| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K981647 |
05/11/1998 |
3M DENT II SYSTEM |
3M COMPANY |
LEAL PICKETT |
| K981570 |
05/04/1998 |
AARON 1200 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1200 AARON 1200 HIGH FREQUENCY ELECTROSURGICAL GENERATOR MOD |
AARON MEDICAL INDUSTRIES |
ROB SARON |
| K981614 |
05/06/1998 |
NON-STERILE HOLSTER, STERILE HOLSTER MODEL ESH1-NS, ESH1, ES PENCIL W/ HOLSTER, ES SMOKE & FLUID PENCIL W/ HOLSTER MODEL |
AARON MEDICAL INDUSTRIES |
J.ROBERT SARON |
| K981639 |
05/08/1998 |
SYSTEM U3 FOR CIPROFLOXACIN |
AB BIODISK |
ANNE BOLMSTROM |
| K981892 |
05/29/1998 |
QUICK & SURE ONESTEP HOME PREGNANCY TEST |
ABACUS DIAGNOSTICS |
PAMELA BAGARIA |
| K981758 |
05/19/1998 |
ALBG |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K981814 |
05/22/1998 |
ALBP |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K981806 |
05/21/1998 |
ALKP |
ABBOTT LABORATORIES |
|
| K981706 |
05/14/1998 |
AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2 |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K981653 |
05/11/1998 |
AMY |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K981843 |
05/26/1998 |
AST |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K981578 |
05/04/1998 |
CA |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K981652 |
05/11/1998 |
CHOL |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K981840 |
05/26/1998 |
CO2 |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K981799 |
05/21/1998 |
CREA |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K981580 |
05/04/1998 |
HDL |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K981581 |
05/04/1998 |
IRON |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K981791 |
05/21/1998 |
MG |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K981759 |
05/19/1998 |
PHOS |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K981654 |
05/11/1998 |
TIBC |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K981682 |
05/13/1998 |
UPRO |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K981766 |
05/19/1998 |
URIC ACID |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K981714 |
05/15/1998 |
TIMX LOW BACK SYSTEM TITANIUM MX ROD BASED LOW BACK SYSTEM |
ACROMED CORP. |
MARY LEWIS |
| K981704 |
05/14/1998 |
AUREX-3 |
ADM TRONICS UNLTD, INC. |
JAMES E LENICK |
| K981625 |
05/07/1998 |
STERRAD 50 STERILIZER |
ADVANCED STERILIZATION PRODUCTS |
KEVIN CORRIGAN |
| K981661 |
05/06/1998 |
HEMAPROMPT |
AERSCHER DIAGNOSTICS |
ROBERT SCHREIBER |
| K981564 |
05/01/1998 |
AIR TECHNIQUES' AIRDENT II |
AIR TECHNIQUES, INC. |
JOSEPH CAREY |
| K981574 |
05/04/1998 |
OPTI-FREE EXPRESS MULTI-PURPOSE SOLUTION |
ALCON |
MICHAEL PFLEGER |
| K981561 |
05/01/1998 |
LIQUID ENZYME ID 90133 |
ALCON LABORATORIES |
RALPH H LARSEN |
| K981571 |
05/04/1998 |
MONARCH IOL DELIVERY SYSTEM |
ALCON LABORATORIES |
MARTIN A KAUFMAN |
| K981728 |
05/15/1998 |
ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER H134 |
ALEXANDER MFG. CO. |
KEN HEIMENDINGER |
| K981776 |
05/20/1998 |
ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER MC146X |
ALEXANDER MFG. CO. |
KEN HEIMENDINGER |
| K981818 |
05/22/1998 |
CONVERTORS TRILAMINATE DRAPES |
ALLEGIANCE HEALTHCARE CORP. |
SHARON ROBBINS |
| K981891 |
05/29/1998 |
AMBU TUBECHECK |
AMBU, INC. |
SANJAY H PARIKH |
| K981705 |
05/14/1998 |
'RAPID DRUG SCREEN' 8 PANEL-LOW VOLUME |
AMERICAN BIO MEDICA CORP. |
JOHN B DUBECK |
| K981819 |
05/22/1998 |
ANGIOLAZ VES-1CAM |
ANGIOLAZ, INC. |
JOHN D PLUMADORE |
| K981827 |
05/22/1998 |
VES 0281-M COMPLETE VIDEO ENDOSCOPIC VIDEO SYSTEM |
ANGIOLAZ, INC. |
JOHN D PLUMADORE |
| K981821 |
05/22/1998 |
VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR |
ANGIOLAZ, INC. |
JOHN D PLUMADORE |
| K981782 |
05/20/1998 |
LOW PROFILE PORT ATTACHABLE CATHETER WITH BLUE FLEX TIP / 8FR. INRODUCER KIT IMPLANTABLE VASCULAR ACCESS SYSTEM |
ARROW INTL., INC. |
BRADLEY J ENEGREN |
| K981870 |
05/28/1998 |
VISAGE COSMETIC SURGERY SYSTEM |
ARTHROCARE CORP. |
Mark Smutka |
| K981858 |
05/27/1998 |
ATLANTIS ABUTMENT AND ATLANTIS ABUTMENT SCREW |
ATLANTIS COMPONENTS, INC. |
ANDREW ZIEGLER |
| K981715 |
05/15/1998 |
DISTAL RADIUS FRACTURE FIXATION PLATE |
AVANTA ORTHOPAEDICS, INC. |
LOUISE M FOCHT |
| K981716 |
05/15/1998 |
EXTERNAL FIXATION |
AVANTA ORTHOPAEDICS, INC. |
LOUISE M FOCHT |
| K981823 |
05/22/1998 |
OPERATING ROOM TOWELS |
BALDUR SYSTEMS CORP. |
STEVE WOODY |
| K981792 |
05/21/1998 |
SOLUTION ADMINISTRATION SET |
BAXTER HEALTHCARE CORP. |
MARY ELLEN SNYDER |
| K981797 |
05/21/1998 |
B-D PEN ULTRA |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
PETER ZURLO |
| K981864 |
05/27/1998 |
ACCESS AFP QC ON THE ACCESS IMMUNOASSAY ANALYZER, MODEL NUMBER 33219 |
BECKMAN COULTER, INC. |
ELLEN M VOSS |
| K981638 |
05/08/1998 |
IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT |
BECKMAN COULTER, INC. |
ANNETTE HELLIE |
| K981816 |
05/22/1998 |
CUE AMBULATORY VOLUMETRIC INFUSION PUMP |
BECTON DICKINSON CURLIN, LLC. |
CHARLES J WELLE |
| K981877 |
05/28/1998 |
NITRILE POWDERFREE EXAMINATION GLOVES |
BESGLOVE MEDICARE SDN. BHD. |
LEE AIK LIM |
| K981674 |
05/12/1998 |
POWDERED GREEN NITRILE EXAMINATION GLOVES |
BESGLOVE MEDICARE SDN. BHD. |
LEE A LIM |
| K981879 |
05/28/1998 |
POWDERED NITRILE EXAMINATION GLOVES |
BESGLOVE MEDICARE SDN. BHD. |
LEE AIK LIM |
| K981673 |
05/12/1998 |
POWDERFREE GREEN NITRILE EXAMINATION GLOVES |
BESGLOVE MEDICARE SDN. BHD. |
LEE A LIM |
| K981675 |
05/12/1998 |
POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED) |
BESGLOVE MEDICARE SDN. BHD. |
LEE A LIM |
| K981878 |
05/28/1998 |
POWDERFREE NITRILE EXAMINATION GLOVES (POLYMER COATED) |
BESGLOVE MEDICARE SDN. BHD. |
LEE AIK LIM |
| K981802 |
05/21/1998 |
ZOLL STAT*PADZ ADULT MULTI-FUNCTION ELECTRODES MODEL NUMBER 8900-4003 |
BIO-DETEK, INC. |
MICHAEL R DUPELLE |
| K981888 |
05/29/1998 |
SMOKE-EVAC |
BIO-MEDICAL DEVICES, INC. |
NICK HERBERT |
| K981665 |
05/11/1998 |
SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE |
BIO-MEDICAL SCIENCES, INC. |
MARK E DILLON |
| K981590 |
05/04/1998 |
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C1, LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2, LIQUICHEK URINE TOXICOLOGY CON |
BIO-RAD |
ELIZABETH PLATT |
| K981563 |
05/01/1998 |
BIOPAK MEASUREMENT SYSTEM |
BIO-RESEARCH ASSOCIATES, INC. |
|
| K981624 |
05/07/1998 |
FLO-THRU |
BIO-VASCULAR, INC. |
D.E. GARDNER |
| K981634 |
05/08/1998 |
BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS |
BIOCIRCUITS CORP. |
SHEILA J RAMERMAN |
| K981666 |
05/11/1998 |
2.5 MM LACTOSORB SCREWS |
BIOMET, INC. |
MARY VERSTYNEN |
| K981798 |
05/21/1998 |
LACTOSORB POP RIVET |
BIOMET, INC. |
JULIE K RYAN |
| K981752 |
05/18/1998 |
I-STAT COAGULATION CONTROL SET |
BIOPOOL INTL., INC. |
MICHAEL D BICK |
| K981651 |
05/11/1998 |
AB FLU OIA |
BIOSTAR, INC. |
ROGER C BRIDEN |
| K981824 |
05/22/1998 |
OPTICOAT T3 EIA KIT |
BIOTECX LABORATORIES, INC. |
MOHAN MEHRA |
| K981883 |
05/29/1998 |
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844 |
BOEHRINGER MANNHEIM CORP. |
LUANN OCHS |
| K981669 |
05/12/1998 |
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR |
BOSTON SCIENTIFIC CORP. |
LISA M QUAGLIA |
| K981808 |
05/21/1998 |
BREATHAID TONGUE SCRAPER |
BREATHAID, LLC. |
J. DOUGLAS NUNN, JR. |
| K981660 |
05/11/1998 |
Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters |
C.R. BARD, INC. |
SANDRA PERREAND |
| K981628 |
05/07/1998 |
BARD QUANTUM SVR MODEL NUMBER H-6440VR |
C.R. BARD, INC. |
KAREN HEFFERNAN |
| K981601 |
05/04/1998 |
CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER |
CALIFORNIA MEDICAL LABORATORIES, INC. |
MEHMET BICAKCI |
| K981697 |
05/11/1998 |
CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM |
CAMBRIDGE HEART, INC. |
JOHN D GREENBAUM |
| K981846 |
05/26/1998 |
PARENCHYMAL BOLT PRESSURE MONITORING KIT |
CAMINO NEUROCARE, INC. |
JODY J FLEMING |
| K981556 |
05/01/1998 |
CANON X-RAY DIGITAL CAMERA CXDI-11 |
CANON U.S.A., INC. |
GLENN IMPAL |
| K981779 |
05/20/1998 |
CANTOR & SILVER 5X (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINTED, LAT |
CANTOR & SILVER LTD. |
MARTIN DALSING |
| K981588 |
05/04/1998 |
CARESIDE TOTAL BILIRUBIN |
CARESIDE, INC. |
KENNETH B ASARCH |
| K981568 |
05/01/1998 |
MASCOT MD HEMATOLOGY ANALYZER, MODEL MD 800 |
CDC TECHNOLOGIES, INC. |
GEORGE J WALLACE |
| K981746 |
05/18/1998 |
CELL ROBOTICS' LASETTE |
CELL ROBOTICS, INC. |
CONNIE WHITE |
| K981698 |
05/14/1998 |
ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) |
CHIRON CORP. |
NANCY A HORNBARKER |
| K981592 |
05/04/1998 |
ACS:CENTAUR AFP |
CHIRON DIAGNOSTICS CORP. |
THOMAS F FLYNN |
| K981839 |
05/26/1998 |
ACS:CENTAUR PSA2 IMMUNOASSAY |
CHIRON DIAGNOSTICS CORP. |
William J Pignato |
| K981555 |
05/01/1998 |
DIASCREEN REAGENT STRIPS |
CHRONIMED, INC. |
VICKI FRAWLEY |
| K981611 |
05/06/1998 |
SNAP-N-PEEL INTRODUCERS |
CIRCON CORP. |
RONALD J EHMSEN |
| K981613 |
05/06/1998 |
COBE SMARXT TUBING AND CONNECTORS |
COBE CARDIOVASCULAR, INC. |
LYNNE LEONARD |
| K981804 |
05/21/1998 |
XENON LIGHT SOURCE MODEL LS6000 |
CONTEC MEDICAL VISION, LTD. |
ALBERT E AUSTIN |
| K981589 |
05/04/1998 |
ELECTROSURGICAL BASKET ELECTRODES ELECTROSURGICAL BASKET ELECTRODES |
CONWAY STUART MEDICAL, INC. |
THOMAS WEHMAN |
| K981886 |
05/29/1998 |
VRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER |
COOK, INC. |
APRIL LAVENDER |
| K981709 |
05/04/1998 |
COAGULATION FACTOR V DEFICIENT PLASMA |
DADE BEHRING, INC. |
MARIO A LOWE |
| K981622 |
05/07/1998 |
DADE TRU-LIQUID CARDIAC CONTROL |
DADE BEHRING, INC. |
RICHARD D BLISS, JR. |
| K981582 |
05/04/1998 |
SURGILON, DERMALON, & OPHTHALON |
DAVIS & GECK, INC. |
VANADA JOHNSON |
| K981680 |
05/13/1998 |
ULTRAPURE WATER TREATMENT SYSTEM FOR HEMODIALYSIS |
DAYTON WATER SYSTEMS |
CINDY HELTON |
| K981734 |
05/18/1998 |
VTEC-RPLA SEIKEN |
DENKA SEIKEN'S |
KEVIN MANGAN |
| K981620 |
05/06/1998 |
MTA MATERIAL II |
DENTSPLY INTL. |
JEFFERY P LEHN |
| K981775 |
05/20/1998 |
DEPUY ACE TIMAX CALCANEAL PERI-ARTICULAR PLATE |
DEPUY ACE MEDICAL CO. |
PAUL DONER |
| K981670 |
05/12/1998 |
DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW AND DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW |
DEPUY, INC. |
SALLY FOUST |
| K981609 |
05/05/1998 |
BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30 |
DIAGNOSTIC CHEMICALS LTD. |
KAREN CALLBECK |
| K981872 |
05/28/1998 |
SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40 |
DIAGNOSTIC CHEMICALS LTD. |
KAREN CALLBECK |
| K981607 |
05/05/1998 |
ACTIVE RENIN IRMA MODEL NUMBER DSL-25100 |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
JOHN CLASS |
| K981871 |
05/28/1998 |
C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100 |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
JOHN CLASS |
| K981812 |
05/22/1998 |
EBV-VCA IGG ELISA TEST SYSTEM |
DIAMEDIX CORP. |
NORMAN JENKINS |
| K981831 |
05/22/1998 |
IS EBV-EA-D IGG ELISA TEST SYSTEM |
DIAMEDIX CORP. |
NORMAN JENKINS |
| K981829 |
05/22/1998 |
IS EBV-EBNA-1 IGG ELISA TEST SYSTEM |
DIAMEDIX CORP. |
NORMAN JENKINS |
| K981729 |
05/15/1998 |
IS-RUBELLA IGG TEST SYSTEM |
DIAMEDIX CORP. |
LYNNE STIRLING |
| K981867 |
05/28/1998 |
IS-VZU IGG TEST SYSTEM |
DIAMEDIX CORP. |
LYNN STIRLING |
| DEN980003 |
05/18/1998 |
DIAMOND PROBE/PERIO 2000 SYSTEM |
DIAMOND GENERAL DEVELOPMENT CORP. |
DALE E SEAMON |
| K981567 |
05/01/1998 |
HYBRID CAPTURE II CT/GC TEST |
DIGENE CORP. |
MARK A DEL VECCHIO |
| K981663 |
05/11/1998 |
DIGITAL DOC |
DIGITAL DOC LLC |
W. EDWARD JOHANSEN |
| K981881 |
05/28/1998 |
DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF DRILLING, COCRMO SELF-TAPPING/ SELF DRILLING |
DOCTOR'S RESEARCH GROUP, INC. |
RICHARD DESLAURIERS |
| K981718 |
05/15/1998 |
DORNIER MEDILAS H |
DORNIER SURGICAL PRODUCTS, INC. |
CAROL WERNECKE |
| K981773 |
05/20/1998 |
DRAGER-VAPOR 19.3 |
DRAEGER MEDICAL, INC. |
J. TERESA DORRIETY |
| K981769 |
05/19/1998 |
HICHEM PHOSPHORUS REAGENT KIT |
ELAN PHARMA, INC. |
WYNN STOCKING |
| K981790 |
05/20/1998 |
IVIEW ELECTRONIC PORTAL IMAGING DEVICE (EPID) MODEL NUMBER IVEW |
ELEKTA ONCOLOGY SYSTEMS, LTD. |
PAUL L SUMNER |
| K981800 |
05/21/1998 |
SENTINEL CHOLINESTERASE LIQUID MODEL NUMBER 17.019A & 17.606 |
EQUAL DIAGNOSTICS, INC. |
BRENDA Y KAN |
| K981579 |
05/04/1998 |
ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG |
ETHICON, INC. |
GREGORY R JONES |
| K981813 |
05/22/1998 |
PERMACEM AUTOMIX LUTING CEMENT SYSTEM |
FOREMOST DENTAL MFG., INC. |
AN-SHIH CHENG |
| K981681 |
05/13/1998 |
PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) |
GAMBRO HEALTHCARE |
WILLIAM M TOWNSEND |
| K981693 |
05/13/1998 |
SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25 |
GEBAUER CO. |
DENISE E SPELLMAN |
| K981575 |
05/04/1998 |
TYMPANOSTOMY TUBE |
Grace Medical, Inc. |
ANTHONY D PRESCOTT |
| K981856 |
05/27/1998 |
MAGNA-CAM (MR ENDOSCOPIC CAMERA) AND MAGNA-PIX ( MR COLOR VIDEO MONITOR) |
GREATBATCH SCIENTIFIC |
GARY J SFEIR |
| K981619 |
05/06/1998 |
VACUETTE MULTIPLE SAMPLE LUER ADAPTER |
GREINER MEDITECH, INC. |
DOUGLAS L HARRIS |
| K981861 |
05/13/1998 |
LINER 1:HARD RELINE LIQUID |
HARRY J. BOSWORTH CO. |
MILDRED M GOLDSTEIN |
| K981618 |
05/06/1998 |
LIQUID A |
HARRY J. BOSWORTH CO. |
MILDRED M GOLDSTEIN |
| K981862 |
05/05/1998 |
RESIN 4 |
HARRY J. BOSWORTH CO. |
MILDRED M GOLDSTEIN |
| K981691 |
05/13/1998 |
SILICONE SOFT RELINE |
HARRY J. BOSWORTH CO. |
MILDRED M GOLDSTEIN |
| K981751 |
05/18/1998 |
SINUSCOPE AND ACCESSORIES |
HENKE SASS WOLF OF AMERICA, INC. |
ELLEN J HENKE |
| K981576 |
05/04/1998 |
MULTI-PARAMETER MODULE, MODEL M3000A & DISPLAY UNIT, MODEL M3046A |
HEWLETT-PACKARD GMBH |
EGON PFEIL |
| K981794 |
05/21/1998 |
HICHEM CALCIUM REAGENT KIT |
HICHEM DIAGNOSTICS |
WYNN STOCKING |
| K981781 |
05/20/1998 |
ELECTROSURGICAL UNIT |
HILL-MED, INC. |
ERNESTO ACKERMAN |
| K981876 |
05/28/1998 |
SYNTHETIC EXAMINATION GLOVE, POWDERED |
HSING YI PLASTICS PROCESSING CO, LTD. |
JANNA P TUCKER |
| K981560 |
05/01/1998 |
IMPLEX CONTINUUM KNEE SYSTEM: POROUS TIBIAL COMPONENT MODEL NUMBER 05-230 SYSTEM |
IMPLEX CORP. |
JOHN A SCHALAGO |
| K981631 |
05/07/1998 |
INFLUENCE CLIP SYSTEM |
INFLUENCE, INC. |
JONATHAN S KAHAN |
| K981677 |
05/12/1998 |
REPOSE BONE SCREW SYSTEM |
INFLUENCE, INC. |
JONATHAN S KAHAN, ESQ. |
| K981753 |
05/18/1998 |
INNOVATIVE TECHNOLOGIES TRANSPARENT FILM AND INTELLIGENT FILM WOUND DRESSING |
INNOVATIVE TECHNOLOGIES LTD. |
CHRISTOPHER OAKES |
| K981857 |
05/27/1998 |
QUANTA LITE TPO ELISA |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
| K981721 |
05/15/1998 |
C0-AXIAL INTRODUCER NEEDLE |
INRAD |
ANNE ARMSTRONG |
| K981641 |
05/08/1998 |
MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQ |
INSTRUMENTARIUM CORP. |
MAX LINDERT |
| K981817 |
05/22/1998 |
COAMATIC PLASMIN INHIBITOR |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K981696 |
05/14/1998 |
IL TEST PLASMIN INHIBITOR |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K981591 |
05/04/1998 |
VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT |
INTERNATIONAL REGULATORY CONSULTANTS |
DONALD F GRABARZ |
| K981703 |
05/14/1998 |
KSEA UNIMAT 45 |
KARL STORZ ENDOSCOPY |
KEVIN KENNAN |
| K981615 |
05/06/1998 |
KSEA UROPUMP |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN KENNAN |
| K981737 |
05/18/1998 |
K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60 |
KATECHO, INC. |
LORNE S CHARNBERG |
| K981667 |
05/11/1998 |
HYDROPHILIC COATED GUIDEWIRE |
LAKE REGION MFG., INC. |
KIM E AVES |
| K981767 |
05/19/1998 |
QTEXX POWDERFREE LATEX EXAMINATION GLOVES |
LATEXX PARTNERS BHD. |
GOH S KHEK |
| K981764 |
05/19/1998 |
LM ANCHOR |
LI MEDICAL TECHNOLOGIES, INC. |
RHODEMANN LI |
| K981755 |
05/18/1998 |
LM ANCHOR |
LI MEDICAL TECHNOLOGIES, INC. |
RHODEMANN LI |
| K981636 |
05/08/1998 |
INTEGRATED DRIVE/PUMP SYSTEM |
LINVATEC CORP. |
CAROL A WEIDEMAN |
| K981637 |
05/08/1998 |
INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY |
LINVATEC CORP. |
CAROL A WEIDEMAN |
| K981692 |
05/13/1998 |
MENISCAL REPAIR DEVICE |
LINVATEC CORP. |
CAROL A WEIDEMAN |
| K981893 |
05/29/1998 |
HEALTH + AID PREMIUM PRE-POWDERED LATEX EXAMINATION GLOVES |
M.R.G. INDUSTRIES SDN. BHD. |
SEE KHEK GOH |
| K981772 |
05/19/1998 |
HALOLITE AAD SYSTEM |
MEDIC-AID LTD. |
PAUL E DRYDEN |
| K981845 |
05/26/1998 |
HAWK ANAESTHESIA INDUCTION UNIT |
MEDICAL INDUSTRIAL EQUIPMENT |
HENRY MARSHALL |
| K981598 |
05/04/1998 |
HERNIA MESH STABILIZER |
MEDIVICES CO. |
JOHN BELKNAP |
| K981724 |
05/15/1998 |
O.R.PRO 300 ELECTROSURGICAL GENERATOR MODEL 40001-100 |
MEDTREX, INC. |
WILLIAM E MCKAY |
| K981815 |
05/22/1998 |
HEPTRAC ELECTRONIC QUALITY CONTROL |
MEDTRONIC BLOOD MANAGEMENT |
JOYCE THOMAS |
| K981642 |
05/08/1998 |
STABLEMAPR STEERABLE INTRACARDIAC CATHETERS |
MEDTRONIC CARDIORHYTHM |
KRISTEN HONL |
| K981733 |
05/18/1998 |
DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111 |
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S |
ANN-CHRISTINE JONSSON |
| K981554 |
05/01/1998 |
MICRATOME MS7000 -ADVANCED CORNEAL/REFRACTIVE INSTRUMENTATION (ACRI) |
MICRA INSTRUMENTS LTD. |
JOHN A.K. BASKERVILLE |
| K981796 |
05/21/1998 |
LIGHT SABER CORE TISSUE NEEDLE |
MINRAD, INC. |
THOMAS L PARKER |
| K981741 |
05/18/1998 |
CARRIAZO BARRAQUER MICROKERATOME |
MORIA, INC. |
ALAIN DUPRAT |
| K981742 |
05/18/1998 |
ONE UP DISPOSABLE KERATOME HEAD |
MORIA, INC. |
ALAIN DUPRAT |
| K981837 |
05/26/1998 |
TRX-CG CENTER-OF-GRAVITY SHIFTING POWER TILT AND RECLINE SYSTEMS |
MOTION CONCEPTS |
DAVID HARDING |
| K981828 |
05/22/1998 |
GALILEO DISPOSABLE HYSTEROSCOPES |
NETOPTIX CORP. |
MARY MCNAMARA-CULLINANE, RAC |
| K981702 |
05/14/1998 |
AUTOMATIC DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR MODEL NUMBER WS-300 |
NIHON SEIMITSU SOKKI CO., LTD. |
ROBERT D WAXHAM |
| K981730 |
05/15/1998 |
DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002 |
NK BIOTECHNICAL CORP. |
KAREN GOTFREDSON |
| K981679 |
05/13/1998 |
TCM 3000 AND TCM ENDO |
NOUVAG AG |
MARGIT ESCHBAUMER |
| K981640 |
05/08/1998 |
S2LO |
ODYSSEY OPTICAL SYSTEMS, LLC. |
MAUREEN O'CONNELL |
| K981743 |
05/18/1998 |
OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER |
OLYMPUS AMERICA, INC. |
LAURA STORMS-TYLER |
| K981854 |
05/26/1998 |
OLYMPUS SERUM PROTEIN MULTICALIBRATOR, |
OLYMPUS DIAGNOSTICA GMBH |
LAURA STORMS-TYLER |
| K981725 |
05/15/1998 |
OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700 |
OPTOVENT, INC. |
CLAES RYMOND |
| K981736 |
05/18/1998 |
BACT/ALERT 3D MICROBIAL DETECTION SYSTEM |
ORGANON TEKNIKA CORP. |
REBECCA A RIVAS |
| K981700 |
05/14/1998 |
VASOVIEW DISSECTION/VESSEL HARVESTING SYSTEM |
ORIGIN MEDSYSTEMS, INC. |
CYNTHIA G ROYSTER |
| K981860 |
05/27/1998 |
A P HARNESS |
PARAWORKS ENTERPRISE, LTD. |
MICHAEL C CAMPBELL |
| K981834 |
05/26/1998 |
PERCEPTION INC, GPS-6TBMD DIAGNOSTIC ULTRASOUND SYSTEM |
PERCEPTION, INC. |
JORGE MILLAN |
| K981687 |
05/13/1998 |
QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1 |
PHAMATECH |
CARL A MONGIOVI |
| K981559 |
05/01/1998 |
UNICAP THYROGLOBULIN IGG ASSAY, UNICAP THYROID PEROXIDASE IGG ASSAY |
PHARMACIA & UPJOHN CO. |
KAREN E MATIS |
| K981930 |
05/01/1998 |
UNICAP THYROID PEROXIDASE IGG |
PHARMACIA & UPJOHN CO. |
KAREN E MATIS |
| K981657 |
05/11/1998 |
PHILIPS THORAVISION |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
PETER ALTMAN |
| K981760 |
05/19/1998 |
PLAYTEX SILK GLIDE ODOR ABSORBING FLUSHABLE CARDBOARD TAMPONS #13598 |
PLAYTIME PRODUCTS, INC. |
MARK ROSENGARTEN |
| K981865 |
05/28/1998 |
MTM BIOSCANNER K TEST STRIPS |
POLYMER TECHNOLOGY SYSTEMS, INC. |
MARGO ENRIGHT |
| K981754 |
05/18/1998 |
AUTOMATIC VACUUM SWITCH (AVS) MODEL NUMBER AVS 5000 |
PORTER INSTRUMENT CO., INC. |
STEPHEN D LOEFFLER |
| K981805 |
05/21/1998 |
POS T-7000 |
POS TECHNOLOGIES, INC. |
MICHAEL BRODY |
| K981855 |
05/26/1998 |
PRINCE MEDICAL CEMENT PLUG |
PRINCE MEDICAL, INC. |
MICHAEL PRINCE |
| K981771 |
05/19/1998 |
ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOP |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
| K981801 |
05/21/1998 |
ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
| K981882 |
05/28/1998 |
CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
| K981869 |
05/28/1998 |
PRO-FLEX DISPOSABLE PROPHY ANGLE |
PROFESSIONAL DENTAL MFG., INC. |
BOB ZAHRADNIK |
| K981822 |
05/22/1998 |
DRS SYSTEM |
PROFESSIONAL DISTRIBUTION SYSTEMS, INC. |
DAVID WILLIAMS |
| K981774 |
05/20/1998 |
MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE |
PWA INDUSTRIES SDN. BHD. |
AZMAN ISMAIL |
| K981722 |
05/15/1998 |
QUIDEL HOME PREGNANCY TEST |
QUIDEL CORP. |
E. JOSEPH MCMULLEN |
| K981643 |
05/08/1998 |
RTM DVT PROSOFT CUFF MODEL NUMBER PS100 |
R.T. MEDICAL SERVICES, INC. |
KAREN L DIEHL |
| K981820 |
05/22/1998 |
NEUROMAP |
RADIONICS, INC. |
JEFFREY R MANNION |
| K981597 |
05/04/1998 |
RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITY |
RADIONICS, INC. |
LISA MISTERKA BENATI |
| K981672 |
05/12/1998 |
RADIOTHERAPEUTICS RF-2000 RADIOFREQUENCY GENERATOR |
RADIOTHERAPEUTICS CORP. |
COLIN J NICHOLS |
| K981770 |
05/19/1998 |
RAPIDHCG PREGNANCY TEST |
RAPID DIAGNOSTICS, INC. |
CHARLES YU |
| K981720 |
05/05/1998 |
IQ SYSTEM |
RENAISSANCE TECHNOLOGY, INC. |
PHILIP E HAMSKI |
| K981841 |
05/26/1998 |
BREATHE EASY, MODELS AD AND CD |
RESPIRAID LTD. |
SHOSHANA FRIEDMAN |
| K981558 |
05/01/1998 |
MYCYCLE HANDMASTER, LIGHT |
RICHVALE LTD. |
SUSAN MAYS |
| K981557 |
05/01/1998 |
MYCYCLE, HANDMASTER, VICTORY |
RICHVALE LTD. |
SUSAN MAYS |
| K981844 |
05/26/1998 |
SLEEP MANAGEMENT SYSTEM |
RMP, INC. |
TERRY G MAHN |
| K981584 |
05/04/1998 |
ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT) |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
RITA SMITH |
| K981585 |
05/04/1998 |
ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT) |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
RITA SMITH |
| K981632 |
05/08/1998 |
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT |
ROCHE DIAGNOSTICS/BOEHRINGER MANNHEIM GMBH |
LUANN OCHS |
| K981612 |
05/06/1998 |
ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETER |
ROCHESTER MEDICAL CORP. |
MARY WILEN |
| K981678 |
05/12/1998 |
STRATA, MODEL V.O.95 |
ROSSES MEDICAL SYSTEMS |
RENE SPECTOR |
| K981629 |
05/07/1998 |
NUTRISAFE ENTERAL FEEDING TUBE |
SCHIFF & CO. |
ANNE M CESARIO |
| K981630 |
05/07/1998 |
VYGON DOUBLE LUMEN UMBILICAL CATHETER |
SCHIFF & CO. |
ANNE M CESARIO |
| K981788 |
05/20/1998 |
SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER |
SCIMED LIFE SYSTEMS, INC. |
MELANIE RASKA |
| K981756 |
05/18/1998 |
SHELHIGH NO-REACT PNEUMOPLEDGETS |
SHELHIGH, INC. |
SHLOMO GABBAY |
| K981807 |
05/21/1998 |
CARDIOVISION SOFTWARE, MODEL S-CV5-96 |
SHL TELEMEDICINE INTERNATIONAL LTD. |
ALROY YARIV |
| K981626 |
05/07/1998 |
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
STEVE HESLER |
| K981850 |
05/26/1998 |
SILIMED CHIN IMPLANTS |
SILIMED, LLC. |
E.J. Smith |
| K981835 |
05/26/1998 |
SILIMED MALAR IMPLANT |
SILIMED, LLC. |
E.J. Smith |
| K981833 |
05/26/1998 |
SILIMED NASAL L SHAPED IMPLANT |
SILIMED, LLC. |
E.J. Smith |
| K981851 |
05/26/1998 |
SILIMED SILICONE CARVING BLOCK |
SILIMED, LLC. |
E.J. Smith |
| K981852 |
05/26/1998 |
SILIMED TISSUE EXPANDER |
SILIMED, LLC. |
E.J. Smith |
| K981847 |
05/26/1998 |
BIOLOX ALUMINA CERAMIC FEMORAL HEAD |
SMITH & NEPHEW, INC. |
JOANN KUHNE |
| K981713 |
05/15/1998 |
CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100600, CICANET WOUND CONTACT LAYER DRESSING - 4 X 5 IN. MODEL0 |
SMITH & NEPHEW, INC. |
JIM G IRVIN |
| K981676 |
05/12/1998 |
CD HORIZON SPINAL SYSTEM |
SOFAMOR DANEK USA,INC. |
RICHARD W TREHARNE |
| K981655 |
05/11/1998 |
SPACELABS MEDICAL DISPOSABLE SP02 SENSOR |
SPACELABS MEDICAL, INC. |
NANCY GERTLAR |
| K981717 |
05/15/1998 |
STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR |
STRYKER INSTRUMENTS |
NICOLE PETTY |
| K981562 |
05/01/1998 |
SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI IMPLANT |
SULZER CALCITEK, INC. |
FOSTER BOOP |
| K981602 |
05/05/1998 |
DEVILBISS MODEL 6305D HEAVY DUTY AC ASPIRATOR |
SUNRISE MEDICAL HHG, INC. |
ALLAN R JONES |
| K981885 |
05/29/1998 |
SUNRISE SCOOTER SERIES, MODEL UNASSIGNED, 3 WHEEL STANDARD MODEL, 3 WHEEL MID RANGE MODEL, 3 WHEEL HIGH END MODEL, 4 WHE |
SUNRISE MEDICAL, INC. |
REBECCA ANDERSEN |
| K981747 |
05/18/1998 |
BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX |
SUNSCOPE INTL., INC. |
JOHN SHULZE |
| K981745 |
05/18/1998 |
BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX |
SUNSCOPE INTL., INC. |
JOHN SHULZE |
| K981621 |
05/06/1998 |
ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS |
SURETEX PROPHYLACTICS (INDIA) LTD. |
V V RAMANA RAO |
| K981686 |
05/13/1998 |
STEALTHSTATION SYSTEM DIGITIZER CHANGE |
SURGICAL NAVIGATION TECHNOLOGIES, INC. |
ROGER WHITE |
| K981684 |
05/13/1998 |
STEALTHSTATION TREATMENT GUIDANCE PLATFORM |
SURGICAL NAVIGATION TECHNOLOGIES, INC. |
ROGER N WHITE |
| K981768 |
05/19/1998 |
STEALTHSTATION TREATMENT GUIDANCE PLATFORM |
SURGICAL NAVIGATION TECHNOLOGIES, INC. |
ROGER N WHITE |
| K981809 |
05/21/1998 |
CAROLINE GUIDE |
SURGICAL SOLUTIONS, INC. |
MATTHEW A HOWARD, III |
| K981890 |
05/29/1998 |
SYNTHES (USA) [SYNTHES] MMFS - 2.0 MM SAGITTAL SPLIT PLATES |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K981757 |
05/19/1998 |
SYNTHES (USA) DHS HELIX SYSTEM |
SYNTHES (USA) |
ANGELA J SILVESTRI |
| K981761 |
05/19/1998 |
SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER |
SYSMEX CORP. |
NINA GAMPERLING |
| K981650 |
05/11/1998 |
AST/SGOT LIQUID REAGENT - KINETIC METHOD |
TECO DIAGNOSTICS |
RHODA FILIPINA |
| K981688 |
05/11/1998 |
ANSPACH SUTURE ANCHOR |
THE ANSPACH EFFORT, INC. |
WILLIAM E ANSPACH, III |
| K981644 |
05/08/1998 |
BINDAZYME ANTIGLIADIN IGG |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K981929 |
05/08/1998 |
BINDAZYME ANTIGLIADIN IGG/IGA COMBI KIT |
THE BINDING SITE, LTD. |
JAY GELLER |
| K981783 |
05/20/1998 |
C3 MININEPH ANTISERUM |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K981785 |
05/20/1998 |
C4 MININEPH ANTISERUM |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K981786 |
05/20/1998 |
IGA MININEPH ANTISERUM |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K981784 |
05/20/1998 |
IGM MININEPH ANTISERUM |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K981795 |
05/21/1998 |
CLEANING SOLUTION (1) MODEL NUMBER A943-795, SALT BRIDGE SOLUTION MODEL NUMBER A943-794, CALIBRATION SOLUTION, PH 7.4 MO |
THERMO BIOANALYSIS CORP. |
JANET A MCGRATH |
| K981596 |
05/04/1998 |
ULTRAPAK E |
ULTRADENT PRODUCTS, INC. |
CHESTER MCCOY |
| K981573 |
05/04/1998 |
UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE |
UNITED BIOTECH, INC. |
SHARON SUN |
| K981838 |
05/26/1998 |
ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002 |
UNOTECH DIAGNOSTICS, INC. |
KEN WU |
| K982229 |
05/15/1998 |
BI-DENT |
VALLEY FORGE SCIENTIFIC CORP. |
THOMAS J GILLOWAY |
| K981683 |
05/13/1998 |
HUBER NEEDLE INFUSION SET MODEL #20G01 & Y-SITE MODEL #20G01Y |
VENUSA LTD. |
NEIL KULKARNI |
| K981668 |
05/11/1998 |
SMARTVENT 201 PORTABLE VENTILATOR |
VERSAMED LTD. |
SHOSHANA FRIEDMAN |
| K981645 |
05/08/1998 |
TITANIUM HEMOSTATIC CLIP |
VITALITEC INT'L., INC. |
ELLEN HENKE-KNUPP |
| K981726 |
05/15/1998 |
PERCUSSIVETECH HF, MODEL 2001 |
VORTRAN MEDICAL TECHNOLOGY 1, INC. |
GORDON A WONG |
| K981744 |
05/18/1998 |
COMBINATION TOA WITH NASAL MASK HOLDER AND UNIVERSAL NASAL MASK HOLDER |
W. KEITH THORNTON, D.D.S. |
W.KEITH THORNTON |
| K981859 |
05/27/1998 |
SURGIFLATOR-20 ECU |
W.O.M. WORLD OF MEDICINE, GMBH |
ROBERT P REZNICK |
| K981565 |
05/01/1998 |
BIOCLEAR CONCENTRATE |
WAGGONER PRODUCT DEVELOPMENT |
MARK WAGGONER |
| K981853 |
05/26/1998 |
BONE INJECTION GUN (B.I.G.) DEVICE |
WAISMED LTD. |
AHAVA STEIN |
| K981789 |
05/20/1998 |
LORENZ PECTUS SUPPORT BAR STABILIZER |
WALTER LORENZ SURGICAL, INC. |
DIANE PRESTON |
| K981748 |
05/18/1998 |
WIELISA ANCA SCREENING KIT TEST SYSTEM |
WIESLAB AB |
WILLIAM L BOTELER, JR. |
| K981750 |
05/18/1998 |
WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM |
WIESLAB AB |
WILLIAM L BOTELER JR. |
| K981553 |
05/01/1998 |
AUTOMATED MEDICAL REPORT WRITER |
WOODSON AND ASSOCIATES, LLC. |
GRATTAN WOODSON, III |
| K981889 |
05/29/1998 |
WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE |
WORLDWIDE MEDICAL TECHNOLOGIES, LLC |
GARY A LAMOUREUX |
| K981880 |
05/28/1998 |
DX-480, ADD ON DIGITAL IMAGER |
WUESTEC MEDICAL, INC. |
DAVID ANDRESS |
| K981627 |
05/07/1998 |
PROTEGE II ER: YAG LASER SYSTEM AND ACCESSOIES (UPGRADE) |
XINTEC CORPORATION |
MARILYN M CHOU |
| K981600 |
05/04/1998 |
LATEX EXAMINATION GLOVES BUBBLE GUM FLAVOURED PRE-POWDERED |
YOUNG INNOVATIONS LLC DBA PLAK SMACKER |
JOHN A TAPOCIK |
