FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
K993526 |
10/18/1999 |
SYNEA - LS LOW-SPEED HANDPIECE |
A-DEC, INC. |
PATRICK RIDENOUR |
K993317 |
10/04/1999 |
ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE) |
ACON LABORATORIES, INC. |
NORA C.R. YORK |
K993483 |
10/14/1999 |
ACON ONE STEP HOME PREGNANCY TEST STRIP |
ACON LABORATORIES, INC. |
NORA C.R. YORK |
K993657 |
10/28/1999 |
ACUMED SUTURE ANCHOR |
ACUMED, INC. |
SHARI JEFFERS |
K993544 |
10/19/1999 |
SPACE-OR RETRACTOR |
ADVANCED SURGICAL CONCEPTS (ASC) |
MARY MCNAMARA CULLINANE |
K993459 |
10/13/1999 |
MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX |
ADVANCED UROSCIENCE, INC. |
KAREN E PETERSON |
K993551 |
10/19/1999 |
SOCON SPINAL SYSTEM |
AESCULAP, INC. |
LIA S JONES |
K993522 |
10/18/1999 |
AKTINA MEDICAL PHYSICS CORPORATION TENNIS RACQUET INSERT |
AKTINA MEDICAL PHYSICS CORP. |
JOAN ZACHAROPOULOS |
K993524 |
10/18/1999 |
ADVANTIS ASC INFUSION PUMP AND ADMINISTRATION SETS |
ALARIS MEDICAL SYSTEMS, INC. |
RENEE L FLUET |
K993623 |
10/26/1999 |
GEMINI E |
ALLEN MEDICAL INSTRUMENTS CORP. |
JUDITH ALLEN |
K993622 |
10/26/1999 |
NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY |
ALPHA OMEGA LTD. |
SHOSHANA S FRIEDMN |
K993513 |
10/18/1999 |
DELTALOC ANTERIOR CERVICAL PLATE SYSTEM |
ALPHATEC MFG., INC. |
JASON BLAIN |
K993629 |
10/27/1999 |
ABI VEST AIRWAY CLEARANCE SYSTEM |
AMERICAN BIOSYSTEMS, INC. |
ERIC J LARSON |
K993550 |
10/20/1999 |
AVIVA SYSTEM, MODEL SL1010 |
AMERICAN TELECARE, INC. |
CHARLES RICHARD ABRUSCATO |
K993650 |
10/29/1999 |
URETERAL ACCESS SHEATH SET - NEW MODELS |
APPLIED MEDICAL RESOURCES |
ANIL BHALANI |
K993592 |
10/22/1999 |
AXIOM MULTIPURPOSE WOUND DRAIN |
AXIOM MEDICAL, INC. |
RIDWAN HARDY |
K993387 |
10/08/1999 |
IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K |
BAXTER HEALTHCARE CORP. |
VICKI L DREWS |
K993309 |
10/04/1999 |
BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR TROPONIN I ASSAY |
BAYER CORP. |
William J Pignato |
K993571 |
10/21/1999 |
BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12 |
BAYER CORP. |
THOMAS F FLYNN |
K993353 |
10/05/1999 |
TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNOSTIC SYSTEM) |
BAYER CORP. |
GABRIEL J MURACA JR |
K993552 |
10/20/1999 |
ISOSEED PD-103 |
BEBIG ISOTOPENTECHNIK GMBH |
SVEN LANGER |
K993549 |
10/19/1999 |
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN A (IGALC) REAGENT, BECKMAN COULTER CEREBR |
BECKMAN COULTER, INC. |
RICHARD T ROSS |
K993547 |
10/19/1999 |
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN M (IGMLC) REAGENT, BECKMAN COULTER CEREB |
BECKMAN COULTER, INC. |
RICHARD T ROSS |
K993473 |
10/14/1999 |
SYNCHRON SYSTEMS DRUG CALIBRATOR 2 |
BECKMAN COULTER, INC. |
GAIL LEFEBVRE |
K993577 |
10/21/1999 |
CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISC |
BECTON DICKINSON MICROBIOLOGY SYSTEMS |
MONICA E GIGUERE |
K993495 |
10/15/1999 |
POWDERED LATEX EXAMINATION GLOVES(PROTEIN LABEL CLAIM 150 MICROGRAMS OR LESS) |
BESGLOVE MEDICARE SDN. BHD. |
LEE AIK LIM |
K993500 |
10/15/1999 |
POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL OF 50 MCROGRAM OR LESS) |
BESGLOVE MEDICARE SDN. BHD. |
LEE AIK LIM |
K993502 |
10/15/1999 |
POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM 50 MICROGRAMS OR LESS) |
BESGLOVE MEDICARE SDN. BHD. |
LEE AIK LIM |
K993536 |
10/19/1999 |
BIO-RAD CODA NEONATAL GALT ASSAY |
BIO-RAD |
ELIZABETH TANG |
K993529 |
10/18/1999 |
POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
BIOGRAFIK (MALAYSIA) SDN BHD |
SHUKUR BIN HASRAN |
K993493 |
10/15/1999 |
THE AUTOTAC SYSTEM |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
WINSTON D GREER |
K993362 |
10/06/1999 |
HYLASINE |
BIOMATRIX, INC. |
MARIO J RERES |
K993319 |
10/04/1999 |
VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210 |
BIOMERIEUX, INC. |
ANNA DEMARINIS |
K993438 |
10/12/1999 |
METAL ON METAL ACETABULAR SYSTEM |
BIOMET, INC. |
MICHELLE L MCKINLEY |
K993510 |
10/18/1999 |
MODIFIED BMP TROCHANTERIC PLATES |
BIOMET, INC. |
FRED MCCLURE |
K993453 |
10/13/1999 |
MENISCUS ARROW, MODELS 531110, 531113, 531116 |
BIONX IMPLANTS, LTD. |
TUIJA ANNALA |
K993434 |
10/12/1999 |
PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A |
BIOTRONIK, INC. |
Jon Brumbaugh |
K993449 |
10/12/1999 |
BIRD V.I.P. GOLD/STERLING |
BIRD PRODUCTS CORP. |
DARRYL SHELBY |
K993488 |
10/15/1999 |
LIGHT-CORE |
BISCO, INC. |
KATHRYN B PATTERSON |
K993591 |
10/22/1999 |
BLADEWORKS DISPOSABLE ALK TUBING |
BLADE WORKS, INC. |
GARY MOCNIK |
K993303 |
10/04/1999 |
SEMI COMPLIANT (SC) 35 BALLOON DILATATION CATHETER |
BOSTON SCIENTIFIC CORP. |
TERRY A MCGOVERN |
K993305 |
10/04/1999 |
TRANSLUMINAL BALLOON DILATATION CATHETER |
BOSTON SCIENTIFIC CORP. |
TERRY A MCGOVERN |
K993648 |
10/29/1999 |
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER |
BOSTON SCIENTIFIC CORPORATION NORTHWEST TECHNOLOGY |
CYNDY ADAMS |
K993292 |
10/01/1999 |
BOSTON SCIENTIFIC/TARGET SENTRY OCCLUSION BALLOON CATHETER |
BOSTON SCIENTIFIC, TARGET |
GOWAN LEE |
K993418 |
10/01/1999 |
FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL |
BOSTON SCIENTIFIC, TARGET |
ROXANE BAXTER |
K993417 |
10/01/1999 |
GDC-10 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC), GDC-18 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC) |
BOSTON SCIENTIFIC, TARGET |
ROXANE BAXTER |
K993415 |
10/01/1999 |
GDC-10 STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-10 2-DIAMETER STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-1 |
BOSTON SCIENTIFIC, TARGET |
ROXANE BAXTER |
K993617 |
10/26/1999 |
DIGITRAKPLUS HOLTER RECORDER |
BRAEMAR CORP. |
DAVID NORBERG |
K993618 |
10/26/1999 |
DXP1000 HOLTER RECORDER |
BRAEMAR CORP. |
DAVID NORBERG |
K993392 |
10/08/1999 |
BARD MEMOTHERM FLEXX BILIARY STENT |
C.R. BARD, INC. |
CAROL VIERLING |
K993464 |
10/13/1999 |
BARDEX I.C. PEDIATRIC FOLEY CATHETER |
C.R. BARD, INC. |
GEORGIA C ABERNATHY |
K993533 |
10/19/1999 |
POWERHEART AECD |
CARDIAC SCIENCE, INC. |
STAN E TILLMAN |
K993519 |
10/18/1999 |
RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST |
CARDIOVASCULAR DIAGNOSTICS, INC. |
PETER SCOTT |
K993634 |
10/27/1999 |
CARESIDE ANALYZER |
CARESIDE, INC. |
KENNETH B ASARCH |
K993357 |
10/06/1999 |
IOLMASTER |
CARL ZEISS, INC. |
SCOTT A MARGOLIN |
K993633 |
10/27/1999 |
SYNTHETIC VDRL ANTIGEN |
CENTERS FOR DISEASE CONTROL AND PREVENTION |
VICTORIA POPE |
K993375 |
10/07/1999 |
CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER |
CLINICAL DIAGNOSTIC SOLUTIONS, INC. |
COLIN ALDERSLEY |
K993557 |
10/20/1999 |
AUTOSTAT II RHEUMATOID FACTOR IGA ELISA |
COGENT DIAGNOTICS LTD. |
DANIELLE M KNIGHT |
K993304 |
10/04/1999 |
AUTOSTAT II RHEUMATOID FACTOR IGG ELISA |
COGENT DIAGNOTICS LTD. |
DANIELLE M KNIGHT |
K993545 |
10/19/1999 |
TENAX WHITE POST |
COLTENE/WHALEDENT INC. |
H.J. VOGELSTEIN |
K993420 |
10/12/1999 |
CONTROL SOLUTIONS INC, MODEL CS3101 |
CONTROL SOLUTIONS, INC. |
JOHN HAYDEN |
K993455 |
10/13/1999 |
FLIPPER DETACHABLE EMBOLIZATION COIL |
COOK, INC. |
KAREN BRADBURN |
K993646 |
10/29/1999 |
S.M.A.R.T. .018 NITINOL STENT TRANSHEPATIC BILIARY SYSTEM |
CORDIS CORP. |
ELENA JUGO |
K993641 |
10/28/1999 |
METALYZER, MODEL 2; METALYZER, MODEL 3 |
CORTEX BIOPHYSIK GMBH |
ART WARD |
K993659 |
10/29/1999 |
RENAMEL PACK |
COSMEDENT, INC. |
MICHAEL O'MALLEY |
K993658 |
10/29/1999 |
RENAMEL SCULPT |
COSMEDENT, INC. |
MICHAEL O'MALLEY |
K993356 |
10/06/1999 |
COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES |
COULTER CORP. |
STAN SUGRUE |
K993489 |
10/15/1999 |
CRYSTAL CUSTOM TINTED SOFT CONTACT LENS |
CRYSTAL REFLECTIONS, INT., INC. |
JACK CARTER |
K993463 |
10/13/1999 |
INTRAVASCULAR ADMINISTRATION SET |
CUSTOM ASSEMBLIES, INC. |
PAUL E DRYDEN |
K993310 |
10/04/1999 |
APOLIPOPROTEIN CONTROL SERUM CHD, MODEL OUPH |
DADE BEHRING, INC. |
DONNA A WOLF |
K993299 |
10/01/1999 |
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 |
DADE BEHRING, INC. |
RADAMES RIESGO |
K993531 |
10/18/1999 |
PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX |
DATASCOPE CORP. |
SUSAN E MANDY |
K993410 |
10/12/1999 |
DATES-OHMEDA AESTIVA SMARTVENT MRI |
DATEX-OHMEDA, INC. |
DANIEL KOSEDNAR |
K993608 |
10/25/1999 |
DATEX-OHMEDA NE12STPR MODULE (MODEL FAMILY M-NE12STPR) |
DATEX-OHMEDA, INC. |
JOEL C KENT |
K993656 |
10/29/1999 |
DATEX-OHMEDA TONOMETRY MODULE M-TONO |
DATEX-OHMEDA, INC. |
JOEL C KENT |
K993512 |
10/18/1999 |
DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER |
DATEX-OHMEDA, INC. |
DALE THANIG |
K993296 |
10/01/1999 |
TRIP TONOMETRY CATHETER, 14F |
DATEX-OHMEDA, INC. |
JOEL KENT |
K993514 |
10/18/1999 |
DEFINITE |
DEGUSSA - NEY DENTAL, INC. |
THOMAS B CAMERON |
K993620 |
10/26/1999 |
IMPRESARIO |
DEL MAR MEDICAL SYSTEMS, LLC. |
NEVINE ERIAN |
K993465 |
10/13/1999 |
DEPUY ACE CALCANEAL PERI-ARTICULAR PLATE |
DEPUY, INC. |
ARLENE C SAULL |
K993554 |
10/20/1999 |
YEASTEST |
DIAGNOSTIC MARKERS, INC. |
GREG HOLLAND |
K993294 |
10/01/1999 |
DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM |
DIAMEDIX CORP. |
LYNNE STIRLING, PH.D |
K993291 |
10/01/1999 |
COPALIS RUBELLA IGM |
DIASORIN, INC. |
JUDITH J SMITH |
K993624 |
10/26/1999 |
SITE-RITE 3 ULTRASOUND SYSTEM |
DYMAX CORP. |
CHARLES MORREALE |
K993649 |
10/29/1999 |
EBI XFIX DFS WRISTFIX SYSTEM |
EBI, L.P. |
JON CAPAROTTA |
K993448 |
10/12/1999 |
STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS |
ELA MEDICAL, INC. |
CATHERINE G GOBLE |
K993630 |
10/27/1999 |
BIOLOK SCREW |
ENCORE ORTHOPEDICS, INC. |
DEBBIE DE LOS SANTOS |
K993376 |
10/07/1999 |
ENSTYLET MODELS EC0010, EC0020 |
ENDOCARDIAL SOLUTIONS, INC. |
JAMES BULLOCK |
K993343 |
10/05/1999 |
ERECXEL ADJUSTABLE PENILE BANDS, CONTREX ADJUSTABLE PENILE BANDS |
ERECXEL ENTERPRISES |
PACIFICO R BURGOS |
K993566 |
10/21/1999 |
PROMPTFLOW |
ESPE DENTAL AG |
ANDREAS PETERMANN |
K993412 |
10/12/1999 |
BITX PROBES |
EVEREST MEDICAL CORP. |
FREDERICK G MADES |
K993614 |
10/25/1999 |
FAS ENDOLUMINAL BRUSH |
FAS MEDICAL LTD. |
LYNNE ARONSON |
K993300 |
10/01/1999 |
COLDLIGHTSOURCE PL3000 |
FIBER IMAGING TECHNOLOGIES, INC. |
JOSEPH RESS |
K993450 |
10/12/1999 |
LATEX SURGICAL GLOVES, PRE-POWDERED |
FITCO DIPPED PRODUCTS PVT. LTD |
JOSEPH PEREIRA |
K993640 |
10/28/1999 |
SPECTRUM LIBRE WHEELCHAIR |
FREEDOM DESIGNS, INC. |
GINNY S MALOCO |
K993560 |
10/21/1999 |
FRIALIT-2 BONE PROFILER |
FRIADENT GMBH |
CAROL PATTERSON |
K993645 |
10/28/1999 |
CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEM |
GE MEDICAL SYSTEMS, INC. |
LARRY A KROGER |
K993364 |
10/06/1999 |
GE LOGIQ 700 WITH CODED EXCITATION MODIFICATION |
GE MEDICAL SYSTEMS, INC. |
ALLEN SCHUH |
K993365 |
10/06/1999 |
GE LOGIQ 700 WITH HARMONIC IMAGING MODIFICATION |
GE MEDICAL SYSTEMS, INC. |
ALLEN SCHUH |
K993665 |
10/29/1999 |
LEGEND CRF FLUORO AND RAD SYSTEM |
GE MEDICAL SYSTEMS, INC. |
LARRY A KROGER |
K993553 |
10/20/1999 |
GTI-FVIII INHIBITOR ASSAY |
GENETIC TESTING INSTITUTE |
MICHAEL MOGHADDAM |
K993625 |
10/26/1999 |
INSUFFLATION NEEDLE- 120MM, MODEL 900-200 |
GENICON, LC |
GARY HABERLAND |
K993332 |
10/04/1999 |
GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05 |
GRADIPORE LTD. |
RHONDA PILGRIM |
K993386 |
10/08/1999 |
LATEX EXAMINATION POWDERED GLOVES |
GREAT GLOVE SDN BHD |
K.M. LEE |
K993588 |
10/22/1999 |
MODIFICATION TO RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005126-13, 1005128-13, 1005130-13, 1005132-13, 1005134-13, |
GUIDANT CORP. |
SANTA SUNDELL |
K993639 |
10/28/1999 |
RX VIATRAC 18 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER |
GUIDANT CORP. |
SUSAN SILAVIN |
K993581 |
10/22/1999 |
HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAEMOLITE 2 FAMILY OF AUTOLOGOUS BLOOD RECOVER |
HAEMONETICS CORP. |
ALICIA R LOPEZ |
K993496 |
10/15/1999 |
RETIC-QUINOX |
HEMATRONIX, INC. |
JAMES D LAPICOLA |
K993330 |
10/04/1999 |
THERMOCHEM-HT SYSTEM |
HEMOCLEANSE, INC. |
STEPHEN R ASH |
K993602 |
10/25/1999 |
PRE-VISION FILL |
HERAEUS KULZER, INC. |
CHERYL V ZIMMERMAN |
K993587 |
10/22/1999 |
HP M2376A DEVICE LINK SYSTEM |
HEWLETT-PACKARD CO. |
MIKE HUDON |
K993516 |
10/18/1999 |
HP M2600A VIRIDIA TELEMETRY SYSTEM |
HEWLETT-PACKARD CO. |
DENISE HALEY |
K993383 |
10/08/1999 |
HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.B |
HEWLETT-PACKARD GMBH |
EGON PFEIL |
K993352 |
10/05/1999 |
CROSSFIRE SYSTEM 12 ACETABULAR INSERTS |
HOWMEDICA OSTEONICS CORP. |
TERRY SHERIDAN POWELL |
K993601 |
10/25/1999 |
HOWMEDICA OSTEONICS FEMORAL HEADS |
HOWMEDICA OSTEONICS CORP. |
NANCY J RIEDER |
K993402 |
10/08/1999 |
OPUS SPINAL SYSTEM |
HOWMEDICA OSTEONICS CORP. |
MARY-CATHERINE DILLON |
K993603 |
10/25/1999 |
WICHITA FUSION NAIL FULLY THREADED SELF-TAPPING SCREW |
HOWMEDICA OSTEONICS CORP. |
JENNIFER A DAUDELIN |
K993355 |
10/06/1999 |
HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43 |
HUDSON RESPIRATORY CARE, INC. |
CHARLES MIERKIEWICZ |
K993361 |
10/06/1999 |
TUBING EXTENSION SET |
HURRICANE MEDICAL |
DAVID A CLAPP |
K993338 |
10/05/1999 |
INTEGRATED DIGITAL MEDICAL RECORD (IDMR) |
IBM ISRAEL LTD. |
ELI M ORBACH |
K993461 |
10/13/1999 |
QUEST INTERSEGMENTAL ROLLER TRACTION TABLE |
ICON INTL., LLC. |
GERALD S AUSLANDER |
K993532 |
10/19/1999 |
DDS, DS3000, RS3000, CS5000, OT3000, IS3000, RS5000, CD3000, US3000, (AMONGST OTHER NAMES) |
IMPAX TECHNOLOGY, INC. |
PAULA PFEIFLE |
K993567 |
10/21/1999 |
INNOVATIVE GLOVES LATEX EXAMINATION GLOVES POWDERFREE WITH PROTEIN LABELING CLAIM [50 MICROGRAMS OR LESS] |
INNOVATIVE GLOVES CO; LTD |
RAJEEV KUMAR SOOD |
K993325 |
10/04/1999 |
INNOVATIVE GLOVES, NITRILE BUTADIENE RUBBER POWDER-FREE |
INNOVATIVE GLOVES CO; LTD |
RAJEEV KUMAR SOOD |
K993503 |
10/15/1999 |
HAIDER-UCR SPINAL SYSTEM |
INTERNATIONAL ADVANCED MEDICAL ENTERPRISES, INC. |
DAVID W SCHLERF |
K993413 |
10/12/1999 |
STORM SERIES, POWER 9000 SERIES AND POWER TIGER WITH GYROSCOPE CONTROL |
INVACARE CORP. |
EDWAED A KROLL |
K993484 |
10/14/1999 |
Q-HTF, CAT# 2001 |
INVITROCARE, INC. |
ROBERT E LOVINS |
K993441 |
10/12/1999 |
K-ASSAY ALPHA-1 AG |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
K993444 |
10/12/1999 |
K-ASSAY ALPHA-1 AT |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
K993606 |
10/25/1999 |
K-ASSAY APO A1/B CALIBRATOR SET |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
K993345 |
10/05/1999 |
K-ASSAY APO AI |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
K993354 |
10/05/1999 |
K-ASSAY APO B |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
K993437 |
10/12/1999 |
K-ASSAY C3 |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
K993481 |
10/14/1999 |
K-ASSAY C4 |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
K993482 |
10/14/1999 |
K-ASSAY FIBRINOGEN |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
K993480 |
10/14/1999 |
K-ASSAY HAPTOGLOBIN |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
K993323 |
10/04/1999 |
K-ASSAY IGM |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
K993537 |
10/19/1999 |
K-ASSAY TRANSFERRIN |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
K993539 |
10/19/1999 |
DCI ENDOSCOPE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN KENNAN |
K993540 |
10/19/1999 |
ENDOSPINE OPERATING TUBE AND TELESCOPE BRIDGE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN KENNAN |
K993373 |
10/07/1999 |
ROTORBLADE SUTURE ANCHOR |
LI MEDICAL TECHNOLOGIES, INC. |
RHODEMANN LI |
K993339 |
10/05/1999 |
ENDOPEARL WITH THREADER |
LINVATEC CORP. |
LAURA SENEFF |
K993568 |
10/21/1999 |
MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L |
MACHIDA ENDOSCOPE CO., LTD. |
GENICHI KANAI |
K993555 |
10/20/1999 |
MASIMO SET/QUARTZ 2500 PULSE OXIMETER AND ACCESSORIES |
MASIMO CORP. |
JAMES J CRONIN |
K993572 |
10/21/1999 |
CERADIUM V NON-PRECIOUS CERAMIC ALLOY |
MATECH, INC. |
PAUL L SAXTON |
K993530 |
10/18/1999 |
SYSTEM 2100 |
MATH SOLUTIONS, LLC. |
WENDEL DEAN RENNER |
K993604 |
10/25/1999 |
ENDOSCOPIC ANTI FOG DEVICE |
MECTRA LABS, INC. |
CHARLES E ALLGOOD |
K993518 |
10/18/1999 |
MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE LL |
MEDEFIL, INC. |
PRADEEP AGGARWAL |
K993515 |
10/18/1999 |
MEDEFIL'S NORMAL SALINE FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE L |
MEDEFIL, INC. |
PRADEEP AGGARWAL |
K993358 |
10/06/1999 |
SIGHTSURE OPERATION INDICATOR, MODEL SS301 |
MEDEVICES, INC. |
MICHELE H VOVOLKA |
K993546 |
10/19/1999 |
TRI-POINT, LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL, LEVELS 1, 2, AND 3 |
MEDICAL ANALYSIS SYSTEMS, INC. |
SCOT KINGHORN |
K993517 |
10/18/1999 |
COMBISON 530D/VOLUSON 530D, TISSUE HARMONIC IMAGING (THI) OPTION |
MEDISON AMERICA, INC. |
GARY J ALLSEBROOK |
K993556 |
10/20/1999 |
LIQUIBAND DENTAL |
MEDLOGIC GLOBAL CORP. |
STEPHEN J TAMSETT |
K993411 |
10/12/1999 |
FEMISCAN CLINIC SYSTEM, MODEL FS-ICTRA AND FEMISCAN PERSONAL SYSTEM, MODEL FS-HMTR |
MEGA ELECTRONICS LTD. |
DAVID MAHONEY |
K993308 |
10/04/1999 |
MENTOR EVACARE VAGINAL PESSARIES |
MENTOR CORP. |
DONNA A CRAWFORD |
K993341 |
10/05/1999 |
INTELLISYSTEM II COLOR MONITOR |
MERIT MEDICAL SYSTEMS, INC. |
CHESTER MCCOY |
K993475 |
10/14/1999 |
AUROFLUID M, ALLOY NO. 5315 |
METALOR DENTAL USA CORP. |
KENNETH A PUTNEY |
K993474 |
10/14/1999 |
DELTAPAL, ALLOY NO. 5161 |
METALOR DENTAL USA CORP. |
KENNETH A PUTNEY |
K993506 |
10/15/1999 |
PAGALINOR 4 , ALLOY NO. 5440 |
METALOR DENTAL USA CORP. |
KENNETH A PUTNEY |
K993505 |
10/15/1999 |
V-DELTA SPECIAL, ALLOY NO. 5154 |
METALOR DENTAL USA CORP. |
KENNITH A PUTNEY |
K993508 |
10/15/1999 |
V-SUPRA PLUS, ALLOY NO. 5025 |
METALOR DENTAL USA CORP. |
KENNETH A PUTNEY |
K993507 |
10/15/1999 |
V-SUPRAGOLD, ALLOY NO. 5024 |
METALOR DENTAL USA CORP. |
KENNETH A PUTNEY |
K993400 |
10/08/1999 |
HDR CONTOUR TP TEMPLATE AND IMPLANT ACCESSORIES |
MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
FELIX MICK |
K993472 |
10/14/1999 |
SEGMENTED VAGINAL APPLICATOR |
MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
FELIX MICK |
K993635 |
10/27/1999 |
MDI SM/RNP TEST |
MICRO DETECT, INC. |
MEHDI ALEM |
K993636 |
10/27/1999 |
MDI SS-A TEST |
MICRO DETECT, INC. |
MEHDI ALEM |
K993575 |
10/21/1999 |
RESOLVE QUICKANCHOR |
MITEK PRODUCTS |
PAULA E BULGER |
K993327 |
10/04/1999 |
TALON ANCHOR SNAP-PAK |
MITEK PRODUCTS |
PAULA E BULGER |
K993477 |
10/14/1999 |
HRW WRIST ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
K993616 |
10/26/1999 |
CARDIO-CARD INTERPRETATION SYSTEM I |
NASIFF ASSOC., INC. |
ROGER E NASIFF |
K993584 |
10/22/1999 |
MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 2 |
NELLCOR PURITAN BENNETT FRANCE DVPT. |
MOUSTAFA ANKI |
K993637 |
10/28/1999 |
N-395 PULSE OXIMETER, WITH EXTENDED DEVICE CLAIMS |
NELLCOR PURITAN BENNETT, INC. |
DAVID A.C. GREEN |
K993654 |
10/29/1999 |
NEUROCOMP |
NEUROCYBERNETICS |
SUSAN D GOLDSTEIN-FALK |
K993643 |
10/28/1999 |
NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100 |
NEXAN TELEMED LTD. |
KENNETH PALMER |
K993600 |
10/25/1999 |
MULTI INTERFERENTIAL STIMULATOR, MODEL TR-841 |
NISHA COMMUNICATION INDUSTRIES |
NISHA JOHARI |
K993595 |
10/25/1999 |
NOBEL BIOCARE'S MODIFIED SURFACE IMPLANT (INTENDED FOR IMMEDIATE LOADING UPON PLACEMENT) |
NOBEL BIOCARE UAS INC |
JEFF HAUSHEER |
K993359 |
10/06/1999 |
RAPTOR TREATMENT PLANNING SYSTEM |
NOMOS CORP. |
WILLIAM O CHISHKO |
K993337 |
10/05/1999 |
APOLLO MULTI-RACIAL REFERENCE POPULATION |
NORLAND MEDICAL SYSTEMS, INC. |
TERRY SCHWALENBERG |
K993344 |
10/05/1999 |
P10 SPECIAL |
NORTH AMERICAN ALLOYS, INC. |
KATHLEEN CALERO |
K993407 |
10/08/1999 |
OHMEDA MEDICAL OMNIBED |
OHMEDA MEDICAL |
ALBERTO F PROFUMO |
K993479 |
10/14/1999 |
OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (100 MICROGRAMS OR LESS) |
OMNIGRACE (THAILAND) LTD. |
K.C. CHOONG |
K993419 |
10/12/1999 |
OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE; POLYMER COATED WITH PROTEIN CLAIM (50 MICROGRAMS OR LESS) |
OMNIGRACE LTD. |
WILLIAM E PATTON |
K993445 |
10/12/1999 |
OMNISONIC ENDOSCOPIC DEFLECTOR |
OMNISONICS MEDICAL TECHNOLOGIES |
DEBBIE IAMPIETRO |
K993628 |
10/27/1999 |
OMNISONICS ULTRASONIC PROBES |
OMNISONICS MEDICAL TECHNOLOGIES |
DEBBIE IAMPIETRO |
K993576 |
10/21/1999 |
BACT/ALERT MP PROCESS BOTTLE |
ORGANON TEKNIKA CORP. |
REBECCA A RIVAS |
K993423 |
10/12/1999 |
BACT/ALERT SA |
ORGANON TEKNIKA CORP. |
REBECCA A RIVAS |
K993421 |
10/12/1999 |
BACT/ALERT SN |
ORGANON TEKNIKA CORP. |
REBECCA A RIVAS |
K993610 |
10/25/1999 |
CYTOPLAST RESORB, MODELS R-250, RP-250, RU-250, RPS-250, RPL-250 |
OSTEOGENICS BIOMEDICAL, INC. |
RICHARD A HAMER |
K993385 |
10/08/1999 |
AUTOJET 2 (NON-FIXED NEEDLE TYPE) |
Owen Mumford USA, Inc. |
ROBERT SHAW |
K993401 |
10/08/1999 |
DRYSPOT E.COLI 0157 KIT |
OXOID, LTD. |
AMANDA SHEPPARD |
K993306 |
10/04/1999 |
NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY) |
PALADIN MEDICAL, INC. |
ELAINE DUNCAN, M.S.M.E., RAC |
K993379 |
10/07/1999 |
PALL SUPOR AEF FILTER |
PALL CORP. |
LEONARD S BERMAN |
K993527 |
10/18/1999 |
LOOP ELECTRODE, BALL ELECTRODE |
PALM MEDICAL USA, INC. |
MARK J KAHN |
K993621 |
10/26/1999 |
HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MIC |
PAMITEX INDUSTRIES SDN BHD |
SAID AWANG |
K993287 |
10/01/1999 |
POWDER FREE (SILICON COATED) LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM |
PAN-CENTURY RUBBER PRODUCTS SDN. BHD. |
H.R.K. MURTHY |
K993486 |
10/15/1999 |
PARAGON LENS CARRIER |
PARAGON VISION SCIENCES |
WILLIAM E MEYERS |
K993487 |
10/15/1999 |
PARAGON LENS VIAL |
PARAGON VISION SCIENCES |
WILLIAM E MEYERS |
K993586 |
10/22/1999 |
SPORTSIGHT GP |
PARAGON VISION SCIENCES |
WILLIAM E MEYERS |
K993406 |
10/08/1999 |
TRAX, POWERED WHEELCHAIR, MODEL 308686-00-0 |
PERMOBIL A.B. |
BENGT PERSSON |
K993388 |
10/08/1999 |
ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F |
PHARMACIA & UPJOHN CO. |
KAREN E MATIS |
K993589 |
10/22/1999 |
VARELISA RNP ANTIBODIES |
PHARMACIA & UPJOHN CO. |
KAREN E MATIS |
K993585 |
10/22/1999 |
VARELISA TPO ANTIBODIES, MODEL 12348/12396 |
PHARMACIA & UPJOHN CO. |
KAREN E MATIS |
K993286 |
10/01/1999 |
PIONEER SILICOAT STERNAL CABLE |
PIONEER SURGICAL TECHNOLOGY |
AMY H MIMMAERTS |
K993558 |
10/20/1999 |
EZFLOW MAX, MODEL 1007 |
PIPER MEDICAL PRODUCTS |
SAMUEL DAVID PIPER |
K993590 |
10/22/1999 |
FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET |
POINTE SCIENTIFIC, INC. |
WILLIAM F WALTERS JR. |
K993564 |
10/21/1999 |
POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002 |
POSSIS MEDICAL, INC. |
TIMOTHY J KAPPERS |
K993298 |
10/01/1999 |
E Z CHAIR |
PREMIER DESIGNS |
CHRIS BERRYHILL |
K993435 |
10/12/1999 |
MANUAL BONE MARROW BIOPSY DEVICE |
PROMEX, INC. |
JOSEPH L MARK |
K993414 |
10/12/1999 |
PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2 |
PRUCKA ENGINEERING, INC. |
MATTHEW W PRUCKA |
K993321 |
10/04/1999 |
R&D HGB/GLC WHOLE BLOOD CONTROL |
R & D SYSTEMS, INC. |
KENNETH T EDDS |
K993594 |
10/25/1999 |
CONFORMAX MMLC VR1 |
RADIONICS, INC. |
NANCY MACDONALD |
K993443 |
10/12/1999 |
RTD ARM ASSISTIVE ROBOTIC DEVICE |
REHABILITATION TECHNOLOGIES DIVISION |
RICHARD M MAHONEY |
K993405 |
10/08/1999 |
REMED MALE DOTTED CONDOM PREVENTOR, LUCKY BOY, SUMMIT |
REMED PHARMA |
E.J. Smith |
K993396 |
10/08/1999 |
REMED MALE EXTRA STRENGTH CONDOM PREVENTOR, LUCKY BOY, SUMMIT |
REMED PHARMA |
E.J. Smith |
K993404 |
10/08/1999 |
REMED MALE LATEX CONDOM (CLASSIC) PREVENTOR, LUCKY BOY, AND SUMMIT |
REMED PHARMA |
E.J. Smith |
K993395 |
10/08/1999 |
REMED MALE LATEX CONDOM (DOUBLE WHOOPER) PREVENTOR, LUCKY BOY AND SUMMIT |
REMED PHARMA |
E.J. Smith |
K993390 |
10/08/1999 |
REMED MALE LATEX CONDOM (SUPER DUPER) PREVENTOR, LUCKY BOY, AND SUMMIT |
REMED PHARMA |
E.J. Smith |
K993408 |
10/08/1999 |
REMED MALE RIBBED CONDOM PREVENTOR, LUCKY BOY SUMMIT |
REMED PHARMA |
E.J. Smith |
K993389 |
10/08/1999 |
REMED MALE TUTTI FRUTTI CONDOM (BANANA), PREVENTOR, LUCKY BOY, SUMMIT |
REMED PHARMA |
E.J. Smith |
K993409 |
10/08/1999 |
REMED MALE TUTTI FRUTTI CONDOM (COCONUT) PREVENTOR, LUCKY BOY, SUMMIT |
REMED PHARMA |
E.J. Smith |
K993403 |
10/08/1999 |
REMED MALE TUTTI FRUTTI CONDOM (STRAWBERRY) PREVENTOR, LUCKY BOY, SUMMIT |
REMED PHARMA |
E.J. Smith |
K993307 |
10/04/1999 |
ARIA LX CPAP SYSTEM |
RESPIRONICS, INC. |
DAVID J VANELLA |
K993433 |
10/12/1999 |
VIRTUOSO LX SMART CPAP SYSTEM |
RESPIRONICS, INC. |
DAVID J VANELLA |
K993535 |
10/19/1999 |
METAPAK MULTI-PURPOSE INSTRUMENT TRAY |
RILEY MEDICAL, INC. |
MARY MCNAMARA-CULLINANE |
K993642 |
10/28/1999 |
ELECSYS PARATHYROID HORMONE CALCHECK |
ROCHE DIAGNOSTICS CORP. |
PRISCILLA A HAMILL |
K993360 |
10/06/1999 |
PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA |
ROCHE DIAGNOSTICS CORP. |
PRISCILLA A HAMILL |
K993426 |
10/12/1999 |
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z44 |
ROSSMAX INTERNATIONAL LTD. |
MICHAEL YEH |
K993542 |
10/19/1999 |
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL V46 |
ROSSMAX INTERNATIONAL LTD. |
MICHAEL YEH |
K993429 |
10/12/1999 |
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z40 |
ROSSMAX INTERNATIONAL LTD. |
MICHAEL YEH |
K993460 |
10/13/1999 |
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z43 |
ROSSMAX INTERNATIONAL LTD. |
MICHAEL YEH |
K993432 |
10/12/1999 |
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z46 |
ROSSMAX INTERNATIONAL LTD. |
MICHAEL YEH |
K993528 |
10/18/1999 |
RUSCH EMERGENCY MASK |
RUSCH, INC. |
RONALD YOUNG |
K993456 |
10/13/1999 |
SAS STREP A TEST |
SA SCIENTIFIC, INC. |
HARBI A SHADFAN |
K993609 |
10/25/1999 |
SOLOGUARD LOCKING PLUS SYRINGE |
SAFEGUARD MEDICAL PRODUCTS, INC. |
PATRICK GRANT |
K993651 |
10/29/1999 |
O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER |
SC HENNIG ENTERPRISES EUROPE SRL |
GEORGE O'NEIL |
K993324 |
10/04/1999 |
CARBOCEM ZINC POLYCARBOXYLATE CEMENT |
SCIENTIFIC PHARMACEUTICALS, INC. |
JAN A ORLOWSKI |
K993501 |
10/15/1999 |
3D1 MICROPOSITIONING HEADSTAGE |
SCIENTIFIC TOOLS, INC. |
T. WHIT ATHEY |
K993326 |
10/04/1999 |
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 |
K993632 |
10/27/1999 |
FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM |
SELFCARE, INC. |
Carol Adiletto |
K993631 |
10/27/1999 |
QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2 |
SERACARE TECHNOLOGY |
RUSTY SEWELL |
K993520 |
10/18/1999 |
H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS |
SERV-A-PURE CO. |
RICHARD C HERZBERGER |
K993425 |
10/12/1999 |
PRIMUS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KATHRYN B DODD |
K993619 |
10/26/1999 |
CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK |
SIMS PORTEX, INC. |
TIMOTHY J TALCOTT |
K993289 |
10/01/1999 |
SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEM |
SMITH & NEPHEW, INC. |
JANET JOHNSON GREEN |
K993580 |
10/22/1999 |
SPECIALTY 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR |
SPECIALTY ULTRAVISION, INC. |
RICHARD LIPPMAN |
K993348 |
10/05/1999 |
NIL, NITRILE EXAMINATION GLOVE - POWDER FREE |
SRI ANUSHAM RUBBER INDUSTRIES PVT., LTD. |
N PARAMASIVAN |
K993347 |
10/05/1999 |
NIL, NITRILE EXAMINATION GLOVE - POWDERED |
SRI ANUSHAM RUBBER INDUSTRIES PVT., LTD. |
N PARAMASIVAN |
K993349 |
10/05/1999 |
NIL, SURGEON'S GLOVE - POWDER FREE |
SRI ANUSHAM RUBBER INDUSTRIES PVT., LTD. |
N PARAMASIVAN |
K993458 |
10/13/1999 |
POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) |
SRI JOHANI SDN. BHD. |
LIM LEE AIK |
K993454 |
10/13/1999 |
POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL CLAIM - 50 MICROGRAMS OR LESS) |
SRI JOHANI SDN. BHD. |
LIM LEE AIK |
K993457 |
10/13/1999 |
POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) [50 MICROGRAMS OR LESS] |
SRI JOHANI SDN. BHD. |
LIM LEE AIK |
K993583 |
10/22/1999 |
ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM |
STRYKER CORP. |
NICOLE PETTY |
K993288 |
10/01/1999 |
SULZER CARBOMEDICS CARDIOFIX PERICARDIUM |
SULZER CARBOMEDICS, INC. |
EDWARD E NEWTON |
K993569 |
10/21/1999 |
APR METASUL ACETABULAR INSERT |
SULZER MEDICA |
MITCHELL A DHORITY |
K993485 |
10/14/1999 |
VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPE |
SUN BIOMEDICAL LABORATORIES, INC. |
MING SUN |
K993492 |
10/15/1999 |
DEVILBISS NEBULIZER MODEL 800 |
SUNRISE MEDICAL HHG, INC. |
FRANK CLEMENTI |
K993328 |
10/04/1999 |
SURGILIGHT, INC EXCIMER LASER |
SURGILIGHT, INC. |
TIMOTHY J SHEA |
K993314 |
10/04/1999 |
SYNTHES LIGHT GUIDE |
SYNTHES (USA) |
JONATHAN GILBERT |
K993335 |
10/04/1999 |
SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM |
SYNTHES (USA) |
SHERI L MUSGNUNG |
K993491 |
10/15/1999 |
QUICKPAC II ONE STEP OPIATES TEST |
SYNTRON BIORESEARCH, INC. |
CLEVE W LAIRD |
K993490 |
10/15/1999 |
QUICKSTRIP ONE STEP OPIATES TEST |
SYNTRON BIORESEARCH, INC. |
CLEVE W LAIRD |
K993562 |
10/21/1999 |
POWDER FREE LATEX STERILE SURGICAL GLOVES |
TG MEDICAL SDN BHD |
T.S. PUON |
K993727 |
10/25/1999 |
BINDAZYME ANTI-DSDNA EIA KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
K993612 |
10/25/1999 |
BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA |
THE BINDING SITE, LTD. |
JAY H GELLER |
K993394 |
10/08/1999 |
ECHO SCAN, EASY SCAN |
TOMTEC IMAGING SYSTEMS, GMBH |
FLORIAN EISENBERGER |
K993398 |
10/08/1999 |
ECHO VIEW, EASY VIEW, OMNI VIEW |
TOMTEC IMAGING SYSTEMS, GMBH |
FLORIAN EISENBERGER |
K993452 |
10/13/1999 |
GREEN POWDERED LATEX EXAMINATION GLOVES |
TOP GLOVE SDN. BHD. |
T.S. PUON |
K993605 |
10/25/1999 |
PEPPER GREEN MINT POWDERED LATEX EXAMINATION GLOVES |
TOP GLOVE SDN. BHD. |
WEE-CHAI LIM |
K993664 |
10/29/1999 |
SYNTHETIC VINYL MEDICAL EXAMINATION POWDERED GLOVES |
TOP GLOVE SDN. BHD. |
WEE-CHAI LIM |
K993574 |
10/21/1999 |
OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON |
TOSHIBA AMERICA MRI, INC. |
KEN NEHMER |
K993316 |
10/04/1999 |
UEDA UDEX SUPER BP-2000 AUTOMATIC BLOOD PRESSURE RECORDING DEVICE |
UEDA AVANCER CORP. |
E.J. Smith |
K993647 |
10/29/1999 |
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 |
K993333 |
10/04/1999 |
CLEARPLAN EASY II HOME PREGNANCY TEST |
UNIPATH LTD. |
Louise Roberts |
K993381 |
10/07/1999 |
TONGUE STABILIZER DEVICE |
UNIVERSITY OF OTAGO |
CHRISTINA M LAJOIE |
K993436 |
10/12/1999 |
CAVERMAP SURGICAL AID |
UROMED CORP. |
FREDERICK TOBIA |
K993599 |
10/25/1999 |
DIAGNOSTIC PRO, MODEL 12772, VXR-16, MODEL 13020, VXR-16 DOSIMETRY PRO, MODEL 13019 |
VIDAR SYSTEMS CORP. |
MARY "PENNIE" DRINKARD |
K993598 |
10/25/1999 |
MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205 |
VIDAR SYSTEMS CORP. |
MARY "PENNIE" DRINKARD |
K993597 |
10/25/1999 |
PLLL, TELERADPRO, MODEL 12714/12715, VXR-12 PLUS, MODEL 8619/9617 |
VIDAR SYSTEMS CORP. |
MARY "PENNIE" DRINKARD |
K993442 |
10/12/1999 |
VYGON LIFECATH-PICC (PUR) CATHETERS (SINGLE AND DOUBLE LUMEN 3FR, 4FR, 4.5FR, AND 5FR) |
VYGON CORP. |
ROBERT SCHIFF |
K993468 |
10/13/1999 |
WAKO L-TYPE GOT TEST |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
K993466 |
10/13/1999 |
WAKO L-TYPE TRIGLYCERIDE TEST |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
K993469 |
10/13/1999 |
WAKO L-TYPE UA F TEST |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
K993342 |
10/05/1999 |
DUCPREP BREAST ASPIRATOR, MODEL PMPO2 |
WINDY HILL TECHNOLOGY, INC. |
ANGELA B SOITO |
K993663 |
10/29/1999 |
FIRST CHECK HOME DRUG TEST (THC) |
WORLDWIDE MEDICAL CORP. |
LARRY R PILOT |
K993371 |
10/07/1999 |
SADDLE SHAPED PATELLA |
WRIGHT MEDICAL TECHNOLOGY, INC. |
LYNNE WITKOWSKI |
K993313 |
10/04/1999 |
COMFIT POWDER FREE BLUE NITRILE EXAMINATION GLOVE, STERILE |
WRP ASIA PACIFIC SDN. BHD. |
YUE WAH CHOW |
K993311 |
10/04/1999 |
COMFIT POWDER FREE NITRILE EXAMINATION GLOVE, STERILE |
WRP ASIA PACIFIC SDN. BHD. |
YUE WAH CHOW |
K993962 |
10/25/1999 |
PENSIL TRAUMA, MODEL WWS6100 |
WUESTEC MEDICAL, INC. |
BRENDA S. D. DAVIS |
K993655 |
10/29/1999 |
MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS |
XOMED, INC. |
MARTIN D SARGENT |
K993653 |
10/29/1999 |
MICRO-FRANCE TROCARS AND ACCESSORIES |
XOMED, INC. |
MARTIN D SARGENT |
K993582 |
10/22/1999 |
MODIFICATION TO LASER-SHIELD II |
XOMED, INC. |
ROY BERENS |
K993424 |
10/12/1999 |
THE TRUE Y CLIP, THE MICRO Y CLIP, THE LAPAROSCOPIC Y CLIP |
Y-CLIP ASSOCIATES |
GEORGE YU |