8000/9000XL |
Draeger Medical Systems, Inc. |
PENELOPE H GRECO |
| 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 |
| K042500 |
02/22/2005 |
DUOPROSS SYRINGES |
DUOPROSS MEDITECH CORPORATION |
FRANK FREGUSON |
| 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 |
| K050118 |
02/16/2005 |
EBI TROCHANTERIC NAIL SYSTEM |
EBI, L.P. |
FREDERIC TESTA |
| 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 |
| K043233 |
02/01/2005 |
GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL |
EFRATGO, LTD. HI TECH BIO-SURGICAL |
GEORGE J HATTUB |
| K042755 |
02/10/2005 |
MONOCHROME LCD MONITOR, RADIFORCE G51 |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
| 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 |
| K043446 |
02/04/2005 |
EMMEBI CENTRAL VENOUS CATHETER KIT WITH LESTEP SAFETY INTRODUCER |
EMMEBI SRL |
MARJORIE BUSH |
| K052320 |
12/30/2005 |
ENCORE CLP OFFSET TOTAL HIP SYSTEM |
ENCORE MEDICAL CORPORATION |
SAM SON |
| K050347 |
02/25/2005 |
MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM |
ENDOCARE, INC. |
EBEN GORDON |
| K053100 |
12/19/2005 |
ESTECH COBRA BIPOLAR SYSTEM |
ENDOSCOPIC TECHNOLOGIES, INC. |
CRAIG COOMBS |
| K043463 |
02/11/2005 |
ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORS |
ENVITEC-WISMAR GMBH |
STEPHEN GORSKI |
| K043257 |
02/03/2005 |
REAL-TIME POSITION MANAGEMENT (RPM) SYSTEM |
EP TECHNOLOGIES, INC. |
TODD G BRILL |
| K050326 |
02/28/2005 |
7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350 |
ESAOTE, S.P.A. |
CARRI GRAHAM |
| 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 |
| K042308 |
02/17/2005 |
SHEATH-IN-SHEATH CATHETER, 18FR, MODEL S00018; SHEATH-IN-SHEATH CATHETER, 6 FR., MODEL S00019 |
FACILE MEDICAL, INC. |
ALBERT REGO |
| K051294 |
12/21/2005 |
FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1 |
FEMSPEC L.L.C. |
CARL YOUNGMANN |
| K031660 |
02/22/2005 |
FERRIS POLYMEM STERILE BREAST PAD |
FERRIS MFG. CORP. |
THEODORE R THORSEN |
| 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 |
| K050067 |
02/01/2005 |
FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS |
FIRST QUALITY HYGIENIC, INC. |
ROBERT J STAAB, PH.D. |
| K041224 |
02/03/2005 |
FOOTHILLS SURGICAL DRAPES |
FOOTHILLS INDUSTRIES, INC. |
JOY SHUFORD |
| K043553 |
02/18/2005 |
SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,04800, 05200, 02406, 04706, 04300 |
FOX HOLLOW TECHNOLOGIES |
MELISSA MURPHY |
| K052531 |
12/14/2005 |
FU HONG INDUSTRIES LIMITED SOOTHER TEETHER |
FU HONG INDUSTRIES LTD. |
Kevin Walls |
| K043407 |
02/11/2005 |
INF 4160, MODEL D-FJ27F |
FUJI DYNAMICS LIMITED |
ANTHONY AH YIN SHUM |
| K052889 |
12/20/2005 |
VITROS CA 19-9 |
FUJIREBIO DIAGNOSTICS, INC. |
DIANA L WOLANIUK |
| K050363 |
02/17/2005 |
FUKUDA DENSHI MODEL UF-850XTD |
FUKUDA DENSHI USA, INC. |
LARRY D WALKER |
| K043525 |
02/09/2005 |
CATHETER INTRODUCER |
GALT MEDICAL CORP. |
DAVID CATLIN |
| K051520 |
12/09/2005 |
GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H |
GAMBRO RENAL PRODUCTS |
THOMAS B DOWELL |
| K050059 |
02/03/2005 |
G-LIGHT |
GC AMERICA, INC. |
TERRY JORITZ |
| K052972 |
12/29/2005 |
DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3 |
GE HEALTHCARE |
JOEL KENT |
| K050126 |
02/02/2005 |
GE LOGIQ TWIN |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
| 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 |
| K043444 |
02/22/2005 |
MULTIPLE, MODEL KTJ-50 |
GOLDEN HORSE MEDICAL EQUIPMENT (WUXI) CO. LTD. |
GEORGE SU |
| 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 |
| K040780 |
02/10/2005 |
ELECTROSURGICAL PENCILS |
HANGZHOU SHUYOU MEDICAL INSTRUMENT COMPANY, LTD. |
JIAN CHEN, M.D. |
| K041690 |
02/11/2005 |
MONARCH NASAL IMPLANT |
HANSON MEDICAL, INC. |
GERALD HANSON |
| K043170 |
02/25/2005 |
BOSWORTH BOND |
HARRY J. BOSWORTH CO. |
MILDRED M GOLDSTEIN |
| K052177 |
12/09/2005 |
POWDER FREE STERILE LATEX SURGICAL GLOVES |
HARTALEGA SDN BHD |
NURUL AISYAH KONG |
| K050107 |
02/11/2005 |
HARVARD 2 SYRINGE PUMP, MODEL 2001-001 |
HARVARD CLINICAL TECHNOLOGY |
ERIC J FLACHBART |
| K052471 |
12/23/2005 |
HDC SPIDER SCREW |
HDC S.R.L. |
MILLIE LYNN BENTLEY |
| K043414 |
02/09/2005 |
HL 188 & HL 189 BODY FAT METER |
HEALTH & LIFE CO., LTD. |
JENNIFER REICH |
| K050228 |
02/18/2005 |
AGFA HEARTLAB CARDIOVASCULAR |
HEARTLAB, INC. |
RICHARD PETROCELLI |
| K052120 |
12/16/2005 |
LUMIMED MONOCHROME LCD MONITOR, MODELS MM 20, MM 30 AND MM50 |
HEEYOUNG CO., LTD. |
DANIEL KAMM |
| K043277 |
02/08/2005 |
C&G ACUPUNCTURE NEEDLE |
HELIO MEDICAL SUPPLIES, INC. |
ERIC CHENG |
| K053258 |
12/09/2005 |
EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER |
HITACHI MEDICAL CORP. |
DOUG THISTLETHWAITE |
| K050307 |
02/28/2005 |
AIRIS ELITE RAPID BODY COIL |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUGLAS THISTLETHWAITE |
| K052597 |
12/16/2005 |
BREATHEX OMEGA CPAP DEVICE, MODEL 322 |
HOFFMAN LABORATORIES, LLC |
KEITH BOSECKER |
| K042719 |
02/03/2005 |
HOME HEALTH POWER WHEELCHAIR, MODEL HC-200 |
HOME HEALTH TECHNOLOGY CO., LTD. |
Ke-Min Jen |
| K043199 |
02/16/2005 |
SURGICAL FACE MASK |
HONG YA NON-WOVEN PRODUCTS CO., LTD. |
JAMES CHU |
| 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 |
| K043374 |
02/16/2005 |
DURACON CONVERSION AND X-SMALL SYMMETRIC PATELLA WITH PERI-APATITE COATING |
HOWMEDICA OSTEONICS CORP |
DENISE DUCHENE |
| K053349 |
12/09/2005 |
HOFFMANN II ROD TO WIRE COUPLING |
HOWMEDICA OSTEONICS CORP |
FRANCISCO HARO |
| K041940 |
02/11/2005 |
HOWMEDICA OSTEONICS ZIRCONIA-TOUGHENED-ALUMINA (BIOLOX DELTA) CERAMIC FEMORAL HEADS |
HOWMEDICA OSTEONICS CORP |
TERRY SHERIDAN POWELL |
| K042343 |
02/09/2005 |
SCORPIO NRG KNEE SYSTEM |
HOWMEDICA OSTEONICS CORP |
DENISE DUCHENE |
| 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 |
| K033716 |
02/10/2005 |
TRIDENT ACETABULAR SYSTEM |
HOWMEDICA OSTEONICS CORP |
DENISE DUCHENE |
| K043431 |
02/16/2005 |
GAMMA3 NAIL SYSTEM |
HOWMEDICA OSTEONICS CORP. |
JENNIFER KOSOY |
| 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 |
| K040303 |
02/02/2005 |
59% EXTREME H2O (HIOXIFILCON A) SOFT CONTACT LENS |
HYDROGEL VISION CORPORATION |
DONNA HOVANEC |
| 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 |
| K043410 |
02/24/2005 |
EPIPHYSIS SCREW |
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH |
AL LIPPINCOTT |
| K052865 |
12/22/2005 |
HOSPIRA CATH LAB CONVENIENCE KITS |
ICU MEDICAL, INC. |
TOM KOZMA |
| K043091 |
02/07/2005 |
NAVIGUS NEXDRIVE, MODEL MI-3000 |
IMAGE-GUIDED NEUROLOGICS, INC. |
DAVID M LEE |
| K042768 |
02/22/2005 |
MEDICOMPASS CONNECT |
IMETRIKUS, INC. |
DANIEL P OLIVIER |
| K052694 |
12/16/2005 |
ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES. |
IND DIAGNOSTIC INC. |
JASON PENG |
| K043142 |
02/18/2005 |
INION OTPS BIODEGRADABLE MINI PLATING SYSTEM |
INION LTD. |
HANNA MARTTILA |
| K050132 |
02/15/2005 |
NEURO II-S |
INNOVATIVE MAGNETIC RESONANCE IMAGING SYSTEMS INC. |
THOMAS M TSAKERIS |
| K053276 |
12/27/2005 |
IST PEDICLE SCREW SYSTEM |
INNOVATIVE SPINAL TECHNOLOGIES INC |
STEPHEN PALUMBO |
| K043074 |
02/22/2005 |
LIBERTY SYSTEM |
INOVISE MEDICAL, INC. |
STEVE HESLER |
| K043612 |
02/09/2005 |
ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200D |
INSTRUMENTARIUM CORP. IMAGING DIVISION |
MARK MASON |
| K043459 |
02/09/2005 |
HEMOSIL FACTOR XII DEFICIENT PLASMA |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K043219 |
02/04/2005 |
AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS |
INTERACOUSTICS AS |
DANIEL EGGAN |
| 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 |
| K050016 |
02/10/2005 |
HEMOCHRON SIGNATURE ELITE |
INTERNATIONAL TECHNIDYNE CORP. |
LESLIE YOUNG |
| K031399 |
02/18/2005 |
INTERGRO DBM |
INTERPORE CROSS INTL. |
MARK LOAR |
| K042984 |
02/18/2005 |
INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C |
INTERVASCULAR |
Amy Aulwes |
| K050073 |
02/11/2005 |
MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER |
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. |
MIKE WINEGAR |
| 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 |
| K043496 |
02/16/2005 |
SPACELINE EMCIA, MODEL CU580 |
J. MORITA USA, INC. |
KEITH A BARRITT |
| K043498 |
02/16/2005 |
TWIN POWER TURBINE HIGH SPEED AIR TURBINE DENTAL HANDPIECE |
J. MORITA USA, INC. |
KEITH A BARRITT |
| K032410 |
02/28/2005 |
SNORENTI |
JAMES P BOYD |
JAMES P BOYD |
| 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 |
| K050339 |
02/25/2005 |
SET GRI-FILL 3.0-1 WAY, 2 WAYS, MULTIPLE |
LABORATORIOS GRIFOLS, S.A. |
SEBASTIAN GASCON |
| K043370 |
02/15/2005 |
PLANET 50 MONITORING SYSTEM |
LARSEN & TOUBRO LIMITED |
E.J. Smith |
| K052604 |
12/16/2005 |
STARLITE 2006 |
LASER DENTAL INNOVATIONS |
HOWARD FEINBERG |
| K043094 |
02/11/2005 |
EASYSPINE SYSTEM |
LDR SPINE USA |
BRIAN BURKINSHAW |
| K050087 |
02/01/2005 |
LERADO AVANTICARE POWER WHEELCHAIR, MODEL PW-1800 |
LERADO OVERSEA LTD. TWN BRANCH (BVI) |
Ke-Min Jen |
| K050290 |
02/18/2005 |
LERADO, COSCO |
LERADO OVERSEA LTD. TWN BRANCH (BVI) |
JEN KE-MIN |
| K053149 |
12/13/2005 |
SPIRO-BALL |
LEVENTON, S.A. |
ORIOL VERNIS |
| K042813 |
02/25/2005 |
BIOBEAM NARROW BAND LIGHT THERAPY DEVICES |
LIFE WITHOUT PAIN, LLC |
DANIEL J DILLON |
| 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 |
| K042730 |
02/14/2005 |
CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0G |
LIFECORE BIOMEDICAL |
JEREMY HUOTARI |
| 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 |
| K040788 |
02/08/2005 |
CALM PATTERNS, VERSION 01.00.00 |
LMS MEDICAL SYSTEMS LTD. |
PAMELA J 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 |
| K043506 |
02/11/2005 |
ACUPUNCTURE NEEDLES |
MARKNEW PRODUCTS |
GREG HOLLAND |
| K050068 |
02/09/2005 |
LNOPV AD-L AND PD-L OXIMETRY SENSORS |
MASIMO CORPORATION |
JAMES CRONIN |
| K053269 |
12/21/2005 |
MASIMO SET RAD-8 PULSE OXIMETER |
MASIMO CORPORATION |
JIM CRONIN |
| K050143 |
02/01/2005 |
OMNIPRO SYSTEM |
MAYS AND ASSOCIATES, INC. |
HARVEY KNAUSS |
| K040318 |
02/03/2005 |
MEDCOMP SPLIT-CATH II |
MEDCOMP |
JEAN CALLOW |
| 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 |
| K043523 |
02/11/2005 |
INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE |
MEDICAL DEVICE TECHNOLOGIES, INC. |
NICOHL WILDING |
| K052338 |
12/15/2005 |
SOLAR GI |
MEDICAL MEASUREMENT SYSTEMS,B.V. |
KARIN OGINK-SOMHORST |
| K041839 |
02/15/2005 |
8NONE |
MEDICAL SOLUTIONS, INC. |
E.J. Smith |
| K043297 |
02/23/2005 |
MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM |
MEDICON, E.G. |
ANGELIKA SCHERP |
| K052751 |
12/23/2005 |
VENTLINK SYSTEM |
MEDISERVE INFORMATION SYSTEMS, INC. |
MARK OFORI-KYEI |
| K042659 |
02/14/2005 |
MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS |
MEDISISS |
BRANDI JAMES |
| 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 |
| K041885 |
02/24/2005 |
BIOFLEX LD-175 AND LD-1200 TREATMENT HEADS |
MEDITECH INTERNATIONAL, INC. |
RICHARD KEEN |
| K053325 |
12/07/2005 |
MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY); MULTISCAN ULTRASOUND SYSTEM, MODEL M0001 |
MEDIWATCH LTD |
ANDREW HOPKINS |
| K041908 |
02/25/2005 |
CONTACT HEAT-EVOKED POTENTIAL STIMULATOR (CHEPS) |
MEDOC LTD. ADVANCED MEDICAL SYSTEMS |
TRACY GRAY |
| K042404 |
12/22/2005 |
LIFEPAK, MODEL 1000 |
MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. |
SHERRI POCOCK |
| K050044 |
02/07/2005 |
MEDTRONIC CLIP GUN KIT |
MEDTRONIC NEUROSURGERY |
JEFFREY HENDERSON |
| K052386 |
12/16/2005 |
MEDTRONIC M2 MAGNET ADJUSTMENT TOOL |
MEDTRONIC NEUROSURGERY |
JEFFREY HENDERSON |
| K043179 |
02/08/2005 |
SELECT 3D ARTERIAL CANNULA |
MEDTRONIC PERFUSION SYSTEMS |
RONALD W BENNETT |
| K050109 |
02/11/2005 |
TRILLIUM BIOPUMP PLUS, MODEL BPX80T |
MEDTRONIC PERFUSION SYSTEMS |
PREETI JAIN |
| K031782 |
02/01/2005 |
GAPP GRAFT CONTIANMENT DEVICE ORTHOPEDICS |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K050117 |
02/17/2005 |
MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K050282 |
02/18/2005 |
MODIFICATION TO TSRH SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K043151 |
02/01/2005 |
MODIFICATION TO: CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K043321 |
02/03/2005 |
MODIFICATION TO: CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K043602 |
02/23/2005 |
QUADRANT RETRACTOR SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K050079 |
02/10/2005 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
RICHARD TREHARNE |
| 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 |
| K050102 |
02/01/2005 |
E-Z PEN, REUSEABLE HANDSWITCHING PENCIL |
MEGADYNE MEDICAL PRODUCTS, INC. |
RONDA K MAGNESON |
| 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 |
| K050303 |
02/25/2005 |
5 SEC DIGITAL CLINICAL THERMOMETER, MODELS ST8630X, ST8640X, ST8730X, ST8740X, ST8930X, ST8940X, ST8030X, ST8040X. |
MESURE TECHNOLOGY CO.,LTD. |
JOHN CHEN |
| K050033 |
02/11/2005 |
LUCION |
MEVISYS CO. LTD |
RICHARD LANZILLOTTO |
| K042834 |
02/11/2005 |
MICROMEDICS FIBRIJET AIR ASSISTED ENDOSCOPIC APPLICATOR |
MICROMEDICS, INC. |
THOMAS A LOPAC |
| 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 |
| K050257 |
02/07/2005 |
LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) (STERILE) |
MONDEAL MEDICAL SYSTEMS GMBH |
ANGELIKA SCHERP |
| K043010 |
02/25/2005 |
HOLTER RECORDER H3+ |
MORTARA INSTRUMENT, INC. |
HARLAN L VAN MATRE |
| 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 |
| K050299 |
02/24/2005 |
HRK-123 KNEE ARRAY COIL |
MRI DEVICES CORPORATION |
TOM SCHUBERT |
| K041884 |
02/28/2005 |
MUELLER WATER CONDITIONING WATER PURIFICATION SYSTEM FOR HEMODIALYSIS |
MUELLER WATER CONDITIONING, INC. |
DAVID W MUELLER |
| K052942 |
12/27/2005 |
21.3INCH MONOCHROME LCD MONITOR |
NEC-MITSUBISHI ELECTRIC VISUAL SYSTEMS CORP. |
SHUICHI KINO |
| K050088 |
02/08/2005 |
QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER |
NEOPROBE CORP. |
RODGER A BROWN |
| K053214 |
12/20/2005 |
THERAKNIT GARMENT ELECTRODE |
NEUROTRON MEDICAL |
JACK GULDALIAN |
| K043046 |
02/01/2005 |
COOLTOUCH, MODEL CT3S |
NEW STAR LASERS, INC. |
DONALD V JOHNSON |
| 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 |
| K043517 |
02/03/2005 |
TRANSMITTER, ZS-940PA SERIES |
NIHON KOHDEN AMERICA, INC. |
SERRAH NAMINI |
| 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 |
| K043312 |
02/01/2005 |
NOBELRONDO DENTAL CERAMIC - ZIRCONIA |
NOBEL BIOCARE USA, LLC |
ELIZABETH J MASON |
| 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 |
| K050160 |
02/07/2005 |
KATANA ZIRCONIA |
NORITAKE CO., INC. |
IVAN J WASSERMAN |
| 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 |
| K043405 |
02/07/2005 |
NUVASIVE COROENT SYSTEM |
NUVASIVE, INC. |
LAETITIA COUSIN |
| K053286 |
12/22/2005 |
MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION |
NXSTAGE MEDICAL, INC. |
NORMA LEMAY |
| K042073 |
02/07/2005 |
OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM |
OLSEN MEDICAL |
TERRY JOHNSON |
| K050220 |
02/10/2005 |
EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
| K042274 |
02/22/2005 |
PSD-60/ENDOPLASMA |
OLYMPUS SHIRAKAWA CO., LTD. |
TINA STEFFANIE-OAK |
| 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 |
| K043254 |
02/10/2005 |
PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH |
ONSET MEDICAL CORPORATION |
ALBERT REGO |
| 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 |
| K043384 |
02/07/2005 |
VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND TDM PERFORMANCE VERIFIERS I, II AND III |
Ortho-Clinical Diagnostics, Inc. |
CAREY A MAYO |
| K043386 |
02/07/2005 |
VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III |
Ortho-Clinical Diagnostics, Inc. |
CAREY A MAYO |
| K053261 |
12/12/2005 |
ORTHOFIX TITANIUM NAILING SYSTEMS |
ORTHOFIX SRL |
CANDACE F CEDERMAN |
| K043434 |
02/10/2005 |
OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM |
OSTEOMED L.P. |
DAWN T HOLDEMAN |
| 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 |
| K043615 |
02/09/2005 |
OXYTEC, MODEL 900 |
OXYTEC MEDICAL CORPORATION |
PAUL E DRYDEN |
| 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 |
| K042531 |
02/01/2005 |
UPDATED SLIP UROLOGY INTRODUCER SHEATH |
PERCUTANEOUS SYSTEMS, INCORPORATED |
THOMAS LAWSON |
| K052701 |
12/13/2005 |
COROLENE |
PETERS SURGICAL |
ANNIE LASSERRE |
| K043599 |
02/25/2005 |
MOMENTS MENOPAUSE CHECK, MODEL 9113 |
PHAMATECH INC. |
CARL A MONGIOVI |
| K043051 |
02/07/2005 |
QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121 |
PHAMATECH INC. |
CARL MONGIOVI |
| K052974 |
12/16/2005 |
WARMING LIQUID PERSONAL LUBRICANT |
PHARMAPAC LLC |
TOM OTTO |
| K050004 |
02/25/2005 |
PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304 |
PHILIPS MEDICAL SYSTEMS |
TISHA TREHERNE |
| K043147 |
02/15/2005 |
ACHIEVA FAMILY |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. |
LYNN T HARMER |
| K050151 |
02/09/2005 |
MULTIDIAGNOST ELEVA |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
LYNN HARMER |
| K052795 |
12/30/2005 |
PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30 |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH |
MARKUS STACHA |
| K050141 |
02/11/2005 |
THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH |
HAUKE SCHIK |
| 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 |
| K043066 |
02/03/2005 |
PIONEER ANTERIOR CERVICAL PLATE SYSTEM |
PIONEER SURGICAL TECHNOLOGY |
JONATHAN M GILBERT |
| K043104 |
02/24/2005 |
KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.0 |
PRACTICEWORKS, INC. |
DANIEL HOEFER |
| 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 |
| K050180 |
02/11/2005 |
EXPA-SYL |
PRODUITS DENTAIRES PIERRE ROLLAND |
COLLEEN BOSWELL |
| K052941 |
12/09/2005 |
I-NEB INSIGHT AAD SYSTEM |
PROFILE THERAPEUTICS PLC |
BARBARA CAMPBELL |
| K042780 |
02/03/2005 |
NEOSCOPE - ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM |
PROSURG, INC. |
ASHVIN DESAI |
| K043188 |
02/09/2005 |
ALCOHAWK PRECISION |
Q3 INNOVATIONS, LLC |
DANIEL KAMM |
| K043236 |
02/07/2005 |
FREQUENCY DOUBLED ND: YAG PHOTOCOAGULATOR, MODEL VITRA |
QUANTEL MEDICAL |
ROGER W BARNES |
| K053146 |
12/14/2005 |
QUICKVUE INFLUENZA A + B TEST |
QUIDEL CORP. |
JOHN D TAMERIUS |
| K043174 |
02/07/2005 |
STEALTH FUSION SYSTEM, MODEL RR 1000 |
R&R MEDICAL, INC. |
JD WEBB |
| K050817 |
12/12/2005 |
T-TEK |
R2 DIAGNOSTICS, INC. |
PEGGY S CARTER |
| K043267 |
02/10/2005 |
POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2 |
RANDOX LABORATORIES, LTD. |
P. ARMSTRONG |
| K043266 |
02/15/2005 |
RANDOX URINE CONTROLS |
RANDOX LABORATORIES, LTD. |
P. ARMSTRONG |
| K043268 |
02/15/2005 |
SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2 |
RANDOX LABORATORIES, LTD. |
P ARMSTRONG |
| K050298 |
02/28/2005 |
IPACS PRISM-5.0 |
REALTIMEIMAGE INC. |
CARL ALLETTO |
| K043421 |
02/16/2005 |
OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC |
REGENERATION TECHNOLOGIES, INC. |
CARRIE HARTILL |
| K043420 |
02/10/2005 |
OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE |
REGENERATION TECHNOLOGIES, INC. |
CARRIE HARTILL |
| K043411 |
02/17/2005 |
RESOFIX BIOABSORBABLE EXPANSION BOLT |
RESOFIX, INC. |
CARL KNOBLOCH |
| K052249 |
12/07/2005 |
UTOPIA |
RESPCARE INC. |
FRANK PELC |
| K053203 |
12/20/2005 |
MYNEB NEBULIZER, MODEL RDD100 |
RESPIRONICS NEW JERSEY, INC. |
Lauren Ziegler |
| K043006 |
02/11/2005 |
MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600; WITH OPI, MODEL M10605 |
RESPIRONICS, INC. |
ZITA A YURKO |
| K052573 |
12/13/2005 |
STARDUST II |
RESPIRONICS, INC. |
ZITA A YURKO |
| K050176 |
02/25/2005 |
VORTEX EZ VASCULAR ACCESS PORT |
RITA MEDICAL SYSTEMS, INC. |
MARY GOSSARD |
| 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 |
| K043327 |
02/07/2005 |
ONLINE DAT BENZODIAZEPINES PLUS |
ROCHE DIAGNOSTICS CORP. |
KERWIN KAUFMAN |
| K050113 |
02/08/2005 |
TINA-QUANT IGG GEN.2 |
ROCHE DIAGNOSTICS CORP. |
THERESA M AMBROSE |
| K043325 |
02/11/2005 |
ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES |
ROLENCE ENTEPRISE, INC. |
STERLING CHENG |
| K052727 |
12/16/2005 |
ROSSMAX NON-INVASIVE BLOOD PRESSURE MONITORS, MODELS S380, K350 |
ROSSMAX INTERNATIONAL LTD. |
YOLANDA LIN |
| K043369 |
02/02/2005 |
CERVEX-BRUSH COMBI |
ROVERS MEDICAL DEVICES B.V. |
IR. M.D. ZWART |
| 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 |
| K050196 |
02/24/2005 |
SECTRA IDS5 WORKSTATION |
SECTRA IMTEC AB |
CARL ALLETTO |
| K052108 |
12/07/2005 |
SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100 |
SEIN ELECTRONICS CO., LTD. |
JAY MANSOUR |
| K050090 |
02/07/2005 |
GEL MARK V |
SENORX, INC. |
AMY BOUCLY |
| 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 |
| K043425 |
02/28/2005 |
SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER) |
SHEATHING TECHNOLOGIES, INC. |
LARRY POLAYES |
| 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 |
| K043499 |
02/04/2005 |
POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE |
SHIJAIZHUANG BRILLIANT OCEAN PLASTIC CO., LTD. |
EMMY TJOENG |
| K043475 |
02/01/2005 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) |
SHIJIAZHUANG WINFUL PLASTIC CO., LTD. |
CHEN YUHONG |
| K043379 |
02/17/2005 |
SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200 |
SHIMADZU CORP. |
RANDAL WALKER |
| K051736 |
12/02/2005 |
FOX PULSE OXIMETER |
SHUNSUKE NAKANISHI |
YINGCHAO XIAO |
| K043122 |
02/09/2005 |
SMD 21500 OR DSB-2103-D-5MP-5M PIXEL GRAYSCALE FLAT PANEL DISPLAY |
SIEMENS AG |
GEORGE SCOTT |
| K043469 |
02/03/2005 |
SYNGO INSPACE 4D |
SIEMENS AG, MEDICAL SOLUTIONS |
RUEDIGER KOERNER |
| K050199 |
02/18/2005 |
MAGNETOM SYMPHONY A TIM SYSTEM |
SIEMENS MEDICAL SOLUTION |
ANA LADINO |
| K050240 |
02/15/2005 |
MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA INC. |
PATRICK LYNCH |
| K050200 |
02/28/2005 |
MAGNETOM TRIO A TIM SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ANA LADINO |
| K053133 |
12/05/2005 |
SYNGO DYNAMICS, VERSION 5.0 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JUDITH CAMPBELL |
| K043289 |
02/11/2005 |
E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT |
SIGNAL MEDICAL CORP. |
LOUIS A SERAFIN, JR. |
| K043316 |
02/07/2005 |
RABEA SPINAL IMPLANT |
SIGNUS MEDIZINTECHNIK GMBH |
TRACY L GRAY |
| K042054 |
02/23/2005 |
SILIMED PECTORAL IMPLANT |
SILIMED, INC. |
E.J. Smith |
| K053007 |
12/05/2005 |
SKYLARK URO PROBE |
SKYLARK DEVICE & SYSTEMS CO., LTD |
GEORGE CHIANG |
| K050226 |
02/11/2005 |
ASIAN INTRAMEDULLARY HIP SCREW NAILS |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
| 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 |
| K043440 |
02/18/2005 |
SMITH & NEPHEW, INC. REVISION KNEE SYSTEM |
SMITH & NEPHEW, INC. |
GINO ROUSS |
| K050314 |
02/18/2005 |
AQUINOX |
SMITHS MEDICAL ASD, INC. |
DAVID GRAY |
| K050187 |
02/18/2005 |
PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES |
SOFRADIM PRODUCTION |
MARY MCNAMARA-CULLINANE |
| K052221 |
12/08/2005 |
AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP |
SORENSON MEDICAL, INC. |
Douglas Bueschel |
| K050023 |
02/18/2005 |
SECURELOC; ADVANCINTRODUCER |
SPECIALIZED HEALTH PRODUCTS, INC. |
Mark Nelson |
| 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 |
| K042600 |
02/18/2005 |
STANSION MATRIX |
SPINEWORKS, LLC |
JONATHAN KAHAN |
| K042957 |
02/17/2005 |
DUREX MALE LATEX CONDOM WITH WARMING LUBRICANT |
SSL AMERICAS |
CHRIS ROBINSON |
| K042563 |
02/23/2005 |
DUREX PLAY WARMER LUBRICANT |
SSL AMERICAS, INC. |
CHRIS ROBINSON |
| K052644 |
12/05/2005 |
SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER |
ST. JUDE MEDICAL |
GLENN JACQUES |
| K050308 |
02/25/2005 |
THERMAL CAUTERY PROBE |
STARION INSTRUMENTS |
BRIAN GRIGSBY |
| K052522 |
12/13/2005 |
STAYHEALTHY BODY COMPOSITION ANALYZER, MODELS BC1 AND BC2 |
STAYHEALTHY, INC. |
COLIN K HILL |
| K050264 |
02/11/2005 |
STEALTH PRODUCTS SEATING SYSTEM |
STEALTH PRODUCTS |
EDWARD A KROLL |
| K051373 |
12/09/2005 |
CRONUS GUIDEWIRE, MODEL 001-001470-1 |
STEREOTAXIS, INC. |
KELLY ROWLAND |
| K043457 |
02/28/2005 |
MODIFICATION TO ENDOVASCULAR GUIDE WIRE |
STEREOTAXIS, INC. |
GARY RAUVOLA |
| K042854 |
02/08/2005 |
STEREOTAXIS ENDOVASCULAR GUIDE WIRE |
STEREOTAXIS, INC. |
GARY RAUVOLA |
| K052283 |
12/23/2005 |
HEART STG SYSTEM AND SOFTWARE |
STETHOGRAPHICS, INC. |
ROZANNE PACIEJ |
| K043334 |
02/09/2005 |
BONE SOURCE HAC RAPID SETTING CEMENT |
STRYKER INSTRUMENTS |
WADE T RUTKOSKIE |
| 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 |
| K042571 |
02/11/2005 |
STRYKER SPINE AVS TL PEEK SPACER |
STRYKER SPINE |
SIMONA VOIC |
| K050189 |
02/16/2005 |
TECHTONIX SYSTEM |
STRYKER SPINE |
SIMONA VOIC |
| K053115 |
12/06/2005 |
XIA SPINAL SYSTEM |
STRYKER SPINE |
SIMONA VOIC |
| K043054 |
02/18/2005 |
GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL |
SULTAN CHEMISTS, INC. |
CLARK SMITH |
| K052875 |
12/27/2005 |
PROSTIM REUSABLE NEUROSTIMULATION ELECTRODES |
SUMMIT MANUFACTURING, L.L.C. |
SUSAN D GOLDSTEIN-FALK |
| K043282 |
02/11/2005 |
DEVILBISS AUTOADJUST, MODEL 9054 SERIES |
SUNRISE MEDICAL |
STEPHEN KREPELKA |
| K043435 |
02/11/2005 |
QUICKIE INTERCHANGE FWD W/LIFT POWER WHEELCHAIR |
SUNRISE MEDICAL |
JOSEPH E OLSAVSKY |
| K043200 |
02/03/2005 |
SIGN FIN NAIL |
SURGICAL IMPLANT GENERATION NETWORK (SIGN) |
DOUGLAS J DONNELLY |
| 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 |
| K050041 |
02/25/2005 |
SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM |
SYNTHES (USA) |
LISA M BOYLE |
| K052683 |
12/05/2005 |
SYNTHES (USA) STERNAL FIXATION SYSTEM |
SYNTHES (USA) |
Lisa Boyle |
| K043185 |
02/03/2005 |
SYNTHES 3.5MM CORTEX SCREWS |
SYNTHES (USA) |
LISA M 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 |
| K043438 |
02/15/2005 |
LARGE BORE SPLITTABLE INTRODUCER KIT |
THOMAS MEDICAL PRODUCTS, INC. |
TIM STOUDT |
| 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 |
| K040905 |
02/23/2005 |
WELLNESS/JOLIVETE |
TOHKAI PRECISION IND. LTD. |
ROBERT T WAGNER |
| K040958 |
02/15/2005 |
PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240 |
TOKYO BOEKI MEDICAL SYSTEM LTD. |
James M Clinton |
| K050380 |
02/23/2005 |
XARIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-660A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K043160 |
02/18/2005 |
TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO |
TRACOE MEDICAL GMBH |
MICHAEL A WARREN |
| K043351 |
02/18/2005 |
4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N; SFCD-45-3040S OR N |
TRIAGE MEDICAL INC |
GAYLE HIROTA |
| 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 |
| K041798 |
02/07/2005 |
ATALIA TITANIUM SURGICAL MESH |
U.S. SPINAL TECHNOLOGIES, LLC. |
ELAINE DUNCAN |
| K042928 |
02/17/2005 |
MODIFICATION TO GLOBAL SPINAL FIXATION SYSTEM |
U&I CORP. |
BETTY LIM |
| K052385 |
12/27/2005 |
TANGORS POLYAXIAL SYSTEM |
ULRICH GMBH & CO. KG |
CHRISTOPH ULRICH |
| K033696 |
02/16/2005 |
PERSONAL INJECTOR |
UNION MEDICO APS |
MICHAEL PERTHU |
| 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 |
| K043139 |
02/15/2005 |
USCOM 1A |
USCOM, LTD. |
CHRISTINA KICHULA |
| K050253 |
02/28/2005 |
USGI SHAPELOCK ENDOSCOPIC GUIDE |
USGI MEDICAL |
MARY LOU MOONEY |
| K053051 |
12/22/2005 |
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES |
VANGUARD MEDICAL CONCEPTS, INC. |
TRISH STEPHENS |
| K042360 |
02/16/2005 |
VARIAN NASOPHARYNX APPLICATOR |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K043387 |
02/16/2005 |
VASCON POLARIS GUIDING CATHETER |
VASCON LLC |
STEPHEN F VADAS |
| K050133 |
02/18/2005 |
D-STAT RADIAL HEMOSTATIC BAND |
VASCULAR SOLUTIONS, INC. |
LINDA BUSKLEIN |
| 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 |
| K043152 |
02/01/2005 |
VERTEBRON PSS PEDICLE SCREW SYSTEM |
VERTEBRON, INC. |
LUIS NESPRIDO |
| K043490 |
02/18/2005 |
PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE |
VIDACARE CORPORATION |
GREG HOLLAND |
| K043368 |
02/01/2005 |
VITELCARE TURTLE, MODEL 400 |
VISUAL TELECOMMUNICATIONS NETWORK, INC. |
ALLEN IZADPANAH |
| K052632 |
12/15/2005 |
VITREA2 VERSION 3.8 MEDICAL IMAGE PROCESSING SOFTWARE |
VITAL IMAGES, INC. |
TIMOTHY J KAPPERS |
| K050223 |
02/24/2005 |
VIVAWAVE MICROWAVE ABLATION SYSTEM, COAXIAL INTRODUCER |
VIVANT MEDICAL, INC. |
KRISTINE FOSS |
| 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 |
| K050317 |
02/24/2005 |
BURANE XL |
WAVELIGHT LASER TECHNOLOGIE AG |
ALEXANDER POPP |
| K050218 |
02/15/2005 |
WAVELIGHT SINON |
WAVELIGHT LASER TECHNOLOGIE AG |
MANFRED DRAX |
| K052160 |
12/16/2005 |
ACUITY CENTRAL STATION, MODEL 020XXXXX (NOTE: XXXXX = VARIOUS CONFIG.) |
WELCH ALLYN, INC. |
JOHN E SAWYER |
| K042683 |
02/18/2005 |
WELL LEAD ENDOTRACHEAL TUBE |
WELL LEAD MEDICAL INSTRUMENTS |
ARTHUR WARD |
| K042684 |
02/17/2005 |
WELL LEAD TRACHEOSTOMY TUBE |
WELL LEAD MEDICAL INSTRUMENTS |
ARTHUR WARD |
| K043540 |
02/01/2005 |
HORIZON 59 OASIS (HIOXIFILCON A) DAILY WEAR CONTACT LENSES |
WESTCON CONTACT LENS CO., INC. |
CAROL NOBLE |
| K050203 |
02/14/2005 |
ALLUX |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
| 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 |
| K050010 |
02/11/2005 |
WU'S POWERED WHEELCHAIR, MAMBO 36X |
WU'S TECH CO., LTD. |
JEN KE-MIN |
| K050011 |
02/11/2005 |
WU'S POWERED WHEELCHAIR, MAMBO F 120 |
WU'S TECH CO., LTD. |
JEN KE-MIN |
| 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 |
| K050154 |
02/07/2005 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) |
ZIBO ZHUANGYUAN PLASTIC & RUBBER CO., LTD. |
CHEN YUHONG |
| K050155 |
02/07/2005 |
POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) |
ZIBO ZHUANGYUAN PLASTIC & RUBBER CO., LTD. |
CHEN YUHONG |
| 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 |
| K041892 |
02/04/2005 |
ZOLL AED PRO EXTERNAL DEFIBRILLATOR |
ZOLL MEDICAL CORPORATION |
SEAN REYNOLDS |
