| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K011200 |
06/14/2001 |
GILB, MODEL 8010 |
3M COMPANY |
KAREN O'MALLEY |
| K011442 |
06/05/2001 |
ABBOTT PLUM A+INFUSION PUMP, MODEL 11971 |
ABBOTT LABORATORIES |
FRANK POKROP |
| K010953 |
06/06/2001 |
CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY |
ABBOTT LABORATORIES |
JOHN DEAN |
| K010553 |
06/18/2001 |
PRECISION XTRA BLOOD GLUCOSE TEST STRIP WITH TRUEMEASURE TECHNOLOGY |
ABBOTT LABORATORIES |
JANET CONNOLLY |
| K011752 |
06/28/2001 |
GOVAN+ WHEELCHAIR AND DOCKING ACCESSORY |
ACCUFAST, INC. |
DON LOGAN |
| K010950 |
06/27/2001 |
CYPRESS SYSTEM |
ACUSON CORP. |
HOWARD M HOLSTEIN |
| K010791 |
06/08/2001 |
REMOTE PRESENCE AND CARE SYSTEM (RPCS 5000) |
ADSIS LTD. |
JONATHAN S KAHAN |
| K010760 |
06/11/2001 |
ART BICARBONATE FOR HEMODIALYSIS, ART BICARBONATE LIQUID FOR HEMODIALYSIS |
ADVANCED RENAL TECHNOLOGIES, INC. |
ROBIN CALLAN |
| K011183 |
06/15/2001 |
OMNIPORT HAND AND INSTRUMENT ACCESS DEVICE |
ADVANCED SURGICAL CONCEPTS (ASC) |
MARY MCNAMARA-CULLINANE |
| K010921 |
06/25/2001 |
ADVANTAGE MARIJUANA (THC) HOME DRUG TEST |
ADVANTAGE DIAGNOSTICS CORP. |
JANIS FREESTONE |
| K003759 |
06/28/2001 |
AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR |
AESCULAP, INC. |
DAVID W SCHLERF |
| K011375 |
06/29/2001 |
AESCULAP, INC., MONOSYN SYNTHETIC ABSORBABLE SURGICAL SUTURE |
AESCULAP, INC. |
STEVE REITZLER |
| K010752 |
06/11/2001 |
AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY |
AESCULAP, INC. |
LESLIE YOUNG |
| K010634 |
06/11/2001 |
HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLATOR/MONITOR.MODEL M2500B |
AGILENT TECHNOLOGIES, INC. |
RICHARD J PETERSEN |
| K011578 |
06/08/2001 |
M2376A DEVICELINK SYSTEM, MODEL M2376A |
AGILENT TECHNOLOGIES, INC. |
MIKE HUDON |
| K010965 |
06/27/2001 |
A-LINE AEP MONITOR |
ALARIS MEDICAL SYSTEMS, INC. |
RENEE FLUET |
| K010966 |
06/08/2001 |
MEDLEY SP02 MODULE, MODEL 8220 |
ALARIS MEDICAL SYSTEMS, INC. |
RENEE L FLUET |
| K011132 |
06/08/2001 |
AIRLIFE HEPA FILTER |
ALLEGIANCE HEALTHCARE CORP. |
SHARON ROBBINS |
| K010862 |
06/07/2001 |
ULTRAFREE MAX STERILE LATEX POWEDER-FREE SURGICAL GLOVES WITH PROTEIN LABELING CLAIM, 50 PER GRAM OR LESS OF TOTAL WATER |
ALLEGIANCE HEALTHCARE CORP. |
ERICA SETHI |
| K011234 |
06/13/2001 |
BIOCURVE SOFT (HIOXIFILCON B) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING L |
AMERICAN BIOCURVE, INC. |
MARTIN DALSING |
| K011316 |
06/13/2001 |
BIOCURVE SOFT (HIOXIFILCOM A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING T |
AMERICAN CONTACT LENS, INC. |
MARTIN DALSING |
| K010990 |
06/22/2001 |
AMS SLING FIXATION SYSTEM |
AMERICAN MEDICAL SYSTEMS, INC. |
ELSA A LINKE |
| K003999 |
06/28/2001 |
AVIVA SYSTEM, MODEL SL 2020; AVIVA SLX SYSTEM SYSTEM, MODEL SLX 1010 |
AMERICAN TELECARE, INC. |
CHARLES RICHARD ABBRUSCATO |
| K010884 |
06/20/2001 |
TITANIUM COMPRESSION ANCHOR SYSTEM |
ANCHOR MEDICAL TECHNOLOGIES |
GREG HOLLAND |
| K011593 |
06/21/2001 |
MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE |
ANSELL HEALTHCARE PRODUCTS, INC. |
JAMES R CHATTERTON |
| K011601 |
06/08/2001 |
ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX |
ARDO MEDICAL AG |
EVA KRAHENBUHL |
| K003778 |
06/08/2001 |
BREAST-BOARD (MULTIPLE) |
ARPLAY MEDICAL S.A. |
RICHARD BORGI |
| K001917 |
06/06/2001 |
PARODI CATHETER FOR ANGIOGRAPHY (PARCA) |
ARTERIA MEDICAL SCIENCE, INC. |
STEVE CHERNOFF |
| K011172 |
06/19/2001 |
ARTHREX BIO-TRANSFIX |
ARTHREX, INC. |
VERNON BROWN |
| K011007 |
06/12/2001 |
TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55 |
ARTHREX, INC. |
ANN WATERHOUSE |
| K011634 |
06/19/2001 |
ARTHROCARE CONTROLLER, MODEL H2000; ARTHROCARE CABLE, MODEL H0970-02; FOOTSWITCH, MODEL H2000-04; POWERCORD, MODEL H2000 |
ARTHROCARE CORP. |
BETTY M JOHNSON |
| K011083 |
06/28/2001 |
ARTHROCARE SYSTEM 2000 CONTROLLER, CABLE, FOOTSWITCH, POWER CORD & ARTHROCARE ARTHROWAND |
ARTHROCARE CORP. |
BRUCE PROTHRO |
| K011534 |
06/15/2001 |
EEG MIS MONITOR MODEL # A-2000; BIS ENGINE |
ASPECT MEDICAL SYSTEMS, INC. |
CHRISTINE M VOZELLA |
| K010473 |
06/06/2001 |
SPARROWHAWK DISPOSABLE |
ATC TECHNOLOGIES, INC. |
PAUL KIERCE |
| K002409 |
06/28/2001 |
MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER |
AUTOMATIC MEDICAL TECHNOLOGIES, INC. |
MICHAEL MITSUNAGA |
| K010847 |
06/19/2001 |
K'FIX |
AVANTA ORTHOPAEDICS, INC. |
LOUISE M FOCHT |
| K011819 |
06/19/2001 |
RADIAL HEAD IMPLANT |
AVANTA ORTHOPAEDICS, INC. |
LOUISE M FOCHT |
| K010029 |
06/29/2001 |
HOME HEALTH MONITORING SYSTEM |
AVID CARE CORP. |
WILLIAM GENTHE |
| K010697 |
06/06/2001 |
UNIQUE AMBULATORY EEG |
AXON SYSTEMS, INC. |
HOWARD BAILIN |
| K011417 |
06/08/2001 |
ULTRASOUND SCANNER, TYPE 2102 |
B-K MEDICAL A/S |
VILLY BRAENDER |
| K003570 |
06/06/2001 |
BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755 |
BACCHUS VASCULAR, INC. |
ROBERT A CLARK |
| K011446 |
06/14/2001 |
BARRIERPLUS POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES |
BARRIERMED, INC. |
CARLO PONCIPE |
| K011317 |
06/28/2001 |
MULTIRATE INFUSOR SV; MULTIRATE INFUSER LV; BAXTER PAIN MATE PAIN MANAGEMENT SYSTEM |
BAXTER HEALTHCARE CORP. |
VICKI L DREWS |
| K011156 |
06/14/2001 |
BCI 3403 SLEEP SCREENING PULSE OXIMETER |
BCI, INC. |
DONALD ALEXANDER |
| K010770 |
06/12/2001 |
BCI ADVISOR VITAL SIGNS MONITOR (9200) |
BCI, INC. |
DONALD ALEXANDER |
| K011103 |
06/13/2001 |
BD SPRING BASED SYRINGE |
BD |
GREG W MORGAN |
| K011858 |
06/19/2001 |
INTERLINK THREADED LOCK CANNULA |
BD |
GREGORY W MORGAN |
| K003062 |
06/06/2001 |
BACTEC MGIT 960 SIR KITS |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
DENNIS R MERTZ |
| K003259 |
06/13/2001 |
ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479 |
BECKMAN COULTER, INC. |
DENISE THOMPSON |
| K010429 |
06/05/2001 |
ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345 |
BECKMAN COULTER, INC. |
BRENT TABER |
| K011465 |
06/08/2001 |
SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO |
BECKMAN COULTER, INC. |
MARY B TANG |
| K011222 |
06/25/2001 |
PORTABELL, MODEL 4200 |
BELL DENTAL PRODUCTS, LLC. |
DAN BELL |
| K011494 |
06/08/2001 |
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1,2,3,1, ML, LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 3 ML, LIQUICHEK IMMUNOLOGY CONTROL |
BIO-RAD |
DONNA CHAPMAN |
| K011579 |
06/26/2001 |
LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580 |
BIO-RAD |
Yvette Lloyd |
| K011675 |
06/22/2001 |
THE AUTOTAC SYSTEM |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
DONALD E DALTON |
| K010209 |
06/12/2001 |
ELECTRO-NERVE STIMULATOR TENS, MODEL HE-DIGITAL |
BIOMEDICAL LIFE SYSTEMS, INC. |
RICHARD SAXON |
| K011509 |
06/13/2001 |
BARRETT UNICONDYLAR TIBIAL BEARING |
BIOMET, INC. |
TRACY J BICKEL |
| K011554 |
06/26/2001 |
LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K011137 |
06/19/2001 |
RESORBABLE HAMMERTOE PIN |
BIOMET, INC. |
SARA A BAILEY |
| K011795 |
06/13/2001 |
WORLAND UNICONDYLAR TIBIAL BEARING |
BIOMET, INC. |
TRACY J BICKEL |
| K010983 |
06/13/2001 |
PLLA PIN |
BIONX IMPLANTS, INC. |
TUIJA ANNALA |
| K011075 |
06/27/2001 |
EASYBELL |
BIOPSYBELL S.A.S. |
LUCIO IMPROTA |
| K010026 |
06/21/2001 |
EMBOGOLD MICROSPHERE |
BIOSPHERE MEDICAL, INC. |
JOHN D BONASERA |
| K011159 |
06/08/2001 |
ONE-STEP PLUS |
BISCO, INC. |
CYNDY ORIS |
| K010874 |
06/21/2001 |
6F MACH 1, MODEL 34356-XXX |
BOSTON SCIENTIFIC CORP. |
TODD KORNMANN |
| K010856 |
06/06/2001 |
STERILE BRIGHTWAY BRAND POWER-FREE, LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) TESTED |
BRIGHTWAY HOLDINGS SDN. BHD. |
G. BASKARAN |
| K011015 |
06/22/2001 |
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 |
C.R. BARD, INC. |
PEGGY KEIFFER |
| K010974 |
06/18/2001 |
RETROGRADE CARDIOPLEGIA CANNULA, MANUAL-INFLATING, WITH MALLEABLE OR GUIDWIRE STYLET |
CALIFORNIA MEDICAL LABORATORIES, INC. |
MEHMET BICAKCI |
| K010184 |
06/22/2001 |
CHESS HAND SURGERY SYSTEM |
CANICA DESIGN, INC. |
GEORGETTE ROY |
| K011389 |
06/21/2001 |
HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL) |
CANTERBURY HEALTH LABORATORIES |
MAURICE OWEN |
| K003927 |
06/26/2001 |
Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02 |
CHEEN HOUNG ENT. CO. LTD. |
JAY WANG |
| K003035 |
06/06/2001 |
CLARREN HELMET |
CHILDREN'S HOSPITAL & MEDICAL CENTER |
DAVID J BLOCH |
| K011336 |
06/12/2001 |
PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK |
CHURCHILL MEDICAL SYSTEMS, INC. |
KEITH PAULCH |
| K011180 |
06/27/2001 |
CT/MASTER, VERSION 1.0 |
COLUMBIA SCIENTIFIC, INC. |
CHARLES D STOCKHAM |
| K011462 |
06/13/2001 |
OIL FOR TISSUE CULTURE |
CONCEPTION TECHNOLOGIES |
GRACE HOLLAND |
| K011677 |
06/22/2001 |
MEDLITE Q-SWITCHED ND:YAG LASER REPLACED BY THE MEDLITE C3 Q-SWTICHED ND:YAG LASER |
CONTINUUM ELECTRO-OPTICS, INC. |
RONALD KOHLHARDT |
| K010055 |
06/14/2001 |
COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH |
COOK VASCULAR, INC. |
THOMAS J KARDOS |
| K003920 |
06/15/2001 |
CORDIS M3 PTA DILATATION CATHETER |
CORDIS CORP. |
CHARLES (CHUCK) J RYAN |
| K010083 |
06/06/2001 |
TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT, MODEL 466-P306A |
CORDIS CORP. |
KAREN WILK |
| K002885 |
06/21/2001 |
DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP |
DADE BEHRING, INC. |
RADAMES RIESGO |
| K011035 |
06/14/2001 |
DIMENSION DRUG CALIBRATOR, MODEL DC22B |
DADE BEHRING, INC. |
RICHARD M VAUGHT |
| K011033 |
06/07/2001 |
DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132 |
DADE BEHRING, INC. |
RICHARD M VAUGHT |
| K010745 |
06/27/2001 |
EMS 3000 |
DAN MED, INC. |
THOMAS SANDGAARD |
| K011611 |
06/08/2001 |
CARDIOCAM MODEL 9CSY0799 |
DANISH DIAGNOSTIC DEVELOPMENT A/S |
NIELS S ORENSEN |
| K011670 |
06/26/2001 |
DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (WITH TRUTRAK+MOTION CORRECTION PERFORMANCE |
DATEX-OHMEDA |
JOEL C KENT |
| K011179 |
06/05/2001 |
DELDENT ULTRASONIC INSERTS |
DELDENT LTD. |
ALAN EDEL |
| K011425 |
06/05/2001 |
CARMEN |
DENTAURUM, INC. |
THOMAS J ANDERSON |
| K011428 |
06/05/2001 |
TRICERAM |
DENTAURUM, INC. |
THOMAS J ANDERSON |
| K011831 |
06/28/2001 |
MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS |
DENVER BIOMEDICAL, INC. |
BONNIE VIVIAN |
| K011020 |
06/01/2001 |
DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER |
DENVER BIOMEDICALS, INC. |
NANCY SAUER |
| K010972 |
06/12/2001 |
ISOLA BAND CLAMP |
DEPUY ACROMED |
LISA GILMAN |
| K011367 |
06/15/2001 |
EXCEL FRACTURE CEMENTED HIP STEM |
DEPUY ORTHOPAEDICS, INC. |
SALLY FOUST |
| K011047 |
06/28/2001 |
GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT |
DEPUY ORTHOPAEDICS, INC. |
MARCIA ARENTZ |
| K003026 |
06/19/2001 |
PFC SIGMA LUGGED TIBIAL TRAY |
DEPUY ORTHOPAEDICS, INC. |
JANET G JOHNSON |
| K010780 |
06/12/2001 |
TROCHANTERIC NAIL |
DEPUY ORTHOPAEDICS, INC. |
MARCIA J ARENTZ |
| K003182 |
06/27/2001 |
ORTHOGENESIS LPS SYSTEM |
DEPUY, INC. |
JANET G JOHNSON |
| K010963 |
06/06/2001 |
STA-LIATEST FREE PROTEIN S TEST KIT |
DIAGNOSTICA STAGO, INC. |
ANDREW LOC B LE |
| K010455 |
06/07/2001 |
ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN |
DIAGNOSTICA-STAGO |
ANDREW LOC B LE |
| K011572 |
06/15/2001 |
QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS) |
DIGIRAD CORP. |
COREY STEWART |
| K011390 |
06/06/2001 |
BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM |
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
ELAD MAGAL |
| K010988 |
06/19/2001 |
FIXION INTERLOCKING PROXIMAL FEMORAL NAILING SYSTEM |
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
JONATHAN S KAHAN |
| K010901 |
06/19/2001 |
FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IMN) MODEL B |
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
JONATHAN S KAHAN |
| K011211 |
06/18/2001 |
FLOWABLE COMPOSITE/ ECUFLOW/ LUXAFLOW |
DMG USA, INC. |
PAMELA PAPINEAU |
| K011773 |
06/22/2001 |
DORNIER LITHOTRIPTER 140(DOLI 140) |
DORNIER |
SUZANNE COURTNEY |
| K010093 |
06/14/2001 |
NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474 |
DRAGER MEDIZINTECHNIK GMBH |
JAMES J BRENNAN |
| K003068 |
06/25/2001 |
SAVINA |
DRAGER MEDIZINTECHNIK GMBH |
JIM BRENNAN |
| K010724 |
06/07/2001 |
SOLA 700,SOLA 500, SOLA 300 |
DRAGER MEDIZINTECHNIK GMBH |
JAMES J BRENNAN |
| K011119 |
06/25/2001 |
BRACHYSEED PD-103 MODELS #PD1 |
DRAXIMAGE, INC. |
RICHARD J FLANAGAN |
| K010703 |
06/25/2001 |
INTER-VIAL |
DUOJECT MEDICAL SYSTEMS, INC. |
DANIEL MACDONALD |
| K011383 |
06/25/2001 |
MICRODOSE CATH, MODELS 90121-201, -202, -203 |
DURECT CORP. |
JEFF P MILLER |
| K002410 |
06/06/2001 |
FREED BIOELECTRIC: DYSPHAGIA TREATMENT DEVICE |
DYSPHAGIA, L.L.C. |
MARCY FREED |
| K011697 |
06/27/2001 |
EBI XFIX ACCESS PELVIC FIXATOR |
EBI, L.P. |
FREDERIC TESTA |
| K011711 |
06/29/2001 |
MODIFICATION TO EBI EFIX VISION FIXATION SYSTEM |
EBI, L.P. |
PATRICIA FLOOD |
| K011516 |
06/08/2001 |
INFANT FLOW SYSTEM, MODEL M672P |
EME (ELECTRO MEDICAL EQUIPMENT) LTD. |
STUART CORNER |
| K010922 |
06/06/2001 |
TRI-FIX SPINAL FIXATION SYSTEM |
ENDIUS, INC. |
SUSAN FINNERAN |
| K010903 |
06/06/2001 |
TRI-FIX SPINAL FIXATION SYSTEM |
ENDIUS, INC. |
GENE DIPOTO |
| K011040 |
06/15/2001 |
CRYOCARE CARDIAC SURGICAL SYSTEM |
ENDOCARE, INC. |
VINCENT CUTARELLI |
| K011587 |
06/01/2001 |
SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMP |
ENTRACON CORP. |
PAUL ZANNECHIA |
| K003741 |
06/01/2001 |
JET SYRINGE MODEL-100500 |
EQUIDYNE SYSTEMS, INC. |
JIM BARLEY |
| K011394 |
06/29/2001 |
LAVA FRAME, LAVA FRAME SHADE, LAVA CERAM |
ESPE DENTAL AG |
ANDREAS PETERMANN |
| K010870 |
06/18/2001 |
LAP DISC 120 X 120, MODEL LD111, LAP DISC 120 X 100, MODEL LD112, LAP DISC 70 X 70, MODEL LD113 |
ETHICON ENDO-SURGERY, INC. |
DENNIS HAHN |
| K010311 |
06/29/2001 |
LIPOMATIC; LIPOMATIC LIPOSUCTION DEVICE |
EUROMI SA |
JOSEPH M AZARY |
| K011617 |
06/08/2001 |
LIFEJET PRINTER 400 |
FERRANIA S.P.A. STABILIMENTO DI FERRANIA |
RICCARDO GENTA |
| K011309 |
06/22/2001 |
LUTE VLC; CORE VLC |
FIRST SCIENTIFIC LIMITED |
ADE AKINMADE |
| K011295 |
06/27/2001 |
RESTORE-PF VIC; RESTORE-PF VLC CAPSULE |
FIRST SCIENTIFIC LIMITED |
ADE AKINMADE |
| K003894 |
06/25/2001 |
ORACLE ORAL MASK |
FISHER & PAYKEL HEALTHCARE, LTD. |
DARRYN ALEXANDER |
| K003973 |
06/01/2001 |
RESPIRATORY HUMIDIFIER, MODEL HC150 |
FISHER & PAYKEL HEALTHCARE, LTD. |
CHRIS MANDER |
| K011485 |
06/06/2001 |
PINNACLE MAGNETIC RESONANCE IMAGING SCANNER |
FONAR CORP. |
LUCIANO BONANNI |
| K010122 |
06/04/2001 |
CONTINUOUS FLOW Y-TUBING |
G.U.-TEK |
ANTHONY SOLAZZO |
| K010667 |
06/04/2001 |
GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R |
GAMBRO RENAL PRODUCTS |
JEFFREY R SHIDEMAN |
| K011624 |
06/08/2001 |
EXPEDIO 500D R&F X-RAY SYSTEM |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K011433 |
06/12/2001 |
BALLERT CRANIAL MOLDING HELMET |
GEMA, INC. |
GENE BERNARDONI |
| K010301 |
06/11/2001 |
IMMUNOWELL EA (D) IGG TEST |
GenBio |
Bryan Kiehl |
| K011000 |
06/29/2001 |
TRAM 2001 MODULE |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
KAREN WEBB |
| K001281 |
06/12/2001 |
GERATHERM BABYWATCH TEMPERATURE MONITOR |
GERATHERM AG |
ED HOLTER |
| K011055 |
06/06/2001 |
THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS |
GO MEDICAL INDUSTRIES PTY. LTD. |
GEORGE O'NEIL |
| K011699 |
06/28/2001 |
VACUETTE EVACUATED BLOOD COLLECTION TUBES |
GREINER BIO-ONE VACUETTE NORTH AMERICA |
Judi Smith |
| K010831 |
06/13/2001 |
AVIATOR PERIPHERAL DILATATION CATHETER |
GUIDANT CORP. |
MERRITT GIRGIS |
| K011506 |
06/15/2001 |
OMNILINK .035 BILIARY STENT SYSTEM |
GUIDANT CORP. |
CURTIS TRUESDALE |
| K011384 |
06/13/2001 |
HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883 |
HARDY DIAGNOSTICS |
MELISSA M TRAYLOR, RAC |
| K002846 |
06/06/2001 |
HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR |
HEADSTAR MEDICAL PRODUCTS CO., LTD |
|
| K011413 |
06/05/2001 |
POWDER-FREE VINYL EXAM GLOVE, YELLOW |
HEYUAN HONGLI INDUSTRIES, INC. |
JANNA TUCKER |
| K011414 |
06/05/2001 |
POWDERED VINAL EXAM GLOVES |
HEYUAN HONGLI INDUSTRIES, INC. |
JANNA TUCKER |
| K011435 |
06/22/2001 |
HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM |
HMT, INC. |
SEUNG K MO |
| K010866 |
06/06/2001 |
TEMP-A-SURE |
HOMECARE TECHNOLOGIES LTD. |
ELI M ORBACH |
| K003180 |
06/28/2001 |
HOMMED OBSERVER, MODEL I |
HOMMED LLC. |
TOMMIE J MORGAN |
| K011623 |
06/15/2001 |
EXETER HIP SYSTEM WITH V40 TAPER |
HOWMEDICA OSTEONICS CORP. |
NANCY J RIEDER |
| K011622 |
06/15/2001 |
OSTEO IC FEMORAL AND TIBIAL NAILS AND OSTEO RETROGRADE/ANTEGRADE FEMORAL NAILS WITH T2 LOCKING SCREWS |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K011643 |
06/28/2001 |
SCORPIO CR SUPERFLEX TIBIAL INSERT |
HOWMEDICA OSTEONICS CORP. |
MARY-CATHERINE DILLON |
| K011529 |
06/12/2001 |
T2 HUMERAL NAIL SYSTEM |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K011125 |
06/13/2001 |
NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI |
HUDSON RESPIRATORY CARE, INC. |
JEANNIE L DENNING |
| K011134 |
06/13/2001 |
OXYGEN SUPPLY TUBING, MODEL 1115 |
HUDSON RESPIRATORY CARE, INC. |
JEANNIE K DENNING |
| K010875 |
06/07/2001 |
HYCARE LATEX EXAMINATION GLOVE, POWDERED |
HYCARE INTL. CO., LTD. |
JOHN GRASSI |
| K011612 |
06/22/2001 |
MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM |
HYDROCISION, INC. |
DEBBIE IAMPIETRO |
| K011181 |
06/25/2001 |
ICS MEDICAL CHARTR OAE WITH TYMP |
ICS MEDICAL CORP. |
DELMAR F BLOEM |
| K010775 |
06/12/2001 |
BIOCELLECT |
IMTEC CORP. |
M.K. PATTERSON |
| K010422 |
06/28/2001 |
ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER |
INNERSPACE, INC. |
DONALD E BOBO |
| K003905 |
06/15/2001 |
ACTI-ICP MONITORING SYSTEM |
INNERSPACE, INC. |
DONALD E BOBO |
| K010919 |
06/15/2001 |
MALE NATURAL RUBBER LATEX CONDOM |
INNOLATEX SDN. BHD |
CHANG AH-KAU |
| K010945 |
06/12/2001 |
HEARTCARD, MODEL 5258 |
INSTROMEDIX |
ALDEN KAY |
| K011424 |
06/25/2001 |
IL TEST PROS |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K011168 |
06/22/2001 |
NEUROGEN NERVE GUIDE |
INTEGRA LIFESCIENCES CORP. |
JUDITH E O'GRADY |
| K010193 |
06/06/2001 |
HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS |
INTERNATIONAL TECHNIDYNE CORP. |
JOHN CLAY |
| K011437 |
06/06/2001 |
SYNERGY 4.0 MM, 4.5 MM VLS SCREWS |
INTERPORE CROSS INTL. |
LYNN RODARTI |
| K011148 |
06/13/2001 |
ULTRACONCENTRATOR SYSTEM |
INTERPORE CROSS INTL. |
PROSIE REY-FESSLER |
| K011616 |
06/21/2001 |
INDUO BLOOD GLUCOSE METER |
INVERNESS MEDICAL INNOVATIONS, INC. |
CAROL A ADILETTO |
| K011095 |
06/13/2001 |
MODEL I0-3DUIMS 3D ULTRASOUND MANAGEMENT SYSTEM |
IODP SA |
DANIEL KAMM |
| K010471 |
06/06/2001 |
AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569 |
IRVINE BIOMEDICAL, INC. |
JAMES FARNWORTH |
| K011598 |
06/13/2001 |
WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE |
IRVINE SCIENTIFIC SALES CO., INC. |
WENDELL LEE |
| K010315 |
06/01/2001 |
ISCREEN VISION SCREENER |
ISCREEN, LLC. |
PETER THRALL |
| K010951 |
06/11/2001 |
ISLAND WOUND DRESSING WITH MICROBAN |
ISLAND DRESSING, LLC. |
JOHN A DOBOS |
| K011490 |
06/27/2001 |
MODIFICATION TO EXCITE |
IVOCLAR NORTH AMERICA, INC. |
DONNA MARIE HARTNETT |
| K011331 |
06/22/2001 |
JP CAST 40 |
JENERIC/PENTRON, INC. |
ANNMARIE TENERO |
| K011330 |
06/22/2001 |
JP CAST 50 |
JENERIC/PENTRON, INC. |
ANNMARIE TENERO |
| K010957 |
06/25/2001 |
QUELL DESENSITIZER |
JENERIC/PENTRON, INC. |
ANNMARIE TENERO |
| K010406 |
06/20/2001 |
JMS A.V. FISTULA NEEDLE SET WING EATER, MODEL 14G-18G |
JMS CO., LTD. |
KEISUKE URATOMI |
| K010410 |
06/20/2001 |
JMS APHERESIS NEEDLE WING EATER, MODEL 14G-18G |
JMS CO., LTD. |
KEISUKE URATOMI |
| K010838 |
06/21/2001 |
FOX PTA CATHETER, 3.0, 4.0, 5.0, 6.0, 7.0, AND 8.0 X 40 MM, MODELS A14003, A14004, A14005, A14006, A14007, A14008 |
JOMED AG |
GLENN BYRD |
| K010987 |
06/19/2001 |
KSEA MINIATURE TELESCOPE AND ACCESSORIES |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
JAMES A LEE |
| K011359 |
06/28/2001 |
MODIFICATION TO KSEA ENDOTIP SYSTEM |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
JAMES A LEE |
| K011860 |
06/27/2001 |
KEYST0NE MEDICAL PICC CATHETER |
KEYSTONE MEDICAL |
ALAN P SCHWARTZ |
| K010139 |
06/29/2001 |
ZURICH DISTRACTION SYSTEM |
KLS-MARTIN L.P. |
ART WARD |
| K010998 |
06/27/2001 |
LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201 |
LANGHAM OPHTHALMIC TECHNOLOGIES |
MAURICE E LANGHAM |
| K003538 |
06/04/2001 |
TDP CQ-27 HEAT LAMP |
LHASA MEDICAL, INC. |
KYUNG P RIIHIMAKI |
| K010049 |
06/14/2001 |
PULSECO HEMODYNAMIC MONITOR CM71 |
LIDCO LTD. |
GREGORY SPELLER |
| K010986 |
06/13/2001 |
LUNAPADS |
LUNAPADS INTERNATIONAL PRODUCTS LTD |
SUZANNE SIEMENS |
| K011071 |
06/07/2001 |
PARADIGM QUICK-SET INFUSION SET |
MAERSK MEDICAL A/S |
GERDA RESCH |
| K010802 |
06/08/2001 |
CARDIAC VIEW, MODEL 2001 |
MAGNA LAB, INC. |
LYNN CARTER |
| K011209 |
06/26/2001 |
MANAN SPRITACRE SPINAL NEEDLES |
MANAN MEDICAL PRODUCTS, INC. |
ROBBIE PALADUGU |
| K003560 |
06/08/2001 |
MAR COR SERVICES BICARB SYSTEM |
MAR COR SERVICES, INC. |
MICHAEL ROBERTSON |
| K003877 |
06/22/2001 |
MAR COR SERVICES SEMPER PURE RO MACHINE |
MAR COR SERVICES, INC. |
ANDREW G STITZINGER |
| K011284 |
06/20/2001 |
THIN FILM DRESSING FOR ULTRASOUND EXAM |
MARTIN E. WENDELKEN |
MARTIN E WENDELKEN |
| K010682 |
06/05/2001 |
HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM |
MDS NORDION |
E.S. MARTELL |
| K010872 |
06/22/2001 |
ML BLADE, MODEL ML7030 |
MED-LOGICS, INC. |
GARY MOCNIK |
| K010885 |
06/07/2001 |
UNI-LASER 470 |
MEDART CORP. |
JAN K ENEMAERKE |
| K011548 |
06/18/2001 |
CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVELS 1, 2, 3 |
MEDICAL ANALYSIS SYSTEMS, INC. |
DARWIN RICHARDSON |
| K010927 |
06/19/2001 |
MODIFICATION TO PROLITE PULSED LIGHT SYSTEM |
MEDICAL BIO CARE SWEDEN AB |
CONNIE WHITE HOY |
| K010928 |
06/19/2001 |
PROLITE VL PULSED LIGHT SYSTEM |
MEDICAL BIO CARE SWEDEN AB |
CONNIE WHITE HOY |
| K010920 |
06/22/2001 |
TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING |
MEDICAL CABLES, INC. |
ROBERT HILMAN |
| K011576 |
06/21/2001 |
MEDCOMP ASH SPLIT |
MEDICAL COMPONENTS, INC. |
JEANNE M CUSH |
| K003207 |
06/12/2001 |
MEDCOMP ULTRA-FLOW CATHETER |
MEDICAL COMPONENTS, INC. |
JEANNE M CUSH |
| K010751 |
06/11/2001 |
BPFONE, MODEL UA 767IT |
MEDICAL MONITORS PTY LIMITED |
HARRY L PLATT |
| K010207 |
06/14/2001 |
PORTABLE INSTENSIVE CARE UNIT |
MEDICAL RESEARCH LABORATORIES, INC. |
JOEL ORLINSKY |
| K010888 |
06/27/2001 |
SIDEPORT PINCH CLAMP DEVICE |
MEDIVICE SYSTEMS, LTD. |
AHAVA STEIN |
| K003937 |
06/06/2001 |
CPR EZY MASK AND PAD |
MEDTEQ INNOVATIONS PTY LTD |
EDUARDO MARCH |
| K010226 |
06/01/2001 |
VERDICT -II METHAMPHETAMINE |
MEDTOX DIAGNOSTICS, INC. |
MICHEAL TURANCHIK |
| K011545 |
06/08/2001 |
VERDICT -II TCA, VERDICT-II MTD |
MEDTOX DIAGNOSTICS, INC. |
MICHAEL TURANCHIK |
| K010701 |
06/05/2001 |
MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLER |
MEDTRONIC SOFAMOR DANEK USA, INC. |
RIHCARD W TREHARNE |
| K011508 |
06/12/2001 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD W TREHARNE |
| K010181 |
06/12/2001 |
CD HORIZON SPINAL SYSTEM, 4.5 ROD FOR POSTERIOR APPLICATION |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
| K011029 |
06/05/2001 |
MODIFICATION TO TSRH SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD W TREHARNE |
| K011584 |
06/22/2001 |
MEDTRONIC SPINAL CORD STIMULATION AND PERIPHERAL NERVE STIMULATION SYSTEMS FOR PAIN RELIEF |
MEDTRONIC VASCULAR |
DAVID H MUELLER |
| K011191 |
06/26/2001 |
MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES |
MEDTRONIC XOMED, INC. |
DIANA TAYLOR |
| K011321 |
06/26/2001 |
MODIFICATION TO XPS 3000 SYSTEM |
MEDTRONIC XOMED, INC. |
MARTIN D SARGENT |
| K010897 |
06/19/2001 |
MERIDIAN-PORTABLE |
MERIDIAN CO., LTD. |
SOO-RANG LEE |
| K011585 |
06/13/2001 |
FAST THERMOMETER MODELS ST713C AND ST713F |
MESURE TECHNOLOGY |
PHIL ZULUETA |
| K001897 |
06/12/2001 |
MULTI-STIM, MODEL MS-100 |
METRON MEDICAL AUSTRALIA PTY LTD |
ROB HOPKINS |
| K011656 |
06/20/2001 |
HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471, 104-4770, 104-4771 |
MICRO THERAPEUTICS, INC. |
EBEN GORDON |
| K011526 |
06/14/2001 |
HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4118, 104-4121, 104-4129, 104-4126, 104-4115, 104-4123 |
MICRO THERAPEUTICS, INC. |
EBEN GORDON |
| K011150 |
06/20/2001 |
DRIDAU OPIATE ASSAY |
MICROGENICS CORP. |
SHERRIE RINNE |
| K004017 |
06/11/2001 |
H-SCRIBE |
MORTARA INSTRUMENT, INC. |
HARLAN L VAN MATRE |
| K011420 |
06/12/2001 |
MM-87 MOTOR-DRIVE MANIPULATOR |
NARISHIGE CO., LTD. |
MITSUKO YONEYAMA |
| K003190 |
06/11/2001 |
EN BLOC BIOPSY SYSTEM |
NEOTHERMIA CORP. |
SHERRIE COVAL-GOLDMSITH |
| K010837 |
06/15/2001 |
HANDMASTER |
NEUROMUSCLAR ELECTRICAL STIMULATION SYSTEMS, LTD. |
JONATHAN S KAHAN |
| K011262 |
06/15/2001 |
MODIFICATION TO THE BOLD SCREW |
NEWDEAL S.A. |
NORMAN F ESTRIN |
| K011346 |
06/28/2001 |
READYSWIM |
NIDACON INTERNATIONAL AB |
DANIEL KAMM |
| K010590 |
06/28/2001 |
NEUROPACK MICRO, MODEL MED-9100A SERIES |
NIHON KOHDEN AMERICA, INC. |
BONNIE BISHOP |
| K010941 |
06/22/2001 |
THE NIMBLE ROCKET POWERED WHEELCHAIR |
NIMBLE, INC. |
SUSAN D GOLDSTEIN-FALK |
| K011297 |
06/20/2001 |
NIPRO SAFETOUCH SCALP VEIN AND BLOOD COLLECTION SET |
NIPRO MEDICAL CORP. |
KAELYN B HADLEY |
| K011704 |
06/27/2001 |
NPAC EAR THERMOMETER MODEL TD 402 |
NORM PACIFIC AUTOMATION CORP. |
CHI-CHU WU CHEN |
| K011450 |
06/13/2001 |
SILICONE IMPRESSION MATERIAL |
NORTHEAST RESINS & SILICONES, LLC. |
SIVANANDA S JADA |
| K010815 |
06/15/2001 |
NTERO NOMAD SYSTEM |
NTERO SURGICAL, INC. |
D. BOMMI BOMMANNNAN |
| K010876 |
06/20/2001 |
NTI TENSION SUPPRESSION SYSTEM |
NTI-TSS, INC. |
BOB WEBER |
| K011577 |
06/19/2001 |
OCU-FLEX 55 SPHERICAL, TORIC,THIN ZONE TORIC,ASPHERICAL,TORIC ASPHERICAL AND THIN ZONE TORIC ASPHERICAL (METHAFILCON A)S |
OCU-EASE OPTICAL PRODUCTS, INC. |
CHARLES R VERMETTE |
| K010887 |
06/08/2001 |
INSULIN PEN NEEDLE ADAPTER |
OHANA NEEDLE CO. |
SPENCER H OWADES |
| K011720 |
06/25/2001 |
OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER |
OLYMPUS AMERICA, INC. |
MICHAEL CAMPBELL |
| K011057 |
06/06/2001 |
INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX |
ORASURE TECHNOLOGIES, INC. |
R.SAM NIEDBALA |
| K011026 |
06/13/2001 |
FORTADERM WOUND DRESSING |
ORGANOGENESIS, INC. |
PATRICK R BILBO |
| K003288 |
06/08/2001 |
ORIGEN DUAL LUMEN CATHETER |
ORIGEN BIOMEDICAL, INC. |
RICHARD MARTIN |
| K011463 |
06/13/2001 |
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS |
ORTHO-CLINICAL DIAGNOSTICS |
Darlene J Phillips |
| K011250 |
06/13/2001 |
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS |
Ortho-Clinical Diagnostics, Inc. |
ANN QUINN |
| K003517 |
06/06/2001 |
OTRES TOOTHBRUSH SANITIZER MODEL TB100W |
OTRES, LLC. |
DAVID BUDDINGH |
| K010233 |
06/22/2001 |
POWDER FREE NITRILE EXAMINATION GLOVES |
P.T. HEALTHCARE GLOVINDO |
ELLEN HUTAPEA |
| K011411 |
06/13/2001 |
SELF-ADHESIVE ELECTRODES |
PAIN MANAGEMENT TECHNOLOGIES |
JOSHUA LEFKOVITZ |
| K011609 |
06/08/2001 |
LIVESURE AMPHETAMINE SCREEN TEST |
PAN PROBE BIOTECH, INC. |
ALICE H YU |
| K011610 |
06/08/2001 |
LIVESURE METHAMPHETAMINE SCREEN TESTS |
PAN PROBE BIOTECH, INC. |
ALICE H YU |
| K010009 |
06/01/2001 |
KOKO PEAK KP; KOKO PEAK KP+ |
PDS HEALTHCARE PRODUCTS, INC. |
CHERYL RAILSBACK |
| K002343 |
06/08/2001 |
SIGMA DELTA |
PENLON LTD. |
ANTHONY PARSONS |
| K003992 |
06/01/2001 |
PERCUSURGE GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM |
PERCUSURGE, INC. |
MATTHEW J MOON |
| K010817 |
06/15/2001 |
MX8000 V5.0 CT SYSTEM |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ROBERT L TUROCY |
| K011619 |
06/29/2001 |
PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT |
PLANMECA OY |
BOB PIENKOWSKI |
| K010456 |
06/20/2001 |
BIOSCANNER CREATININE TEST STRIPS |
POLYMER TECHNOLOGY SYSTEMS, INC. |
MARGO ENRIGHT |
| K011193 |
06/12/2001 |
NAC PLUS NEEDLELESS ACCESS CONNECTOR |
POREX MEDICAL PRODUCTS |
TIM TRUITT |
| K010902 |
06/19/2001 |
MEDPOR QUAD MOTILITY IMPLANT |
POREX SURGICAL, INC. |
HOWARD MERCER |
| K011789 |
06/22/2001 |
PROCEDURE MASKS: PM4-301 AND PM4-304 |
PRIMELINE MEDICAL PRODUCTS, INC. |
KATHERINE CO |
| K003909 |
06/13/2001 |
PROACT 1 |
PROACT CO. |
JEAN ROZINT |
| K011270 |
06/22/2001 |
AUTOMATED CORE BIOPSY DEVICE |
PROMEX, INC. |
JOSEPH L MARK |
| K010854 |
06/13/2001 |
CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES, (BLUE, GREEN) |
PROTECTION GLOVES SDN. BHD. |
RICHARD CHOOI |
| K011231 |
06/13/2001 |
CHLORINATED POWDERED LATEX EXAMINATION GLOVES, BLUE, GREEN |
PROTECTION GLOVES SDN. BHD. |
RICHARD CHOOI |
| K010916 |
06/20/2001 |
PTW DOSIMETRY DIODE, T60008 |
PTW-NEW YORK CORP. |
STEPHEN R SZEGLIN |
| K011486 |
06/20/2001 |
Q-RAD RADIOGRAPHIC SYSTEM |
QUANTUM MEDICAL IMAGING, LLC. |
MARK CAMIRAND |
| K002911 |
06/07/2001 |
XSCAN32 TELERADIOLOGY SOFTWARE |
RADIOGRAPHIC DIGITAL IMAGING, INC. |
STEPHEN NEUSHUL |
| K011714 |
06/28/2001 |
BIPAP PRO BI-LEVEL SYSTEM |
RESPIRONICS, INC. |
DAVID J VANELLA |
| K011738 |
06/20/2001 |
ACCU-CHEK ACTIVE SYSTEM |
ROCHE DIAGNOSTICS CORP. |
MIKE FLIS |
| K011226 |
06/25/2001 |
CALIBRATOR FOR AUTOMATED SYSTEMS |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
| K011145 |
06/25/2001 |
MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658 |
ROCHE DIAGNOSTICS CORP. |
JENNIFER TRIBETT |
| K003047 |
06/12/2001 |
AMBULATORY ENTERAL NUTRITION PUMP |
ROSS PRODUCT DIV. ABBOTT LABORATORIES |
YUKA HENDERSHOT |
| K011523 |
06/14/2001 |
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL BPW138 |
ROSSMAX INTERNATIONAL LTD. |
MICHAEL YEH |
| K011277 |
06/26/2001 |
HARD RELINER |
S & C POLYMER GMBH |
JURGEN ENGELBRECHT |
| K011431 |
06/11/2001 |
RESIN CEM |
S & C POLYMER GMBH |
CHRISTIAN BOTTCHER |
| K002543 |
06/14/2001 |
COMOACT ULTRASONIC NEBULIZER, MODEL 3060 |
SAN UP S.A. |
SUSAN D GOLDSTEIN-FALK |
| K002427 |
06/22/2001 |
SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026 |
SANDHILL SCIENTIFIC, INC. |
LIUNDA L DIEDERICH |
| K011001 |
06/07/2001 |
TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEM |
SATELEC |
JEAN-LUC BOULNOIS |
| K010824 |
06/05/2001 |
PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT |
SCIENCE INCORPORATED |
LYNN S WEIST |
| K011348 |
06/25/2001 |
PHASE II GBM IGG ANTIBODY EIA TEST |
SCIMEDX CORP. |
Gary Lehnus |
| K011082 |
06/06/2001 |
TPO IGG ANTIBODY EIA TEST |
SCIMEDX CORP. |
Gary Lehnus |
| K011113 |
06/13/2001 |
HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132) |
SEBIA |
BOREK JANIK |
| K003472 |
06/04/2001 |
INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM |
SEQUAL TECHNOLOGIES, INC. |
RON HALL |
| K011371 |
06/07/2001 |
NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE AND NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE WITH STRAW |
SGMP CO., LTD. |
JANNA P TUCKER |
| K011370 |
06/07/2001 |
NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH AND WITHOUT GRAPE SCENT AND WITH PROTEIN LABELING (50 MICROG |
SGMP CO., LTD. |
JANNA P TUCKER |
| K011377 |
06/07/2001 |
NON-STERILE POWDER-FREE BLUE LATEX EXAMINATION GLOVES, WITH AND WITHOUT BUBBLEGUM SCENTING & A PROTEIN LABELING CLAIM (5 |
SGMP CO., LTD. |
JANNA P TUCKER |
| K011364 |
06/07/2001 |
CUSTOM TCI (TINNITUS CONTROL INSTRUMENT) |
SIEMENS HEARING INSTRUMENTS, INC. |
DAVE SLAVIN |
| K011366 |
06/01/2001 |
CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) |
SIEMENS HEARING INSTRUMENTS, INC. |
DAVE SLAVIN |
| K010938 |
06/26/2001 |
SYNGO MULTIMODALITY WORKSTATION |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KATHLEEN RUTHERFORD |
| K003596 |
06/06/2001 |
SMITH & NEPHEW RESTIM |
SMITH & NEPHEW, INC. |
CORDELL C HOFFINS |
| K011299 |
06/27/2001 |
SMITH AND NEPHEW 5.00MM ABSORBABLE POLYMER ANCHOR |
SMITH & NEPHEW, INC. |
TIM CRABTREE |
| K003663 |
06/28/2001 |
SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODE |
SPACELABS MEDICAL, INC. |
IRENE JAWORSKI |
| K011542 |
06/26/2001 |
SPECIALTY D-UV (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY D-UV MULTIFOCAL (OCUFLICON D) |
SPECIALTY ULTRAVISION, INC. |
DEBBIE MCINTIRE |
| K010692 |
06/29/2001 |
THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM |
SPINTECH, INC. |
DANIEL J MANELLI |
| K010799 |
06/07/2001 |
COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE) |
STANDARD TEXTILE CO., INC. |
BRADLEY J BUSCHMAN |
| K011580 |
06/05/2001 |
SIMPLICITY SOFT QD SILVER INFUSION SET |
STERLING MEDIVATIONS, INC. |
JOEL S DOUGLAS |
| K011187 |
06/19/2001 |
SIMPLICITY SOFT YP INFUSION SET FOR USE WITH THE MINIMED PARAGIGM INFUSION PUMPS |
STERLING MEDIVATIONS, INC. |
JOEL DOUGLAS |
| K003433 |
06/15/2001 |
NEURO-TRAIN III (3) |
STERNE EQUIPMENT CO., LTD. |
THOMAS WALLACE |
| K003983 |
06/06/2001 |
STIMUPLEX HNS-11 |
STOCKERT GMBH |
DOMINIKA SCHULER |
| K011410 |
06/26/2001 |
PARA 5X |
STRECK LABORATORIES, INC. |
PAUL KETTELSON |
| K011755 |
06/22/2001 |
STRYKER T4 HYTREL (R) TOGAS |
STRYKER CORP. |
SUZANNE VELASQUEZ |
| K003543 |
06/05/2001 |
STRYKER PAINPUMP PCA |
STRYKER INSTRUMENTS |
NICOLE PETTY |
| K011245 |
06/25/2001 |
ADVENT IMPLANT SYSTEM, SWISS PLUS IMPLANT SYSTEM |
SULZER DENTAL, INC. |
FOSTER BOOP |
| K011466 |
06/06/2001 |
QED DIODE DETECTORS, MODELS 1112-1116 |
SUN NUCLEAR CORP. |
JIM MIXON |
| K011409 |
06/14/2001 |
SLT LASERPRO CTH HOLMIUM LASER SYSTEM |
SURGICAL LASER TECHNOLOGIES, INC. |
DAVIS WOODWARD |
| K010940 |
06/20/2001 |
SEALAPEX 4 |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K010108 |
06/06/2001 |
USS-LINE EXTENSION |
SYNTHES |
JONATHAN GILBERT |
| K010658 |
06/04/2001 |
MODIFIED USS FRACTURE SYSTEM |
SYNTHES (USA) |
JONATHAN GILBERT |
| K010766 |
06/12/2001 |
SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATE |
SYNTHES (USA) |
BONNIE SMITH |
| K011034 |
06/27/2001 |
SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM |
SYNTHES (USA) |
BONNIE J SMITH |
| K010943 |
06/27/2001 |
SYNTHES STERNAL FIXATION SYSTEM |
SYNTHES (USA) |
MATTHEW M HULL |
| K011528 |
06/06/2001 |
EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 |
SYVA CO. |
SUSAN COLLINS |
| K011620 |
06/18/2001 |
EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229 |
SYVA CO., DADE BEHRING, INC. |
CYNTHIA ARREDONDO |
| K011605 |
06/12/2001 |
EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229 |
SYVA CO., DADE BEHRING, INC. |
SUSAN COLLINS |
| K011701 |
06/22/2001 |
BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR |
TAIWAN ARMADA ENTERPRISE CO., LTD. |
JEN KE-MIN |
| K011018 |
06/22/2001 |
TAUT BALLOON CATHETER, MODEL 50640 |
TAUT, INC. |
RON KENSETH |
| K002405 |
06/01/2001 |
SPINAL EPIDURAL NEEDLES |
TE ME NA S.A.R.L. |
ART WARD |
| K011396 |
06/18/2001 |
IBD-CHEK |
TECHLAB, INC. |
DAVID M LYERLY |
| K010239 |
06/25/2001 |
COCAINE DIPSTICK TEST, MODEL D747-A |
TECO DIAGNOSTICS |
DINDO CARRILLO |
| K002695 |
06/13/2001 |
MEMODYN STAPLE |
TELOS MEDICAL EQUIPMENT |
AL E AUSTIN |
| K010669 |
06/04/2001 |
NEUROGRAPH EVOKED POTENTIAL SYSTEMS (EPS), MODEL EPS-1 |
THURIS CORP. |
GRACE BARTOO |
| K011567 |
06/19/2001 |
TORNIER TOTAL ELBOW PROSTHESIS |
TORNIER |
IRENE GOSSET |
| K010545 |
06/06/2001 |
TBW |
TRI-MED, INC. |
ROBERT J MEDOFF |
| K011693 |
06/13/2001 |
TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001 |
TRUMPF MEDICAL SYSTEMS, INC. |
WILLIAM APPERSON |
| K011563 |
06/05/2001 |
POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM |
U.O.P. RUBBER PRODUCTS SDN BHD |
CHUA BENG CHUAN |
| K011464 |
06/13/2001 |
RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER, RX HERCULINK 14 BILIARY STN |
VASCULAR INTERVENTION |
JENNIFER PAE RIGGS |
| K010937 |
06/25/2001 |
SEP-10S PLUS, AND SP-12S PRO. |
VILTECHMEDA |
KOBY BEN-BARAK |
| K011061 |
06/28/2001 |
SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11 |
W & H DENTALWERK BUERMOOS GMBH |
HERBERT TRASCHWANDTNER |
| K010326 |
06/25/2001 |
WAKO AUTOKIT C3 |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
| K010325 |
06/25/2001 |
WAKO AUTOKIT C4 |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
| K010334 |
06/25/2001 |
WAKO LIPID CALIBRATOR |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
| K010186 |
06/08/2001 |
WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM |
WELCH ALLYN, INC. |
DAVID A YOUNG II |
| K002727 |
06/13/2001 |
YOUNG-HEALTH SUPER EAR THERMOMETER |
YOUNG HEALTH IND. CO., LTD. |
YANG RONK-JEH |
| K011292 |
06/20/2001 |
ZIEHM VISION |
ZIEHM INTERNATIONAL, INC. |
LANELL SAMANIEGO |
