| 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 |
| K033356 |
12/30/2003 |
VERASOFT ES |
AALBA DENT, INC. |
VINCENT BENETTI |
| 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 |
| K033299 |
12/12/2003 |
ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND 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 |
| K033429 |
12/04/2003 |
LAMITRODE SPINAL CORD STIMULATION LEADS |
ADVANCED NEUROMODULATION SYSTEMS |
DANIELLE ALARCON |
| K032469 |
12/16/2003 |
AESKULISA ANA 8PRO |
AESKU, INC |
STANLEY AMMONS |
| 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 |
| 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 |
| 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 |
| K033637 |
12/17/2003 |
MEDICAL IMAGE DIGITIZER, MODEL 2908 |
ARRAY CORP. |
TAKASHI INAMI |
| K030895 |
12/03/2003 |
ASEPTICO ENDOPEX V, MODEL AEU-40 |
ASEPTICO, INC. |
GRANT RAMALEY |
| K033256 |
12/30/2003 |
ATHENA PELVIC MUSCLE TRAINER II |
ATHENA FEMININE TECHNOLOGIES, INC. |
BARBARA SARKIS |
| 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 |
| K030713 |
12/19/2003 |
BAY AREA HYPERSCIENCES |
BAY AREA HYPERSCIENCES, LLC |
EDWARD F GOOD |
| 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 |
| 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 |
| 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 |
| K033229 |
12/17/2003 |
(MULTIPLE LABELS) POWDER-FREE VINYL EXAMINATION GLOVES |
BERNARD TECHNOLOGIES, INC. |
MICHAEL D LELAH, PHD |
| 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 |
| K032268 |
12/11/2003 |
MBCP |
BIOMATLANTE |
MYRIAM VINCENT |
| 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. |
| K033613 |
12/08/2003 |
MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K033287 |
12/19/2003 |
EXACTRAC GATING |
BRAINLAB AG |
RAINER BIRKENBACH |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| K032762 |
12/02/2003 |
XIO RADIATION TREATMENT PLANNING SYSTEM |
COMPUTERIZED MEDICAL SYSTEMS, INC. |
KATHRYN STINSON |
| 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 |
| K033156 |
12/09/2003 |
OB1 OBSTETRICAL DOPPLER |
D. E. HOKANSON, INC. |
D. EUGENE HOKANSON |
| 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 |
| K031124 |
12/04/2003 |
POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR |
DATEX-OHMEDA, INC. |
AL VAN HOUDT |
| K033705 |
12/04/2003 |
BOBCAT PRO SCALER SYSTEM, MODEL G-130 |
DENTSPLY INTERNATIONAL |
P. JEFFERY LEHN |
| K033553 |
12/02/2003 |
PFZ PORCELAIN SYSTEM |
DENTSPLY INTL. |
P. JEFFERY LEHN |
| 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 |
| 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 |
| 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 |
| 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 |
| K033206 |
12/18/2003 |
EPW FOLDABLE POWER WHEELCHAIR, EPW-03 |
EMG TECHNOLOGY CO., LTD. |
JEN KE-MIN |
| 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 |
| 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 |
| K031818 |
12/03/2003 |
FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE |
FACILAI ENTERPRISES LTD. |
Ke-Min Jen |
| 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 |
| K033510 |
12/03/2003 |
MODIFICATION TO TELEGRAPH HUMERAL NAIL |
FOURNITURES HOSPITALIERES INDUSTRIE |
CHRISTINE QUENDEZ |
| K033542 |
12/05/2003 |
EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE |
GALT MEDICAL CORP. |
DAVID CATLIN |
| K033874 |
12/30/2003 |
MYOLIGHT |
GE MEDICAL SYSTEMS F.I. HAIFA |
LAURENCE BIGIO |
| 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. |
| 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 |
| K033478 |
12/29/2003 |
VACUETTE QUICKSHIELD SAFETY TUBE HOLDER |
GREINER BIO-ONE VACUETTE NORTH AMERICA |
Judi Smith |
| K033161 |
12/18/2003 |
VISU-LOCK 5MM CLIP APPLIER |
GYRX, LLC |
CORY EDWARDS |
| K033054 |
12/16/2003 |
HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP |
HARVARD CLINICAL TECHNOLOGY |
ERIC J FLACHBART |
| K032127 |
12/30/2003 |
HEMEDEX FIXATION DEVICE |
HEMEDEX INCORPORATED |
DEBBIE IAMPIETRO |
| 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 |
| K032829 |
12/10/2003 |
SCORPIO LOW PROFILE TIBIAL TRAY |
HOWMEDICA OSTEONICS CORP. |
MARGARET F CROWE |
| 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 |
| 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 |
| K033602 |
12/16/2003 |
INSORB ABSORBABLE STAPLE, MODEL SP-B20 |
INCISIVE SURGICAL, INC. |
JIM PETERSON |
| 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 |
| 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 |
| 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 |
| K033520 |
12/05/2003 |
BLUEPHASE |
IVOCLAR VIVADENT, INC. |
DONNA MARIE HARTNETT |
| 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 |
| K032950 |
12/19/2003 |
GEM INSET PATELLAR COMPONENT |
KINAMED, INC. |
VINEET SARIN |
| 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 |
| K033758 |
12/19/2003 |
HYDROPHILIC 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 |
| 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 |
| 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 |
| K033666 |
12/17/2003 |
HEMADERM |
MEDAFOR, INC. |
JENNIFER A MAY |
| 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 |
| K033495 |
12/03/2003 |
MODIFICATION TO EQUATION FIXATION SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
| K032222 |
12/05/2003 |
IMMUNOCARDSTAT HPSA |
MERIDIAN BIOSCIENCE, INC. |
SUSAN ROLIH |
| 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 |
| K031102 |
12/01/2003 |
MICROLAB SPIROMETER |
MICRO DIRECT, INC. |
DAVID R STASZAK |
| K033836 |
12/30/2003 |
HYDROCOIL EMBOLIC SYSTEM (HES) |
MICROVENTION, INC. |
VINCENT CUTARELLI |
| K032690 |
12/09/2003 |
MISONIX INC. FS 1000 RF ULTRASONIC SURGICAL ASPIRATOR SYSTEM |
MISONIX, INC. |
RONALD R MANNA |
| K032841 |
12/10/2003 |
MOORLDI INFRARED LASER DOPPLER IMAGER, MODEL MOORLD12-IR |
MOOR INSTRUMENTS LTD. |
DAVID BOGGETT |
| 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 |
| K031733 |
12/04/2003 |
NON-CONTACT TONOMETER, MODEL NT-4000 |
NIDEK, INC. |
CAROL PATTERSON |
| K031968 |
12/22/2003 |
CERABIEN ZR |
NORITAKE CO., INC. |
IVAN J WASSERMAN |
| K032309 |
12/04/2003 |
NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESSORY |
NOVELENS, INC. |
RICHARD E LIPPMAN |
| 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 |
| 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 |
| K033230 |
12/12/2003 |
TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA |
PARALLAX MEDICAL, INC. |
LINDA PAUL |
| 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 |
| K033782 |
12/19/2003 |
ALLEGRO IMAGING SYSTEM |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
CHRISTOF LITTWITZ |
| K033604 |
12/15/2003 |
TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L |
PIE MEDICAL |
COLLEEN DENSMORE |
| 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 |
| K033691 |
12/19/2003 |
SAFYRE VS AND SAFYRE T |
PROMEDON |
DEBBIE IAMPIETRO |
| K032953 |
12/10/2003 |
EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT |
PULPDENT CORPORATION |
KENNETH J BERK |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| K031436 |
12/19/2003 |
MEDISCOPE |
SOMETECH CORPORATION |
KI CHEOL HAN |
| 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 |
| 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 |
| 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 |
| K033586 |
12/10/2003 |
MODIFICATION TO AURORA DS |
SYNERON MEDICAL LTD. |
AMIR WALDMAN |
| K031671 |
12/01/2003 |
POLARIS WR |
SYNERON MEDICAL LTD. |
AMIR WALDMAN |
| 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 |
| K033681 |
12/11/2003 |
GLIDESHEATH |
TERUMO CORP. |
MARK UNTERREINER |
| K033583 |
12/12/2003 |
PROGREAT |
TERUMO MEDICAL CORP. |
MARK UNTERREINER |
| 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 |
| 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 |
| 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 |
| 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 |
| K033541 |
12/23/2003 |
LONG LOVE CONDOM |
UNIDUS CORP. |
ELI J CARTER |
| 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 |
| K033753 |
12/17/2003 |
PELVIC ARRAY COIL |
USA INSTRUMENTS, INC. |
CHRISTIE SHUMAKER |
| 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 |
| 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 |
| K032102 |
12/12/2003 |
VERTELINK KOBRA SPINAL FIXATION SYSTEM |
VERTELINK CORPORATION |
GREG HOLLAND |
| K033671 |
12/31/2003 |
GORE BIOABSORBABLE MESH |
W. L. GORE & ASSOCIATES, INC. |
BRANDON HANSEN |
| K033137 |
12/08/2003 |
POTENS + |
WADA, INC. |
GAIL RODRICK-HIGHBERG |
| K033740 |
12/15/2003 |
LORENZ STERNAL CLOSURE SYSTEM |
WALTER LORENZ SURGICAL, INC. |
KIM REED |
| K033857 |
12/19/2003 |
T-TECH DIGITAL, MODEL WL-22XXA SERIES |
WELL-LIFE HEALTHCARE, INC. |
JENNY HSIAH |
| K033754 |
12/30/2003 |
TRACER METRO SMART WIRE GUIDE |
WILSON-COOK MEDICAL, INC. |
MARGE WALLS-WALKER |
| K033203 |
12/19/2003 |
WILSON-COOK TRI-TOME SELECT PLUS |
WILSON-COOK MEDICAL, INC. |
MARGE WALLS-WALKER |
| K033529 |
12/03/2003 |
TIE-IN TRAPEZIUM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
KATIE LOGEROT |
| 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 |
| 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 |
