| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K992709 |
11/09/1999 |
1818 TENS UNIT |
138 MEDICAL SUPPLIES, INC. |
SUSAN D GOLDSTEIN-FALK |
| K972383 |
11/23/1999 |
EASY-JET DEVICE |
A. STEIN - REGULATORY AFFAIRS CONSULTING |
AHAVA STEIN |
| K992993 |
11/16/1999 |
ETEST FOR QUINUPRISTIN/DALFOPRISTIN |
AB BIODISK |
ANNE BOLMSTROM |
| K992710 |
11/24/1999 |
ABBOTT ARCHITECH GLYCATED HEMOGLOBIN MASTERCHECK |
ABBOTT LABORATORIES |
KATHERINE M WORTLEY |
| K991483 |
11/01/1999 |
ABBOTT ARCHITECT GLYCATED HEMOGLOBIN |
ABBOTT LABORATORIES |
KATHERINE M WORTLEY |
| K990788 |
11/02/1999 |
AD-TECH'S FORAMEN OVALE ELECTRODE |
AD-TECH MEDICAL INSTRUMENT CORP. |
DAVID PUTZ |
| K992621 |
11/08/1999 |
ADI 9000/9001 ARTHROSCOPE AND ACCESSORIES |
ADVANCED DIAGNOSTICS & INTERVENTIONS |
ANTONY FENDER |
| K993459 |
11/05/1999 |
MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX |
ADVANCED UROSCIENCE, INC. |
KAREN E PETERSON |
| K990779 |
11/17/1999 |
HEMASEAL & CIDE |
ADVANTAGE DENTAL PRODUCTS, INC. |
INGRID K PELERIN |
| K991993 |
11/17/1999 |
PHACOLASE ER: YAG LASER |
AESCULAP-MEDITEC GMBH |
WILLIAM T KELLEY |
| K992702 |
11/08/1999 |
EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM |
ALLERGY DIRECT |
GAVIN MCLACLAN |
| K990677 |
11/01/1999 |
ABSOGEL CHEMOTHERAPHY GLOVES |
AMPRI RUBBERWARE INDUSTRIES SDN BHD |
LI KIM PHNG |
| K992852 |
11/22/1999 |
SUTURE CLINCH |
APPLIED MEDICAL RESOURCES |
ANIL BHALANI |
| K992776 |
11/16/1999 |
UNI-GRAFT K DV PATCH |
ATRIUM MEDICAL CORP. |
JOSEPH P DE PAOLO |
| K991286 |
11/18/1999 |
AVOCET ACUSURE SYSTEM |
AVOCET MEDICAL, INC. |
Judith Blunt |
| K990683 |
11/03/1999 |
AXON MP-1 MICROPOSITIONER |
AXON INSTRUMENTS, INC. |
ANDREW L BLATZ |
| K993387 |
11/01/1999 |
IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K |
BAXTER HEALTHCARE CORP. |
VICKI L DREWS |
| K992894 |
11/24/1999 |
MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576 |
BAXTER HEALTHCARE CORP. |
ROBERT L WILKINSON |
| K993120 |
11/17/1999 |
MODIFIED BLOOD RECIPIENT SET |
BAXTER HEALTHCARE CORP. |
JUDY KANNENBERG |
| K991907 |
11/09/1999 |
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM |
BAYER CORP. |
GABRIEL J MURACA, JR |
| K992136 |
11/09/1999 |
BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS) |
BAYER CORP. |
GABRIEL J MURACA |
| K991315 |
11/12/1999 |
MICROALBUSTIX REAGENT STRIPS (OTC) |
BAYER CORP. |
GEORGE M TANCOS |
| K992257 |
11/24/1999 |
NEW MULTIPLES REAGENT STRIPS |
BAYER CORP. |
SYED ATAULLAH |
| K993186 |
11/03/1999 |
SYNERCID, 15 UG, BBL SENSI-DISC |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
BRADFORD M SPRING |
| K993473 |
11/26/1999 |
SYNCHRON SYSTEMS DRUG CALIBRATOR 2 |
BECKMAN COULTER, INC. |
GAIL LEFEBVRE |
| K993022 |
11/09/1999 |
SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS |
BECKMAN COULTER, INC. |
GAIL LEFEBVRE |
| K993023 |
11/26/1999 |
SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS |
BECKMAN COULTER, INC. |
GAIL L EFEBVRE |
| K984631 |
11/04/1999 |
BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY |
BECTON DICKINSON MICROBIOLOGY SYSTEMS |
COLLEEN ROHRBECK |
| K993495 |
11/24/1999 |
POWDERED LATEX EXAMINATION GLOVES(PROTEIN LABEL CLAIM 150 MICROGRAMS OR LESS) |
BESGLOVE MEDICARE SDN. BHD. |
LEE AIK LIM |
| K993502 |
11/24/1999 |
POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM 50 MICROGRAMS OR LESS) |
BESGLOVE MEDICARE SDN. BHD. |
LEE AIK LIM |
| K992793 |
11/16/1999 |
SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM |
BETTER WATER, INC. |
MIKE S STERLING |
| K993536 |
11/04/1999 |
BIO-RAD CODA NEONATAL GALT ASSAY |
BIO-RAD |
ELIZABETH TANG |
| K992741 |
11/09/1999 |
LYPHOCHEK ANEMIA CONTROL, MODEL 500 |
BIO-RAD |
ELIZABETH PLATT |
| K992838 |
11/15/1999 |
ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC ACTIVATOR, ADHERE CYLANATE |
BIOMAT SCIENCES, INC. |
IVAN STANGEL |
| K992915 |
11/18/1999 |
ONE-STEP DOUBLE-CHEK PREGNANCY TEST |
BIOMEDICAL PRODUCTS CORP. |
FRAN WHITE |
| K992330 |
11/23/1999 |
THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY |
BIOMEDICS |
ERIC V HOHENSTEIN |
| K990290 |
11/18/1999 |
CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER |
BIOMET, INC. |
MICHELLE L MCKINLEY |
| K993510 |
11/16/1999 |
MODIFIED BMP TROCHANTERIC PLATES |
BIOMET, INC. |
FRED MCCLURE |
| K993453 |
11/09/1999 |
MENISCUS ARROW, MODELS 531110, 531113, 531116 |
BIONX IMPLANTS, LTD. |
TUIJA ANNALA |
| K991850 |
11/26/1999 |
SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC |
BIOSAFE LABORATORIES, INC. |
STEVEN P TYRRELL |
| K991829 |
11/02/1999 |
CDTOX A OIA |
BIOSTAR, INC. |
ROGER C BRIDEN |
| K993434 |
11/10/1999 |
PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K993488 |
11/10/1999 |
LIGHT-CORE |
BISCO, INC. |
KATHRYN B PATTERSON |
| K992777 |
11/12/1999 |
CONSTELLATION CATHETERS, MODEL 8039 |
BOSTON SCIENTIFIC CORP. |
STEVE JWANOUSKOS |
| K992510 |
11/18/1999 |
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM |
BOSTON SCIENTIFIC CORP. |
RON BENNETT |
| K993648 |
11/24/1999 |
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER |
BOSTON SCIENTIFIC CORPORATION NORTHWEST TECHNOLOGY |
CYNDY ADAMS |
| K993617 |
11/24/1999 |
DIGITRAKPLUS HOLTER RECORDER |
BRAEMAR CORP. |
DAVID NORBERG |
| K993618 |
11/24/1999 |
DXP1000 HOLTER RECORDER |
BRAEMAR CORP. |
DAVID NORBERG |
| K992790 |
11/12/1999 |
BRAHMS DIAGNOSTICA DYNOTEST ANTI-TG |
BRAHMS DIAGNOSTICA, LLC. |
H. LEE HERRON |
| K992791 |
11/12/1999 |
BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPO |
BRAHMS DIAGNOSTICA, LLC. |
H. LEE HERRON |
| K990659 |
11/26/1999 |
NASAL AIRE |
BREATHING TECHNOLOGIES CORP. |
TERRY C MCMAHAON |
| K991954 |
11/02/1999 |
THE BRUNO POWERBASE, MODEL PSB-2200 |
BRUNO INDEPENDENT LIVING AIDS, INC. |
WILLIAM W BELSON III |
| K993000 |
11/02/1999 |
BARD HYDROPHILIC COATED GUIDE WIRES |
C.R. BARD, INC. |
DEBORAH L HERRINGTON |
| K992373 |
11/05/1999 |
ORBITER ST DIAGNOSTIC ELECTRODE CATHETER & ORBITER ST EXTENSION CABLE |
C.R. BARD, INC. |
DEBORAH L HERRINGTON |
| K992833 |
11/10/1999 |
VACUUM ASSIST STABILIZER |
CARDIO THORACIC SYSTEMS |
Michael Billig |
| K993014 |
11/26/1999 |
MODIFICATION TO DOCUMENT THYROID CAL.VER |
CASCO-NERL DIAGNOSTICS CORPORATION (MAINE) |
KAREN HICKEY |
| K992449 |
11/24/1999 |
AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA |
COGENT DIAGNOTICS LTD. |
DANIELLE M KNIGHT |
| K993086 |
11/12/1999 |
AUTOSTAT II ANTI-GLIADIN IGA ELISA |
COGENT DIAGNOTICS LTD. |
DANIELLE M KNIGHT |
| K993087 |
11/12/1999 |
AUTOSTAT II ANTI-GLIADIN IGG ELISA |
COGENT DIAGNOTICS LTD. |
DANIELLE M KNIGHT |
| K984219 |
11/18/1999 |
COLORMAX COLOR VISION ENHANCEMENT LENSES |
COLOR VISION TECHNOLOGIES, INC. |
JULIE KIM |
| K991105 |
11/26/1999 |
ECG ELECTRODE (VARIOUS) |
CONMED CORP. |
IRA D DUESLER |
| K992866 |
11/18/1999 |
OPTILITE IX LASER SURGERY ACCESSORIES |
CONVERGENT LASER TECHNOLOGIES |
MARILYN M CHOU |
| K993252 |
11/24/1999 |
METHAFILCON A SOFT HYDROPHILIC CONTACT LENSES, FREQUENCY 55, FREQUENCY 55 UV (TO BE MARKETED YR. 2000), FREQUENCY 55 ASP |
COOPERVISION, INC. |
BONNIE TSYMBAL |
| K993161 |
11/09/1999 |
COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM |
COPAN DIAGNOSTICS, INC. |
MARY MCNAMARA-CULLINANE |
| K993646 |
11/28/1999 |
S.M.A.R.T. .018 NITINOL STENT TRANSHEPATIC BILIARY SYSTEM |
CORDIS CORP. |
ELENA JUGO |
| K992965 |
11/26/1999 |
CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085 |
CORDIS WEBSTER, INC. |
MARY ADAMS |
| K992234 |
11/10/1999 |
THE TAPER-FIT TOTAL HIP SYSTEM |
CORIN U.S.A. |
CRAIG CORRANCE |
| K992235 |
11/23/1999 |
ZYRANOX ZIRCONIA CERAMIC FEMORAL HEADS |
CORIN U.S.A. |
CRAIG CORRANCE |
| K992255 |
11/30/1999 |
CKHEMO, MODEL CKHEMO VERSION 1.0 |
CSAM, INC. |
YOOBONG KIM |
| K992836 |
11/09/1999 |
SL990, SL980, SL950 |
CSO |
R. BRENT MINER |
| K993310 |
11/30/1999 |
APOLIPOPROTEIN CONTROL SERUM CHD, MODEL OUPH |
DADE BEHRING, INC. |
DONNA A WOLF |
| K993273 |
11/23/1999 |
N LATEX FERRITIN |
DADE BEHRING, INC. |
REBECCA S AYASH |
| K993174 |
11/09/1999 |
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 |
DADE BEHRING, INC. |
REDAMES RIESGO |
| K991241 |
11/02/1999 |
IF8000 |
DAN MED, INC. |
THOMAS SANDGAARD |
| K992848 |
11/19/1999 |
ALARMVIEW SYSTEM |
DATA CRITICAL CORP. |
DREW WEAVER |
| K992323 |
11/01/1999 |
DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES |
DATEX-OHMEDA, INC. |
JOEL C KENT |
| K993620 |
11/12/1999 |
IMPRESARIO |
DEL MAR MEDICAL SYSTEMS, LLC. |
NEVINE ERIAN |
| K992233 |
11/30/1999 |
APEX LOCATOR BINGO-1020 |
DENT CORP. RESEARCH & DEVELOPMENT |
DAVID ALBELDA |
| K992822 |
11/17/1999 |
SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINE |
DENTSPLY INTL. |
P. JEFFERY LEHN |
| K992656 |
11/05/1999 |
DEPUY TOTAL ELBOW SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
JANET G JOHNSON |
| K991561 |
11/10/1999 |
ROADRUNNER, PEP THERAPY DEVICE |
DHD HEALTHCARE CORP. |
LARRY WEINSTEIN |
| K993254 |
11/12/1999 |
IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06 |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K993251 |
11/17/1999 |
IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6 |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K983198 |
11/23/1999 |
TRENDCARE CALIBRATOR MODEL SCU 7007 |
DIAMETRICS MEDICAL, LTD. |
JAN WALTERS |
| K992999 |
11/05/1999 |
DAISY PROTECTED SCALP VEIN SET |
DIASOL, INC. |
MONICA ABELES |
| K993187 |
11/05/1999 |
SHELLY PROTECTED AV FISTULA NEEDLE |
DIASOL, INC. |
MONICA ABELES |
| K993669 |
11/17/1999 |
LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET |
DIASORIN, INC. |
JUDITH J SMITH |
| K992599 |
11/01/1999 |
DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR |
DIDECO S.P.A. |
CYNTHIA J.M. NOLTE |
| K981485 |
11/29/1999 |
HYBRID CAPTURE II GC-ID |
DIGENE CORP. |
MARK A DEL VECCHIO |
| K993666 |
11/22/1999 |
DISETRONIC PEN P100 |
DISETRONIC MEDICAL SYSTEMS |
Lee Leichter |
| K992879 |
11/09/1999 |
ECUSIT COMPOSITE REPAIR |
DMG HAMBURG |
PAMELA PAPINEAU |
| K993146 |
11/08/1999 |
DORNIER SCANNER HANDPIECE |
DORNIER SURGICAL PRODUCTS, INC. |
CAROL WERNECKE |
| K993119 |
11/23/1999 |
STERILE HYDROGEL |
DUMEX MEDICAL SURGICAL PRODUCTS, LTD. |
SAM LAKHANI |
| K993624 |
11/10/1999 |
SITE-RITE 3 ULTRASOUND SYSTEM |
DYMAX CORP. |
CHARLES MORREALE |
| K992920 |
11/23/1999 |
EBI SPINELINK SYSTEM |
EBI, L.P. |
JONAS WILF |
| K993649 |
11/19/1999 |
EBI XFIX DFS WRISTFIX SYSTEM |
EBI, L.P. |
JON CAPAROTTA |
| K990727 |
11/26/1999 |
SYNEFLASH & SYNEVIEW |
ELA MEDICAL, INC. |
CATHERINE G GOBLE |
| K992844 |
11/26/1999 |
HICHEM ISE ELECTROLYTE BUFFER |
ELAN HOLDINGS, INC. |
WYNN STOCKING |
| K992842 |
11/26/1999 |
HICHEM ISE ELECTROLYTE REFERENCE |
ELAN HOLDINGS, INC. |
WYNN STOCKING |
| K992824 |
11/17/1999 |
LASEREX ND:YAG OPHTHALMIC LASER (LQ2106), ALCON ND:YAG OPHTHALMIC LASER (3000LE), LASEREX ND:YAG OPHTHALMIC LASER, MODEL |
Ellex Medical Pty. Ltd. |
KEITH DEGENHARDT |
| K992996 |
11/24/1999 |
ENABLE ENDOSCOPIC BIPOLAR SCISSORS |
ENABLE MEDICAL CORP. |
MARK L FRIEDMAN |
| K992738 |
11/08/1999 |
ISOBAR SPINAL SYSTEM |
ENCORE ORTHOPEDICS, INC. |
DEBBIE DE LOS SANTOS |
| K992872 |
11/24/1999 |
BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II |
ENTIFIC MEDICAL SYSTEMS, INC. |
BESTY A BROWN |
| K992909 |
11/24/1999 |
HYTAC |
ESPE DENTAL AG |
ANDREAS PETERMAN |
| K992813 |
11/18/1999 |
11 GAUGE PROBE, STEREOTACTIC, 14 GAUGE PROBE, STEREOTACTIC,14 GAUGE PROBE, ULTRASOUND, HOUSING STEREOTACTIC,HOUSING, ULT |
ETHICON ENDO-SURGERY, INC. |
TAMIMA ITANI |
| K993082 |
11/19/1999 |
EXACTECH ACUMATCH INTEGRATED HIP SYSTEM A-SERIES POROUS COATED ACETABULAR COMPONENT |
EXACTECH, INC. |
GARY J MILLER |
| K993300 |
11/05/1999 |
COLDLIGHTSOURCE PL3000 |
FIBER IMAGING TECHNOLOGIES, INC. |
JOSEPH RESS |
| K993046 |
11/22/1999 |
FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000 |
FIBRA SONICS, INC. |
ROBERT BROHM |
| K992884 |
11/02/1999 |
WHEELCHAIR (MANUAL, NOT ELECTRICAL) |
FOSHAN MACHINERY & EQUIPMENT IMPORT & EXPORT CO. |
DON W KANG |
| K993640 |
11/16/1999 |
SPECTRUM LIBRE WHEELCHAIR |
FREEDOM DESIGNS, INC. |
GINNY S MALOCO |
| K993791 |
11/24/1999 |
CT PERFUSION OPTION |
GE MEDICAL SYSTEMS, INC. |
LARRY A KROGER |
| K993364 |
11/05/1999 |
GE LOGIQ 700 WITH CODED EXCITATION MODIFICATION |
GE MEDICAL SYSTEMS, INC. |
ALLEN SCHUH |
| K993365 |
11/05/1999 |
GE LOGIQ 700 WITH HARMONIC IMAGING MODIFICATION |
GE MEDICAL SYSTEMS, INC. |
ALLEN SCHUH |
| K993665 |
11/12/1999 |
LEGEND CRF FLUORO AND RAD SYSTEM |
GE MEDICAL SYSTEMS, INC. |
LARRY A KROGER |
| K992746 |
11/09/1999 |
SIGNA HFO/I MAGNETIC RESONANCE SYSTEM |
GE MEDICAL SYSTEMS, INC. |
LARRY A KROGER |
| K993792 |
11/24/1999 |
SMART VESSEL ANALYSIS (SMART VA) OPTION |
GE MEDICAL SYSTEMS, INC. |
LARRY A KROGER |
| K992929 |
11/26/1999 |
DASH 3000 PATIENT MONITOR |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
DAVID WAHLIG |
| K992948 |
11/29/1999 |
MAC-LAB SYSTEM |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
MARIA VITUG FOUTS |
| K991786 |
11/18/1999 |
MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
LAURA L MCCOMIS |
| K992637 |
11/03/1999 |
MUSE CARDIOVASCULAR INFORMATION SYSTEM |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
LAURA L MCCOMIS |
| K993242 |
11/08/1999 |
CASTLE SURGICAL LIGHT, MODEL 3000 |
GETINGE/CASTLE, INC. |
PETER L KOSTE |
| K992863 |
11/12/1999 |
LEAD STYLET,MODELS 6505,6506,6507,6508 |
GUIDANT CORP. |
SHERYL POGANSKI |
| K993588 |
11/17/1999 |
MODIFICATION TO RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005126-13, 1005128-13, 1005130-13, 1005132-13, 1005134-13, |
GUIDANT CORP. |
SANTA SUNDELL |
| K992994 |
11/23/1999 |
TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS; |
GYRUS ENT L.L.C. |
JEFF COBB |
| K993581 |
11/18/1999 |
HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAEMOLITE 2 FAMILY OF AUTOLOGOUS BLOOD RECOVER |
HAEMONETICS CORP. |
ALICIA R LOPEZ |
| K992970 |
11/08/1999 |
DIGIT WIDGET |
HAND BIOMECHANICS LAB, INC. |
JOHN M AGEE |
| K993722 |
11/23/1999 |
BLUE CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS. |
HARTALEGA SDN BHD |
KUAN KAM HON |
| K993725 |
11/23/1999 |
GREEN CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS |
HARTALEGA SDN BHD |
JUAN KAM HON |
| K993128 |
11/23/1999 |
HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER] |
HEALTH HERO NETWORK, INC. |
JOE SCHWOEBEL |
| K993496 |
11/30/1999 |
RETIC-QUINOX |
HEMATRONIX, INC. |
JAMES D LAPICOLA |
| K993516 |
11/08/1999 |
HP M2600A VIRIDIA TELEMETRY SYSTEM |
HEWLETT-PACKARD CO. |
DENISE HALEY |
| K992674 |
11/08/1999 |
HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027A |
HEWLETT-PACKARD GMBH |
EGON PFEIL |
| K993352 |
11/19/1999 |
CROSSFIRE SYSTEM 12 ACETABULAR INSERTS |
HOWMEDICA OSTEONICS CORP. |
TERRY SHERIDAN POWELL |
| K992287 |
11/16/1999 |
FIRST STEP UNICOMPARTMENTAL KNEE SYSTEM |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K993601 |
11/16/1999 |
HOWMEDICA OSTEONICS FEMORAL HEADS |
HOWMEDICA OSTEONICS CORP. |
NANCY J RIEDER |
| K993670 |
11/16/1999 |
MODIFIED LONG LENGTH GAMMA NAIL |
HOWMEDICA OSTEONICS CORP. |
MARGARET CROWE |
| K993603 |
11/19/1999 |
WICHITA FUSION NAIL FULLY THREADED SELF-TAPPING SCREW |
HOWMEDICA OSTEONICS CORP. |
JENNIFER A DAUDELIN |
| K992792 |
11/16/1999 |
XIA SPINAL SYSTEM C-C ADAPTOR |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K992733 |
11/10/1999 |
AKRON ATP9 TRACTION MACHINE |
HUNTLEIGH TECHNOLOGY, INC. |
AUDREY WITKO |
| K992740 |
11/09/1999 |
EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS |
IMATRON, INC. |
J.A. CODUTO |
| K992512 |
11/01/1999 |
ALTIVA CORPORATION NTR 3.3 MM SELF-TAPPING SCREW IMPLANTS, ALTIVA CORPORATION CORPORATION NTR-3.3 MM SELF-TAPPING HA COA |
IMCOR |
ROBERT S URA |
| K992794 |
11/09/1999 |
STINGRAY DR, MODEL 1 |
INFIMED, INC. |
RALPH FLATAU |
| K993222 |
11/05/1999 |
INNOVATIVE GLOVES, LATEX EXAMINATION GLOVES POWDERFREE |
INNOVATIVE GLOVES CO; LTD |
RAJEEV KUMAR SOOD |
| K993221 |
11/05/1999 |
INNOVATIVE GLOVES, LATEX EXAMINATION GLOVES, PREPOWDERED |
INNOVATIVE GLOVES CO; LTD |
RAJEEV KUMAR SOOD |
| K993325 |
11/05/1999 |
INNOVATIVE GLOVES, NITRILE BUTADIENE RUBBER POWDER-FREE |
INNOVATIVE GLOVES CO; LTD |
RAJEEV KUMAR SOOD |
| K992834 |
11/24/1999 |
GEM PREMIER 3000 |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K992704 |
11/01/1999 |
IL TEST VON WILLEBRAND FACTOR |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K991473 |
11/23/1999 |
SIRSCAN |
INTELLIGENCE ARTIFICIELLE APPLICATIONS |
MARC J SCHEINESON |
| K992964 |
11/19/1999 |
IBC VENT VALVE, MODEL 1400 |
INTERNATIONAL BIOPHYSICS CORP. |
H. DAVID SHOCKLET, JR |
| K993247 |
11/05/1999 |
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES |
JDA INTL., INC. |
KEIDY GU |
| K993249 |
11/29/1999 |
OPC LOW WEAR OPAQUE PORCELAIN |
JENERIC/PENTRON, INC. |
ANNMARIE TENERO |
| K990229 |
11/04/1999 |
HPA PORTABLE KIDNEY PRESERVATION SYSTEM, MODEL J-1000-1 |
JUSTEC MEDICAL PRODUCTS, INC. |
JEFFREY L ROTHMAN |
| K993441 |
11/24/1999 |
K-ASSAY ALPHA-1 AG |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
| K993444 |
11/24/1999 |
K-ASSAY ALPHA-1 AT |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
| K993606 |
11/26/1999 |
K-ASSAY APO A1/B CALIBRATOR SET |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
| K993437 |
11/24/1999 |
K-ASSAY C3 |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
| K993481 |
11/29/1999 |
K-ASSAY C4 |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
| K993480 |
11/24/1999 |
K-ASSAY HAPTOGLOBIN |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
| K993213 |
11/23/1999 |
K-ASSAY IGA |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
| K993281 |
11/09/1999 |
K-ASSAY IGG |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
| K993323 |
11/30/1999 |
K-ASSAY IGM |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
| K992976 |
11/01/1999 |
K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
| K993537 |
11/30/1999 |
K-ASSAY TRANSFERRIN |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
| K993540 |
11/22/1999 |
ENDOSPINE OPERATING TUBE AND TELESCOPE BRIDGE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN KENNAN |
| K991592 |
11/02/1999 |
KSEA DE LA PLAZA BLEPHAROPLASTY SET |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN KENNAN |
| K990475 |
11/18/1999 |
TRAPIS (TRANSPERINEAL PROSTATE IMPLANT SIMULATOR), VERSION 1.5 |
KPS & ASSOC., INC. |
KRISHNA P SINHA |
| K993721 |
11/29/1999 |
UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBES |
LABORIE MEDICAL TECH CORP. |
DALE COLEMAN |
| K991015 |
11/02/1999 |
LM-70 (LIDOFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT) |
LAMDA POLYTECH LTD. |
MARTIN DALSING |
| K992924 |
11/05/1999 |
QTEXX, NON-CHLORINATED, POWDER FREE NITRILE EXAMINATION GLOVES, POLYMER-COATED |
LATEXX PARTNERS BHD. |
LIM CHONG ENG |
| K991880 |
11/09/1999 |
LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY |
LIGHT DIAGNOSTICS |
CINDY PENNY |
| K991024 |
11/16/1999 |
BONE BULLET SUTURE ANCHOR |
LINVATEC CORP. |
LAURA SENEFF |
| K990537 |
11/19/1999 |
OSTEO-PIN MEMBRANE FIXATION PIN |
LUITPOLD PHARMACEUTICALS, INC. |
PETER S REICHERTZ |
| K993555 |
11/19/1999 |
MASIMO SET/QUARTZ 2500 PULSE OXIMETER AND ACCESSORIES |
MASIMO CORP. |
JAMES J CRONIN |
| K992881 |
11/19/1999 |
HI BOND NON-PRECIOUS CERAMIC ALLOY |
MATECH, INC. |
PAUL L SAXTON |
| K992682 |
11/24/1999 |
MODUS 2.5 MANDIBULAR RECONSTRUCTION SET |
MEDARTIS AG |
LINDA JALBERT |
| K992683 |
11/24/1999 |
MODUS 2.5 MANDIBULAR TRAUMA SET |
MEDARTIS AG |
LINDA JALBERT |
| K991486 |
11/05/1999 |
ULTRA-CBX |
MEDCANICA, INC. |
AL WEISENBORN |
| K993034 |
11/01/1999 |
MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI- ENDOMYSIAL ANTIBODY (AEMA) TEST KIT, MODEL 6001-ESD |
MEDICA, INC. |
RHODORA CHAPOCO |
| K992829 |
11/22/1999 |
CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3 |
MEDICAL ANALYSIS SYSTEMS, INC. |
MARY D THORSNESS |
| K993546 |
11/30/1999 |
TRI-POINT, LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL, LEVELS 1, 2, AND 3 |
MEDICAL ANALYSIS SYSTEMS, INC. |
SCOT KINGHORN |
| K991320 |
11/10/1999 |
MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN |
MEDICAL COMPONENTS, INC. |
JEANNE M CUSH |
| K990808 |
11/26/1999 |
PBN DILATORS |
MEDICAL DEVICE TECHNOLOGIES, INC. |
KARL SWARTZ |
| K993740 |
11/26/1999 |
MAMEX |
MEDICAL SYSTEMS GROUP |
JEFFREY N MOELLER |
| K993223 |
11/01/1999 |
RAPICURE 200 (CURING AND WHITENING LIGHT) |
MEDIPHOTONIX, LC |
ROBERT MCCLANE |
| K993763 |
11/26/1999 |
QUANTITATIVE ANALYSIS OF CORONARY ANGIOGRAMS (QCA) |
MEDIS MEDICAL IMAGING SYSTEMS, B.V. |
DOUGLAS F ORR |
| K993765 |
11/26/1999 |
QUANTITATIVE ANALYSIS OF LEFT VENTRICULAR ANGIOGRAMS (QLV) |
MEDIS MEDICAL IMAGING SYSTEMS, B.V. |
DOUGLAS F ORR |
| K993517 |
11/02/1999 |
COMBISON 530D/VOLUSON 530D, TISSUE HARMONIC IMAGING (THI) OPTION |
MEDISON AMERICA, INC. |
GARY J ALLSEBROOK |
| K993728 |
11/26/1999 |
MEDRAD ENVISION CT INJECTOR SYSTEM |
MEDRAD, INC. |
JAN E DOBSCHA |
| K992713 |
11/10/1999 |
POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G0121-9043G0151, 9043S0101 |
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S |
ANN-CHRISTINE JONSSON |
| K993012 |
11/15/1999 |
MINIMED COM-STATION, HARDWARE-7301; SOFTWARE-7311 |
MEDTRONIC MINIMED |
JENNIFER LYONS |
| K993032 |
11/05/1999 |
MODIFICATION TO MP-3 POWER BASE CHAIR |
MERITS HEALTH PRODUCTS., INC. |
WINSTON ANDERSON |
| K992997 |
11/09/1999 |
OSTEOMARK NTX POC |
METRIKA, INC. |
Erika B Ammirati |
| K993823 |
11/19/1999 |
MED-4000 |
MICRO CURRENT TECHNOLOGY, INC. |
JAMES Y SUZUKI |
| K993234 |
11/10/1999 |
MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS |
MICROMEDICS, INC. |
CHARLES GROTE |
| K993013 |
11/29/1999 |
SURE BOND |
MIRADENT DISTRIBUTING CO., LLC. |
BERNARD SESSMAN |
| K992623 |
11/02/1999 |
MITEK MINI ANCHOR |
MITEK PRODUCTS |
PAULA E BULGER |
| K993477 |
11/01/1999 |
HRW WRIST ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K993719 |
11/26/1999 |
KAC-300 KNEE ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K993780 |
11/26/1999 |
QSC-300 SHOULDER ARRAY COILS |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K993637 |
11/24/1999 |
N-395 PULSE OXIMETER, WITH EXTENDED DEVICE CLAIMS |
NELLCOR PURITAN BENNETT, INC. |
DAVID A.C. GREEN |
| K990177 |
11/18/1999 |
NELLCOR PURITAN BENNETT ACHIEVA VENTILATOR AND REPORT GENERATOR |
NELLCOR PURITAN BENNETT, INC. |
CHERYL ROSENBERG |
| K991054 |
11/03/1999 |
BRAVO MULTI-MODALITY SYSTEM |
NICOLET BIOMEDICAL, INC. |
DOUGLAS E PFRANG |
| K992538 |
11/23/1999 |
AMORPHOUS DIAMOND COATED SCREW |
NOBEL BIOCARE UAS INC |
KIM RENDON |
| K992125 |
11/22/1999 |
XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46 |
NORLAND MEDICAL SYSTEMS, INC. |
TERRY SCHWALENBERG |
| K993344 |
11/15/1999 |
P10 SPECIAL |
NORTH AMERICAN ALLOYS, INC. |
KATHLEEN CALERO |
| K992264 |
11/24/1999 |
OCULAR SCIENCES, INC., BIOMEDICS 60 (OCUFILCON F) UV BLOCKING DAILY WEAR SOFT CONTACT LENS |
OCULAR SCIENCES PUERTO RICO, INC. |
RICHARD E LIPPMAN |
| K992843 |
11/02/1999 |
THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F |
OHIO MEDICAL INSTRUMENT CO., INC. |
KENNETH B MILLER |
| K993712 |
11/09/1999 |
BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM |
OHMEDA MEDICAL |
ALBERTO F PROFUMO |
| K992906 |
11/10/1999 |
COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT |
OLSON MEDICAL SALES, INC. |
GARRY A COURTNEY |
| K991672 |
11/03/1999 |
OLYMPUS NA-10J-KB ASPIRATION NEEDLE |
OLYMPUS AMERICA, INC. |
LAURA STORMS-TYLER |
| K993479 |
11/19/1999 |
OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (100 MICROGRAMS OR LESS) |
OMNIGRACE (THAILAND) LTD. |
K.C. CHOONG |
| K993050 |
11/09/1999 |
OMNI GRACE NITRILE, GREEN, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED |
OMNIGRACE LTD. |
WILLIAM E PATTON |
| K993419 |
11/19/1999 |
OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE; POLYMER COATED WITH PROTEIN CLAIM (50 MICROGRAMS OR LESS) |
OMNIGRACE LTD. |
WILLIAM E PATTON |
| K990292 |
11/19/1999 |
I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN |
OPHTHALMIC CONSULTANTS, INC. |
JOHN E LINCOLN |
| K983753 |
11/18/1999 |
STAR TEMPORARY WOUND COVER |
OSTEOGENICS, INC. |
MICHAEL DEUTSCH |
| K992885 |
11/19/1999 |
VERSALOK LOW BACK FIXATION SYSTEM |
OSTEOTECH, INC. |
JING ZHANG |
| K993385 |
11/10/1999 |
AUTOJET 2 (NON-FIXED NEEDLE TYPE) |
Owen Mumford USA, Inc. |
ROBERT SHAW |
| K992752 |
11/05/1999 |
SURGEON'S GLOVES PRE-POWDERED, MODELS 6.5, 7, 7.5, 8, 8.5 |
P.T. MAJA AGUNG LATEXINDO |
EMMY TJOENG |
| K993306 |
11/03/1999 |
NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY) |
PALADIN MEDICAL, INC. |
ELAINE DUNCAN, M.S.M.E., RAC |
| K993183 |
11/19/1999 |
POWDER FREE GLOVES (POLYMER COATED) |
PAN-CENTURY RUBBER PRODUCTS SDN. BHD. |
H.R.K MURTHY |
| K992853 |
11/04/1999 |
PASCO MIC AND MIC/ID PANELS, CEFDINIR |
PASCO LABORATORIES, INC. |
LINDA K DILLON |
| K992726 |
11/03/1999 |
PASCO MIC AND MIC/ID PANELS, QUINUPRISTIN/DALFOPRISTIN FOR NONFASTIDIOUS ORGANISMS |
PASCO LABORATORIES, INC. |
LINDA K DILLON |
| K992717 |
11/02/1999 |
PASCO MIC AND MIC/ID PANELS,QUINUPRISTIN/DALFOPRISTIN |
PASCO LABORATORIES, INC. |
LINDA K DILLON |
| K990927 |
11/12/1999 |
SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER |
PERRY BAROMEDICAL CORP. |
JAMES P DODSON |
| K993141 |
11/08/1999 |
AT HOME QUICKCUP PREGNANCY TEST, MODEL 9015 |
PHAMATECH |
CARL A MONGIOVI |
| K993109 |
11/12/1999 |
VARELISA RECOMBI ANA PROFILE |
PHARMACIA & UPJOHN CO. |
KAREN E MATIS |
| K993108 |
11/12/1999 |
VARELISA RECOMBI ANA SCREEN EIA, MODELS 128 48/ 128 96 |
PHARMACIA & UPJOHN CO. |
KAREN E MATIS |
| K993589 |
11/26/1999 |
VARELISA RNP ANTIBODIES |
PHARMACIA & UPJOHN CO. |
KAREN E MATIS |
| K992239 |
11/22/1999 |
PILLAR CHIN IMPLANT |
PILLAR SURGICAL, INC. |
ROB FRITZENKOTTER |
| K992240 |
11/22/1999 |
PILLAR MALAR IMPLANT |
PILLAR SURGICAL, INC. |
ROB FRITZENKOTTER |
| K992242 |
11/22/1999 |
PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS |
PILLAR SURGICAL, INC. |
RPB FRITZENKOTTER |
| K993286 |
11/23/1999 |
PIONEER SILICOAT STERNAL CABLE |
PIONEER SURGICAL TECHNOLOGY |
AMY H MIMMAERTS |
| K993558 |
11/12/1999 |
EZFLOW MAX, MODEL 1007 |
PIPER MEDICAL PRODUCTS |
SAMUEL DAVID PIPER |
| K993298 |
11/16/1999 |
E Z CHAIR |
PREMIER DESIGNS |
CHRIS BERRYHILL |
| K993285 |
11/18/1999 |
AURORA SL |
PREMIER LASER SYSTEMS, INC. |
BETH A ROBERTS |
| K992921 |
11/12/1999 |
PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL II |
PRIMUS CORP. |
JIMMIE K NOFFSINGER |
| K992950 |
11/18/1999 |
CUSTOM PROSTHETIC (HEFILCON A) SOFT LENS |
PROSTHETIC SOFT LENS CORP. |
WILLIAM HOFFMAN |
| K993071 |
11/24/1999 |
PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC, OPTION, MODEL 840 |
PURITAN BENNETT CORP. |
DELTON WEST |
| K984433 |
11/01/1999 |
QUANTECH CK-MB ASSAY |
QUANTECH LTD. |
ROBIN J HELLEN |
| K993723 |
11/23/1999 |
CARDIASURE CARDIAC MARKERS CONTROL |
QUANTIMETRIX CORP. |
EVY K JOHNSON |
| K991975 |
11/02/1999 |
SERAQUEST EB NA IGG |
QUEST INTL., INC. |
ROBERT A CORT |
| K993321 |
11/12/1999 |
R&D HGB/GLC WHOLE BLOOD CONTROL |
R & D SYSTEMS, INC. |
KENNETH T EDDS |
| K991417 |
11/24/1999 |
ABL 735 ANALYZER |
RADIOMETER AMERICA, INC. |
VINCE SIGMUND |
| K983239 |
11/18/1999 |
WATER PURIFICATION COMPONENTS AND SYSTEMS HEMODIALYSIS |
RASCO |
VINCENT J CICCONE |
| K991052 |
11/10/1999 |
FS 1000 KNEE SYSTEM |
RENAISSANCE INSTRUMENTS, LLC. |
KENT M SAMUELSON |
| K992969 |
11/10/1999 |
RESPIRONICS TOTAL FACE MASK |
RESPIRONICS, INC. |
DAVID J VANELLA |
| K991906 |
11/23/1999 |
LAPARO CO2-PNEU AUTOMATIC INSUFFLATOR WITH 30L FLOW RATE,AND VIDEO-SCREEN DISPLAY, HIGH FLOW INSUFFLATION TUBE WITH HEAT |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K993642 |
11/30/1999 |
ELECSYS PARATHYROID HORMONE CALCHECK |
ROCHE DIAGNOSTICS CORP. |
PRISCILLA A HAMILL |
| K992900 |
11/24/1999 |
PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA |
ROCHE DIAGNOSTICS CORP. |
PRICILLA A HAMILL |
| K993360 |
11/24/1999 |
PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA |
ROCHE DIAGNOSTICS CORP. |
PRISCILLA A HAMILL |
| K992492 |
11/02/1999 |
PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM |
ROCHE DIAGNOSTICS CORP. |
LUANN OCHS |
| K992890 |
11/23/1999 |
ROCHE COBAS INTEGRA OPIATES 300/2000 |
ROCHE DIAGNOSTICS CORP. |
LISA GERARD |
| K992857 |
11/10/1999 |
LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070 |
ROCKY MOUNTAIN RESEARCH, INC. |
ROBERT W GRIFFITHS |
| K992310 |
11/02/1999 |
TONICROSS TRICYCLES, MODELS, T0, T1,T2,T3 AND T4. |
RUPIANI MEDICAL |
JEAN-MARIE MANGENOT |
| K991326 |
11/08/1999 |
ISOBAR SEMI-RIGID SPINAL SYSTEM |
SCIEN'TX USA INC. |
DEBBIE DE LOS SANTOS |
| K993324 |
11/09/1999 |
CARBOCEM ZINC POLYCARBOXYLATE CEMENT |
SCIENTIFIC PHARMACEUTICALS, INC. |
JAN A ORLOWSKI |
| K993501 |
11/22/1999 |
3D1 MICROPOSITIONING HEADSTAGE |
SCIENTIFIC TOOLS, INC. |
T. WHIT ATHEY |
| K990546 |
11/05/1999 |
DELSONIC 2000 |
SDS DENTAL, INC. |
CESAR CORAL |
| K993134 |
11/17/1999 |
CASHMERE NON-STERILE BLUE POWDERED NITRILE EXAMINATION GLOVESBLUE AND GREEN) |
SEAL POLYMER INDUSTRIES BHD. |
CHAN CHIN HONG |
| K993133 |
11/17/1999 |
CASHMERE NON-STERILE POWDERED NITRILE EXAMINATION GLOVES BLUE AND GREEN |
SEAL POLYMER INDUSTRIES BHD. |
CHAN CHIN HONG |
| K993326 |
11/17/1999 |
NON-STERILE POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (70 MICROGRAMS OR LESS PER |
SEAL POLYMER INDUSTRIES BHD. |
CHAN CHIN HONG |
| K993167 |
11/10/1999 |
MILLENNIUM INFANT VENTILATOR |
SECHRIST INDUSTRIES, INC. |
GREG GODFREY |
| K993632 |
11/12/1999 |
FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM |
SELFCARE, INC. |
Carol Adiletto |
| K993715 |
11/16/1999 |
QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3 |
SERACARE TECHNOLOGY |
RUSTY SEWELL |
| K992770 |
11/12/1999 |
QUALITROL IMMUNOLOGY CONTROL, LEVEL 1, 2 AND 3 |
SERACARE TECHNOLOGY |
RUSTY SEWELL |
| K992341 |
11/23/1999 |
CIDEX OPA SOLUTION TEST STRIP |
SERIM RESEARCH CORP. |
JAMES E CHRISTNER |
| K993049 |
11/19/1999 |
DISPOSABLE PVC POWDERED SYNTHETIC EXAMINATION GLOVES |
SHANGHAI ANTARES INDUSTRIES, INC. |
JOHN LAI |
| K984203 |
11/01/1999 |
SIUI APOGEE 800PLUS ULTRASOUND IMAGING SYSTEM |
SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS |
ROBERT MORTON |
| K992862 |
11/29/1999 |
SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT |
SUSAN D GOLDSTEIN-FALK |
| K992797 |
11/05/1999 |
SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO., LTD |
KAREN ABELL |
| K992925 |
11/23/1999 |
AX WORKSTATION DR-VIEWER SOFTWARE OPTION |
SIEMENS CORP. |
KATHLEEN RUTHERFORD |
| K992731 |
11/10/1999 |
E.CAM COMPUTER |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ROBERT W CALLAHAN |
| K990826 |
11/01/1999 |
INTERACTIVE MR LOCALIZER/ MAGNETOM OPEN AND OPEN VIVA SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JAMIE YIEH |
| K993425 |
11/26/1999 |
PRIMUS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KATHRYN B DODD |
| K991884 |
11/03/1999 |
SIEMENS FIO2 SENSOR |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PENELOPE H GRECO |
| K992660 |
11/05/1999 |
URF DIGITAL - OT |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
MALGORZATA STANEK |
| K992001 |
11/02/1999 |
TRAY-LINK |
SILICON-UND COMPOSITE SPEZIALITATEN GMBH |
JURGEN ENGELBRECHT |
| K992931 |
11/17/1999 |
NON-STICK BIPOLAR FORCEPS |
SILVERGLIDE SURGICAL TECHNOLOGIES |
KEVIN MORNINGSTAR |
| K992697 |
11/18/1999 |
PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM |
SIMS DELTEC, INC. |
LISA J STONE |
| K993177 |
11/16/1999 |
SABRE |
SLE LIMITED |
FRANK FERGUSON |
| K992945 |
11/18/1999 |
RCI FIXATION SCREWS (WITH ASSORTED SIZES) |
SMITH & NEPHEW, INC. |
NICHOLAS CONDAKES |
| K990103 |
11/05/1999 |
MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE |
SORIN BIOMEDICAL, INC. |
LYNNE LEONARD |
| K991059 |
11/16/1999 |
SPECTRANETICS 0.014 SUPPORT CATHETER, MODEL 518-016, SPECTRANETICS 0.018 SUPPORT CATHETER, MODEL 518-017 |
SPECTRANETICS CORP. |
MICHAEL J QUINN |
| K993348 |
11/19/1999 |
NIL, NITRILE EXAMINATION GLOVE - POWDER FREE |
SRI ANUSHAM RUBBER INDUSTRIES PVT., LTD. |
N PARAMASIVAN |
| K993347 |
11/19/1999 |
NIL, NITRILE EXAMINATION GLOVE - POWDERED |
SRI ANUSHAM RUBBER INDUSTRIES PVT., LTD. |
N PARAMASIVAN |
| K993349 |
11/23/1999 |
NIL, SURGEON'S GLOVE - POWDER FREE |
SRI ANUSHAM RUBBER INDUSTRIES PVT., LTD. |
N PARAMASIVAN |
| K993458 |
11/10/1999 |
POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) |
SRI JOHANI SDN. BHD. |
LIM LEE AIK |
| K990512 |
11/23/1999 |
STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS |
STOECKERT INSTRUMENTE |
CYNTHIA JM NOLTE |
| K993126 |
11/26/1999 |
CD-CHEX CD 34 |
STRECK LABORATORIES, INC. |
HAL SORNSON |
| K993825 |
11/30/1999 |
PARA TECH PLUS RETICS |
STRECK LABORATORIES, INC. |
PAUL KITTELSON |
| K992887 |
11/22/1999 |
STAK-CHEX PLUS RETICS |
STRECK LABORATORIES, INC. |
PAUL KITTELSON |
| K993583 |
11/10/1999 |
ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM |
STRYKER CORP. |
NICOLE PETTY |
| K993061 |
11/19/1999 |
STRYKER LEIBINGER RESORBABLE FIXATION SYSTEM |
STRYKER INSTRUMENTS |
KRISTEN R KELLEY |
| K992832 |
11/19/1999 |
SULZER VASCUTEK EPTFE VASCULAR PROSTHESIS |
SULZER MEDICA |
EDWARD E NEWTON |
| K993067 |
11/16/1999 |
SILHOUETTE SPINAL FIXATION SYSTEM |
SULZER SPINE-TECH |
JANELL A COLLEY |
| K991722 |
11/03/1999 |
DEVILBISS 5 LITER OXYGEN CONCENTRATOR |
SUNRISE MEDICAL HHG, INC. |
GREG CLITES |
| K992919 |
11/19/1999 |
OXY-GLIDE ROOT CANAL CLEANSER & LUB. |
SUPER GLIDE, INC. |
VICTOR L RATKUS |
| K993021 |
11/10/1999 |
METRX SYSTEM |
SURGICAL NAVIGATION TECHNOLOGIES, INC. |
ROGER N WHITE |
| K991662 |
11/08/1999 |
TITANIUM HARTSHILL SYSTEM |
SURGICRAFT LTD. |
SIMON FITZER |
| K992978 |
11/16/1999 |
RICROKERATOME BLADE |
SURGISTAR, INC. |
JONATHAN WOODWARD |
| K992891 |
11/02/1999 |
SYNTHES CERCLAGE POSITIONING PIN |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K992875 |
11/09/1999 |
SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER |
SYSMEX CORP. |
NINA GAMPERLING |
| K993160 |
11/18/1999 |
OMEGA TRAC, MODEL Z100 |
TEFTEC CORP. |
THOMAS E FINCH, III |
| K990457 |
11/09/1999 |
TED 60T OXYGEN ANALYZER |
TELEDYNE ELECTRONIC TECHNOLOGIES |
RAY KHAJAVI |
| K992505 |
11/10/1999 |
TERATECH, MODEL 2000 IMAGING IMAGING |
TERATECH CORP. |
SHEILA HEMEON-HEYER |
| K992722 |
11/10/1999 |
PRIMEAIRE |
THAYER MEDICAL CORP. |
DAVID T SLADEK |
| K981786 |
11/24/1999 |
IGA MININEPH ANTISERUM |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K981914 |
11/26/1999 |
TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K993147 |
11/02/1999 |
DECAP |
THE KIPP GROUP |
GARY WERSCHMIDT |
| K993394 |
11/05/1999 |
ECHO SCAN, EASY SCAN |
TOMTEC IMAGING SYSTEMS, GMBH |
FLORIAN EISENBERGER |
| K993398 |
11/05/1999 |
ECHO VIEW, EASY VIEW, OMNI VIEW |
TOMTEC IMAGING SYSTEMS, GMBH |
FLORIAN EISENBERGER |
| K992886 |
11/09/1999 |
POWERVIEW ULTRASOUND WORKSTATION, UIDM-400A |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K992665 |
11/26/1999 |
MACRA LP(A) ENZYME IMMUNOASSAY KIT |
TRINITY BIOTECH USA |
WAYNE A KVETKOSKY |
| K993647 |
11/16/1999 |
UNIMED DISPOSABLE HAND AND FOOT-SWITCHING PENCILS WITH HOLSTER AND 1BLADE AND TIP CLEANER, UNIMED DISPOSABLE HAND AND F |
UNIMED SURGICAL PRODUCTS, INC. |
LEE ALEXANDER |
| K992654 |
11/05/1999 |
PLUG 'N VIEW 3D, VERSION 1.0 |
VOXAR LIMITED |
ROB MACKEAN |
| K993219 |
11/09/1999 |
WAKO BILIRUBIN CALIBRATOR |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
| K993466 |
11/09/1999 |
WAKO L-TYPE TRIGLYCERIDE TEST |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
| K993469 |
11/09/1999 |
WAKO L-TYPE UA F TEST |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
| K993162 |
11/12/1999 |
WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
| K992952 |
11/19/1999 |
LORENZ DISTRACTION SYSTEM |
WALTER LORENZ SURGICAL, INC. |
DIANA PRESTON |
| K992961 |
11/08/1999 |
LORENZ SMALL FRAGMENT SYSTEM |
WALTER LORENZ SURGICAL, INC. |
DIANA PRESTON |
| K992678 |
11/17/1999 |
PATIENT NITRILE EXAMINATION GLOVES POWDER FREE CHLORINATED |
WEAR SAFE MALAYSIA SDN. BHD. |
CLAUDE COTTET |
| K991617 |
11/03/1999 |
FACE-2-FACE CPR PROTECTION SHIELD |
WHITELINE PLASTICS, INC. |
WALLY SIMPSON |
| K992817 |
11/05/1999 |
ANTIBACTERIAL ADHESIVE BANDAGE |
WILLIAM FEINSTEIN & ASSOCIATES, INC. |
WILLIAM FEINSTEIN |
| K991344 |
11/05/1999 |
WORLDWIDE MEDICAL TECHNOLOGIES SEEDING SPACERS |
WORLDWIDE MEDICAL TECHNOLOGIES, LLC |
GARY A LAMOUREUX |
| K992874 |
11/18/1999 |
Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM |
WR MEDICAL ELECTRONICS CO. |
PATRICK J ANDERSON |
| K993313 |
11/23/1999 |
COMFIT POWDER FREE BLUE NITRILE EXAMINATION GLOVE, STERILE |
WRP ASIA PACIFIC SDN. BHD. |
YUE WAH CHOW |
| K993311 |
11/19/1999 |
COMFIT POWDER FREE NITRILE EXAMINATION GLOVE, STERILE |
WRP ASIA PACIFIC SDN. BHD. |
YUE WAH CHOW |
| K993250 |
11/12/1999 |
THE APTUS (AUTOMATED) APPLICATION OF THE GLIADIN IGG ELISA TEST SYSTEM. |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
