FDA 510(k) Decisions During February, 2003  

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
K022906 02/12/2003 RESQPOD CIRCULATORY ENHANCER CPRX LLC JOHN F STAPLETON
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
K022891 02/19/2003 THE BREATHE EZ ANTI-SNORING DEVICE D&S REDHAGE DANIEL J REDHAGE
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
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
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