| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K003723 |
03/27/2001 |
3M LITTMANN |
3M COMPANY |
LINDA JOHNSEN |
| K010828 |
03/29/2001 |
DIGITAL BLOOD PRESSURE MONITORS, MODELS TM-2655, TM-2655P, & TM-2655VP |
A & D ENGINEERING, INC. |
JERRY WANG |
| K001856 |
03/07/2001 |
SUPERCROSS CATHETER |
ABBOTT VASCULAR INC. |
DAUN S PUTNAM |
| K003746 |
03/13/2001 |
3D-DOCTOR |
ABLE SOFTWARE CORP. |
YECHENG WU |
| K010390 |
03/09/2001 |
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS |
ACIST MEDICAL SYSTEMS, INC. |
CARL M BEAURLINE |
| K003557 |
03/15/2001 |
ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE) |
ACON LABORATORIES, INC. |
NORA C.R. YORK |
| K003185 |
03/20/2001 |
FS ACTIVATOR III |
ACTIVATOR METHODS INTERNATIONAL, LTD |
ARLAN W FUHR |
| K003965 |
03/16/2001 |
MRI SAFE INSTRUMENTS |
AESCULAP, INC. |
LISA M MILLINGTON |
| K010571 |
03/28/2001 |
ADC QS/IPD WORKSTATION |
AGFA CORP. |
T. WHIT ATHEY |
| K010453 |
03/02/2001 |
M2376A DEVICELINK SYSTEM |
AGILENT TECHNOLOGIES, INC. |
MIKE HUDON |
| K000655 |
03/26/2001 |
PPCID- PNEUMATIC PERIPHERAL CIRCULATION IMPROVEMENT (FOOTREST) DEVICE |
AHAVA STEIN |
AHAVA STEIN |
| K010223 |
03/16/2001 |
BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT) |
AMERICAN CONTACT LENS, INC. |
MARTIN DALSING |
| K010277 |
03/26/2001 |
AMS FASCIAL-ANCHORING SYSTEM |
AMERICAN MEDICAL SYSTEMS, INC. |
ELSA LINKE |
| K002382 |
03/14/2001 |
'ALL 2000' % OXYGEN ANALYZER |
ANALYTICAL INDUSTRIES, INC. |
PATRICK J PRINDIBLE |
| K003787 |
03/08/2001 |
NEWTOM QR-DVT 9000 |
APERIO SERVICES, LLC |
GREGORY W BOWMAN |
| K003923 |
03/20/2001 |
APEX MODULAR ZIRCONIA FEMORAL HEAD |
APEX SURGICAL, LLC. |
EDWARD J CHEAL |
| K010182 |
03/09/2001 |
VCF PERSONAL LUBRICANT |
APOTHECUS PHARMACEUTICAL CORP. |
GARY L YINGLING |
| K004015 |
03/13/2001 |
BEAM BLOCK TRAYS |
ARPLAY MEDICAL S.A. |
RICHARD BORGI |
| K010062 |
03/13/2001 |
STYROFOAM CUTTERS FOR BLOCK CASTING SYSTEM |
ARPLAY MEDICAL S.A. |
RICHARD BORGI |
| K010330 |
03/02/2001 |
ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R950-U |
ARROW INTL., INC. |
WILLIAM PAQUIN |
| K002507 |
03/21/2001 |
TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT |
ARROW INTL., INC. |
THOMAS D NICKEL |
| K003777 |
03/06/2001 |
CARIS SITE MARKER |
ARTEMIS MEDICAL, INC. |
ROBIN BUSH |
| K003816 |
03/09/2001 |
ARTHREX TITANIUM CORKSCREW, 3.5 MM, ARTHREX TITANIUM CORKSCREW, 5.0 MM, ARTHREX TITANIUM CORKSCREW 6.5MM |
ARTHREX, INC. |
VERNON C BROWN |
| K010568 |
03/27/2001 |
ARTHROCARE UROLOGY ELECTROSURGERY SYSTEM |
ARTHROCARE CORP. |
BETTY M JOHNSON |
| K003971 |
03/21/2001 |
AXYA MEDICAL, INC. MODEL 1000 AXYALOOP BONE ANCHOR |
AXYA MEDICAL, INC. |
HOWARD L SCHRAYER |
| K003975 |
03/19/2001 |
BAUMER CEMENTED HIP PROSTHESIS |
BAUMER S.A. |
BRENO C FARAGO |
| K003976 |
03/19/2001 |
BAUMER MULLER HIP PROSTHESIS |
BAUMER S.A. |
BRENO C FARAGO |
| K002705 |
03/28/2001 |
EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400 |
BAXA CORP. |
CARL STEINECK |
| K003747 |
03/19/2001 |
C1-INHIBITOR MICROTITER ASSAY DEVICE |
BAXTER HEALTHCARE CORP. |
ARLENE VIDOR |
| K010201 |
03/29/2001 |
BAYER ADVIA IMS SYSTEM |
BAYER CORP. |
FREDICK CLERIE |
| K003553 |
03/21/2001 |
0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
GREGORY W MORGAN |
| K010188 |
03/01/2001 |
BD ECLIPSE HYPODERMIC NEEDLE |
BD MEDICAL SYSTEMS |
GREG W MORGAN |
| K010428 |
03/13/2001 |
ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349 |
BECKMAN COULTER, INC. |
BRENT TABER |
| K010358 |
03/05/2001 |
VIGIL SEROLOGY CONTROL LEVEL C |
BECKMAN COULTER, INC. |
ANNETTE HELLIE |
| K010572 |
03/12/2001 |
BD VISIDRAPE OPHTHALMIC DRAPES; BD VISIFLEX INCISE DRAPE |
BECTON DICKINSON AND CO. |
JAMES STAFFIERA |
| K003861 |
03/08/2001 |
BENZ-MF (VISIBILITY HANGLING TINT) (METHAFILCON A) SOFT DAILY WEAR CONTACT LENS (LATHE-CUT) |
BENZ RESEARCH AND DEVELOPMENT CORP. |
MARTIN DALSING |
| K000814 |
03/29/2001 |
FINGER PULSE METER |
BHS INTL., INC. |
CHRIS REDDING |
| K010523 |
03/15/2001 |
MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST |
BINAX, INC. |
PAMELA S ANGELL |
| K003867 |
03/09/2001 |
EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET) |
BIOFILM, INC. |
ROBERT L DE ARMOND |
| K003908 |
03/08/2001 |
SEROJET |
BIOJECT, INC. |
NANCY J GERTLAR |
| K001353 |
03/13/2001 |
MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM |
BIOMEDICAL ENT., INC. |
W. CASEY FOX |
| K001354 |
03/13/2001 |
MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRAGMENT FIXATION FOR THE MEMOGRAPH STAPLE SYSTEM |
BIOMEDICAL ENT., INC. |
W. CASEY FOX |
| K001581 |
03/20/2001 |
LACTOSORB 5.0 MM WASHER |
BIOMET, INC. |
CAROL LAUSTER |
| K010560 |
03/20/2001 |
PORTRAIT FEMORAL COMPONENT |
BIOMET, INC. |
MICHELLE L MCKINLEY |
| K010687 |
03/14/2001 |
BIOSORBFX AND BIOSORBPDX MESH |
BIONX IMPLANTS, INC. |
TUIJA ANNALA |
| K003752 |
03/23/2001 |
BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (TSH) |
BIOSAFE LABORATORIES, INC. |
JACK A MAGGIORE |
| K010266 |
03/16/2001 |
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST, CATALOG #98000 |
BIOSITE INCORPORATED |
JEFFREY R DAHLEN |
| K010405 |
03/13/2001 |
7230 ULTRASOUND IMAGING SYSTEM WITH TEI |
BIOSOUND ESAOTE, INC. |
COLLEEN HITTLE |
| K003362 |
03/01/2001 |
ASTRONOMER+WITH SLD |
BOSTON SCIENTIFIC CORP. |
ANDREA J BOUMIS |
| K003929 |
03/22/2001 |
NIROYAL BILIARY PREMOUNTED STENT SYSTEM |
BOSTON SCIENTIFIC CORP. |
JODI L GREENIZEN |
| K010610 |
03/27/2001 |
RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527 |
BOSTON SCIENTIFIC CORP. |
LISA M QUAGLIA |
| K010707 |
03/29/2001 |
ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975 |
BOSTON SCIENTIFIC, TARGET |
IRENE JAWORSKI |
| K004034 |
03/08/2001 |
MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12 |
BRANAN MEDICAL CORP. |
RAPHAEL WONG |
| K010505 |
03/09/2001 |
TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY |
BRENTWOOD MEDICAL TECHNOLOGY CORP. |
RUOMEI ZHANG |
| K010649 |
03/20/2001 |
EXHALE DOPPLER SYSTEM |
BRONCUS TECHNOLOGIES, INC. |
TIMOTHY R WILLIAMS |
| K010567 |
03/28/2001 |
OPTIFLOW CATHETER #5641190 CATHETER ONLY #5643150 CATHETER KIT #5631000 CATHETERLESS TRAY-GENERIC (COMBINED WITH CATHETR |
C.R. BARD, INC. |
PEGGY KEIFFER |
| K002019 |
03/30/2001 |
RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE OR GUIDEWIRE STYLET |
CALIFORNIA MEDICAL LABORATORIES, INC. |
MEHMET BICAKCI |
| K010393 |
03/12/2001 |
APOLLO MOBILE C ARM SYSTEM |
CARES BUILT, INC. |
TIMOTHY TELYMONDE |
| K010392 |
03/12/2001 |
ATHENA REMOTE CONTROLLED RF SYSTEM |
CARES BUILT, INC. |
TIMOTHY TELYMONDE |
| K010391 |
03/12/2001 |
ATLAS MULTI-PURPOSE DSA SYSTEM |
CARES BUILT, INC. |
TIMOTHY TELYMONDE |
| K003301 |
03/15/2001 |
DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER |
CELLAVISION AB |
CONSTANCE G BUNDY |
| K010389 |
03/23/2001 |
CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411 |
CHAD THERAPEUTICS, INC. |
KEVIN MCCULLOH |
| K010191 |
03/14/2001 |
Y2000 POCKET RESCUE |
CHEEN HOUNG ENT. CO. LTD. |
JAY WANG |
| K003345 |
03/26/2001 |
AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION |
CIBA VISION CORPORATION |
STEVEN DOWDLEY |
| K010636 |
03/23/2001 |
FOCUS DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENSES, FOCUS DAILIES PROGRESSIVES (NELFILCON A) ONE-DAY SOFT CONTACT |
CIBA VISION CORPORATION |
ALICIA M PLESNARSKI |
| K003826 |
03/08/2001 |
FOCUS DAILIES PROGRESSIVES |
CIBA VISION CORPORATION |
ALICIA M PLESNARSKI |
| K010126 |
03/12/2001 |
PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) |
CL-TINTERS |
MARTIN S KNOPF |
| K003614 |
03/13/2001 |
LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM |
COHERENT STAR |
ILIRIJA ENCINAS |
| K003085 |
03/07/2001 |
CONCENTRIC GUIDE CATHETER, MODELS 90018, 90020 |
CONCENTRIC MEDICAL, INC. |
LINDA BRADLEY |
| K002254 |
03/16/2001 |
COOK PRESSURE MONITORING CATHETER |
COOK, INC. |
APRIL LAVENDER |
| K002286 |
03/22/2001 |
LDOB OCCLUSION BALLOON CATHETER |
COOK, INC. |
MARY A GOSSARD |
| K003715 |
03/01/2001 |
COOLTOUCH ND:YAG LASER SYSTEM, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH II |
COOLTOUCH CORP. |
DONALD V JOHNSON |
| K010445 |
03/16/2001 |
PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEM |
CORDIS CORP. |
SAM MIRZA |
| K010511 |
03/01/2001 |
MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES |
CORDIS NEUROVASCULAR, INC. |
Amarilys Machado |
| K001398 |
03/30/2001 |
REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT |
CORGENIX, INC. |
NANCI DEXTER |
| K004039 |
03/29/2001 |
CYNOSURE PHOTOGENICA NEO-V |
CYNOSURE, INC. |
GEORGE CHO |
| K010061 |
03/14/2001 |
DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND |
DADE BEHRING, INC. |
RICHARD M VAUGHT |
| K010206 |
03/16/2001 |
DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137 |
DADE BEHRING, INC. |
RICHARD M VAUGHT |
| K003503 |
03/13/2001 |
N LATEX CYSTATIN C |
DADE BEHRING, INC. |
REBECCA S AYASH |
| K003501 |
03/15/2001 |
N PROTEIN STANDARD UY CALIBRATOR |
DADE BEHRING, INC. |
REBECCA S AYASH |
| K003998 |
03/07/2001 |
FLEXVIEW CLINICAL MONITORING SYSTEM |
DATA CRITICAL CORP. |
TERESA DAVIDSON |
| K010463 |
03/15/2001 |
DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES |
DATEX-OHMEDA, INC. |
JOEL C KENT |
| K010037 |
03/22/2001 |
DAUM DOUBLE-SHOOT BISOPSY GUN |
DAUM GMBH |
CHRISTINA SMITH |
| K004031 |
03/28/2001 |
NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES |
DENTAL POWER, INC. |
JOHN SCHOEFFEL |
| K010642 |
03/20/2001 |
PLEURX PLEURAL CATHETER AND DRAINAGE KITS |
DENVER BIOMEDICALS, INC. |
NANCY SAUER |
| K010320 |
03/01/2001 |
MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM |
DEPUY ACROMED |
KAREN F JURCZAK |
| K010367 |
03/09/2001 |
MODIFICATION TO TITANIUM TRI-LOCK HIPS STEM |
DEPUY ORTHOPAEDICS, INC. |
ARLENE C SAULL |
| K003875 |
03/01/2001 |
TI-REPLICA HIP STEM |
DEPUY ORTHOPAEDICS, INC. |
ARLENE C SAULL |
| K002829 |
03/26/2001 |
DJ ORTHOPEDICS FEMORAL ANCHOR |
DJ ORTHOPEDICS, LLC |
JAMAL D RUSHDY |
| K003960 |
03/21/2001 |
DJ ORTHOPEDICS TIBIAL ANCHOR |
DJ ORTHOPEDICS, LLC |
JAMAL D RUSHDY |
| K003993 |
03/26/2001 |
DORNIER MEDILAS D SKINPULSE LASER SYSTEM (SKINPULSE) |
DORNIER SURGICAL PRODUCTS, INC. |
WALTER PAYERL |
| K010082 |
03/12/2001 |
D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM |
DUTCH OPHTHALMIC USA, INC. |
MARK W FURLONG |
| K004016 |
03/27/2001 |
SHEER THIN AROMAS BLUE LATEX CONDOM |
EAGLE TWE, INC. |
KEITH F HEINTZ |
| K004036 |
03/27/2001 |
SHEER THIN AROMAS GREEN LATEX CONDOM |
EAGLE TWE, INC. |
KEITH F HEINTZ |
| K010028 |
03/30/2001 |
SHEER THIN AROMAS RED LATEX CONDOM |
EAGLE TWE, INC. |
KEITH HEINTZ |
| K004051 |
03/29/2001 |
SHEER THIN AROMAS YELLOW LATEX CONDOM |
EAGLE TWE, INC. |
KEITH F HEINTZ |
| K010437 |
03/13/2001 |
MODIFICATION TO EBI XFIX DFS RAIL SYSTEM |
EBI, L.P. |
PATRICIA FLOOD |
| K010482 |
03/20/2001 |
ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1 |
ECHOCATH, INC. |
DAVID LYONS |
| K001734 |
03/26/2001 |
FOGARTY VALVULOTOME, MODEL 700091 |
EDWARDS LIFESCIENCES, LLC. |
DIANE PETERSON |
| K003955 |
03/15/2001 |
LASEREX INTEGRE, MODEL LP2532 |
Ellex Medical Pty. Ltd. |
KEITH DEGENHARDT |
| K002154 |
03/22/2001 |
K.E.A.T. |
EMD ELECTRONIC MEDICAL DEVICES, CORP. |
JEAN CLAUDE MARTY |
| K003897 |
03/22/2001 |
ENDIUS BIPOLAR SHEATH |
ENDIUS, INC. |
SUSAN FINNERAN |
| K010535 |
03/19/2001 |
TRIFIX SPINAL FIXATION SYSTEM |
ENDIUS, INC. |
SUSAN FINNERAN |
| K010339 |
03/07/2001 |
ENDOCARE PERCUTANEOUS ACCESS SET |
ENDOCARE, INC. |
VINCENT CUTARELLI |
| K010356 |
03/27/2001 |
LATEX EXAMINATION GLOVES-POWDER FREE |
ENZYMIC TECHNOLOGIES SDN BHD |
LEE HONG YEN |
| K010347 |
03/27/2001 |
LATEX EXAMINATION GLOVES-POWDERED, NONSTERILE |
ENZYMIC TECHNOLOGIES SDN BHD |
LEE HONG YEN |
| K010718 |
03/23/2001 |
FLEXI-SITE SP02 EAR SENSOR |
EPIC MEDICAL EQUIPMENT SERVICES, INC. |
KRISTA OAKES |
| K003864 |
03/06/2001 |
INJEX 50 SYSTEM |
EQUIDYNE SYSTEMS, INC. |
JIM BARLEY |
| K003352 |
03/20/2001 |
ESCREEN SYSTEM |
ESCREEN, INC. |
JONATHAN S KAHAN |
| K003953 |
03/16/2001 |
INDIGO DIFFUSER-TIP FIBEROPTIC WITH TEMPERATURE SENSING OPTION, MODEL LF001 |
ETHICON ENDO-SURGERY, INC. |
JACKIE HUGHES |
| K003952 |
03/16/2001 |
INDIGO LASEROPTIC TREATMENT SYSTEM |
ETHICON ENDO-SURGERY, INC. |
JACQUELYN A HUGHES |
| K010165 |
03/12/2001 |
ERO SCAN OAE TEST SYSTEM |
ETYMOTIC RESEARCH |
STEVE ISEBERG |
| K010434 |
03/13/2001 |
OPTETRAK B-SERIES TOTAL KNEE SYSTEM |
EXACTECH, INC. |
Lisa Simpson |
| K010085 |
03/15/2001 |
EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED) |
EXCEL TECH. LTD. |
SONJA MARKEZ |
| K010088 |
03/26/2001 |
REAL PATIENT AMBULATORY EEG, MODEL EX-AMB-RP (PROPOSED) |
EXCEL TECH. LTD. |
CAMERON MAHON |
| K010084 |
03/16/2001 |
REAL PATIENT REAL PATIENT 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128-RP |
EXCEL TECH. LTD. |
DEBBIE DAVY |
| K010089 |
03/26/2001 |
REAL PATIENT WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS-RP (PROPOSED) |
EXCEL TECH. LTD. |
DEBBIE DAVY |
| K010090 |
03/26/2001 |
XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4-RP (PROPOSED) |
EXCEL TECH. LTD. |
SONJA MARKEZ |
| K010087 |
03/19/2001 |
XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP |
EXCEL TECH. LTD. |
CAMERON MAHON |
| K010562 |
03/13/2001 |
ALPHA DX SYSTEM |
FIRST MEDICAL, INC. |
GREG HOLLAND |
| K992706 |
03/15/2001 |
GALIX GBI -3S-LP |
GALIX BIOMEDICAL INSTRUMENTATION, INC. |
JORDAN GAVRIELIDES |
| K003947 |
03/13/2001 |
FUNCTIONAL BRAIN MAPPING OPTION FOR MRI |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K010641 |
03/30/2001 |
GE CT-PET SYSTEM |
GE MEDICAL SYSTEMS, INC. |
D DUERSTELER |
| K003837 |
03/12/2001 |
FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM |
GE OEC MEDICAL SYSTEMS |
TED PARROT |
| K010329 |
03/01/2001 |
LOGIQ 500 |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
| K004014 |
03/16/2001 |
MD 30 COMPACT |
GENERAL PROJECT |
CORNELIA DAMSKY |
| K010217 |
03/18/2001 |
4 PORT, 4 WAY STOPCOCK |
GEORGE LOO, MD |
GEORGE LOO |
| K003803 |
03/07/2001 |
GENERAL SURGICAL LAPAROSCOPES |
GLOBAL ENDOSCOPY, INC. |
NICK MIRCEA |
| K010686 |
03/21/2001 |
KTJ-20C BLOOD PRESSURE CUFF, MODEL KTJ-20C |
GOLDEN HORSE MEDICAL EQUIPMENT (WUXI) CO. LTD. |
GARY C BAUMAN |
| K003590 |
03/05/2001 |
GRAMS POLYESTER NONABSORBABLE SUTURE |
GRAMSMED LLC |
ANTHONY J DIMERCURIO |
| K003017 |
03/13/2001 |
GRAMSORB SYNTHETIC ABSORBABLE SUTURE |
GRAMSMED LLC |
A. J DIMERCURIO |
| K010425 |
03/15/2001 |
EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY) |
HDC CORP. |
EARL SMART |
| K010442 |
03/08/2001 |
KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652 |
HEINZ KURZ |
DAGMAR S MASER |
| K010617 |
03/15/2001 |
SPIFE IFE CALIBRATOR AND CONTROL KIT |
HELENA LABORATORIES |
PAT FRANKS |
| K010616 |
03/28/2001 |
DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A |
HMI INDUSTRIES, INC. |
JACQUELINE PERCELL |
| K010403 |
03/26/2001 |
PRESTIGE IQ BLOOD GLUCOSE TEST SYSTEM, MODEL 507400, 537600, 550600, 561700, 563700 |
HOME DIAGNOSTICS, INC. |
KAREN DEVINCENT |
| K004044 |
03/02/2001 |
HOMMED SENTRY III PATIENT MONITOR SYSTEM |
HOMMED LLC. |
TOMMIE J MORGAN |
| K010310 |
03/20/2001 |
MODIFICATION TO TRIDENT ALL POLY CUP |
HOWMEDICA OSTEONICS CORP. |
JENNIFER A DAUDELIN |
| K010402 |
03/14/2001 |
SMOOTH-FLO CIRCUIT |
HUDSON RESPIRATORY CARE, INC. |
CHARLES MIERKIEWICZ |
| K002548 |
03/06/2001 |
FETAL ASSIST |
HUNTLEIGH DIAGNOSTICS LTD. |
B.J. COLLEYPRIEST |
| K004011 |
03/27/2001 |
IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS |
IMPRA, INC. |
LORI CHAVEZ |
| K010352 |
03/14/2001 |
CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM |
INION LTD. |
HANNA MARTTILA |
| K010351 |
03/15/2001 |
INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM |
INION LTD. |
HANNA MARTTILA |
| K003271 |
03/20/2001 |
MODIFICATION TO ITI DENTAL IMPLANT SYSTEM |
INSTITUT STRAUMANN AG |
CAROLYN BITETTI |
| K010515 |
03/22/2001 |
MODIFICATION TO SYNERGY SPINAL SYSTEM |
INTERPORE CROSS INTL. |
LYNN M RODARTI |
| K002489 |
03/02/2001 |
INTUITIVE SURGICAL DA VINCI ENDOSCOPIC CONTROL SYSTEM |
INTUITIVE SURGICAL, INC. |
DAVID CASAL |
| K010364 |
03/22/2001 |
MCC-MIV ONE 2 ONE SOFTWARE |
INVACARE CORP. |
RAE ANN FARROW |
| K003939 |
03/21/2001 |
VENTURE HOME FILL II, MODEL IOH 200 |
INVACARE CORP. |
EDWARD A KROLL |
| K010381 |
03/06/2001 |
D.SIGN 30 |
IVOCLAR NORTH AMERICA, INC. |
ANDY GULATI |
| K003835 |
03/23/2001 |
JAS MAGNESIUM REAGENT |
JAS Diagnostics, Inc. |
David Johnston |
| K010416 |
03/08/2001 |
HERACERAM 75 |
JELENKO CO. |
RAPHAEL JUDKINS |
| K010414 |
03/27/2001 |
R & D DESIGNATION AP-035 |
JENSEN INDUSTRIES, INC. |
JOHN SLANSKI |
| K010611 |
03/27/2001 |
R & D DESIGNATION AP-047 |
JENSEN INDUSTRIES, INC. |
JOHN SLANSKI |
| K010160 |
03/27/2001 |
WILLI GELLER CREAPEARL |
JENSEN INDUSTRIES, INC. |
JOHN SLANSKI |
| K002665 |
03/19/2001 |
WRISTWATCH BPM BLOOD PRESSURE MONITOR, MODEL KP-6120 |
K-JUMP HEALTH CO., LTD. |
JOHATHAN S KAHAN |
| K003113 |
03/27/2001 |
KSEA SCB-RUI SCO |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN KENNAN |
| K010040 |
03/09/2001 |
SLEEVED FILTER |
KING SYSTEMS CORP. |
CHARLES A BURT |
| K003765 |
03/06/2001 |
LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION) |
LASERSCOPE |
PAUL H HARDMAN |
| K003369 |
03/08/2001 |
LIFECARE COMPACT TENS DEVICE |
LIFECARE LTD. |
AHAVA STEIN |
| K002088 |
03/06/2001 |
SHAVER ABLATOR |
LINVATEC CORP. |
LAURA D SENEFF |
| K003984 |
03/19/2001 |
SUPER REVO SUTURE ANCHOR |
LINVATEC CORP. |
LAURA D SENEFF |
| K004006 |
03/26/2001 |
SELECTA 7000 FREQUENCY DOUBLED, Q-SWITCHED ND:YAG OPHTHALMIC LASER |
LUMENIS, INC. |
KAREN BAKER |
| K004028 |
03/27/2001 |
ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING |
MAERSK MEDICAL, LTD. |
LARA N SIMMONS |
| K003913 |
03/16/2001 |
HINT AUDIOMETER, OR HINT |
MAICO-DIAGNOSTICS |
DANIEL EGGAN |
| K010419 |
03/06/2001 |
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES |
MASIMO CORP. |
JAMES J CRONIN |
| K004050 |
03/15/2001 |
PANASONIC TELE-HOMECARE SYSTEM |
MATSUSHITA ELECTRIC INDUSTRIAL CO., LTD. |
DAVID L WEST |
| K002789 |
03/21/2001 |
MEDEVIEW SYSTEM |
MEDEVIEW.COM |
JEFFREY O BOILY |
| K000724 |
03/22/2001 |
MEDICA HP 300 HEMOFILTRATION PUMP, MODEL 300 |
MEDICA S.R.L. |
JAMES DELANEY |
| K003344 |
03/15/2001 |
MEDICAL DEPOT NEBULIZER, MODEL POWER NEB 2 |
MEDICAL DEPOT, INC. |
ART WARD |
| K010495 |
03/09/2001 |
CENTURA PHOTOTHERAPY SPOTLIGHT |
MEDICAL ILLUMINATION INTERNATIONAL, INC. |
DAVID GLOVER |
| K003156 |
03/22/2001 |
BLASTASSIST SYSTEM |
MEDICULT A/S |
RONALD G LEONARDI |
| K003404 |
03/22/2001 |
SUPRASPERM SYSTEM |
MEDICULT A/S |
RONALD G LEONARDI |
| K003163 |
03/22/2001 |
SYNVITRO FLUSH |
MEDICULT A/S |
RONALD G LEONARDI |
| K002153 |
03/13/2001 |
ULTRASONIC NEBULIZER, MODEL NE-520 |
MEDISANA USA, INC. |
GUENTER GINSBERG |
| K010338 |
03/07/2001 |
ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200 |
MEDIVANCE, INC. |
LYNNE ARONSON |
| K003979 |
03/19/2001 |
MEDTRADE PRODUCTS SILICON SCAR MANAGEMENT PAD |
MEDTRADE PRODUCTS LTD. |
JONATHAN D RANFIELD |
| K002869 |
03/27/2001 |
LOCALISA CARDIAC NAVIGATION SYSTEM |
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES |
THOMAS PARKER |
| K003873 |
03/29/2001 |
MENTOR SELF-CATH CLOSED SYSTEM |
MENTOR CORP. |
DONNA A CRAWFORD |
| K003784 |
03/05/2001 |
MENTOR SELF-CATH PLUS |
MENTOR CORP. |
DONNA A CRAWFORD |
| K010609 |
03/16/2001 |
ACCUSONIC, MODEL AS-260 |
METRON MEDICAL AUSTRALIA PTY LTD |
ROB HOPKINS |
| K003794 |
03/30/2001 |
ELISA TEST, SEROLOGY |
MICRO DETECT, INC. |
MEDHI ALEM |
| K010497 |
03/22/2001 |
SILVERSPEED HYDROPHILIC GUIDEWIRE, MODELS 103-0601-300 AND 103-0602-300 |
MICRO THERAPEUTICS, INC. |
EBEN GORDON |
| K003584 |
03/19/2001 |
NEOLYNX SCREENING APPLICATION MANAGER |
MICROMASS, INC. |
DANIEL J DILLON |
| K003594 |
03/09/2001 |
CARRIAZO BARRAQUER SINGLE USE MICROKERATOME |
MORIA, INC. |
DAVID CONRAD |
| K003899 |
03/15/2001 |
IFIS-SA INTEGRATED FUCTIONAL IMAGING SYSTEM |
MRI DEVICES CORP. |
WILLIAM DINEHART |
| K010096 |
03/05/2001 |
MULTI CARE THERAPEUTIC VIBRATOR |
MULTICEPT A/S |
KLAUS VAMMEN |
| K010589 |
03/19/2001 |
MICROWAVAE DELIVERY SYSTEM #MW2000 |
MW MEDICAL, INC. |
GREG HOLLAND |
| K010298 |
03/16/2001 |
MN-4 COARSE MANIPULATOR |
NARISHIGE CO., LTD. |
MITSUKO YONEYAMA |
| K010521 |
03/09/2001 |
NICOLET VERSALAB |
NICOLET BIOMEDICAL |
DAVID W WAGNER |
| K010019 |
03/19/2001 |
STERILE SUBDERMAL NEEDLE ELECTRODES |
NICOLET BIOMEDICAL, INC. |
Gary Syring |
| K003299 |
03/09/2001 |
OPD-SCAN, MODELS ARK-10000 AND ARK-9000 |
NIDEK CO., LTD. |
CAROL PATTERSON |
| K010224 |
03/18/2001 |
NPAC MULTI-USE THERMOMETER, MODEL TD400 |
NORM PACIFIC AUTOMATION CORP. |
CHI-CHU WU CHEN |
| K010359 |
03/14/2001 |
INNOVO |
NOVO NORDISK A/S |
ROBERT FISCHER |
| K003820 |
03/08/2001 |
DISPOSABLE CB-PE MICROKERATOME BLADES |
OASIS MEDICAL, INC. |
YVONNE FERNANDEZ |
| K010222 |
03/21/2001 |
OHMEDA MEDICAL GIRAFFE INCUBATOR |
OHMEDA MEDICAL |
ALBERTO F PROFUMO |
| K000977 |
03/23/2001 |
COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS |
OLSON MEDICAL SALES, INC. |
GARY A COURTNEY |
| K010591 |
03/15/2001 |
OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER |
OLYMPUS OPTICAL CO., LTD. |
TSUYOSHI YANAI |
| K003824 |
03/08/2001 |
OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI |
OMNISONICS MEDICAL TECHNOLOGIES |
DOUG CHARLAND |
| K010256 |
03/26/2001 |
ULTRAVUE/P 2000T, ULTRAVUE/C 2000T (HIOXIFILCON B) SOFT (MULTIFOCAL TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBIL |
OPTI-CENTRE LABORATORIES |
MARTIN DALSING |
| K004021 |
03/27/2001 |
F1 DIODE LASER SYSTEM |
OPUS MEDICAL, INC. |
CONNIE WHITE-HOY |
| K003893 |
03/01/2001 |
VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL PROBES, MODEL 91000X,91002X,91300X |
ORATEC INTERVENTIONS, INC. |
LINDA GUTHRIE |
| K010024 |
03/14/2001 |
O2/CO2 NASAL FILTERLINE |
ORIDION MEDICAL 1987 LTD. |
SANFORD BROWN |
| K001535 |
03/20/2001 |
ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION |
ORTHOTEC, L.L.C. |
DAVID W SCHLERF |
| K002150 |
03/09/2001 |
SONICAID FM820, SONICAID FM830 |
OXFORD INSTRUMENTS |
STEVE VALE |
| K003886 |
03/01/2001 |
PALOMAR SPALIGHT PULSED LIGHT SYSTEM |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
Marcy Moore |
| K002862 |
03/13/2001 |
PRONEB ULTRA MODEL NUMBER 85B0100 |
PARI HOLDING CO. |
DEBRA A PEKAR |
| K003951 |
03/21/2001 |
PECTOFIX STERNAL REPAIR WIRE |
PECTOFIX, INC. |
ERIC BANNON |
| K010645 |
03/30/2001 |
AT HOME DRUG TEST, MODEL 9063 T |
PHAMATECH |
CARL A MONGIOVI |
| K010650 |
03/30/2001 |
AT HOME DRUG TEST, MODEL 9073 T |
PHAMATECH |
CARL A MONGIOVI |
| K010646 |
03/30/2001 |
AT HOME DRUG TEST, MODEL 9083 T |
PHAMATECH |
CARL A MONGIOVI |
| K010651 |
03/30/2001 |
AT HOME DRUG TEST, MODEL 9133 T |
PHAMATECH |
CARL A MONGIOVI |
| K010435 |
03/12/2001 |
PHILIPS BV PULSERA/ENDURA |
PHILIPS MEDICAL SYSTEMS, INC. |
MARCIA JONES |
| K003705 |
03/01/2001 |
XTRAC EXCIMER LASER SYSTEM, MODEL AL7000 |
PHOTO MEDEX, INC. |
AL MEMMOLO |
| K003725 |
03/01/2001 |
240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUS |
PIE MEDICAL |
COLLEEN J HITTLE |
| K010116 |
03/15/2001 |
PLANMED SOPHIE, PLANMED SOPHIE CLASSIC |
PLANMED OY |
BOB PIENKOWSKI |
| K001412 |
03/20/2001 |
PM 1800 CONSERVING DEVICE |
PRECISION MEDICAL, INC. |
CONLEY WALLACE |
| K002907 |
03/08/2001 |
PVS 1300 NEURO GUIDE WIRE |
PRECISION VASCULAR SYSTEMS, INC. |
JOHN R RAGAZZO |
| K003058 |
03/08/2001 |
LASER 3 SPSC300 |
PRIDE MOBILITY PRODUCTS CORP. |
GENE R KULON |
| K003059 |
03/01/2001 |
LASER 4SPSC340 |
PRIDE MOBILITY PRODUCTS CORP. |
GENE R K ULON |
| K010608 |
03/20/2001 |
MODIFICATION TO LAP TOP VENTILATOR (LTV) |
PULMONETIC SYSTEMS, INC. |
DARRYL SHELBY |
| K010598 |
03/23/2001 |
SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL |
QUANTIMETRIX CORP. |
EVA LASZLO |
| K002689 |
03/06/2001 |
SWABSITE SWABBABLE VALVE, MODEL 245000 |
QUEST MEDICAL, INC. |
DOUG BRYAN |
| K010409 |
03/16/2001 |
CBC-SF |
R & D SYSTEMS, INC. |
KENNETH T EDDS |
| K010548 |
03/12/2001 |
MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) |
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP |
KEVIN J O'CONNELL |
| K003346 |
03/15/2001 |
RANDOX GLUCOSE (GOD/PAP) |
RANDOX LABORATORIES, LTD. |
P. ARMSTRONG |
| K010606 |
03/16/2001 |
SAFARI |
RANGER ALL SEASON CORP. |
RON STEWART |
| K994381 |
03/30/2001 |
PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR |
RAVEN BIOLOGICAL LABORATORIES, INC. |
WENDY ROYALTY |
| K010538 |
03/30/2001 |
PARSET NEEDLELESS PRIMARY SET FOR BLUNT CANNULA, A10003E, PARSET NEEDLELESS SECONDARY SET WITH BLUNT CANNULA, A14003E |
RD MEDICAL MFG., INC. |
CARLOS A RODRIGUEZ-GARCIA |
| K004040 |
03/29/2001 |
REDTECH GIPC 2000 |
RED-TECH, INC. |
GARY MOCNIK |
| K001708 |
03/01/2001 |
PROFOX SOFTWARE, MODEL 920M-41 |
RESPIRONICS GEORGIA, INC. |
GERRY RICHARDSON |
| K010263 |
03/29/2001 |
REMSTAR PLUS CPAP SYSTEM |
RESPIRONICS, INC. |
DAVID J VANELLA |
| K010052 |
03/19/2001 |
RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER |
RESPIRONICS, INC. |
DAVID J VANELLA |
| K000180 |
03/02/2001 |
TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K010240 |
03/27/2001 |
POLYCARBOXYLATE (PCA) CEMENT |
RITE-DENT MANUFACTURING CORP. |
CESAR E VELIZ |
| K010362 |
03/07/2001 |
ACCU-CHEK COMFORT CURVE TEST STRIP |
ROCHE DIAGNOSTICS CORP. |
MIKE FLIS |
| K003846 |
03/19/2001 |
ACCU-CHEK INFORM METER |
ROCHE DIAGNOSTICS CORP. |
MIKE FLIS |
| K003411 |
03/01/2001 |
ELECSYS TESTOSTERONE CALSET II |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
| K010588 |
03/28/2001 |
ELECSYSCA 15-3 II ASSAY |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
| K002706 |
03/16/2001 |
ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA; ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON HITACHI |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
| K010498 |
03/20/2001 |
WRISTWATCH BLOOD PRESSURE MONITOR A46 |
ROSSMAX INTERNATIONL LTD. |
MICHAEL YEH |
| K002468 |
03/02/2001 |
SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 3050 |
SAN UP S.A. |
SUSAN D GOLDSTEIN-FALK |
| K003382 |
03/30/2001 |
SARSTEDT NEEDLE PROTECTOR |
SARSTEDT, INC. |
PETER RUMSWINKEL |
| K010289 |
03/07/2001 |
SCIMEDX PHASE II MPO IGG ANTIBODY EIA |
SCIMEDX CORP. |
Gary Lehnus |
| K010287 |
03/16/2001 |
SCIMEDX PHASE II PR3 IGG ANTIBODY EIA |
SCIMEDX CORP. |
Gary Lehnus |
| K010285 |
03/01/2001 |
CONTOUR PROFILE LASER |
SCITON, INC. |
PETER N ALLEN |
| K010382 |
03/01/2001 |
100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I |
SENSIDYNE, INC. |
GEORGE MASON |
| K010097 |
03/30/2001 |
POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) |
SHEN WEI (USA), INC. |
BELLE L CHOU |
| K010721 |
03/30/2001 |
AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM |
SIEMENS MEDICAL CORP. |
PRAVEEN NADKARNI |
| K003550 |
03/07/2001 |
INFINITY ETCO2 + RESPIRATORY MECHANICS POD |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PENELOPE H GREEN |
| K010640 |
03/20/2001 |
SIEMENS MEDICAL INFORMATION BUS (MIB II) PROTOCOL CONVERTER |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PENELOPE H GRECO |
| K003328 |
03/01/2001 |
ACCUCLOT CONTROL I, MODEL A4089 |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT |
| K003267 |
03/15/2001 |
SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT II |
| K010652 |
03/30/2001 |
SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT II |
| K003329 |
03/01/2001 |
SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT |
| K010158 |
03/22/2001 |
THROMBOMAX-HS WITH CALCIUM, MODEL T6540 |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT II |
| K010426 |
03/08/2001 |
PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER |
SIMS DELTEC, INC. |
LISA J STONE |
| K002274 |
03/07/2001 |
SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW |
SMITH & NEPHEW, INC. |
TEDD GOSIAN |
| K002095 |
03/02/2001 |
SNAP MODEL 6 |
SNAP LABORATORIES, L.L.C. |
GIL RAVIV |
| K010176 |
03/27/2001 |
CALEX CONDITIONER |
STEPHEN M. KORAL, D.M.D. |
STEPHEN M KORAL |
| K010373 |
03/13/2001 |
SIMPLICITY SOFT Y INFUSION SET FOR USE WITH THE MINIMED INFUSION PUMPS AND MINIMED MEDICATION RESERVOIRS (MODEL MMT-103) |
STERLING MEDIVATIONS, INC. |
JOEL DOUGLASS |
| K003758 |
03/07/2001 |
ALLOFIT ACETABULAR SYSTEM |
SULZER ORTHOPEDICS, INC. |
MITCHELL A DHORITY |
| K010622 |
03/29/2001 |
PRESSURE TRAK, MODEL 222-B |
SUNTECH MEDICAL INSTRUMENTS, INC. |
DAVID GALLICK |
| K010041 |
03/07/2001 |
SLT DIFFUSER FIBER |
SURGICAL LASER TECHNOLOGIES, INC. |
DAVIS WOODWARD |
| K003808 |
03/01/2001 |
TAKE 1 |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K003717 |
03/01/2001 |
INSTRUMENTS FOR LAPAROSCOPY 5 MM, 10 MM WITH COLOURED HANDLE, DETACHABLE ENDODCOPIC INSTRUMENTS 5 MM, 10MM (HANDLE, SHAF |
TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO. |
HARALD JUNG |
| K003911 |
03/13/2001 |
TERRAY STAINLESS STEEL ROD (STRAIGHT, L, RECTANGLE) |
TERRAY CORP. |
STEVE WANG |
| K010103 |
03/15/2001 |
SURSHIELD WINGED INFUSION SET |
TERUMO MEDICAL CORP. |
BARBARA SMITH |
| K010147 |
03/01/2001 |
ENA EIA KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K010146 |
03/01/2001 |
ENA EIA KIT RANGE |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K002901 |
03/28/2001 |
KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER |
THE KENDALL COMPANY |
PAUL EVANS |
| K010663 |
03/30/2001 |
POWDERED SYNTHETIC VINYL PATIENT EXAM GLOVE |
TONG RUHN MEDICAL PRODUCTS CO., LTD. |
ANTONIO L GIACCIO |
| K010631 |
03/15/2001 |
NEMIO |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K004045 |
03/06/2001 |
SUSCEPTIBILITY TEST PANEL |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
| K003995 |
03/16/2001 |
SPECULITE/ORALLITE |
TRYLON CORP. |
MARTIN LONKY |
| K003449 |
03/16/2001 |
E MOTION WHEELCHAIR DRIVE SYSTEM (POWER-ASSIST FOR MANUAL WHEELCHAIRS) |
ULRICH ALBER GMBH & CO. |
SUSAN D GOLDSTEIN-FALK |
| K010070 |
03/15/2001 |
ULTRAPAK NEHA |
ULTRADENT PRODUCTS, INC. |
MARKUS R GEE |
| K002297 |
03/15/2001 |
YORAMED, MODEL T-202 |
UNITED YORAM DISTRIBUTORS, INC. |
MORRIS MIZRAHI |
| K010013 |
03/26/2001 |
LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100 |
VALLEYLAB, INC. |
KEVIN RANDALL |
| K003173 |
03/13/2001 |
ASPIRE COVERED STENT AND DELIVERY CATHETER |
VASCULAR ARCHITECTS, INC. |
KEVIN F MACDONALD |
| K010218 |
03/16/2001 |
VISTAKON (HEFILCON C) CONTACT LENSES |
VISTAKON |
MICHAEL J TERSAK |
| K002454 |
03/07/2001 |
BREAS HA50 HUMIDIFIER, MODEL HA50 |
VITAL SIGNS, INC. |
THOMAS W DIELMANN |
| K000881 |
03/08/2001 |
PERFADEX SOLUTION FOR ORGAN PRESERVATION |
VITROLIFE SWEDEN AB |
KARL A POSSELT |
| K010427 |
03/15/2001 |
LORENZ FIDUCAIL SCREW |
WALTER LORENZ SURGICAL, INC. |
KIM REED |
| K010031 |
03/20/2001 |
NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM |
WESCOR, INC. |
WAYNE K BARLOW |
| K010447 |
03/15/2001 |
MODIFICATION TO ACTICOAT FOAM DRESSING |
WESTAIM BIOMEDICAL, INC. |
Steve Chartier |
| K002696 |
03/21/2001 |
WHITTLESTONE BREASTPUMP |
WHITTLESTONE, INC. |
BRUCE MCKENDRY |
| K002315 |
03/15/2001 |
WISEBANDS SKIN CLOSURE DEVICE |
WISEBANDS LTD. |
MARY PAGE |
| K010058 |
03/21/2001 |
IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORK |
WITT BIOMEDICAL CORPORATION |
LORRAINE R FREDES |
| K003910 |
03/19/2001 |
NEXGEN COMPLETE KNEE SOLUTION CROSS-LINKED POLYETHYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTS |
ZIMMER, INC. |
STEPHEN MCKELVEY |
