| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K030480 |
05/14/2003 |
L600 HAIR REMOVAL |
A&M TECHNOLOGY |
PASCAL DANET |
| K030513 |
05/12/2003 |
CELL-DYN 1800 SYSTEM |
ABBOTT LABORATORIES |
JOHN DEAN |
| K030884 |
05/27/2003 |
APTUS BLUE |
ACADENTAL |
CHRISTOPHER CRAIG |
| K031001 |
05/21/2003 |
ACMI VISTA CTR BIPOLAR LOOP ELECTRODE |
ACMI CORPORATION |
GABRIEL J MURACA |
| K031226 |
05/02/2003 |
STERRAD CYCLESURE BIOLOGICAL INDICATOR |
ADVANCED STERILIZATION PRODUCTS |
NATALIE BENNINGTON |
| K031008 |
05/09/2003 |
AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE) |
AESCULAP |
MATTHEW M HULL |
| K031286 |
05/29/2003 |
SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE |
AESCULAP, INC. |
GEORG KELLER |
| K023673 |
05/02/2003 |
AIRLIFE DEMAND NASAL CANNULA |
ALLEGIANCE HEALTHCARE CORP. |
SHARON NICHOLS |
| K023602 |
05/01/2003 |
SMALL VOLUME NEBULIZER |
ALLEGIANCE HEALTHCARE CORPORATION |
SHARON NICHOLS |
| K030026 |
05/02/2003 |
REPROCESSED ELECTROPHYSIOLOGY CATHETER |
ALLIANCE MEDICAL CORP. |
MOIRA BARTON |
| K030947 |
05/15/2003 |
ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM |
ALVEOLUS, INC. |
HOWARD L SCHRAYER |
| K030835 |
05/22/2003 |
'RAPID ONE' - PROPOXYPHENE TEST |
AMERICAN BIO MEDICA CORP. |
HENRY WELLS |
| K030518 |
05/20/2003 |
AMERITEK SURE-POINT TRACKER SYSTEM |
AMERTEK MEDICAL, INC. |
GREG WIITA |
| K030664 |
05/23/2003 |
AMSURE FOLEY INSERTION TRAY |
AMSINO INTERNATIONAL, INC. |
CHING CHING SEAH |
| K030712 |
05/23/2003 |
AMSURE URETHRAL CATHETERIZATION TRAY |
AMSINO INTERNATIONAL, INC. |
CHING CHING SEAH |
| K030931 |
05/09/2003 |
C3 PATIENT MONITOR |
ANALOGIC CORP. |
MARVIN ROSENBAUM |
| K031110 |
05/22/2003 |
APEX MODULAR ACETABULAR CUP |
APEX SURGICAL, LLC. |
EDWARD J CHEAL |
| K030642 |
05/23/2003 |
DEFLECTING URETERAL ACCESS SHEATH |
APPLIED MEDICAL RESOURCES CORP. |
ANIL BHALANI |
| K022662 |
05/09/2003 |
DIATEK CANNON-CATHETER, MODEL CC5500 |
ARROW INTL., INC. |
THOMAS NICKEL |
| K020738 |
05/22/2003 |
AVITA BF1 (VITALIO) BODY FAT ANALYZER |
AVITA CORPORATION |
JENNIFER REICH |
| K030230 |
05/23/2003 |
AVITA BPM1 SERIES (WRIST TYPE) BLOOD PRESSURE METER (OR MONITOR) |
AVITA CORPORATION |
JENNIFER REICH |
| K023253 |
05/06/2003 |
PEDIATRIC CENTRAL VENOUS CATHETER KIT |
B. BRAUN MEDICAL, INC. |
PATRICIA D WILSON |
| K024289 |
05/02/2003 |
BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION |
BAUSCH & LOMB INCORPORATED |
JENNIFER B MURRAY |
| K030573 |
05/08/2003 |
BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341 |
BD VACUTAINER SYSTEMS PREANALYICAL SOLUTIONS |
M. WENDY BALLESTEROS |
| K031270 |
05/06/2003 |
ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS |
BECKMAN COULTER, INC. |
LYNN WEIST |
| K031297 |
05/02/2003 |
ACCESS OV MONITOR ASSAY |
BECKMAN COULTER, INC. |
LYNN WEIST |
| K031269 |
05/02/2003 |
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS |
BECKMAN COULTER, INC. |
LYNN WEIST |
| K030828 |
05/21/2003 |
TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE) |
BECKMAN COULTER, INC. |
STAN SUGRUE |
| K030986 |
05/16/2003 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TRIMETHOPRIM - GN 0.5-16 UG/ML |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
| K030907 |
05/09/2003 |
STACKED ABR FOR NAVIGATOR PRO |
BIO-LOGIC SYSTEMS CORP. |
NORMAN E BRUNNER |
| K023857 |
05/16/2003 |
PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794 |
BIO-RAD |
CHRISTOPHER BENTSEN |
| K011399 |
05/05/2003 |
BIOMET CRANIOFACIAL ACRYLIC CEMENT |
BIOMET, INC. |
MICHELLE L MCKINLEY |
| K031334 |
05/22/2003 |
TEXAS T - PLATE |
BIOMET, INC. |
GARY BAKER |
| K023478 |
05/13/2003 |
INBODY AP1 BODY COMPOSITION ANALYZER |
BIOSPACE CO.,LTD |
DANIEL KAMM |
| K022849 |
05/20/2003 |
BODY CLOCK TENS N' TONE |
BODY CLOCK HEALTH CARE LTD |
JONATHAN BASH |
| K030349 |
05/02/2003 |
HEALTHOMETER PROFESSIONAL BODY FAT MONITOR AND SCALE, MODELS BFM 940, BFM 945 & BFM 960 |
BONSO ELECTRONICS INTERNATIONAL INC. |
RUSS PAGANO |
| K030956 |
05/23/2003 |
NAVIGATOR URETERAL ACCESS SHEATH SET |
BOSTON SCIENTIFIC CORP. |
JANET A MCGRATH |
| K030617 |
05/21/2003 |
PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE |
BOSTON SCIENTIFIC SCIMED, INC. |
ANNE V ROSSI |
| K031168 |
05/14/2003 |
MATRIX STRETCH RESISTANT DETACHABLE COIL |
BOSTON SCIENTIFIC, TARGET |
JAMES LEATHLEY |
| K031202 |
05/01/2003 |
MEDIPALM-20 |
BRAEBON MEDICAL CORP. |
RICHARD A BONATO |
| K030489 |
05/02/2003 |
BRM2 BRAIN MONITOR |
BRAINZ INSTRUMENTS LTD. |
CHRIS MANDER |
| K023820 |
05/07/2003 |
CO2 CLIP |
BREGAS AB |
PAUL KRILL |
| K031295 |
05/15/2003 |
BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM |
C.R. BARD, INC. |
FRANCES E HARRISON |
| K031332 |
05/15/2003 |
BARD PELVISOFT ACELLULAR COLLAGEN BIOMESH |
C.R. BARD, INC. |
TERRINA WILDER |
| K031186 |
05/06/2003 |
LUMINEXX ENDOSCOPIC BILIARY STENT |
C.R. BARD, INC. |
THOMAS HIRTE |
| K031129 |
05/05/2003 |
POLY PER-Q-CATH PICC CATHETERS; POLY RADPICC |
C.R. BARD, INC. |
PEGGY KEIFFER |
| K031272 |
05/20/2003 |
C.T.M. MOBILITY SCOOTER, MODEL HS-120 |
C.T.M. HOMECARE PRODUCT, INC. |
ROBERT S MCQUATE |
| K031447 |
05/21/2003 |
CANON, DIGITAL RADIOGRAPHY, MODEL CXDI-50G |
CANON INC. |
SHEILA DRISCOLL |
| K030398 |
05/23/2003 |
CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221 |
CARDIAC ASSIST, INC. |
TIM KRAUSKOPF |
| K030433 |
05/01/2003 |
STRATUSOCT WITH RNFL NORMATIVE DATABASE |
CARL ZEISS MEDITEC INC |
R. MICHAEL CROMPTON |
| K022978 |
05/09/2003 |
STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY PRODUCTS |
CASE MEDICAL, INC. |
MARCIA A FRIEZE |
| K030748 |
05/14/2003 |
AQUASOFT (OCUFILCON D) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER |
CLEARLAB PTE LTD. |
MARTIN DALSING |
| K031123 |
05/14/2003 |
CODMAN BACTISEAL BARIUM STRIPED CATHETERS |
Codman & Shurtleff, Inc. |
ELIZABETH DOLAN |
| K023566 |
05/22/2003 |
CODMAN ISOCOOL BIPOLAR FORCEPS |
Codman & Shurtleff, Inc. |
ELIZABETH DOLAN |
| K030921 |
05/15/2003 |
COLLAGEN TOPICAL WOUND DRESSING |
COLLAGEN MATRIX, INC. |
PEGGY HANSEN |
| K030917 |
05/14/2003 |
GEM; HAWK; EAGLE; MODELS 004110, 0044120, 004130 |
COLLINS MEDICAL, INC. |
DONALD HENTON |
| K030017 |
05/01/2003 |
CHUMP |
COLOURS 'N MOTION |
VICTOR R BOX |
| K030355 |
05/20/2003 |
COMFORT POWERED WHEELCHAIR, CONQUEROR LY-EB 202 |
COMFORT ORTHOPEDIC CO. LTD. |
Ke-Min Jen |
| K030356 |
05/20/2003 |
COMFORT POWERED WHEELCHAIR, TRAVELLER LY-EB 103 |
COMFORT ORTHOPEDIC CO. LTD. |
Ke-Min Jen |
| K030743 |
05/09/2003 |
ETCHANT 40% |
CONFI-DENTAL PRODUCTS CO. |
STEPHEN RUDOLPH |
| K031069 |
05/15/2003 |
SURGISIS NERVE CUFF |
COOK BIOTECH, INC. |
MARK BLEYER |
| K023937 |
05/27/2003 |
COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM |
COOK VASCULAR, INC. |
THOMAS J KARDOS |
| K021557 |
05/30/2003 |
SPECTRUM SILICONE CATHETER |
COOK, INC. |
APRIL LAVENDER |
| K021944 |
05/14/2003 |
COZART EIA COTININE URINE KIT |
COZART BIOSCIENCE LTD. |
ROBERTO LIDDI |
| K030786 |
05/06/2003 |
MONO-SWIFT |
CP MEDICAL |
MARY ANN GREENAWALT |
| K031317 |
05/22/2003 |
SMART 2940 D ER: YAG LASER |
CYNOSURE, INC. |
GEORGE CHO |
| K031224 |
05/09/2003 |
SMARTXIDE |
CYNOSURE, INC. |
GEORGE CHO |
| K031343 |
05/15/2003 |
TPSA FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
GEORGE M PLUMMER |
| K030812 |
05/21/2003 |
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-AN03 AND L-ANE03A SOFTWARE |
DATEX-OHMEDA |
JOEL KENT |
| K031361 |
05/23/2003 |
CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP |
DELTEC, INC. |
LISA STONE |
| K023424 |
05/09/2003 |
IGI-SYSTEM |
DENX ADVANCED DENTAL SYSTEMS |
KOBY BEN-BARAK |
| K030508 |
05/20/2003 |
DEPILASE TRIO LASE LASER SYSTEM |
DEPILASE GROUP LTD. |
MARIO LUCA RUSSO |
| K030510 |
05/14/2003 |
DEPILASE TWIN YAG LASER SYSTEM |
DEPILASE GROUP LTD. |
MARIO LUCA RUSSO |
| K030506 |
05/09/2003 |
DEPILASE YAG LASE PLUS LASER SYSTEM |
DEPILASE GROUP LTD. |
MARIO LUCA RUSSO |
| K031223 |
05/02/2003 |
SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR |
DIDECO S.P.A. |
BARRY SALL |
| K030972 |
05/30/2003 |
FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH) |
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
HILA WACHSLER-AVRAHAMI |
| K030776 |
05/09/2003 |
MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL |
DISCUS DENTAL, INC. |
YOGI SHAH |
| K030952 |
05/19/2003 |
DOLPHIN 2000 PULSE OXIMETRY SENSORS MODELS 2010, 2311 ADULT, 2312 PEDIATRIC, 2313 INFANT, 2314 NEONATAL, 2421 |
DOLPHIN MEDICAL INC. |
BILL CURNAN |
| K030781 |
05/29/2003 |
KODAK DIRECTVIEW PACS/IMAGE MANAGEMENT SYSTEM, KODAK DIRECTVIEW WORKFLOW MANAGER,KODAK DIRECTVIEW CX/DX, KODAK DIRECTVIB |
EASTMAN KODAK COMPANY |
LINDA J MOORE |
| K030347 |
05/02/2003 |
20.1 MONOCHROME LCD MONITOR, RADIFORCE G20 |
EIZO NANAO CORPORATION |
AKIRA WAKAYAMA |
| K031134 |
05/20/2003 |
DISPOSABLE POWDERED VINYL EXAM GLOVES |
ELITE INTERNATIONAL, INC. |
BOBBY LING |
| K030667 |
05/28/2003 |
ENCORE ANTERIOR SPINAL STAPLE SYSTEM |
ENCORE MEDICAL, L.P. |
DEBBIE DE LOS SANTOS |
| K030925 |
05/15/2003 |
PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH01 |
ETHICON ENDO-SURGERY, INC. |
CAROL SPRINKLE |
| K031430 |
05/22/2003 |
CEMEX SYSTEM FAST |
EXACTECH, INC. |
GARY J MILLER |
| K023740 |
05/13/2003 |
SYREX PRE-FILLED SYRINGE |
EXCELSIOR MEDICAL CORP. |
DAVID LUMIA |
| K030346 |
05/02/2003 |
TWINHEADS TH-101 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER |
FMD, LLC |
STEVEN CHERNOFF |
| K023338 |
05/09/2003 |
PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-2 |
FMS, FINAPRES MEDICAL SYSTEMS BV |
CHRISTINE EMANUEL |
| K031292 |
05/22/2003 |
MODIFICATION TO FOSSA URETERAL STONE SWEEPER |
FOSSA MEDICAL, INC. |
PAMELA PAPINEAU |
| K030497 |
05/20/2003 |
FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIES |
FRESENIUS MEDICAL CARE |
ART EILINSFELD |
| K031378 |
05/30/2003 |
FRESENIUS ULTRAFLUX HEMODIALYZER |
FRESENIUS MEDICAL CARE NORTH AMERICA |
ARTHUR EILINSFELD |
| K023963 |
05/05/2003 |
ADHOC CLAW |
FUTURE MEDICAL SYSTEMS, INC. |
STEVE JANIN |
| K031117 |
05/23/2003 |
SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM |
GALIL MEDICAL LTD. |
RONI ZVULONI |
| K030592 |
05/23/2003 |
GAMBRO POLYFLUX, MODEL 140H, 170H, 210H |
GAMBRO RENAL CARE PRODUCTS |
JEFFREY R SCHIDMAN |
| K023615 |
05/06/2003 |
GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR |
GAMBRO RENAL PRODUCTS |
JEFFREY R SHIDEMAN |
| K031396 |
05/13/2003 |
ADVANTAGE WORKSTATION PASTING 1.1 |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K031261 |
05/06/2003 |
CARD EP |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K031230 |
05/02/2003 |
GE PROPELLER IMAGING OPTION FOR MRI |
GE MEDICAL SYSTEMS |
LARRY KROGER |
| K022834 |
05/13/2003 |
DINAMAP PRO 1000 MONITOR WITH SUPERSTAT, MODEL 1000 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
MELISSA ROBINSON |
| K031320 |
05/06/2003 |
EK-PRO ARRHYTHMIA DETECTION ALGORITHM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
KAREN M LUNDE |
| K023943 |
05/06/2003 |
CT COLONOGRAPHY |
GE MEDICAL SYSTEMS, INC. |
LARRY A KROGER |
| K031209 |
05/23/2003 |
GE 1.5T 8 CHANNEL TORSO COIL |
GE MEDICAL SYSTEMS, INC. |
LARRY KROGER |
| K031259 |
05/12/2003 |
MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER |
GETINGE USA, INC |
FREDERICK R CATT |
| K030726 |
05/30/2003 |
GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATING |
GISH BIOMEDICAL, INC. |
J. HARVEY KNAUSS |
| K031300 |
05/14/2003 |
IBC FLOPUMP WITH GBS COATING |
GISH BIOMEDICAL, INC. |
J. HARVEY KNAUSS |
| K030512 |
05/14/2003 |
GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM |
GUIDANT CORP. |
NANCY LINCE |
| K031398 |
05/20/2003 |
IS-1 HEMOSTASIS VALVE, MODEL 6799 |
GUIDANT CORP. |
Colleen McCarter Bloom |
| K030549 |
05/14/2003 |
HI-TORQUE PILOT 50 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE PILOT 150 GUIDE WIRE WITH HYDROCOAT HYDROPHG |
GUIDCORP |
STACEY BROWN |
| K030343 |
05/02/2003 |
DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE |
GYRUS ENT L.L.C. |
GREGORY SREDIN |
| K031082 |
05/21/2003 |
EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOK |
GYRUS MEDICAL, INC. |
MERCEDES P BAYANI |
| K031080 |
05/16/2003 |
EVEREST BIPOLAR LYONS DISSECTING FORCEPS & GYRUS BIPOLAR LYONS DISSECTING FORCEPS |
GYRUS MEDICAL, INC. |
MERCEDES BIRYANI |
| K031078 |
05/16/2003 |
EVEREST BIPOLAR MACRO, MICRO & MOLLY FORCEPS & GYRUS BIPOLAR MACRO, MICRO & MOLLY FORCEPS |
GYRUS MEDICAL, INC. |
MERCEDES P BAYANI |
| K031079 |
05/21/2003 |
EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE |
GYRUS MEDICAL, INC. |
MERCEDES BAYANI |
| K031081 |
05/21/2003 |
EVEREST LP BIPOLAR SCISSORS AND GYRUS LP BIPOLAR SCISSORS |
GYRUS MEDICAL, INC. |
MERCEDES BAYANI |
| K030515 |
05/02/2003 |
HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS |
HANS RUDOLPH, INC. |
KEVIN RUDOLPH |
| K030997 |
05/02/2003 |
POWDERED VINYL EXAM GLOVES, WHITE |
HEYUAN HONGLI INDUSTRIES, INC. |
JANNA P TUCKER |
| K021952 |
05/02/2003 |
HIVOX DREAMATE DM-800 |
HIVOX BIOTEK, INC. |
Ke-Min Jen |
| K022998 |
05/20/2003 |
HOME CARE VAREIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-311, HT-311N, HT-312 |
HOME CARE TECHNOLOGY CO., LTD. |
SHU-CHEN CHENG |
| K031217 |
05/23/2003 |
GMRS PRESS FIT STEMS WITH PUREFIX HA |
HOWMEDICA OSTEONICS |
MARGARET F CROWE |
| K014199 |
05/06/2003 |
SURGICAL SIMPLEX P WITH TOBRAMYCIN |
HOWMEDICA OSTEONICS CORP. |
WILLIAM J CYMBALUK |
| K023662 |
05/28/2003 |
PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER |
HWADONG INTERNATIONAL COMPANY LTD. |
MARIAN COCHRAN |
| K030741 |
05/01/2003 |
AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA |
HYCOR BIOMEDICAL LTD. |
DANIELLE M KNIGHT |
| K021813 |
05/09/2003 |
HYDROCISION GENERAL SURGERY FLUIDJET SYSTEM |
HYDROCISION, INC. |
DEBBIE IAMPIETRO |
| K031388 |
05/22/2003 |
MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM |
HYPOGUARD USA, INC. |
BRUCE A MACFARLANE |
| K030432 |
05/01/2003 |
IMC-HEARTWAY MODEL HPS ELECTRIC POWERED WHEELCHAIR |
IMC-HEARTWAY, LLC |
JUAN CARLOS RIVERA |
| K030775 |
05/12/2003 |
AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM |
IMMUNO CONCEPTS, N.A., LTD |
ERIC S HOY |
| K022062 |
05/06/2003 |
IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00 |
IMPACT INSTRUMENTATION, INC. |
LESLIE H SHERMAN |
| K023483 |
05/06/2003 |
KALAZAR DETECT |
INBIOS INTL., INC. |
ESTELA I RAYCHAUDHURI |
| K023733 |
05/14/2003 |
COA-COMP/M, AUTOMATED BIPOLAR COAGULATOR |
INGENJORSFIRMAN BJORN BERGDAHL AB |
BJORN BERGDAHL |
| K023887 |
05/30/2003 |
INION OTPS BIODEGRADABLE MINI PLATING SYSTEM |
INION LTD. |
HANNA MARTTILA |
| K030889 |
05/23/2003 |
ULTRAEKOGEL MODELS EK 2000 & EK 2001 |
INMED LTDA. |
JAY MANSOUR |
| K031122 |
05/19/2003 |
HEMOSIL FACTOR X DEFICIENT PLASMA |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K031086 |
05/14/2003 |
CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1 |
INTEGRA NEURO SCIENCES |
NANCY A MATHEWSON |
| K023908 |
05/16/2003 |
INTERPORE CROSS CEMENT RESTRICTOR |
INTERPORE CROSS INTL. |
PROSIE REY-FESSLER |
| K030131 |
05/20/2003 |
OSSATURA BCP BONE VOID FILLER |
ISOTIS NV |
MARY MCNAMARA-CULLINANE |
| K030699 |
05/29/2003 |
VERAVIEWEPOCS PANORAMIC/CEPHALOMETRIC X-RAY UNIT WITH CEPHALOMETRIC |
J. MORITA MFG. CORP. |
KEITH A BARRITT |
| K030450 |
05/06/2003 |
3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH |
J. MORITA USA, INC. |
KEITH A BARRITT |
| K031148 |
05/28/2003 |
IN-VISION IMAGING SYSTEM |
JOMED, INC. |
LORRAINE W HUFFMAN |
| K031277 |
05/14/2003 |
JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002 |
JOMED, INC. |
TERRY SCHULTZ |
| K030607 |
05/02/2003 |
KAVO EVEREST G-BLANK, KAVO EVEREST G-CERAM, COATING CERAMIC LF-3-PFM, GLAZE AND COLORINGS/STAINING/SHADES |
KAVO AMERICA |
JENNIFER POTTALA |
| K030646 |
05/06/2003 |
BELLEGLASS POINT 4 |
KERR DENTAL MATERIALS CENTER |
COLLEEN BOSWELL |
| K030536 |
05/06/2003 |
LAC-MAC LIMITED INNERBLOC O.R. GOWN |
LAC MAC, LTD. |
JEFFREY O STULL |
| K031362 |
05/30/2003 |
LAC-MAC LIMITED INNERBLOC VARIOUS O.R. DRAPE BASED ON THE REPEL, PLUS AND GORE SURGICAL BARRIER FABRIC MATERIALS |
LAC MAC, LTD. |
JEFFREY O STULL |
| K030300 |
05/09/2003 |
OPAQUE HERRICK LACRIMAL PLUG |
LACRIMEDICS, INC. |
JERRY HENDERSON |
| K030976 |
05/30/2003 |
CAREO RETRACTABLE SAFETY SYRINGE |
LIFE-SHIELD PRODUCTS, INC |
ROSINA ROBINSON |
| K030527 |
05/20/2003 |
LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS |
LUMENIS |
ANDREA L RUTH |
| K023068 |
05/28/2003 |
PAPILLON MASK SET |
MAP MEDIZINTECHNIK FUR ARZT UND PATIENT GMBH |
ROGER KOTTER |
| K031330 |
05/12/2003 |
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES |
MASIMO CORP. |
JAMES J CRONIN |
| K030502 |
05/20/2003 |
14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55 |
MEDCOMP |
MEGHAN J TINTLE |
| K031364 |
05/30/2003 |
MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3 |
MEDICAL ANALYSIS SYSTEMS, INC. |
PENNY M LAYMAN |
| K021230 |
05/09/2003 |
HERO |
MEDICAL DECISION NETWORKS |
WILLIAM E KING |
| K030439 |
05/08/2003 |
HEADFIX |
MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH |
CORNELIA DAMSKY |
| K031552 |
05/30/2003 |
MYCOLOR 202 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS |
MEDISON AMERICA, INC. |
BOB DEPALMA |
| K030996 |
05/30/2003 |
MSI SA ELECTRODES |
MEDSPHERE INTERNATIONAL, INC |
ERIC KAO |
| K030839 |
05/30/2003 |
MEDTRONIC AVE BRIDGE AURORA BILIARY STENT SYSTEM (AURORA) |
MEDTRONIC AVE, INC. |
MARLENE COBB-CARLSON |
| K031037 |
05/13/2003 |
EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE |
MEDTRONIC PERFUSION SYSTEMS |
RONALD W BENNETT |
| K030932 |
05/16/2003 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
| K030840 |
05/15/2003 |
MODIFICATION TO HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
| K031518 |
05/22/2003 |
EOPA CAP ELONGATED ONE-PIECE ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODELS 774XX, 775XX, 776XX, 777XX, 788XX, |
MEDTRONIC VASCULAR |
DAWN STENSTROM |
| K031274 |
05/22/2003 |
MODEL 5071 MYOCARDIAL PACING LEAD |
MEDTRONIC VASCULAR |
TINA BENOIT |
| K024278 |
05/29/2003 |
PACEART SYSTEM |
MEDTRONIC VASCULAR |
KAREN RUTH-JARMON |
| K031285 |
05/19/2003 |
MEGA 2000 SOFT DUAL CORD PATIENT RETURN ELECTRODE PAD |
MEGADYNE MEDICAL PRODUCTS, INC. |
RONDA K MAGNESON |
| K030588 |
05/07/2003 |
ARTEGRAL AND POLYSTAR SELECTION |
MERZ DENTAL GMBH |
JAMES DELANEY |
| K031210 |
05/16/2003 |
MODEL 4951M MYOCARDIAL UNIPOLAR LEAD |
METRONIC, INC. |
TINA BENOIT |
| K031017 |
05/30/2003 |
SYS*STIM 208 AND 208A |
METTLER ELECTRONICS CORP. |
ROBERT E FLEMING |
| K030649 |
05/22/2003 |
DRI COTININE EIA ASSAY |
MICROGENICS CORP. |
LAKSHMI ANNE |
| K031406 |
05/30/2003 |
EXOJET TISSUE MANAGEMENT SYSTEM |
MITEK WORLDWIDE |
SERGIO J GADALETA |
| K031514 |
05/23/2003 |
MODIFICATION TO TRUPEAK PEAK FLOW METER |
MONAGHAN MEDICAL CORP. |
JAMES A COCHIE |
| K030632 |
05/07/2003 |
PD CASTA-H |
MOUNTAIN MEDICO, INC. |
RUTH C JOLINE |
| K030728 |
05/23/2003 |
FYRELINK VL |
MPACS, LLC. |
GREG SOPOTNICK |
| K030805 |
05/21/2003 |
MYTHOS 500 |
MSQ (M2) LTD. |
ARAVA HACOHEN |
| K030561 |
05/09/2003 |
MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODELS HPL-100 AND HPL-100A |
MYTECH TECHNOLOGY CO., LTD. |
SHU CHEN CHENG |
| K030443 |
05/09/2003 |
MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST |
NASTECH PHARMACEUTICAL COMPANY, INC. |
PETER C APRILE |
| K031262 |
05/23/2003 |
ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760 |
NDO SURGICAL, INC. |
ERIC BANNON |
| K030930 |
05/23/2003 |
OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N |
NELLCOR PURITAN BENNETT, INC. |
GINA TO |
| K022274 |
05/29/2003 |
CARECOMPANION PATIENT STATION & NURSE STATION |
NEPTEC DESIGN GROUP, LTD. |
JOHN SCHNEIDER |
| K023286 |
05/02/2003 |
CARECOMPANION PATIENT STATION/CARECOMPANION PATIENT STATION |
NEPTEC DESIGN GROUP, LTD. |
JOHN SCHNEIDER |
| K031184 |
05/21/2003 |
COOL TOUCH 3 |
NEW STAR LASERS, INC. |
DONALD V JOHNSON |
| K030453 |
05/12/2003 |
COOLTOUCH ND: YAG LASER SYSTEM |
NEW STAR LASERS, INC. |
DAVID R HENNINGS |
| K030589 |
05/21/2003 |
MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS |
NUMED, INC. |
NICHELLE R LAFLESH |
| K031149 |
05/14/2003 |
OLYMPIC CFM 6000 |
OLYMPIC MEDICAL CORP. |
EDWARD B. (TED) WEILER |
| K031347 |
05/09/2003 |
ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8 |
OLYMPUS OPTICAL CO., LTD. |
LAURA STORMS-TYLER |
| K030929 |
05/02/2003 |
ANA DETECT |
ORGENTEC DIAGNOSTIKA GMBH |
MICHAEL H FOLEY |
| K023594 |
05/15/2003 |
TENO FIX |
ORTHEON MEDICAL, LLC. |
JONATHAN S KAHAN |
| K031219 |
05/28/2003 |
MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR) |
ORTHOFIX, INC. |
MARY BIGGERS |
| K031156 |
05/09/2003 |
NAVITRACK SYSTEM-FLUOROSPINE, MODEL 900.005 |
ORTHOSOFT, INC. |
CHRISTOPHER MCLEAN |
| K030827 |
05/23/2003 |
NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE CUP, MODEL 900.204 |
ORTHOSOFT, INC. |
CHRISTOPHER MCLEAN |
| K030448 |
05/09/2003 |
OSTEOMED 2.0 LOCKING PLATES AND SCREWS |
OSTEOMED L.P. |
DAWN T HOLDEMAN |
| K030375 |
05/05/2003 |
SOFT-TOUCH TENS ELECTRODE |
PAIN MANAGEMENT TECHNOLOGIES |
JOSHUA LEFKOVITZ |
| K030469 |
05/09/2003 |
LAPAROSHIELD CONDITIONED INSUFFLATION SET |
PALL MEDICAL |
JONATHAN S KAHAN |
| K012889 |
05/27/2003 |
BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT |
PASCAL CO., INC. |
DAVID R JOY |
| K030488 |
05/02/2003 |
FLUORILAQ |
PASCAL CO., INC. |
VINCENT M TENTARELLI |
| K030933 |
05/01/2003 |
PASCO MIC AND MIC/ID PANELS |
PASCO LABORATORIES, INC. |
LINDA K SILLON |
| K030714 |
05/16/2003 |
PEAK MOTUS |
PEAK PERFORMANCE TECHNOLOGIES, INC |
LARRY SCHEIRMAN |
| K031404 |
05/22/2003 |
DIGNITY OPHTHALMIC SURGICAL SYSTEM |
PHACOR INC., A SANTEN COMPANY |
JEFF B PAUL |
| K030417 |
05/09/2003 |
DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (SWITCHED-LARGE), DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES |
PHILIPS MEDICAL SYSTEMS |
PETER OHANIAN |
| K031333 |
05/13/2003 |
PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2 |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
LYNN HARMER |
| K031403 |
05/30/2003 |
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.1 |
PHILIPS MEDICAL SYSTEMS, INC. |
DAVID OSBORN |
| K031481 |
05/29/2003 |
THE PHILIPS INTELLIVUE MP60, MP70, AND MP90 PATIENT MONITORS, RELEASE A.20 |
PHILIPS MEDIZINSYSTEME BOBLINGEN GMBH |
HAUKE SCHIK |
| K023654 |
05/02/2003 |
GLYCA-DIRECT FRUCTOSAMINE |
POLYMEDCO, INC. |
HELEN LANDICHO |
| K030423 |
05/09/2003 |
POWERLITE 600 EP SYSTEM |
PRESWEDE AB |
SUSAN GOLDSTEIN FALK |
| K030813 |
05/30/2003 |
PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND |
PRIMARY CARE SOLUTIONS, INC. |
RON MADDIX |
| K030631 |
05/19/2003 |
ZIPPERE - BIOABSORBABLE/NON-ABSORBABLE POLYMER SLING & SURGICAL MESH |
PROSURG, INC. |
ASHVIN DESAI |
| K030558 |
05/21/2003 |
MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY |
PROXIMA THERAPEUTICS, INC. |
MARTINE D SCHNEIDER |
| K031020 |
05/21/2003 |
FLEXISKIN LATEX EXAMINATION GLOVES, POWDERED, NON STERILE |
PT. MANDIRI INTI BUANA |
NG POY SIN |
| K022448 |
05/28/2003 |
WATER PURIFICATION SYSTEM |
PURITY WATER COMPANY OF SAN ANTONIO, INC. |
BERT HUDSON |
| K023734 |
05/06/2003 |
ARAMIS II DERMATOLOGICAL LASER |
QUANTEL MEDICAL |
ROGER W BARNES |
| K031206 |
05/21/2003 |
RADIOMED SOFT TISSUE MARKER |
RADIOMED CORP. |
GORDON ROBERTS |
| K030873 |
05/12/2003 |
RANDOX AMMONIA |
RANDOX LABORATORIES, LTD. |
LYNNE HAMILTON |
| K031344 |
05/23/2003 |
RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLE |
RANFAC CORP. |
ANNETTE M FAGNANT |
| K030751 |
05/29/2003 |
IPACS PRISM |
REAL TIME IMAGE INC. |
CARL ALLETTO |
| K031610 |
05/27/2003 |
REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM |
REX MEDICAL |
SUSAN D GOLDSTEIN-FALK |
| K031257 |
05/02/2003 |
RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR |
RITA MEDICAL SYSTEMS INC |
VICKI HACKER |
| K030845 |
05/22/2003 |
COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING |
ROCHE DIAGNOSTICS CORP. |
JENNIFER TRIBBETT |
| K031299 |
05/12/2003 |
ELECSYS LH CALSET II |
ROCHE DIAGNOSTICS CORP. |
THERESA M AMBROSE |
| K031407 |
05/20/2003 |
ROSS EMBRACE ENTERAL PUMP |
ROSS PRODUCT DIV. ABBOTT LABORATORIES |
DANIEL HAMILTON |
| K030587 |
05/30/2003 |
EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP |
S-TCT HEALTH INC. |
KATHERINE L GIANNAMORE |
| K031291 |
05/05/2003 |
CDR PANX, MODEL 4792 |
SCHICK TECHNOLOGIES, INC. |
DANIEL J SHERRATT |
| K031290 |
05/13/2003 |
MODIFICATION TO EASYS TRANSVERSE CONNECTION |
SCIENT'X USA, INC. |
J.D. WEBB |
| K031053 |
05/20/2003 |
SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7 |
SELECTIVE MED COMPONENTS, INC. |
RICHARD J FISHER |
| K030207 |
05/02/2003 |
NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735 |
SHANGHAI MOTEX HEALTHCARE CO., LTD. |
TONY T.K. CHENG |
| K031072 |
05/06/2003 |
DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN E |
SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC. |
|
| K031293 |
05/09/2003 |
SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE |
SHIJIAZHUANG EVERSHARP PLASTIC PRODUCTS CO., LTD. |
JAMES CHU |
| K030544 |
05/21/2003 |
RFX FLUROSCOPIC DIGITAL IMAGING SYSTEM |
SIGMA VISION, INC. |
OMID KIA |
| K030554 |
05/20/2003 |
CALLOS |
SKELETAL KINETICS, LLC |
HOWARD HOLSTEIN |
| K031379 |
05/22/2003 |
DYONICS VISION 325Z DV3-CCD HERMES READY CAMERA SYSTEM, MODEL 7209531 |
SMITH & NEPHEW, INC. |
JANICE HASELTON |
| K030612 |
05/27/2003 |
GENESIS II TOTAL KNEE SYSTEM |
SMITH & NEPHEW, INC. |
KIM P KELLEY |
| K031371 |
05/23/2003 |
SAPHYRE BIPOLAR ABLATION PROBES |
SMITH & NEPHEW, INC. |
LINDA GUTHRIE |
| K031162 |
05/01/2003 |
SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM |
SMITH & NEPHEW, INC. |
KANU VADODARIA |
| K030623 |
05/22/2003 |
SMITH & NEPHEW PROFIX TOTAL KNEE SYSTEM |
SMITH & NEPHEW, INC. |
GINO J ROUSS |
| K023759 |
05/06/2003 |
CARDIOVASCULAR SONOSPECTROGRAPHIC ANALYZER |
SONOMEDICA |
SAILOR MOHLER |
| K030494 |
05/20/2003 |
SR-130 |
SOURCE-RAY, INC. |
RAY MANEZ |
| K030680 |
05/09/2003 |
SPSMEDICAL GAS PLASMA CHEMICAL INDICATOR |
SPS MEDICAL SUPPLY CORP. |
GARY J SOCOLA |
| K031543 |
05/30/2003 |
STARCAST DENTAL ALLOYS |
STAR REFINING PRECIOUS METALS SOUTH AFRICA |
YOLANDA SMITH |
| K030820 |
05/20/2003 |
EVERSTICK POST |
STICK TECH LTD. |
WILLIAM TROETEL |
| K030661 |
05/30/2003 |
STRYKER PAINPUMP2 |
STRYKER INSTRUMENTS |
NICOLE PETTY |
| K023648 |
05/06/2003 |
VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPHETAMI |
SUN BIOMEDICAL LABORATORIES, INC. |
MING SUN |
| K024175 |
05/01/2003 |
SUNPEX TECHNOLOGIES MODEL PW |
SUNPEX TECHNOLOGY CO., LTD. |
LEONARD FRIER |
| K031289 |
05/09/2003 |
QUICKIE FREESTYLE POWER WHEELCHAIR, MODEL G-424 |
SUNRISE MEDICAL, INC. |
MICHAEL CHELLSON |
| K031120 |
05/23/2003 |
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES |
SYNMERTEX CO, LTD |
ALBERT LING |
| K031076 |
05/23/2003 |
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR |
SYNMERTEX CO, LTD |
ALBERT LING |
| K031171 |
05/23/2003 |
DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES |
SYNMERTEX CO, LTD |
ALBERT LING |
| K031178 |
05/05/2003 |
SYNTHES (USA) 3.5 MM BROAD LCP & 4.5 MM LCP DISTAL HUMERUS PLATES |
SYNTHES (USA) |
LISA M BOYLE |
| K031508 |
05/30/2003 |
SYNTHES (USA) STERNAL RECONSTRUCTION SYSTEM |
SYNTHES (USA) |
LISA M BOYLE |
| K031062 |
05/02/2003 |
TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML/FA51 SERIES U-100 INSULIN/FA71 SERIES TUBERCULIN) |
TAIJECT MEDICAL DEVICE CO., LTD. |
JIM-SON CHOU |
| K031312 |
05/06/2003 |
RTA MODEL D RETINAL THICKNESS ANALYZER |
TALIA TECHNOLOGY LTD. |
JONATHAN S KAHN |
| K030505 |
05/14/2003 |
CAPIOX CARDIOTOMY RESERVOIR |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
GARRY A COURTNEY |
| K031266 |
05/30/2003 |
SURSHIELD SAFETY WINGED INFUSION SET |
TERUMO CORP. |
BARBARA SMITH |
| K031279 |
05/30/2003 |
SURSHIELD SAFETY WINGED BLOOD COLLECTION SET |
TERUMO MEDICAL PRODUCTS HANGZHOU CO., LTD. |
KAZUHITO INOUE |
| K030576 |
05/21/2003 |
ANSPACH IRRIGATION PUMP AND IRRIGATION PUMP II |
THE ANSPACH EFFORT, INC. |
WILLIAM G CONETY |
| K030209 |
05/13/2003 |
MAHURKAR OPLUS CATHETER, MODEL 13.5 FR |
THE KENDALL COMPANY |
REGINA YEH |
| K030039 |
05/23/2003 |
PATHWAY STM-10 PELVIC FLOOR STIMULATOR |
THE PROMETHEUS GROUP |
PETER SULLIVAN |
| K031046 |
05/22/2003 |
THERMACOOL TC SYSTEM |
THERMAGE, INC. |
PAMELA M BUCKMAN |
| K030663 |
05/29/2003 |
TOKUYAMA SOFRELINER TOUGH |
TOKUYAMA DENTAL CORPORATION |
DANIEL J MANELLI |
| K022211 |
05/22/2003 |
HLS UNI EVOLUTION PROSTHESIS |
TORNIER |
Mireille Lemery |
| K031218 |
05/16/2003 |
MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS |
TORNIER |
Mireille Lemery |
| K031469 |
05/22/2003 |
AQUILION SUPER 4 MULTISLICE CT SCANNER, MODEL TSX-101A/7 |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K030659 |
05/02/2003 |
CLEARBLUE EASY DIGITAL PREGNANCY TEST |
UNIPATH LTD. |
Louise Roberts |
| K031143 |
05/29/2003 |
ALPHA 5000 WRIST COIL |
USA INSTRUMENTS, INC. |
CHRISTIE SHUMAKER |
| K031056 |
05/08/2003 |
MODIFICATION TO PREMIER III PHASED ARRAY CTL SPINE COIL |
USA INSTRUMENTS, INC. |
CHRISTIE SHUMAKER |
| K031139 |
05/29/2003 |
PREMIER III PHASED ARRAY CTL SPINE COIL |
USA INSTRUMENTS, INC. |
CHRISTIE SHUMAKER |
| K030371 |
05/05/2003 |
PRIMA III TOTALSENSE TORSO COIL |
USA INSTRUMENTS, INC. |
CHRISTIE SHUMAKER |
| K031172 |
05/29/2003 |
SPIRIT III TOTALSENSE CARDIAC COIL |
USA INSTRUMENTS, INC. |
CHRISTIE SHUMAKER |
| K031011 |
05/29/2003 |
LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500 |
VALLEYLAB, INC. |
HERBERT VINSON |
| K013486 |
05/30/2003 |
VAPOTHERM 2000H |
VAPOTHERM, INC. |
PAUL E DRYDEN |
| K030534 |
05/21/2003 |
VARISEED 7.1 |
VARIAN MEDICAL SYSTEMS |
LINDA S NASH |
| K031358 |
05/09/2003 |
TRANSVAGINAL DOPPLER PROBE |
VASCULAR CONTROL SYSTEMS, INC |
KATHLEEN ROBERTS |
| K030507 |
05/20/2003 |
T.E.A.R. TECH3 MODEL #44TT03 |
VISION QUEST INDUSTRIES, INC. |
ALAN WADE |
| K030915 |
05/30/2003 |
GRANDIO |
VOCO GMBH |
GERALD W SHIPPS |
| K030914 |
05/30/2003 |
REBILDA DC |
VOCO GMBH |
GERALD W SHIPPS |
| K031089 |
05/08/2003 |
GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY |
W.L. GORE & ASSOCIATES,INC |
TRACY DE VAN WOLF |
| K031034 |
05/21/2003 |
SPIN DOWN RAPIDFLAP |
WALTER LORENZ SURGICAL, INC. |
KIM REED |
| K030580 |
05/06/2003 |
SURETEMP PLUS |
WELCH ALLYN, INC. |
DEBRA L JACKSON |
| K023230 |
05/05/2003 |
ECHOPULSE MUSCLE STIMULATOR SYSTEM, MODEL 800 |
WESTERN CLINICAL TECHNOLOGY SYSTEMS, INC. |
W.T. WORKMAN |
| K030759 |
05/01/2003 |
LITTLE COACH |
WHEELCHAIR & SCOOTER EXPRESS |
CHRIS TINSLEY |
| K022506 |
05/15/2003 |
MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM |
WIDEMED LTD |
DAVID SOLOMON |
| K030618 |
05/27/2003 |
WILSON-COOK CELIAC PLEXUS NEUROLYSIS NEEDLE |
WILSON-COOK MEDICAL, INC. |
MARGARET J POSNER |
| K022389 |
05/06/2003 |
READI-LOAD SYSTEM, MODEL PSS 1820RL |
WORLDWIDE MEDICAL TECHNOLOGIES, LLC |
RICK TERWILLIGER |
| K030593 |
05/30/2003 |
FLEXLENS AND HARRISON POST REFRACTIVE SURGERY (BIOXIFILCON A), (HIOXIFILCON B), (ACOFILCON A), (ACOFILCON B) SOFT CONTAC |
X-CEL CONTACTS, A WALMAN CO. |
MARTIN DALSING |
| K023823 |
05/22/2003 |
EASYCUP |
ZER HITECH |
JAY MANSOUR |
| K030733 |
05/01/2003 |
MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 8026 SERIES |
ZIMMER, INC. |
LAURA D WILLIAMS |
