| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K033392 |
12/10/2003 |
IMMEDIATE STABILIZING IMPLANT (ISI) |
"O" CO., INC. |
DAVID D DALISE |
| K031281 |
12/23/2003 |
ERGO SRS |
3D LINE USA, INC. |
NADER SALEHI |
| K032756 |
12/04/2003 |
A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533 |
A-DEC, INC. |
TOM LOUISELL |
| K032757 |
12/10/2003 |
A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE |
A-DEC, INC. |
TOM LOUISELL |
| K032572 |
12/03/2003 |
A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT |
A-DEC, INC. |
TOM LOUISELL |
| K022816 |
02/07/2003 |
W & H LISA STEAM STERILIZER |
A-DEC, INC. |
TOM LOUISELL |
| K033356 |
12/30/2003 |
VERASOFT ES |
AALBA DENT, INC. |
VINCENT BENETTI |
| K022856 |
02/10/2003 |
BOVIE IDS-300 HIGH FREQUENCY ELECTROSURGICAL GENERATOR |
AARON MEDICAL INDUSTRIES |
RICHARD A KOZLOFF |
| K031260 |
12/19/2003 |
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005 |
ABBOTT DIABETES CARE INC. |
DONNA K TEMPLEMAN |
| K033576 |
12/04/2003 |
LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE |
ABBOTT LABORATORIES |
PATRICIA MELERSKI |
| K033537 |
12/10/2003 |
SELFX XPERT BILIARY STENT, MODELS EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006, EX8L4006, EX8S2005, AND EX8S3005 |
ABBOTT LABORATORIES |
JOANNA KUSKOWSKI |
| K024149 |
02/21/2003 |
PRIMELUNG |
ACCUIMAGE DIAGNOSTICS CORP. |
OSCAR G CARBO |
| K023766 |
02/10/2003 |
ACON STREP A TWIST TEST DEVICE |
ACON LABORATORIES CO. |
EDWARD TUNG |
| K033299 |
12/12/2003 |
ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICE |
ACON LABORATORIES, INC. |
EDWARD TUNG |
| K023946 |
02/05/2003 |
ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE |
ACON LABORATORIES, INC. |
EDWARD TUNG |
| K032970 |
12/08/2003 |
ACRA-CUT XPRESS 120 |
ACRA CUT, INC. |
KENNETH M NICOLL |
| K033735 |
12/12/2003 |
VANTAGE PRO ATTENUATION CORRECTION DEVICE |
ADAC LABORATORIES |
CHARLENE BRUMBAUGH |
| K023929 |
02/21/2003 |
MAGNETIC RESONANCE DIAGNOSTIC DEVICE |
ADVANCED IMAGING RESEARCH, INC. |
RAVI SRINIVASAN |
| K023351 |
02/20/2003 |
MAGIC INFUSION CATHETER |
ADVANCED INTERVENTIONAL TECHNOLOGIES, LLC |
TRACY PALMER BERNS |
| K033429 |
12/04/2003 |
LAMITRODE SPINAL CORD STIMULATION LEADS |
ADVANCED NEUROMODULATION SYSTEMS |
DANIELLE ALARCON |
| K024309 |
02/21/2003 |
THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104 |
ADVANCED RESPIRATORY |
ERIC J LARSON |
| K030004 |
02/27/2003 |
0.55% ORTH-PHTHALALDEHYDE SOLUTION |
ADVANCED STERILIZATION PRODUCTS |
NEELU MEDHEKAR |
| K032469 |
12/16/2003 |
AESKULISA ANA 8PRO |
AESKU, INC |
STANLEY AMMONS |
| K023800 |
02/10/2003 |
VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER, MODEL 3017 |
AIRCAST, INC. |
STEPHEN L KENNEY |
| K031579 |
12/19/2003 |
INSTAREAD LITHIUM SYSTEM |
AKERS LABORATORIES, INC. |
Erika B Ammirati |
| K032422 |
12/15/2003 |
EUSOL-C |
AL.CHI.MI.A |
GEORGE MYERS |
| K023419 |
02/11/2003 |
TRILAMINATE DRAPES/TIBURON |
ALLEGIANCE HEALTHCARE CORP. |
SHARON NICHOLS |
| K023714 |
02/03/2003 |
REPROCESSED EXTERNAL FIXATION DEVICE |
ALLIANCE MEDICAL CORP. |
DON SELVEY |
| K021654 |
02/05/2003 |
REPROCESSED COMPRESSION SLEEVE |
ALLIANCE MEDICAL, INC. |
LORRI CHAVEZ |
| K032417 |
12/23/2003 |
HEPARIN LOCK FLUSH SYRINGE |
AM2 PAT INC. |
DUSHYANT PATEL |
| K031711 |
12/18/2003 |
TANGO, MODELS, BP1 |
AMERICAN BANTEX CORP. |
TRACY S BEST |
| K033045 |
12/23/2003 |
DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST |
AMERICAN GREEN DENT. MFG, INC. |
ANDREW ROWE |
| K033636 |
12/31/2003 |
AMS LARGE PORE POLYPROPYLENE MESH |
AMERICAN MEDICAL SYSTEMS, INC. |
ELSA A LINKE |
| K030123 |
02/06/2003 |
BIOARC SP SLING KIT |
AMERICAN MEDICAL SYSTEMS, INC. |
MARK MCINTYRE |
| K033076 |
12/19/2003 |
LIFESTYLES LIQUID PERSONAL LUBRICANT |
ANSELL HEALTHCARE, INC. |
LON D MCILVAIN |
| K033201 |
12/02/2003 |
LA500 BLUE LIGHT |
APOZA ENTERPRISE CO. LTD. |
SHIH MIN-TEH |
| K023890 |
02/07/2003 |
PREPARE CARTRIDGE |
APPRO HEALTHCARE, INC. |
JOHN R SEMLER |
| K024079 |
02/27/2003 |
ALIBI BIOLOGICAL INDICATOR, MODEL WS |
ARDEN LABORATORIES, INCORPORATED |
ANGELEA STRANTZ |
| K023072 |
02/13/2003 |
POWDER FREE NITRILE EXAMINATION GLOVES, PURPLE COLOR |
ARISTA LATINDO INDUSTRIAL, LTD. P.T. |
LINGA SUMARTA |
| K030258 |
02/25/2003 |
FIRST RESPONSE PREGNANCY TEST |
ARMKEL, LLC. |
STEPHEN C KOLAKOWSKY |
| K033637 |
12/17/2003 |
MEDICAL IMAGE DIGITIZER, MODEL 2908 |
ARRAY CORP. |
TAKASHI INAMI |
| K030108 |
02/03/2003 |
ARTHROCARE ENT COBLATOR SURGERY SYSTEM |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K030895 |
12/03/2003 |
ASEPTICO ENDOPEX V, MODEL AEU-40 |
ASEPTICO, INC. |
GRANT RAMALEY |
| K023729 |
02/03/2003 |
SIASCOPE II |
ASTRON CLINICA LIMITED |
E.J. Smith |
| K033256 |
12/30/2003 |
ATHENA PELVIC MUSCLE TRAINER II |
ATHENA FEMININE TECHNOLOGIES, INC. |
BARBARA SARKIS |
| K024090 |
02/28/2003 |
NYLON SUTURE |
AUROLAB |
MICHAEL G PRICE |
| K024091 |
02/28/2003 |
SILK SUTURES |
AUROLAB |
MICHAEL G PRICE |
| K030137 |
02/19/2003 |
MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-358S6, MMT-358M6, MMT-358L6, MMT-358S9, MMT-358M9, AND MMT-358L9 |
AVAIL MEDICAL PRODUCTS, INC. |
COURTLAND IMEL |
| K031612 |
12/11/2003 |
ALT LASER, MODEL VTR 75 |
AVICENNA LASER TECHNOLOGY, INC. |
BRUCE R COREN |
| K032741 |
12/16/2003 |
EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION |
AXON SYSTEMS, INC. |
HOWARD BAILIN |
| K033653 |
12/17/2003 |
VENTURI PHACO PACK |
BAUSCH & LOMB, INC. |
DENNIS POZZO |
| K023664 |
02/21/2003 |
SYNTRA + DIALYZER, MODEL 200 |
BAXTER HEALTHCARE CORP. |
DAVID E CURTIN |
| K030713 |
12/19/2003 |
BAY AREA HYPERSCIENCES |
BAY AREA HYPERSCIENCES, LLC |
EDWARD F GOOD |
| K023944 |
02/11/2003 |
BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST |
BAYER CORP. |
THOMAS F FLYNN |
| K033380 |
12/16/2003 |
BAYER SPECIAL CHEMISTRY CALIBRATORS |
BAYER DIAGNOSTICS CORP. |
ANDRES HOLLE |
| K033379 |
12/19/2003 |
BAYER SPECIAL CHEMISTRY CONTROLS |
BAYER DIAGNOSTICS CORP. |
ANDRES HOLLE |
| K031947 |
12/19/2003 |
BAYER CLINITEK STATUS ANALYZER |
BAYER HEALTHCARE, LLC |
MARY E GRAY |
| K031560 |
12/17/2003 |
BAYER RAPIDLAB 1200 SYSTEM |
BAYER HEALTHCARE, LLC |
MARY E GRAY |
| K032563 |
12/23/2003 |
CLINITEST HCG PREGNANCY TEST |
BAYER HEALTHCARE, LLC |
MARY GRAY |
| K031949 |
12/10/2003 |
TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75 |
BAYLIS MEDICAL CO., INC. |
AMANDA HARTLEY |
| K023752 |
02/07/2003 |
BD INTEGRA SYRINGE |
BD |
PASQUALE AMATO |
| K030091 |
02/28/2003 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML |
BD DIAGNOSTIC SYSTEMS |
KATHRYN BABKA POWERS |
| K033781 |
12/30/2003 |
BEBIG ISOSEED I-125 |
BEBIG ISOTOPEN-UND MEDIZINTECHNIK GMBH |
SVEN LANGER |
| K033038 |
12/29/2003 |
GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688 |
BECKMAN COULTER, INC. |
BRENT TABER |
| K024210 |
02/24/2003 |
IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR |
BECKMAN COULTER, INC. |
ANNETTE HELLIE |
| K033603 |
12/19/2003 |
INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999 |
BECKMAN COULTER, INC. |
VALYNDA MACHEN |
| K033558 |
12/19/2003 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS |
BECTON, DICKINSON & CO. |
BRADFORD SPRING |
| K024153 |
02/10/2003 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE - 0.5-16 UG/ML |
BECTON, DICKINSON & CO. |
MICHELLE B BANDY |
| K030266 |
02/20/2003 |
CEM-OSTETIC BONE; CEMO-10G, CEMO-20G, CEMO-30G, CEMO-40G, CEMO-60G, CEM0-XXGC; CEMO-XYZ202005P, CEMO-XYZ20210P, CEMO-XYZ |
BERKELEY ADVANCED BIOMATERIALS, INC. |
FRANCOIS GENIN |
| K033229 |
12/17/2003 |
(MULTIPLE LABELS) POWDER-FREE VINYL EXAMINATION GLOVES |
BERNARD TECHNOLOGIES, INC. |
MICHAEL D LELAH, PHD |
| K030182 |
02/24/2003 |
LIQUICHEK D-DIMER CONTROL, MODEL 356, 357 |
BIO-RAD |
ELIZABETH PLATT |
| K033366 |
12/12/2003 |
LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454; POSITIVE, MODEL 455 |
BIO-RAD |
MARIA ZEBALLOS |
| K033404 |
12/12/2003 |
LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES) |
BIO-RAD |
MARIA ZEBALLOS |
| K033387 |
12/02/2003 |
QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 |
BIO-RAD |
MARIA ZEBALLOS |
| K032104 |
12/12/2003 |
AMNIOLENS |
BIO-TISSUE, INC. |
DAVID J BLOCH |
| K033398 |
12/12/2003 |
LARYNGEAL AUGMENTATION IMPLANT |
BIOFORM, INC. |
JAMES MILLER |
| K030463 |
02/26/2003 |
MODIFICATION TO THE MAESTRO SYSTEM |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
WINSTON GREER |
| K022803 |
02/03/2003 |
WATERLASE FOR APICOECTOMY |
BIOLASE TECHNOLOGY, INC. |
IOANA M RIZOIU |
| K032268 |
12/11/2003 |
MBCP |
BIOMATLANTE |
MYRIAM VINCENT |
| K021270 |
02/06/2003 |
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-2 |
BIOMEDICAL LIFE SYSTEMS |
HANS REISS |
| K021271 |
02/06/2003 |
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-3 |
BIOMEDICAL LIFE SYSTEMS |
HANS REISS |
| K021588 |
02/13/2003 |
ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS02-5 |
BIOMEDICAL LIFE SYSTEMS, INC. |
RICHARD SAXON |
| K030048 |
02/05/2003 |
HA PMI FEMORAL HIP STEM |
BIOMET ORTHOPEDICS, INC. |
PATRICIA BERES |
| K030178 |
02/26/2003 |
CALCIGEN PSI BONE GRAFT SUBSTITUTE |
BIOMET, INC. |
MARY VERSTYNEN |
| K033519 |
12/05/2003 |
CANNULATED ARTHRORIVET AND CANNULATED RC ARTHRORIVET |
BIOMET, INC. |
GARY BAKER |
| K031804 |
12/18/2003 |
COMPRESS DISTAL FEMORAL REPLACEMENT |
BIOMET, INC. |
GARY BAKER |
| K033280 |
12/19/2003 |
DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEM |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K030086 |
12/17/2003 |
PALACOS R BONE CEMENT WITH GENTAMICIN |
BIOMET, INC. |
LONNIE WITHAM |
| K033383 |
12/23/2003 |
TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200 |
BIOSITE INCORPORATED |
JEFFREY R DAHLEN, PH.D. |
| K030286 |
02/21/2003 |
TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL |
BIOSITE INCORPORATED |
JEFFREY R DAHLEN |
| K023255 |
02/11/2003 |
TECHNOS MP, MODEL AU6 |
BIOSOUND ESAOTE, INC. |
COLLEEN HITTLE DENSMORE |
| K033613 |
12/08/2003 |
MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K030354 |
02/19/2003 |
BISCOVER LIQUID POLISH KIT, BISCOVER LIQUID POLISH AND BISCOVER VISCOSITY MODIFIER |
BISCO, INC. |
STEPHEN D SMITH |
| K024046 |
02/06/2003 |
TESCERA GLAZING RESIN, MODEL T-1804, BISCOVER XT, MODEL G-93220P |
BISCO, INC. |
STEPHEN SMITH |
| K030241 |
02/21/2003 |
MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM |
BLACKSTONE MEDICAL, INC. |
DEAN CIPORKIN |
| K033287 |
12/19/2003 |
EXACTRAC GATING |
BRAINLAB AG |
RAINER BIRKENBACH |
| K024302 |
02/19/2003 |
PRECISION CAPILLARIES FOR MICROMANIPULATION |
BRINKMANN INSTRUMENTS, INC. |
CYNTHIA J.M. NOLTE |
| K033829 |
12/29/2003 |
BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM, MODEL CRE-2100 |
BRUNO INDEPENDENT LIVING AIDS, INC. |
RICHARD KELLER |
| K033752 |
12/12/2003 |
BRUNO ELECTRA-RIDE STAIRWAY ELEVATOR SYSTEM. MODEL SRE-1540 |
BRUNO INDEPENDENT LIVING AIDS, INC. |
RICHARD A KELLER |
| K032029 |
12/18/2003 |
BTG SMARTEST GLUCOSE TEST SYSTEM |
BT MEDICAL |
DEBBIE CHENG |
| K033695 |
12/23/2003 |
IRRIGATION CHANNEL TUBING, MODEL 100135 |
BYRNE MEDICAL, INC. |
J. HARVEY KNAUSS |
| K033562 |
12/12/2003 |
FASTRAC GASTRIC ACCESS PORT KIT |
C.R. BARD, INC. |
THOMAS HIRTE, P.E. |
| K033778 |
12/30/2003 |
MODIFICATION TO BARD AQUAGUIDE URETERAL CONDUIT |
C.R. BARD, INC. |
FRAN HARRISON |
| K030255 |
02/07/2003 |
SILICONE DUAL LUMEN RADPICC CATHETERS |
C.R. BARD, INC. |
PEGGY KEIFFER |
| K024008 |
02/20/2003 |
SMALL BARD VENTRALEX PATCH |
C.R. BARD, INC. |
BRIAN A KANERVIKO |
| K030834 |
12/03/2003 |
CANDELA SMOOTHBEAM LASER SYSTEM |
CANDELA CORP. |
LORRAINE C PATROVIC |
| K033624 |
12/15/2003 |
PACS SOFTWARE SOLUTION 2003 |
CANON U.S.A., INC. |
SEAN M CURRY |
| K030141 |
02/26/2003 |
MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100 |
CARDIOVENTION, INC. |
TESSA YAMUT |
| K032835 |
12/11/2003 |
H/S CATHETER SET |
CATHETER RESEARCH, INC. |
JOHN A STEEN |
| K031599 |
12/09/2003 |
CD LEYCOM PRESSURE/VOLUME CATHETERS |
CD LEYCOM BV |
T. LOPES |
| K033799 |
12/22/2003 |
CLINICAL LASETTE P-200 |
CELL ROBOTICS, INC. |
LINDA A BLAIR |
| K033664 |
12/17/2003 |
MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM |
CENTERPULSE ORTHOPEDICS, INC. |
JEAN ASQUITH |
| K030060 |
02/05/2003 |
SPINEMED |
CERT HEALTH SCIENCES, LLC |
LYNETTE HOWARD |
| K031116 |
12/03/2003 |
VECTRA (INTELECT) EPR ULTRASOUND |
CHATTANOOGA GROUP |
MICK DAVIS |
| K031077 |
12/11/2003 |
VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM |
CHATTANOOGA GROUP |
CHERYL L BAGWELL |
| K031689 |
12/23/2003 |
DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) |
CHF SOLUTIONS, INC. |
AMY PETERSON |
| K032113 |
12/23/2003 |
ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) |
CHROMA VISION MEDICAL SYSTEMS INC. |
DAVID DAVIS |
| K023455 |
02/28/2003 |
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION |
CIBA VISION CORPORATION |
STEVEN DOWDLEY |
| K033701 |
12/15/2003 |
FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES ONE-DAY SOFT CONTACT LENSES |
CIBA VISION CORPORATION |
ALICIA M PLESNARSKI |
| K033147 |
12/30/2003 |
CLEARTOOTH DIGITAL X-RAY SYSTEM |
CLEARTOOTH ELECTRONICS, INC. |
GREG HOLLAND |
| K033020 |
12/19/2003 |
IMPAK ACRYLIC REPAIR RESIN LIQUID |
CMP INDUSTRIES LLC. |
WILLIAM REGAN |
| K033524 |
12/18/2003 |
COAPT ENDOTINE CHIN 3.5 DEVICE |
COAPT SYSTEMS, INC. |
LORI DONDIEGO |
| K023914 |
02/21/2003 |
COAXIA FLOCONTROL CATHETER |
COAXIA INC |
GREGORY W SACHS |
| K033641 |
12/11/2003 |
SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800 |
COBE CARDIOVASCULAR, INC. |
LYNNE LEONARD |
| K032920 |
12/16/2003 |
THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003 |
COEUR MEDICAL |
DEBRA F MANNING |
| K022416 |
02/03/2003 |
CONTREET FOAM ADHESIVE/NON-ADHESIVE |
COLOPLAST CORP. |
ELIZABETH BOOTS |
| K031618 |
12/18/2003 |
COMFORT VARIOUS OF STANDING WHEELCHAIR, HERO 2 |
COMFORT ORTHOPEDIC CO. LTD. |
ERIC H.C. LEE |
| K033052 |
12/17/2003 |
CONDUCTIVE EEG ELECTROLYTE |
COMPUMEDICS USA, LTD. |
ELVIRA GARCIA |
| K030240 |
02/21/2003 |
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER |
COMPUTER MOTION, INC. |
CATHY STUPAK |
| K032762 |
12/02/2003 |
XIO RADIATION TREATMENT PLANNING SYSTEM |
COMPUTERIZED MEDICAL SYSTEMS, INC. |
KATHRYN STINSON |
| K030116 |
02/12/2003 |
ENHANCE-S PLUS H |
CONCEPTION TECHNOLOGY, INC. |
GRACE HOLLAND |
| K023987 |
02/26/2003 |
CONTAFLEX 38 (POLYMACON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) |
CONTAMAC LTD. |
MARTIN DALSING |
| K023989 |
02/26/2003 |
CONTAFLEX 55 (METHAFILCON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) |
CONTAMAC LTD. |
MARTIN DALSING |
| K024045 |
02/14/2003 |
CONTAFLEX GM3 49% (ACOFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) |
CONTAMAC LTD. |
MARTIN DALSING |
| K022865 |
02/13/2003 |
6203 |
CONTEMPORARY PRODUCTS, INC. |
BARRY A SCHWARTZ |
| K022709 |
02/20/2003 |
MEDLITE Q-SWITHCED LASER |
CONTINUUM ELECTRO-OPTICS, INC. |
DAVID W SCHLERF |
| K024050 |
02/27/2003 |
COOK NEPHROSTOMY DILATION BALLOON CATHETER SET |
COOK UROLOGICAL, INC. |
DEBBIE SCHMITT |
| K033348 |
12/15/2003 |
ZILVER 518 BILIARY STENT |
COOK, INC. |
LELAND KEYT |
| K033394 |
12/22/2003 |
CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM |
CORDIS CORP. |
KAREN WILK |
| K023463 |
02/19/2003 |
CVSI PERIPHERAL BALLOON CATHETER; CVSI CATHETER INFLATION UNIT |
CRYOVASCULAR SYSTEMS, INC. |
R. MICHAEL CROMPTON |
| K030338 |
02/12/2003 |
ICLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0002 |
CURELIGHT LTD |
JONATHAN S KAHAN |
| K020534 |
02/11/2003 |
MEDSTAR SYSTEM, MODELS 533-300 |
CYBERNET MEDICAL |
DAVID A.C. GREEN |
| K023707 |
02/12/2003 |
A16 BLOOD FLOW MEASUREMENT SYSTEM |
D. E. HOKANSON, INC. |
D. EUGENE HOKANSON |
| K033156 |
12/09/2003 |
OB1 OBSTETRICAL DOPPLER |
D. E. HOKANSON, INC. |
D. EUGENE HOKANSON |
| K022891 |
02/19/2003 |
THE BREATHE EZ ANTI-SNORING DEVICE |
D&S REDHAGE |
DANIEL J REDHAGE |
| K024038 |
02/13/2003 |
N LATEX IGA |
DADE BEHRING, INC. |
KATHLEEN A DRAY-LYONS |
| K033487 |
12/24/2003 |
STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI |
DADE BEHRING, INC. |
GEORGE M PLUMMER |
| K032955 |
12/15/2003 |
AUTOMOVE, MODEL AM800 |
DANMETER A/S |
HANNE NIELSEN |
| K032988 |
12/03/2003 |
ELPHA 4 CONTI |
DANMETER A/S |
HANNE NIELSEN |
| K023868 |
02/07/2003 |
DAN KERRISON RONGEURS, MODELS K1 + BILLY 1 |
DANNORITZER MEDICAL INSTRUMENTS |
DAGMAR S MASER |
| K031124 |
12/04/2003 |
POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR |
DATEX-OHMEDA, INC. |
AL VAN HOUDT |
| K030307 |
02/13/2003 |
DAVOL ARTHROVENT OUTFLOW TUBING |
DAVOL, INC. |
LUCINDA L FOX |
| K033705 |
12/04/2003 |
BOBCAT PRO SCALER SYSTEM, MODEL G-130 |
DENTSPLY INTERNATIONAL |
P. JEFFERY LEHN |
| K030111 |
02/07/2003 |
DIAMONDCOAT ULTRASONIC INSERTS |
DENTSPLY INTERNATIONAL |
P. JEFFERY LEHN |
| K033553 |
12/02/2003 |
PFZ PORCELAIN SYSTEM |
DENTSPLY INTL. |
P. JEFFERY LEHN |
| K030383 |
02/26/2003 |
MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS |
DEPUY ACROMED |
LISA GILMAN |
| K030103 |
02/05/2003 |
SUMMIT OCT SPINAL SYSTEM MINIPOLYAXIAL SCREWS |
DEPUY ACROMED |
FRANK MASS |
| K030249 |
02/14/2003 |
SURGICAL TITANIUM MESH SYSTEM |
DEPUY ACROMED |
KAREN F JURCZAK |
| K032659 |
12/04/2003 |
DEPUY ASR RESURFACING FEMORAL HEADS |
DEPUY ORTHOPAEDICS, INC. |
Natalie Heck |
| K033516 |
12/03/2003 |
DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS |
DEPUY ORTHOPAEDICS, INC. |
TIFFANI D ROGERS |
| K030122 |
02/05/2003 |
DEPUY SUMMIT BASIC PRESS-FIT HIP STEM |
DEPUY ORTHOPAEDICS, INC. |
CHERYL HASTINGS |
| K023012 |
02/13/2003 |
SMARTSET HV BONE CEMENT |
DEPUY ORTHOPAEDICS, INC. |
JANET JOHNSON |
| K033234 |
12/12/2003 |
IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD LEVINE |
| K033063 |
12/12/2003 |
MISSION CONTROLS |
DIAMOND DIAGNOSTICS, INC. |
LINDA M STUNDTNER |
| K033714 |
12/11/2003 |
MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING |
DIDECO S.P.A. |
BARRY SALL |
| K030085 |
02/05/2003 |
CARDIUS-1 AND CARDIS-2 |
DIGIRAD CORP. |
COREY STEWART |
| K032171 |
12/15/2003 |
ACCUSOFT |
DIREX SYSTEMS CORP. |
LARISA GERSHTEIN |
| K032358 |
12/17/2003 |
B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM) |
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
JONANTHAN S KAHN |
| K033600 |
12/11/2003 |
INFINITY GAMMAXL |
Draeger Medical Systems, Inc. |
PENELOPE H GRECO |
| K022340 |
02/19/2003 |
TRAVELAIR PORTABLE COMPRESSION SYSTEM |
DYNAMIC AIR, INC. |
BRENT KNIGHT |
| K033635 |
12/03/2003 |
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM |
EBI, L.P. |
FREDERIC TESTA |
| K033250 |
12/30/2003 |
EDWARDS LIFESCIENCES VANTEX CENTRAL VENOUS CATHETERS WITH THERMISTOR |
EDWARDS LIFESCIENCES, LLC. |
JASON SMITH |
| K032900 |
12/04/2003 |
LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED VASCULAR GRAFTS, STEPPED VASCULAR GRAFTS |
EDWARDS LIFESCIENCES, LLC. |
Daun Putnam |
| K033795 |
12/19/2003 |
PLASMACURE BXE |
EELE LABORATORIES, LLC |
ROBERT GRASMAN |
| K023407 |
02/14/2003 |
ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR |
ELAN DIAGNOSTICS |
WYNN STOCKING |
| K022071 |
02/14/2003 |
EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF4000 |
EMBOL-X, INC. |
ED LEE |
| K033206 |
12/18/2003 |
EPW FOLDABLE POWER WHEELCHAIR, EPW-03 |
EMG TECHNOLOGY CO., LTD. |
JEN KE-MIN |
| K023603 |
02/19/2003 |
ENDO-GLIDE GUIDEWIRE |
ENDO-THERAPEUTICS, INC. |
TODD ADKISSON |
| K023683 |
12/01/2003 |
MULTI-STRAP FULL FACE MASK |
ENGINEERED MEDICAL SYSTEMS |
PAUL DRYDEN |
| K031267 |
12/23/2003 |
STERICHEK BICARB PH REAGENT STRIPS |
ENVIRONMENTAL TEST SYSTEMS, INC. |
DAVID A MORRIS |
| K021138 |
02/12/2003 |
SLEEPSCREEN/APNOESCREEN CARDIO |
ERICH JAEGER GMBH |
BRIAN LONG |
| K033138 |
12/02/2003 |
CAP3 BONE SUBSTITUTE MATERIAL |
ETEX CORP. |
PAMELA W ADAMS |
| K033269 |
12/10/2003 |
ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE RELOAD |
ETHICON ENDO-SURGERY, INC. |
GEORGIA C ABERNATHY |
| K033568 |
12/08/2003 |
GYNECARE TVT OBTURATOR SYSTEM |
ETHICON, INC. |
SEAN O'BRYAN |
| K033746 |
12/18/2003 |
MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE |
ETHICON, INC. |
REY LIBROJO |
| K033544 |
12/10/2003 |
ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607 |
EVERYWAY MEDICAL INSTRUMENTS CO., LTD. |
JAY MANSOUR |
| K030236 |
02/20/2003 |
ACUMATCH P-SERIES POROUS PRESS-FIT FEMORAL COMPONENT |
EXACTECH, INC. |
GARY MILLER |
| K031818 |
12/03/2003 |
FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE |
FACILAI ENTERPRISES LTD. |
Ke-Min Jen |
| K030054 |
02/26/2003 |
DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES |
FCI OPHTHALMICS, INC. |
HILLARD WELCH |
| K032208 |
12/09/2003 |
MONA LISA ASPIRATION NEEDLE |
FERTILITY TECHNOLOGY RESOURCES, INC. |
CONSTANCE W STURGEON |
| K031649 |
12/05/2003 |
SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES |
FINK ENGINEERING PTY LTD |
W.T. WORKMAN |
| K021193 |
02/12/2003 |
FORTUNE SILICONE VACUUM SUCTION, MODEL #1300 |
FORTUNE MEDICAL INSTRUMENT CORP. |
TAIPEI HSIEN |
| K033510 |
12/03/2003 |
MODIFICATION TO TELEGRAPH HUMERAL NAIL |
FOURNITURES HOSPITALIERES INDUSTRIE |
CHRISTINE QUENDEZ |
| K023799 |
02/05/2003 |
FRIOS ALGIPORE |
FRIADENT GMBH |
CAROL PATTERSON |
| K033542 |
12/05/2003 |
EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE |
GALT MEDICAL CORP. |
DAVID CATLIN |
| K023988 |
02/04/2003 |
GE DISCOVERY LS SYSTEM |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K033874 |
12/30/2003 |
MYOLIGHT |
GE MEDICAL SYSTEMS F.I. HAIFA |
LAURENCE BIGIO |
| K030431 |
02/26/2003 |
MODIFICATION TO DASH 3000/4000 PATIENT MONITOR |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
KAREN M LUNDE |
| K033672 |
12/18/2003 |
MODIFICATION TO UNITY NETWORK ID |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
DIANA M THORSON |
| K033400 |
12/04/2003 |
SENO ADVANTAGE |
GE MEDICAL SYSTEMS W-400 |
LARRY A KROGER, PH.D. |
| K024003 |
02/05/2003 |
GELFLEX DELTA SOFT CONTACT LENS MATERIAL METHAFILCON A 55% WATER CONTENT CLEAR OR BLUE VISITINT, GELFLEX ALPHA SOFT CONT |
GELFLEX |
PETER G BRYANT |
| K032720 |
12/10/2003 |
GEM-STIM TENS, MODELS GM3XY AND GM3AXY |
GEMORE TECHNOLOGY CO., LTD. |
BODEN S.P. LAI |
| K032994 |
12/16/2003 |
GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING) |
GEMORE TECHNOLOGY CO., LTD. |
BODEN S.P. LAI |
| K032719 |
12/10/2003 |
GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIFFERENT HOUSING) |
GEMORE TECHNOLOGY CO., LTD. |
BODEN S.P. LAI |
| K032554 |
12/31/2003 |
GEN-PROBE APTIMA COMBO 2 ASSAY |
GEN-PROBE, INC. |
ALAN MADERAZO |
| K032194 |
12/24/2003 |
TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS |
GEN-PROBE, INC. |
WAYNE A KVETKOSKY |
| K033360 |
12/23/2003 |
DIAZYME LITHIUM ENZYMATIC ASSAY KIT |
GENERAL ATOMICS |
CHONG YUAN |
| K033867 |
12/19/2003 |
GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS |
GENERAL ELECTRIC CO. |
LARRY A KROGER |
| K030199 |
02/11/2003 |
GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM |
GENERAL ELECTRIC CO. |
DAVID DUERSTELER |
| K022980 |
02/27/2003 |
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM |
GIVEN IMAGING LTD. |
SHOSHANA (SHOS) FRIEDMAN |
| K021153 |
02/10/2003 |
GOLDWAY DIGITAL VIDEO COLPOSCOPE IMAGING SYSTEM, MODEL #SLC-2000 |
GOLDWAY US, INC. |
Y. JUSTIN CHEN |
| K033478 |
12/29/2003 |
VACUETTE QUICKSHIELD SAFETY TUBE HOLDER |
GREINER BIO-ONE VACUETTE NORTH AMERICA |
Judi Smith |
| K023630 |
02/20/2003 |
ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, MODEL SY-1400 |
GUIDANT CORPORATION, CARDIAC SURGERY |
RON ALLEN |
| K024071 |
02/14/2003 |
GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM |
GUIDANT CORPORATION, CARDIAC SURGERY |
DEBBIE COGAN |
| K033161 |
12/18/2003 |
VISU-LOCK 5MM CLIP APPLIER |
GYRX, LLC |
CORY EDWARDS |
| K030361 |
02/21/2003 |
JASUN, MODELS DT-01F AND DT-11F |
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., |
TING LU |
| K033054 |
12/16/2003 |
HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP |
HARVARD CLINICAL TECHNOLOGY |
ERIC J FLACHBART |
| K023854 |
02/14/2003 |
SAMARITAN AED, MODEL SAM-01 |
HEARTSINE TECHNOLOGIES, INC. |
WILLIAM J SMIRLES |
| K023761 |
02/14/2003 |
PLATELETWORKS, MODELS PW-A, PW-C |
HELENA LABORATORIES |
PATRICIA FRANKS |
| K024162 |
02/19/2003 |
SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 |
HELENA LABORATORIES |
ERIC PETERSEN |
| K023863 |
02/07/2003 |
AUTOMED 3000 INFUSION PUMP |
HELP TECHNOLOGIES |
ROBERT J BARD |
| K023973 |
02/27/2003 |
AUTOMED 3200 INFUSION PUMP |
HELP TECHNOLOGIES |
ROBERT J BARD |
| K032127 |
12/30/2003 |
HEMEDEX FIXATION DEVICE |
HEMEDEX INCORPORATED |
DEBBIE IAMPIETRO |
| K022251 |
02/26/2003 |
PALABOND |
HERAEUS KULZER GMBH & CO. KG |
K. D. KUHN |
| K033665 |
12/30/2003 |
VENUS FLOW |
HERAEUS KULZER, INC. |
CHERYL V ZIMMERMAN |
| K033629 |
12/22/2003 |
VERSYO.BOND |
HERAEUS KULZER, INC. |
CHERYL V ZIMMERMAN |
| K032855 |
12/10/2003 |
STRYKER SPINE MAPS SYSTEM |
HOWMEDICA OSTEONICS |
KAREN ARIEMMA |
| K023724 |
02/03/2003 |
DURACON CS LIPPED EXTRA SMALL TIBIAL INSERT |
HOWMEDICA OSTEONICS CORP. |
MARGARET F CROWE |
| K032829 |
12/10/2003 |
SCORPIO LOW PROFILE TIBIAL TRAY |
HOWMEDICA OSTEONICS CORP. |
MARGARET F CROWE |
| K022747 |
02/11/2003 |
HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM; HYDROPURE BACK-UP PEDI SYSTEM |
HYDROPURE SYSTEMS, INC. |
ROBERT V PRICE |
| K032821 |
12/05/2003 |
HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF |
HYGIA HEALTH SERVICES, INC. |
TRACY W COMAS |
| K021692 |
12/04/2003 |
CLC2000 CATHETER PATENCY DEVICE |
ICU MEDICAL, INC. |
ALISON D BURCAR |
| K023848 |
02/14/2003 |
MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64: |
IGC-MEDICAL ADVANCES, INC. |
R. JERRY FROHLICH |
| K023949 |
02/25/2003 |
NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES |
IMAGE-GUIDED NEUROLOGICS, INC. |
DAVID M LEE |
| K033242 |
12/31/2003 |
KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS) |
IMAGING THERAPEUTICS, INC. |
LYNDALL ERB |
| K032571 |
12/24/2003 |
IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA |
IMMCO DIAGNOSTICS, INC. |
KEVIN LAWSON |
| K032251 |
12/19/2003 |
IMMUNETECH TOTAL IGE SYSTEM |
IMMUNETECH CORPORATION |
VIVIANNE NOETZEL |
| K023882 |
02/19/2003 |
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM |
IMPLEX CORP. |
ROBERT POGGIE |
| K024044 |
02/21/2003 |
SABER TECH IMPLANTS SYSTEM |
IMTEC CORP. |
J BRAD VANCE |
| K033602 |
12/16/2003 |
INSORB ABSORBABLE STAPLE, MODEL SP-B20 |
INCISIVE SURGICAL, INC. |
JIM PETERSON |
| K030215 |
02/24/2003 |
BIORAPID MONONUCLEOSIS |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K024082 |
02/12/2003 |
HEMOSIL FACTOR VII DEFICIENT PLASMA |
INSTRUMENTATION LABORATORY CO. |
CAROL MABLE |
| K033631 |
12/15/2003 |
MODIFICATION TO COATEST FACTOR VIII |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K032663 |
12/19/2003 |
QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2 |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K031373 |
12/19/2003 |
IXL DIABETES MANAGEMENT SYSTEM |
INSULET CORP. |
A. ARTHUR RANKIS |
| K030289 |
02/26/2003 |
HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830N |
INTEGRA LIFESCIENCES CORP. |
DONNA WALLACE |
| K033698 |
12/17/2003 |
CONTOUR-FLEX VALVE AND SHUNT SYSTEM |
INTEGRA NEUROSCIENCES IMPLANTS S.A. |
JUDITH E O'GRADY |
| K033040 |
12/17/2003 |
PHOENIX INFANT RADIANT WARMER, MODEL 100NWS |
INTERNATIONAL HOSPITAL SUPPLY CO. |
DAGMAR MASER |
| K031322 |
12/23/2003 |
INTRA-LOCK HYDROXYAPATITE COATED IMPLANTS |
INTRA-LOCK INTERNATIONAL |
JEFFERY SAKOFF |
| K033708 |
12/11/2003 |
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM |
INTRALUMINAL THERAPEUTICS, INC. |
PAMELA MISAJON |
| K022642 |
02/11/2003 |
TWLIGHT, MODEL ISP 9600 |
INVACARE CORP. |
RAE ANN FARROW |
| K033192 |
12/22/2003 |
RH-950 |
IOMED, INC. |
CURTIS JENSEN |
| K032887 |
12/19/2003 |
PHENOL RED STOCK SOLUTION |
IRVINE SCIENTIFIC SALES CO., INC. |
WENDELL LEE |
| K032779 |
12/17/2003 |
MODIFICATION TO: NUCAMMA RX |
IS2 RESEARCH, INC. |
VICTOR WOODBURN |
| K023824 |
02/14/2003 |
ALBUMIN COBALT BINDING TEST (ACB TEST) |
ISCHEMIA TECHNOLOGIES, INC. |
PETER CROSBY |
| K024094 |
02/14/2003 |
4 SEASONS |
IVOCLAR VIVADENT, INC. |
DONNA MARIE HARTNETT |
| K033520 |
12/05/2003 |
BLUEPHASE |
IVOCLAR VIVADENT, INC. |
DONNA MARIE HARTNETT |
| K023925 |
02/11/2003 |
MARK I THERMAL IMAGER |
IX-DR, INC. |
WILLIAM J O'NEILL |
| K022863 |
02/04/2003 |
HTS COIL |
JOCKEY CLUB MRI ENGINEERING CENTER |
EDWARD S YANG |
| K022483 |
02/03/2003 |
ACTISORB SILVER 220 ANTIMICROBIAL BINDING DRESSING |
JOHNSON & JOHNSON MEDICAL, LTD. |
PATRICIA FLOOD |
| K030264 |
02/26/2003 |
QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030 |
JOSTRA AG |
KATRIN SCHWENKGLENKS |
| K032643 |
12/02/2003 |
JUSTWIN SCOOTER, JS-3013 |
JOY RIDE TECH CO., LTD. |
JEN KE-MIN |
| K032645 |
12/02/2003 |
JUSTWIN SCOOTER, JS-3014 |
JOY RIDE TECH CO., LTD. |
JEN KE-MIN |
| K033166 |
12/12/2003 |
KACEY INSULIN SYRINGE |
KACEY, INC. |
CHARLES F NEILSON, PHD |
| K023828 |
02/04/2003 |
K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR |
KAMIYA BIOMEDICAL CO. |
BRIAN SCHLIESMAN |
| K023924 |
02/21/2003 |
AUTOCON II 200 ELECTROSURGICAL GENERATOR |
KARL STORZ ENDOSCOPY |
JAMES A LEE |
| K023917 |
02/26/2003 |
WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR |
KAWASUMI LABORATORIES, INC. |
DONALD R STONE |
| K023830 |
02/04/2003 |
AIROCIDE TI02 |
KES SCIENCE & TECHNOLOGY, INC |
JOHN HAYMAN, JR |
| K032950 |
12/19/2003 |
GEM INSET PATELLAR COMPONENT |
KINAMED, INC. |
VINEET SARIN |
| K022011 |
02/26/2003 |
V.A.C. ABDOMINAL DRESSING |
KINETIC CONCEPTS, INC. |
JUDITH A HARBOUR |
| K024233 |
02/06/2003 |
KOMPRESSOR SCREW SYSTEM |
KINETIKOS MEDICAL, INC. |
JOHN G SPAMPINATO |
| K030037 |
02/05/2003 |
UNIVERSAL TOTAL WRIST SYSTEM |
KINETIKOS MEDICAL, INC. |
JOHN SPAMPINATO |
| K021469 |
02/12/2003 |
MINOLTA PULSOX-2 |
KONICA MINOLTA SENSING, INC. |
NANCI DEXTER |
| K023842 |
02/11/2003 |
CLEARFIL SE BOND PLUS |
KURARAY MEDICAL INC. |
MASAYA SASAKI |
| K033267 |
12/22/2003 |
EPRICORD |
KURARAY MEDICAL INC. |
SATOSHI YAMAGUCHI |
| K033916 |
12/30/2003 |
GRI-BAG, GRI-BAG AP |
LABORATORIOS GRIFOLS, S.A. |
SEBASTIAN GASCON |
| K033682 |
12/17/2003 |
SET GRI-FILL 2.0-1 WAY; 2.0-2 WAYS; LUER CONNECTION TUBE |
LABORATORIOS GRIFOLS, S.A. |
SEBASTIAN GASCON |
| K023805 |
02/11/2003 |
LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050 |
LAERDAL MEDICAL A/S |
MAGNE STEINSET |
| K033758 |
12/19/2003 |
HYDROPHILIC GUIDEWIRE |
LAKE REGION MFG., INC. |
KAREN MORTENSEN |
| K022813 |
02/14/2003 |
STEERABLE GUIDEWIRE |
LAKE REGION MFG., INC. |
KAREN MORTENSEN |
| K033159 |
12/19/2003 |
LEMAITRE VASCULAR STRAIGHT CAROTID SHUNT, MODEL 2002-01, 2002-05, 2003-01, 2003-05, 2004-01, 2004-05, 2005-01, 2005-05 |
LEMAITRE VASCULAR, INC. |
BRIAN K KEOGH |
| K021580 |
02/12/2003 |
OPTILOCK IMPLANTABLE ACCESS PORT, MODELS #1700-01, 1700-02, 1700-03, 1700-04 AND 1700-05 |
LEMAITRE VASCULAR, INC. |
JAMES ASHBY |
| K023787 |
02/14/2003 |
TAI-CHI AND MASTER ACUPUNCTURE NEEDLES |
LHASA MEDICAL, INC. |
KYUNG P RIIHIMAKI |
| K024194 |
02/07/2003 |
ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS |
LIFESCAN, INC. |
MARY ELLEN HOLDEN |
| K033094 |
12/19/2003 |
ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT) |
Lin-Zhi International, Inc. |
CHENG-I LIN |
| K033804 |
12/31/2003 |
BIOANCHOR WITH DISPOSABLE DRIVER |
LINVATEC CORP. |
LAURA D KREJCI |
| K033748 |
12/15/2003 |
TRIDENT RESECTION ABLATOR |
LINVATEC CORP. |
LAURA D KREJCI |
| K033657 |
12/19/2003 |
MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V |
LIVING DATA TECHNOLOGIES CORPORATION |
SUSAN D GOLDSTEIN-FALK |
| K033202 |
12/03/2003 |
ADVANTAGE PADDLE |
LIVINGSTON PRODUCTS, INC. |
DANIEL KAMM |
| K023838 |
02/20/2003 |
LUNEAU STERILE TONOMETER SEPARATION PRISMS |
LUNEAU SA |
JEAN N YOUNG |
| K023643 |
02/21/2003 |
MACROPORE SURGICAL BARRIER FILM |
MACROPORE BIOSURGERY, INC. |
KENNETH K KLEINHENZ |
| K023725 |
02/03/2003 |
HEMORRHAGE OCCLUDER PIN (HOP), MODEL 337-247 |
MARINA MEDICAL INSTRUMENTS, INC. |
JAY MANSOUR |
| K033298 |
12/12/2003 |
SPO2.COM OXIMETRY SENSORS, MULTIPLE MODELS |
MASIMO CORP. |
JAMES J CRONIN |
| K032968 |
12/02/2003 |
TRSANSDERM IONTO SYSTEM |
MATTIOLI ENGINEERING CORP. |
MELISSA MAHALL |
| K032735 |
12/03/2003 |
SPECTRA QT: Q-SWITCHED ND: YAG LASER SYSTEM |
MAX ENGINEERING LTD. |
MAUREEN O'CONNELL |
| K022959 |
02/05/2003 |
SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1 |
MDC RESEARCH LTD. |
CAROL PATTERSON |
| K022214 |
02/26/2003 |
MSI I2010 DUAL PLACE HYPERBARIC CHAMBER |
MECHIDYNE SYSTEMS, INC. |
AUDREY L AARON |
| K033666 |
12/17/2003 |
HEMADERM |
MEDAFOR, INC. |
JENNIFER A MAY |
| K022678 |
02/24/2003 |
MEDCOMP SC4 |
MEDCOMP |
FLORENCE A CAIKOSKI |
| K033412 |
12/30/2003 |
MEDICLUNG, RELEASE 1 |
MEDICSIGHT |
CAROL MACDONALD |
| K032928 |
12/19/2003 |
MEDIPHYSICS PAIN TREATMENT SYSTEM, MODEL 1 |
MEDIPHYSICS PAIN CENTERS OF AMERICA |
JAMES ROGERS |
| K032362 |
12/04/2003 |
UP-GRADE FOREHEAD THERMOMETER |
MEDISIM LTD. |
DALIA GIVONY |
| K033906 |
12/24/2003 |
PORTASCAN BLADDER SCANNER, MODEL PA00146 |
MEDIWATCH PLC |
ANDREW HOPKINS |
| K032810 |
12/05/2003 |
DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B), DURAN ANCORE RING (MODEL 620R), DURAN ANCORE |
MEDTRONIC HEART VALVES |
JULIE SHERMAN |
| K033322 |
12/15/2003 |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD W TREHARNE |
| K030327 |
02/26/2003 |
ZEPHIR ANTERIOR CERVICAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K033495 |
12/03/2003 |
MODIFICATION TO EQUATION FIXATION SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
| K030285 |
02/25/2003 |
MODIFICATION TO TSRH SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD W TREHARNE |
| K024049 |
02/26/2003 |
VERTE-SPAN SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
| K030106 |
02/12/2003 |
STEALTHSTATION SYSTEM ADVANCED CONTOUR REGISTRATION SOFTWARE MODULE |
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES |
VICTORIA G RENDON |
| K032222 |
12/05/2003 |
IMMUNOCARDSTAT HPSA |
MERIDIAN BIOSCIENCE, INC. |
SUSAN ROLIH |
| K023238 |
02/19/2003 |
MCPULSE |
MERIDIAN CO., LTD. |
DANIEL KAMM |
| K024052 |
02/21/2003 |
MERIT MEDICAL 1-ML SYRINGE |
MERIT MEDICAL SYSTEMS, INC. |
STEPHANIE A ERSKINE |
| K033082 |
12/03/2003 |
9 SECOND DIGITAL THERMOMETER, MODEL BT-S09 |
METATECH CO., LTD. |
GUENTER GINSBERG |
| K033847 |
12/23/2003 |
A1CNOW FOR HOME AND PROFESSIONAL USE |
METRIKA, INC. |
ERIKA AMMIRATI |
| K024164 |
02/12/2003 |
COMFORTKONE KERATOCONUS ASPHERIC (HYBUFOCON A, FILOFILCON A, PEMUFOCON A) RIGID GAS PERMEABLE (RGP) DAILY WEAR CONTACT |
METRO OPTICS, INC. |
DEANNA WERBER |
| K030410 |
02/20/2003 |
ACCOUSONIC PLUS, MODEL AP-170 |
METRON MEDICAL AUSTRALIA PTY LTD |
DAVE TOMAN |
| K023083 |
02/28/2003 |
SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800 |
METTLER ELECTRONICS CORP. |
ROBERT E FLEMING |
| K031102 |
12/01/2003 |
MICROLAB SPIROMETER |
MICRO DIRECT, INC. |
DAVID R STASZAK |
| K024118 |
02/03/2003 |
ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, MODELS 105-5065 AND 105-5066 |
MICRO THERAPEUTICS, INC. |
Bill Hyatt |
| K023780 |
02/10/2003 |
DRI PRIMIDONE CALIBRATORS |
MICROGENICS CORP. |
LAKSHMI ANNE |
| K033836 |
12/30/2003 |
HYDROCOIL EMBOLIC SYSTEM (HES) |
MICROVENTION, INC. |
VINCENT CUTARELLI |
| K022186 |
02/26/2003 |
SCLERAL PLUGS, 19 AND 20 GAUGE |
MICROVISION, INC. |
LEONARD KASTRILEVICH |
| K032690 |
12/09/2003 |
MISONIX INC. FS 1000 RF ULTRASONIC SURGICAL ASPIRATOR SYSTEM |
MISONIX, INC. |
RONALD R MANNA |
| K023966 |
02/27/2003 |
DISPOSABLE BI-POLAR CABLE |
MODERN MEDICAL EQUIPMENT MFG., LTD. |
ROGER STRUBE |
| K032841 |
12/10/2003 |
MOORLDI INFRARED LASER DOPPLER IMAGER, MODEL MOORLD12-IR |
MOOR INSTRUMENTS LTD. |
DAVID BOGGETT |
| K024128 |
02/10/2003 |
ALLON 2001 VERSION 5 |
MTRE ADVANCED TECHNOLOGY LTD. |
DOUGLAS RASH |
| K023494 |
02/07/2003 |
NELLCOR INDGO MANUAL RESUSCITATOR |
NELLCOR PURITAN BENNETT, INC. |
GINA TO |
| K024304 |
02/25/2003 |
MICROSURGICAL BIPOLAR HANDPIECE |
NEOMEDIX CORP. |
SOHEILA MIRHASEMI |
| K024279 |
02/05/2003 |
NESS CHILDREN SYSTEM |
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS |
JONATHAN S KAHAN |
| K023771 |
02/06/2003 |
SYNAMPS2 |
NEUROSCAN |
ELVIRA GARCIA |
| K030485 |
12/03/2003 |
NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR |
NEWMEDICAL TECHNOLOGY, INC. |
HAITHAM MATLOUB |
| K032902 |
12/15/2003 |
SUBTALAR ARTHRORISIS IMPLANT |
NEXA ORTHOPEDICS, INC. |
LOUISE M FOCHT |
| K033046 |
12/23/2003 |
SUBTALAR PEG IMPLANT |
NEXA ORTHOPEDICS, INC. |
LOUISE M FOCHT |
| K024363 |
02/19/2003 |
NEXUS INJECTION SITE (NIS), MODEL NIS-1 |
NEXUS MEDICAL, LLC |
JAMIE ABOURCHED |
| K031733 |
12/04/2003 |
NON-CONTACT TONOMETER, MODEL NT-4000 |
NIDEK, INC. |
CAROL PATTERSON |
| K030257 |
02/10/2003 |
NOBEL PERFECT IMPLANT SYSTEM |
NOBEL BIOCARE UAS INC |
ELIZABETH J MASON |
| K031968 |
12/22/2003 |
CERABIEN ZR |
NORITAKE CO., INC. |
IVAN J WASSERMAN |
| K030126 |
02/07/2003 |
NPAC MULTI-USE EAR THERMOMETER, MODELS TD 600,610,620,630,602,612,622,632, TN 600,610,620,630,602,612,622,632, TS 600,6 |
NORM PACIFIC AUTOMATION CORP. |
CHI-CHU WU CHEN |
| K023899 |
02/20/2003 |
DUAL YELLOW LASER, MODEL D10B |
NORSELD PTY., LTD. |
ROGER W BARNES |
| K032309 |
12/04/2003 |
NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESSORY |
NOVELENS, INC. |
RICHARD E LIPPMAN |
| K030045 |
02/21/2003 |
OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114) |
OLYMPUS AMERICA, INC. |
MICHAEL CAMPBELL |
| K030124 |
02/06/2003 |
OLYMPUS FERRITIN REAGENT |
OLYMPUS AMERICA, INC. |
MICHAEL CAMPBELL |
| K021852 |
02/11/2003 |
OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM & ITS ASSOCIATED ACCESSORIES |
OLYMPUS OPTICAL CO., LTD. |
LAURA STORMS-TYLER |
| K023843 |
02/14/2003 |
SMARTSTITCH M-CONNECTOR, MODEL OM-8005; SMARTSTITCH ACTUATION HANDLE, MODEL OM-8500; AND SMARTSTITCH SUTURE CARTRIDGE |
OPUS MEDICAL, INC. |
JAMES W HART |
| K033317 |
12/30/2003 |
SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070 |
OPUS MEDICAL, INC. |
LAURA N KASPEROWICZ |
| K014001 |
02/04/2003 |
DISTRACTION OSTEOGENESIS ROD APPLIANCES, MODELS 1, 2, AND 3 |
ORAL OSTEODISTRACTION, L.P. |
ARTHUR WARD |
| K023248 |
02/11/2003 |
LIFESTENT LP SDS BILIARY ENDOPROSTHESIS |
ORBUS MEDICAL TECHNOLOGIES |
JIM CLOSSICK |
| K030299 |
02/25/2003 |
TEMPTELLER INFARED EAR THERMOMETERS, MODEL CT-31/31DX/32/32DX |
ORIENTAL SYSTEM TECHNOLOGY, INC. |
SUSAN D GOLDSTEIN-FALK |
| K024193 |
02/21/2003 |
MODIFICATION TO VITROS IMMUNDODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/CALIBRATORS |
ORTHO-CLINICAL DIAGNOSTICS |
ANN M QUINN |
| K022364 |
02/04/2003 |
NAVITRACK SYSTEM TOTAL HIP REPLACEMENT,MODEL 900.200 |
ORTHOSOFT, INC. |
CHRISTOPHER MCLEAN |
| K030252 |
02/21/2003 |
ORIA SPINAL CLIP SYSTEM EXTENDED OMNIAXIAL CONNECTORS (CO05 & CO07) |
ORTHOTEC, L.L.C. |
PATRICK BERTRANOU |
| K030253 |
02/21/2003 |
ORIA SPINAL CLIP SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06 |
ORTHOTEC, L.L.C. |
|
| K023994 |
02/05/2003 |
ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJ |
ORTHOTEC, L.L.C. |
PATRICK BERTRANOU |
| K032812 |
12/08/2003 |
ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT |
ORTHOVITA, INC. |
DAVID J MCILHENNY |
| K032288 |
12/19/2003 |
VITOSS SCAFFOLD FOAM BONE GRAFT MATERIAL |
ORTHOVITA, INC. |
GINA M NAGVAJARA |
| K023414 |
12/05/2003 |
MIDA ALGORITHM REV. B |
ORTIVUS AB |
KENNETH EKLUND |
| K032729 |
12/03/2003 |
Z-SERIES MODULAR TOTAL HIP SYSTEM |
OSTEOIMPLANT TECHNOLOGY, INC. |
SAM SON |
| K023456 |
02/24/2003 |
OXYBOX SYSTEM |
OXYFAST CORPORATION |
MELVYN BURKE |
| K033230 |
12/12/2003 |
TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA |
PARALLAX MEDICAL, INC. |
LINDA PAUL |
| K020885 |
02/06/2003 |
FASSIRE-DUVAL TELESCOPIC IM SYSTEM |
PEGA MEDICAL INC. |
ARIEL R DUJOVNE |
| K013856 |
02/21/2003 |
PMH 1000 HEATED HUMIDIFIER |
PEGASUS RESEARCH CORP. |
KENNETH G MILLER |
| K023401 |
02/11/2003 |
EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE |
PENTAX PRECISION INSTRUMENT CORP. |
PAUL SILVA |
| K033680 |
12/11/2003 |
M2376A PHILIPS DEVICE LINK SYSTEM |
PHILIPS MEDICAL SYSTEMS |
HERBERT VAN DYK |
| K033737 |
12/09/2003 |
ALLURA XPER FD20 |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
LYNN HARMER |
| K024042 |
02/04/2003 |
PANORAMA ENHANCEMENTS |
PHILIPS MEDICAL SYSTEMS, INC. |
DUANE C PRASCHAN |
| K023931 |
02/24/2003 |
PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A |
PHILIPS MEDICAL SYSTEMS, INC. |
MARKUS STACHA |
| K033782 |
12/19/2003 |
ALLEGRO IMAGING SYSTEM |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
CHRISTOF LITTWITZ |
| K024066 |
02/04/2003 |
INFINION SOFTWARE FEATURES |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
DUANE PRASCHAN |
| K023785 |
02/10/2003 |
LUNG NODULE ASSESSMENT AND COMPARISON OPTION |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ROBERT L TUROCY |
| K033604 |
12/15/2003 |
TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L |
PIE MEDICAL |
COLLEEN DENSMORE |
| K021945 |
02/21/2003 |
PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE) |
PLANMED OY |
BOB PIENKOWSKI |
| K033763 |
12/18/2003 |
MODIFICATION TO SLIM GLIDING NAIL SYSTEM |
PLUS ORTHOPEDICS |
NEIL DELANEY |
| K033084 |
12/19/2003 |
WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER |
PORTEX LTD. |
STEVE OGILVIE |
| K023793 |
02/11/2003 |
1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR |
PORTEX, INC. |
CINDY ENGELHARDT |
| K033691 |
12/19/2003 |
SAFYRE VS AND SAFYRE T |
PROMEDON |
DEBBIE IAMPIETRO |
| K022814 |
02/19/2003 |
MULTIPLE NITRILE EXAMINATION GLOVES (POWDERED) |
PT. SMART GLOVE INDONESIA |
FOO KHON PU |
| K022815 |
02/13/2003 |
MULTIPLE PATIENT EXAMINATION GLOVES POWDERED LATEX |
PT. SMART GLOVE INDONESIA |
FOO KHON PU |
| K030406 |
02/27/2003 |
NITRILE POWDER FREE EXAM GLOVE, WITH PEPPERMINT FLAVOR |
PT. SMART GLOVE INDONESIA |
FOO KHON PU |
| K030112 |
02/27/2003 |
POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM LESS THAN 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTAB |
PT. SMART GLOVE INDONESIA |
FOO KHON PU |
| K032953 |
12/10/2003 |
EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT |
PULPDENT CORPORATION |
KENNETH J BERK |
| K023593 |
02/06/2003 |
SERAQUEST ANTI-THYROID PEROXIDASE (TPO) |
QUEST INTL., INC. |
ROBERT A CORT |
| K032752 |
12/03/2003 |
R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM |
R&B SURGICAL SOLUTIONS, LLC. |
KAREN E WARDEN |
| K032205 |
12/11/2003 |
RADIANCY ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT ASSEMBLY |
RADIANCY (ISRAEL) LTD. |
JONATHAN S KAHN |
| K030324 |
02/27/2003 |
RADIANT INNOVATION INC. INFRARED EAR THERMOMETER, MODELS TH1 SERIES |
RADIANT INNOVATION, INC. |
CHARLES CHANG |
| K022201 |
02/03/2003 |
RADIUS MICRO SNARE |
RADIUS MEDICAL TECHNOLOGIES, INC. |
DEBBIE IAMPIETRO |
| K030360 |
12/23/2003 |
RANDOX EVIDENCE |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
| K024014 |
12/04/2003 |
RANDOX RX DAYTONA |
RANDOX LABORATORIES, LTD. |
LYNNE HAMILTON |
| K033551 |
12/16/2003 |
EVOLVE |
RELIANCE ORTHODONTIC PRODUCTS, INC. |
BENJAMIN LICHTENWALNER |
| K023050 |
02/14/2003 |
RELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT BTL 5000 SONO ULTRASOUND SYSTEM, RELIANT BTL 5000 COMBI |
RELIANT TECHNOLOGIES, INC. |
ANNE WORDEN |
| K032916 |
12/04/2003 |
MIRAGE ACTIVA MASK |
RESMED LTD. |
DAVID D'CRUZ |
| K033793 |
12/16/2003 |
CLEANER II ROTATIONAL THROMBECTOMY SYSTEM |
REX MEDICAL |
SUSAN D GOLDSTEIN-FALK |
| K033528 |
12/22/2003 |
MESACUP-2 TEST JO-1, MODEL 10756 |
RHIGENE, INC. |
NANCI DEXTER |
| K031018 |
12/08/2003 |
AUTOGEL PAD |
RICH-MAR CORP. |
DAVID RICHARDS |
| K033113 |
12/23/2003 |
UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSISTING OF OPTIC, INNER AND OUTER SHEATHS, FORCEPS, MODEL 8753 |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K033827 |
12/18/2003 |
UB 140 |
RIVERTRAIL MOBILITY |
CLARK STANCIL |
| K033612 |
12/18/2003 |
FACTOR II (PROTHROMBIN) G20210A KIT |
ROCHE DIAGNOSTICS CORP. |
ROBERT A GREGG |
| DEN030005 |
12/17/2003 |
FACTOR V LEIDEN KIT |
ROCHE DIAGNOSTICS CORP. |
ROBERT A GREGG |
| K033610 |
12/05/2003 |
HDL-CHOLESTEROL PLUS 2ND GENERATION |
ROCHE DIAGNOSTICS CORP. |
SHERRI L COENEN |
| K033734 |
12/17/2003 |
LIGHTCYCLER INSTRUMENT VERSION 1.2 |
ROCHE DIAGNOSTICS CORP. |
ROBERT A GREGG |
| K033306 |
12/15/2003 |
PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS |
ROCHE DIAGNOSTICS CORP. |
KERWIN KAUFMAN |
| K033246 |
12/02/2003 |
PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS |
ROCHE DIAGNOSTICS CORP. |
KERWIN KAUFMAN |
| K023985 |
02/28/2003 |
ACIDIFIED COMPONENT CONCENTRATES FOR BICARBONATE DIALYSIS CONTAINING DI-ACETATE |
ROCKWELL MEDICAL TECHNOLOGIES, INC. |
GERRY FRITZ |
| K032925 |
12/22/2003 |
B&R DEVICE |
RONVIG A/S |
ANNETTE RAVN NIELSEN |
| K031094 |
12/08/2003 |
FLUID FILLED TEETHERS |
ROYAL KING INFANT PRODUCTS CO. LTD. |
DALBIR SINGH KHURANA |
| K033023 |
12/23/2003 |
INTERMITTENT URETHRAL CATHETERS |
RUSCH INTL. |
RICK LYKINS |
| K030254 |
02/26/2003 |
INTERFERENTIAL STIMULATOR, MODEL RTM1000 |
RYAN TELEMEDICINE |
JIM KLETT |
| K023801 |
02/12/2003 |
FILM PROCESSOR, MODEL LIFE RAY PRO 1000 |
S.A.I.E.P. S.R.L. |
DOUG HALE |
| K023825 |
02/12/2003 |
FILM PROCESSOR, MODEL LIFE RAY PRO 2500 |
S.A.I.E.P. S.R.L. |
DOUG HALE |
| K023912 |
02/11/2003 |
POWDER FREE LATEX SURGEON'S GLOVES CONTAINS 50 MEGM OR LESS OF TOTAL WATER EXTRACTABLE PER GRAM |
SANREA HEALTHCARE PRIVATE LIMITED |
JOSEPH J E PEREIRA |
| K023910 |
02/11/2003 |
STERILE PATIENT POWDERFREE LATEX EXAMINATION GLOVES |
SANREA HEALTHCARE PRIVATE LIMITED |
JOSEPH J E PEREIRA |
| K023915 |
02/11/2003 |
STERILE POWDERED LATEX PATIENT EXAMINATION GLOVES |
SANREA HEALTHCARE PRIVATE LIMITED |
JOSEPH J E PEREIRA |
| K020318 |
02/03/2003 |
SCIVOLUTIONS VARIOUS ANTIBACTERIAL BANDAGES |
SCIVOLUTIONS, INC |
ART WARD |
| K031643 |
12/09/2003 |
SPIROTEL, MODEL 29-1020 |
SDI DIAGNOSTICS, INC. |
MICHAEL J BOYLE |
| K033712 |
12/23/2003 |
MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1 |
SECTRA-IMTEC AB |
CARL ALLETTO |
| K030473 |
02/26/2003 |
SENORX ES-300 |
SENORX, INC. |
AMY BOUCLY |
| K024345 |
02/26/2003 |
B.07 STAIRWAY CHAIRLIFT |
SERVICES INDUSTRIELS SAVARIA, INC. |
STEPHEN BROPHY |
| K024167 |
02/06/2003 |
STEP-SAVER STAIRWAY CHAIRLIFT |
SERVICES INDUSTRIELS SAVARIA, INC. |
STEPHEN BROPHY |
| K030148 |
02/19/2003 |
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR |
SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC. |
DANNY WANG |
| K032866 |
12/12/2003 |
CLARITY PET |
SHARED P.E.T. IMAGING, LLC |
RUSS PAGANO |
| K032893 |
12/19/2003 |
SHELHIGH NO-REACT BIOCUFF |
SHELHIGH, INC. |
SHLOMO GABBAY |
| K033184 |
12/09/2003 |
LATERAL ANGIOGRAPHIC C-ARM SUPPORT MH-400 |
SHIMADZU CORP. |
TAKESHI OZAKI |
| K033831 |
12/19/2003 |
SIENET COSMOS |
SIEMENS AG, MEDICAL SOLUTIONS |
EVA-MARIA REITER |
| K033832 |
12/23/2003 |
SYNGO PERFUSION-CT |
SIEMENS AG, MEDICAL SOLUTIONS |
RUDIGER KORNER |
| K030313 |
02/11/2003 |
SIEMENS INFINITY SC 6002XL MODIFICATIONS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PENELOPE H GRECO |
| K032952 |
12/12/2003 |
AIACT KIT |
SIENCO, INC. |
BARBARA DEBIASE |
| K031169 |
12/12/2003 |
MOTILITY VISUALIZATION SYSTEM |
SIERRA SCIENTIFIC INSTRUMENTS, INC. |
SEAN M CURRY |
| K033640 |
12/12/2003 |
SIROSON L AND SIROSONIC L ULTRASONIC SCALERS |
SIRONA DENTAL SYSTEMS GMBH |
MARY MCNAMARA-CULLINANE |
| K024027 |
12/03/2003 |
LIGHTWAVE INFRARED LAMPS LW10D AND LW30D |
SKYTECH ENTERPRISES, INC. |
LEWIS WARD |
| K030196 |
02/20/2003 |
DYONICS POWER CONTROL UNIT |
SMITH & NEPHEW, INC. |
JANICE HASELTON |
| K010555 |
02/25/2003 |
JAX |
SMITH & NEPHEW, INC. |
KIM P KELLY |
| K023921 |
02/05/2003 |
JET-X HA COATED HALF PINS |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
| K024340 |
02/26/2003 |
SMITH & NEPHEW FEMORAL HEADS |
SMITH & NEPHEW, INC. |
KIM P KELLY |
| K031787 |
12/02/2003 |
SMITH & NEPHEW IUR MORCELLATION SYSTEM |
SMITH & NEPHEW, INC. |
JANICE HASELTON |
| K033669 |
12/10/2003 |
SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS) |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
| K030301 |
02/25/2003 |
UNICONDYLAR FEMORAL COMPONENT |
SMITH & NEPHEW, INC. |
KIM KELLY |
| K023783 |
02/07/2003 |
SOHNIKS |
SOHNIKS ENDOSCOPY, INC. |
MARC HOSKINS |
| K031436 |
12/19/2003 |
MEDISCOPE |
SOMETECH CORPORATION |
KI CHEOL HAN |
| K030223 |
02/06/2003 |
SONOCALC |
SONOMETRIC HEALTH, LLC |
HELMUT FRITZ |
| K024188 |
02/04/2003 |
UP-DF500 FILMSTATION DIGITAL FILM IMAGER |
SONY MEDICAL SYSTEMS |
CYNTHIA A SINCLAIR |
| K032846 |
12/11/2003 |
SPECTRA PULSED DIODE LASER, MODEL DR-1 |
SPECTRAGENICS, INC. |
ROBERT E GROVE |
| K032219 |
12/19/2003 |
REVOLUTION SPINAL FIXATION SYSTEM |
SPINAL INNOVATIONS, INC. |
JOE CLIFT |
| K030871 |
12/22/2003 |
FIDJI LARGE CEMENT RESTRICTOR |
SPINE NEXT SA |
DIANE JOHNSON |
| K030767 |
12/22/2003 |
FIDJI SMALL CEMENT RESTRICTOR |
SPINE NEXT SA |
DIANE JOHNSON |
| K032061 |
12/23/2003 |
DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NH |
SPIRE BIOMEDICAL, INC. |
DONALD FICKETT |
| K032424 |
12/16/2003 |
LOTUS |
SRA DEVELOPMENTS, LTD. |
T WHIT ATHEY |
| K023953 |
02/14/2003 |
ST. GEORGE TECHNOLOGY, INC PERFECTION PLUS DISPOSABLE PROPHY ANGLE |
ST. GEORGE TECHNOLOGY, INC. |
VERNON WATKINS |
| K023715 |
02/04/2003 |
STARMATRIX POWDER FREE LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM |
STARMATRIX SDN BHD |
NGAN BOON SENG |
| K022388 |
02/27/2003 |
STARTOX DRUG OF ABUSE SCREENING TEST (4) |
STARPLEX SCIENTIFIC, INC. |
FRAN WHITE |
| K032943 |
12/17/2003 |
STRYKER VERTEBRAL BODY AND BONE BIOPSY KITS, STRYKER CAPTURE BODY AND BONE BIOSPSY KITS |
STRYKER CORP. |
DANNIELLE WHEELER |
| K032901 |
12/02/2003 |
STRYKER MINI-MENDER MENISCAL REPAIR SYSTEM |
Stryker Endoscopy |
MELISSA MURPHY |
| K023013 |
02/26/2003 |
STRYKER XCEL ANCHOR SYSTEM |
Stryker Endoscopy |
ALISA MILLER |
| K024097 |
02/14/2003 |
SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14 |
SUMMIT MEDICAL LTD. |
NEIL R ARMSTRONG |
| K031869 |
12/24/2003 |
SISS INC. (D.B.A. MEDISISS) REPROCESSED ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES |
SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC. |
MARY ANN BARKER |
| K033359 |
12/19/2003 |
DEGALL II GALLBLADDER EXTRACTOR |
SURGICON, INC. |
CURTIS RAYMOND |
| K033190 |
12/04/2003 |
VISION-TECH YZ SLIT LAMP, MODEL 66 |
SUZHOU 66 VISION-TECH CO., LTD |
ERIC LUO |
| K030190 |
02/21/2003 |
CARBO/OPTIMED BRAND ACUPUNCTURE NEEDLES |
SUZHOU SEN SEN MEDICAL SUPPLIES LTD. |
KEVIN LIU |
| K033586 |
12/10/2003 |
MODIFICATION TO AURORA DS |
SYNERON MEDICAL LTD. |
AMIR WALDMAN |
| K024064 |
02/10/2003 |
POLARIS DS |
SYNERON MEDICAL LTD. |
AMIR WALDMAN |
| K031671 |
12/01/2003 |
POLARIS WR |
SYNERON MEDICAL LTD. |
AMIR WALDMAN |
| K023879 |
02/05/2003 |
SMALL TITANIUM WRIST FUSION PLATE |
SYNTHES (USA) |
LISA M BOYLE |
| K033100 |
12/02/2003 |
TAIWAN KING STRONG POWERED WHEELCHAIR, TP 01 |
TAIWAN KING STRONG CO., LTD. |
JEN KE-MIN |
| K033031 |
12/02/2003 |
TAIWAN KING STRONG TC 03 MECHANICAL WHEELCHAIR |
TAIWAN KING STRONG CO., LTD. |
JEN KE-MIN |
| K033308 |
12/22/2003 |
VINYL EXAMINATION GLOVES, POWDERED |
TANGSHAN TRANSOCEAN PLASTIC PRODUCTS CO.,LTD. |
IRIS YANG |
| K022696 |
02/07/2003 |
TEH LIN POWERED WHEELCHAIR, MODEL MDG-201 |
TEH LIN PROSTHETIC & ORTHOPAEDIC, INC. |
JEN KE-MIN |
| K033681 |
12/11/2003 |
GLIDESHEATH |
TERUMO CORP. |
MARK UNTERREINER |
| K033583 |
12/12/2003 |
PROGREAT |
TERUMO MEDICAL CORP. |
MARK UNTERREINER |
| K024249 |
02/21/2003 |
TERUMO SURGUARD SAFETY SYRINGE |
TERUMO MEDICAL CORP. |
BARBARA SMITH |
| K030370 |
12/09/2003 |
REDLINE ANTHRAX ALERT TEST |
TETRACORE, INC |
BEVERLY L MANGOLD |
| K032909 |
12/16/2003 |
THAI NIPPON EXTRA STRENGTH MALE LATEX CONDOM |
THAI NIPPON RUBBER INDUSTRY CO., LTD. |
ELI J CARTER |
| K033110 |
12/10/2003 |
C-GRAFT |
THE CLINICIAN'S PREFERENCE LLC |
CHARLES L MORIN |
| K023959 |
02/21/2003 |
JEROME GLASS RING |
THE JEROME GROUP, INC. |
BERNIE TATRO |
| K021962 |
02/12/2003 |
OLYMPUS ULTRASONIC SURGICAL SYSTEM |
THE OLYMPUS OPTICAL CO. |
LAURA STORMS-TYLER |
| K023906 |
02/19/2003 |
PATHWAY CTS2000 PELVIC FLOOR TRAINING SYSTEM |
THE PROMETHEUS GROUP |
HEATHER MAGOON |
| K024100 |
02/25/2003 |
IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR/MODEL: WL-2206, WELL IF, LIFE IF AND THE CUSTOMER PRIVATE BRAND |
THERATECH, INC. |
TONY C.S. CHANG |
| K024151 |
02/06/2003 |
EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P |
THERATEST LABORATORIES, INC. |
MARIUS TEODORESCU |
| K024031 |
02/06/2003 |
THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE |
THERATEST LABORATORIES, INC. |
MARIUS TEODORESCU |
| K030142 |
02/03/2003 |
THERMACOOL TC SYSTEM |
THERMAGE, INC. |
PAMELA M BUCKMAN |
| K030226 |
02/10/2003 |
THOR DDII 830CL3 LASER SYSTEM |
THOR INTL. |
M. JOYCE HEINRICH |
| K022532 |
02/12/2003 |
TISSUELINK BIPOLAR FLOATING BALL DEVICE |
TISSUELINK MEDICAL, INC. |
VICKI S ANASTASI |
| K024016 |
02/03/2003 |
POWDERED VINYL EXAMINATION GLOVES |
TOP GLOVE (ZHANGJIAGANG) CO. LTD. |
LIM WEE CHAI |
| K024216 |
02/27/2003 |
TOP GLOVE VINYL EXAMINATION GLOVE |
TOP GLOVE (ZHANGJIAGANG) CO. LTD. |
LIM WEE CHAI |
| K023974 |
02/13/2003 |
ALOE VERA & VITAMIN E POWDERFREE LATEX EXAMINATION GLOVES |
TOP GLOVE SDN. BHD. |
LIM WEE CHAI |
| K031831 |
12/19/2003 |
TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM |
TOPCON MEDICAL SYSTEMS, INC. |
DONALD H WINFIELD |
| K032679 |
12/15/2003 |
AEQUALIS SHOULDER FRACTURE SYSTEM |
TORNIER |
MIRELLE LEMERY |
| K033424 |
12/11/2003 |
ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002 |
TRANSONIC SYSTEMS, INC. |
MARK S ALSBERGE |
| K033001 |
12/24/2003 |
APEX DETECTOR ELECTRONICS & ACQUISITION INTERFACE, MODEL XL-4 |
TRANSPHOTON CORPORATION |
SCOTT JENNINGS |
| K023510 |
02/04/2003 |
TRUTEK SELECT MODEL TT-1001 |
TRUTEK, INC. |
E.J. Smith |
| K033240 |
12/18/2003 |
BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S200 |
TUNG KENG ENTERPRISE CO., LTD. |
Ke-Min Jen |
| K033220 |
12/18/2003 |
BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S280 |
TUNG KENG ENTERPRISE CO., LTD. |
JEN KE-MIN |
| K032827 |
12/08/2003 |
KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501 |
TYCO HEALTHCARE |
GAIL CHRISTIE |
| K023637 |
02/26/2003 |
TYTAN ELECTRONIC STETHOSCOPES (MODEL #600) |
TYTAN MEDICAL CORP. |
JENNIFER REICH |
| K033025 |
12/10/2003 |
TYTAN PROFESSIONAL /ECONOMY SERIES SPHYGMOMANOMETER, NO 710/NO 700 |
TYTAN MEDICAL CORP. |
WILLIAM HSIEH |
| K033794 |
12/30/2003 |
ULTICARE DISPOSABLE SYRINGE 3 ML/CC |
ULTIMED, INC. |
ELLEN G REDDING |
| K032626 |
12/03/2003 |
PERMAQUICK SE BONDING SYSTEM |
ULTRADENT PRODUCTS, INC. |
PETER ALLRED |
| K030315 |
02/27/2003 |
MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM |
ULTROID, LLC |
RONALD R NEWTON |
| K033541 |
12/23/2003 |
LONG LOVE CONDOM |
UNIDUS CORP. |
ELI J CARTER |
| K022520 |
02/25/2003 |
U2 ACETABULAR CUP |
UNITED ORTHOPEDIC CORP. |
JIANN-JONG LIAU |
| K032696 |
12/01/2003 |
AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& OPEN) GIA SURGICAL STAPLING INSTRUMENT |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
CHESTER MCCOY |
| K033235 |
12/17/2003 |
GEMINI III HYBRID TX/RX 4 CHANNEL HEAD COIL |
USA INSTRUMENTS, INC. |
CHRISTIE SHUMAKER |
| K023982 |
02/21/2003 |
LEO III TX/RX QUADRATURE KNEE COIL; ALPHA III TX/RX QUADRATURE WRIST COIL |
USA INSTRUMENTS, INC. |
CHRISTIE SHUMAKER |
| K033753 |
12/17/2003 |
PELVIC ARRAY COIL |
USA INSTRUMENTS, INC. |
CHRISTIE SHUMAKER |
| K030042 |
02/24/2003 |
PREMIER III PHASED ARRAY CTL SPINE COIL |
USA INSTRUMENTS, INC. |
CHRISTIE SHUMAKER |
| K024187 |
02/04/2003 |
SPIRIT III TOTALSENSE CARDIAC COIL |
USA INSTRUMENTS, INC. |
CHRISTIE SHUMAKER |
| K023540 |
02/04/2003 |
SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09 |
VALUMED |
THOMAS E COTTONE |
| K032980 |
12/18/2003 |
AMI REPROCESSED MULTIPLE CLIP APPLIERS |
VANGUARD MEDICAL CONCEPTS, INC. |
MARK ALDANA |
| K032973 |
12/18/2003 |
REPROCESSED DISPOSABLE CUTTERS, STAPLERS AND APPLIERS |
VANGUARD MEDICAL CONCEPTS, INC. |
MARK ALDANA |
| K033371 |
12/24/2003 |
VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS |
VARIAN MEDICAL SYSTEMS |
VY TRAN |
| K033339 |
12/30/2003 |
ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K024147 |
02/12/2003 |
PAXSCAN 4030 MEDICAL DIGITAL IMAGING SYSTEM |
VARIAN MEDICAL SYSTEMS, INC. |
LINDA S NASH |
| K033343 |
12/23/2003 |
TRILOGY RADIOTHERAPY DELIVERY SYSTEM |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K023023 |
12/04/2003 |
LIFESITE HEMODIALYSIS ACCESS SYSTEM, CANNULA EXCHANGE KIT, INSERTION KIT, ACCESS CANNILA |
VASCA, INC. |
NAMA DODDI |
| K031812 |
12/12/2003 |
TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03 |
VASCULAR CONTROL SYSTEMS, INC |
AL MEMMOLO |
| K033709 |
12/18/2003 |
VASCULAR SOLUTIONS D-STAT 2 DRY HEMOSTATIC BANDAGE |
VASCULAR SOLUTIONS, INC. |
GREGORY W SACHS |
| K032763 |
12/19/2003 |
VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER |
VASCULAR SOLUTIONS, INC. |
GREGORY SACHS |
| K030260 |
02/20/2003 |
GELBFISH FLEX VASCULAR DILATOR |
VASCUMETRIX, LLC |
NICK RAIBLE |
| K032102 |
12/12/2003 |
VERTELINK KOBRA SPINAL FIXATION SYSTEM |
VERTELINK CORPORATION |
GREG HOLLAND |
| K030246 |
02/26/2003 |
VICTUS I.V. ADMINISTRATION SET, MODELS 27071 AND 27072 |
VICTUS, INC. |
ILEANA YATES |
| K022877 |
02/05/2003 |
OBSERVER ULTRASOUND REPORTING AND IMAGING SYSTEM |
VISION CHIPS, INC. |
RONALD "JOCK" PHILIP |
| K033671 |
12/31/2003 |
GORE BIOABSORBABLE MESH |
W. L. GORE & ASSOCIATES, INC. |
BRANDON HANSEN |
| K033137 |
12/08/2003 |
POTENS + |
WADA, INC. |
GAIL RODRICK-HIGHBERG |
| K024281 |
02/24/2003 |
WAKO L-TYPE GLUCOSE 2 |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
| K030065 |
02/11/2003 |
WAKO NEFA LINEARITY SET |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
| K033740 |
12/15/2003 |
LORENZ STERNAL CLOSURE SYSTEM |
WALTER LORENZ SURGICAL, INC. |
KIM REED |
| K030311 |
02/26/2003 |
HEM-O-LOK XL CLIP |
WECK |
BRIAN YOUNG |
| K024005 |
02/12/2003 |
WELCH ALLYN VITAL SIGN MONITOR WITH MP506 |
WELCH ALLYN, INC. |
DAVID KLEMENTOWKI |
| K033857 |
12/19/2003 |
T-TECH DIGITAL, MODEL WL-22XXA SERIES |
WELL-LIFE HEALTHCARE, INC. |
JENNY HSIAH |
| K023992 |
02/12/2003 |
WIENER LAB COLINESTERASA AA |
WIENER LABORATORIES S.A.I.C. |
VIVIANA CETOLA |
| K024116 |
02/12/2003 |
WIENER LAB. BILIRUBINA DIRECT AA |
WIENER LABORATORIES S.A.I.C. |
VIVIANA CETILA |
| K033754 |
12/30/2003 |
TRACER METRO SMART WIRE GUIDE |
WILSON-COOK MEDICAL, INC. |
MARGE WALLS-WALKER |
| K023903 |
02/20/2003 |
WILSON-COOK ENDOSCOPIC CLIPPING DEVICE |
WILSON-COOK MEDICAL, INC. |
MARGARET POSNER |
| K033203 |
12/19/2003 |
WILSON-COOK TRI-TOME SELECT PLUS |
WILSON-COOK MEDICAL, INC. |
MARGE WALLS-WALKER |
| K023690 |
02/28/2003 |
CATHETER CONNECTOR |
WORLD METALS, INC, |
MARTIN MITCHELL |
| K030193 |
02/20/2003 |
ADVANCE LESS CONFORMING TIBIAL COMPONENT |
WRIGHT MEDICAL TECHNOLOGY, INC. |
TIM CRABTREE |
| K033529 |
12/03/2003 |
TIE-IN TRAPEZIUM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
KATIE LOGEROT |
| K030157 |
02/19/2003 |
POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM |
WRP ASIA PACIFIC SDN. BHD. |
TERENCE LIM |
| K032942 |
12/17/2003 |
PROFEEL POWDER FREE, PLOYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE |
WRP ASIA PACIFIC SDN. BHD. |
TERENCE LIM |
| K032488 |
12/02/2003 |
WU'S 3-WHEELED NEO SCOOTER, WT-T3D |
WU'S TECH CO., LTD. |
JEN KE-MIN |
| K020595 |
02/20/2003 |
XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01 |
XENOTOPE DIAGNOSTICS, INC. |
ROBIN J HELLEN |
| K030829 |
12/05/2003 |
VPT METER |
XILAS MEDICAL, INC. |
RUBEN G ZAMORANO |
| K032944 |
12/19/2003 |
YA-MAN LASER 21 |
YA-MAN LTD |
ROBERT T HANDREN |
| K023942 |
02/24/2003 |
CLOCKMINI, MODEL DF301; CLOCKNAVI, MODEL DF311 |
YAMATO CORP. |
CLAY ANSELMO |
| K024355 |
02/03/2003 |
EVERGREEN NON-STERILE POWDERED NATURAL OR COLORED LATEX EXAMINATION GLOVE |
YTY INDUSTRY (MANJUNG) SDN. BHD. |
JANNA P TUCKER |
| K030079 |
02/05/2003 |
VERSYS BEADED FULLCOAT BOWED REVISION HIP PROSTHESIS |
ZIMMER, INC. |
FRED MCCLURE |
