| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K914299 |
06/03/1992 |
CARDIAC CATHERIZATION KIT |
ABBOTT LABORATORIES |
FREDERICK GUSTAFSON |
| K915735 |
06/24/1992 |
FLEXIFLO QUANTUM ENT. PUMP SETS AND ENT. NUT. CONT |
ABBOTT LABORATORIES |
DANIEL HAMILTON |
| K921365 |
06/30/1992 |
NUTRIMIX MICROCOMPOUNDER |
ABBOTT LABORATORIES |
FREDERICK GUSTAFSON |
| K921480 |
06/26/1992 |
OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEM |
ACU-MED, INC. |
RANDY HUEBNER |
| K920667 |
06/19/1992 |
GREAT TOE IMPLANT |
ACUMED, INC. |
RANDALL HUEBNER |
| K911916 |
06/18/1992 |
ACUSON C366 TRANSDUCER |
ACUSON CORP. |
SHEILA W PICKERING |
| K921670 |
06/25/1992 |
ACUSON IMAGE MANAGEMENT SYSTEM |
ACUSON CORP. |
SHEILA W PICKERING |
| K915723 |
06/09/1992 |
.10' HI-TORQUE FLOPPY, INTER. & STAND. GUIDE WIRE |
ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
JANE BEGGS |
| K921642 |
06/03/1992 |
AMSEN DOUBLE-ENDED FORAMINAL PROBE |
ADVANCED MED/SURG, INC. |
RONALD C ALLEN |
| K921644 |
06/03/1992 |
AMSEN HOCKEY STICK CHISEL |
ADVANCED MED/SURG, INC. |
RONALD C ALLEN |
| K921643 |
06/03/1992 |
AMSEN POSTERIOR DISC EVACUATOR |
ADVANCED MED/SURG, INC. |
RONALD C ALLEN |
| K921645 |
06/03/1992 |
AMSEN SPINE IMPACTOR INSTRUMENTS |
ADVANCED MED/SURG, INC. |
RONALD C ALLEN |
| K915658 |
06/10/1992 |
SPECTRA ECG |
ADVANCED MEDICAL PRODUCTS, INC. |
KEVIN WORTEL |
| K912925 |
06/18/1992 |
ULTRA PVD |
ADVANCED MEDICAL PRODUCTS, INC. |
DONALD R STONE |
| K914471 |
06/29/1992 |
NEEDLECRIC |
AJS MEDICAL CO., INC. |
JAMES D WEINSTEIN |
| K922010 |
06/19/1992 |
PROSPECT(TM) GIARDIA MICROTITER ASSAY/MODIFICATION |
ALEXON, INC. |
SUSAN TURNER |
| K922338 |
06/11/1992 |
X-330/SPIRIT MOTORIZED THREE-WHEELED SCOOTER |
AM SCOOTERS |
NIELSEN |
| K922707 |
06/19/1992 |
SPUR ADULT WITH OPEN RESERVOIR SYSTEM |
AMBU, INC. |
DAVID LEE |
| K922712 |
06/19/1992 |
SPUR INFANT/CHILD WITH OPEN RESERVOIR SYSTEM |
AMBU, INC. |
DAVID LEE |
| K921665 |
06/09/1992 |
AVK CONTROL I & II |
AMERICAN BIOPRODUCTS CO. |
LOC B LE |
| K922040 |
06/23/1992 |
NEOPLASTINE CI PLUS |
AMERICAN BIOPRODUCTS CO. |
LOC B LE |
| K921684 |
06/09/1992 |
PTT-LA TEST KIT |
AMERICAN BIOPRODUCTS CO. |
LOC B LE |
| K921344 |
06/09/1992 |
THROMBO-CALIBRATOR KIT |
AMERICAN BIOPRODUCTS CO. |
LOC B LE |
| K922021 |
06/09/1992 |
UNICALIBRATOR KIT |
AMERICAN BIOPRODUCTS CO. |
LOC B LE |
| K922348 |
06/09/1992 |
VALTRAC(R) INTRODUCER FORCEP |
AMERICAN CYANAMID CO. |
STEPHEN J TAMSETT |
| K910830 |
06/09/1992 |
INVALIFT |
AMERICAN INVALIFT CORP. |
THERESE RUBINO |
| K922079 |
06/16/1992 |
ROTOLUX, SELECTOLUX, SHUTTERVUE |
AMERICAN MEDICAL SALES, INC. |
DANIEL J GIESBERG |
| K915740 |
06/22/1992 |
DISPOSABLE O.R. TOWEL, STERILE |
AMERICAN THRESHOLD INDUSTRIES, INC. |
ROBERT T BAYER |
| K912471 |
06/26/1992 |
EAGLE 3000 SDS |
AMSCO CO. |
MICHAEL J ZMUDA |
| K915826 |
06/02/1992 |
BIO-POLAR FORCEPS |
APPLIED MEDICAL |
R. W SCHAEFER |
| K922160 |
06/19/1992 |
AQUAMOTION BY FERNO ILLE HYDROTHERAPY POOLS |
AQUAMOTION, INC. |
B. N GOSSETT |
| K911874 |
06/25/1992 |
SLEEPTRACE 2000 |
ARECA SCIENCE CORP. |
KEVIN MCHALE |
| K911065 |
06/18/1992 |
ARROW QUADPOLAR MAPPING/PACING CATHETER |
ARROW INTL., INC. |
THOMAS D NICKEL |
| K914300 |
06/02/1992 |
PHOENIX 5 URODYNAMICS SYSTEM |
ASPEN MEDICAL LTD. |
ROSS K MAXWELL |
| K922422 |
06/10/1992 |
PROGRAMMABLE HEARING SYSTEM, ITE AND BTE TYPES |
AUDIOSCIENCE, INC. |
DON A ORTON |
| K920432 |
06/18/1992 |
BAIR HUGGER CUB BLANKET- SHORT MODEL 536 |
AUGUSTINE MEDICAL, INC. |
SCOTT D AUGUSTINE |
| K921795 |
06/23/1992 |
BACTON(TM), AUTO-APO A-1 REAGENT |
BACTON ASSAY SYSTEMS, INC. |
GEORGE L LIGGINS |
| K921862 |
06/22/1992 |
BACTON(TM), AUTO-APO B REAGENT |
BACTON ASSAY SYSTEMS, INC. |
GEORGE L LIGGINS |
| K921999 |
06/03/1992 |
INTERJET(TM) GINGIVAL CARE INSTRUMENT |
BAUSCH & LOMB, INC. |
STEPHENS |
| K920895 |
06/04/1992 |
DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA |
BAXTER DIAGNOSTICS, INC. |
ALODIA M RUIZ |
| K921703 |
06/04/1992 |
CONTINU-FLO(R) SOLUTION SET |
BAXTER HEALTHCARE CORP. |
MARCIA MARCONI |
| K920258 |
06/26/1992 |
QBC FIBRINOGEN |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
RUSSELL ARNSBERGER |
| K912619 |
06/11/1992 |
BEAR 7 VENTILATOR |
BEAR MEDICAL SYSTEMS, INC. |
LEE ADAIR |
| K922301 |
06/10/1992 |
BELTONE OPERA CLEARVOICE IC, ITC (IN THE CANAL) |
BELTONE ELECTRONICS CORP. |
ROBERT A KRATOCHVIL |
| K920761 |
06/19/1992 |
URINE CULTUR STABILIZATION TRANSPORT TUBE |
BIO MEDICUS, INC. |
GEPPERT SR. |
| K920264 |
06/02/1992 |
BIO-DETEK TRACERITE EEG ELECTRODE |
BIO-DETEK, INC. |
MICHAEL R DUPELLE |
| K921286 |
06/09/1992 |
LIQUICHEK LIPIDS CONTROL LEVELS 1 AND 2 |
BIO-RAD |
DONNA CHAPMAN |
| K922602 |
06/19/1992 |
CABLE COLUMN WEIGHT SYSTEM MODEL #940-200 |
BIODAN MEDICAL SYSTEMS, LTD. |
CLYDE SCHLEIN |
| K922606 |
06/19/1992 |
MULTI JOINT WEIGHT SYSTEM MODEL #940-100 |
BIODAN MEDICAL SYSTEMS, LTD. |
CYLDE SCHLEIN |
| K922603 |
06/19/1992 |
TOTAL WORK INTEGRATOR, MODEL #940-110 |
BIODAN MEDICAL SYSTEMS, LTD. |
CLYDE SCHLEIN |
| K921816 |
06/18/1992 |
VITEK IMMUN ASSAY SYS(VIDAS) THYROI STIM HOR ASSAY |
BIOMERIEUX VITEK, INC. |
VICKI ANASTASI |
| K921746 |
06/16/1992 |
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM |
BIOMERIEUX VITEK, INC. |
VICKI ANASTASI |
| K920640 |
06/30/1992 |
FULL HEMISPHERE RING-LOC LINER |
BIOMET, INC. |
DUTCH HARRISON |
| K920800 |
06/30/1992 |
INTEGRATED ENDOSCOPY SYSTEM 1000 |
BIOMET, INC. |
PATRICIA S BERES |
| K920639 |
06/30/1992 |
RX 90 ACETABULAR COMPONENT SYSTEM |
BIOMET, INC. |
DUTCH HARRISON |
| K922386 |
06/26/1992 |
RNA MEDICAL TONOMETER |
BIONOSTICS, INC. |
BRUCE R WILLIAMS |
| K922357 |
06/30/1992 |
RNA MEDICAL'S EQUIL 55 |
BIONOSTICS, INC. |
BRUCE R WILLIAMS |
| K915761 |
06/29/1992 |
BIVONA-COLORADO VOICE PROSTHESIS |
BIVONA MEDICAL TECHNOLOGIES |
HARRY KAUFMAN |
| K921661 |
06/30/1992 |
BOEHRINGER MANNHEIM/ HITACHI 911 ANALYZER |
BOEHRINGER MANNHEIM CORP. |
JOHN STEVENS |
| K922401 |
06/10/1992 |
4 SURE TM COLOSTOMY POUCH |
BOSTON PACIFIC MEDICAL, INC. |
RANDALL GREEN |
| K914945 |
06/26/1992 |
DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED |
BRUEL & KJAER INDUSTRI A/S |
AAGE RUBY |
| K920539 |
06/30/1992 |
ORWO X-RAY FILM |
BURKHART ROENTGEN INTL., INC. |
NORMAN JACKVONY |
| K920062 |
06/05/1992 |
CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LAS. |
CANDELA LASER CORP. |
THOMAS VARRICCHIONE |
| K921038 |
06/04/1992 |
ECLIPSE 2100 |
CARDIOGENES |
MURPHY-CHUTORIAN |
| K922172 |
06/11/1992 |
MODEL # 230 ST STEALTH-TRODE DEFIB PADS (STERILE) |
CARDIOTRONICS, INC. |
TIM J WAY |
| K922173 |
06/11/1992 |
MODEL # 830 ST ADULT STIMULATION PADS (STERILE) |
CARDIOTRONICS, INC. |
TIM J WAY |
| K922227 |
06/11/1992 |
MODEL #225-ST SHOCK-TRODE ADULT DEFIB PADS STERILE |
CARDIOTRONICS, INC. |
TIM J WAY |
| K921148 |
06/16/1992 |
CVIS INSIGHT CATHETERS FOR INTRACARDIAC USE |
CARDIOVASCULAR IMAGING SYSTEMS, INC. |
STAN TILLMAN |
| K921147 |
06/16/1992 |
CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL USE |
CARDIOVASCULAR IMAGING SYSTEMS, INC. |
STAN TILLMAN |
| K921469 |
06/25/1992 |
OSTEOGRAF/N-700 NATURAL HYDROXYLAPATITE 18-40 MESH |
CERAMED CORP. |
BARBARA A WATSON |
| K921728 |
06/09/1992 |
DEXSOL CORNEAL STORAGE MEDIA CONTAINER, MODIFIED |
CHIRON INTRAOPTICS |
CAROL L PATTERSON |
| K921729 |
06/09/1992 |
OPTISOL CORNEAL STORAGE MEDIA CONTAINER/MODIFIED |
CHIRON INTRAOPTICS |
CAROL L PATTERSON |
| K921607 |
06/30/1992 |
IOLAB REUSABLE PERISTATIC CASSETTE/OPHTHALMIC USE |
CHIRON VISION CORP. |
JAMES K MCCRACKEN |
| K922077 |
06/23/1992 |
MODIFIED SITE POWER HANDPIECE |
CHIRON VISION CORP. |
BRNT MILLER |
| K922612 |
06/24/1992 |
CHOLESTECH LIPID MONITORING SYSTEM, TOTAL CHOLESTE |
CHOLESTECH CORP. |
GARY HEWETT |
| K921678 |
06/09/1992 |
CIBA CORNING ACS FOLATE IMMUNOASSAY |
CIBA CORNING DIAGNOSTICS CORP. |
WILLIAM J PIGNATO |
| K921704 |
06/09/1992 |
IMMULITE(R) FSH |
CIRRUS DIAGNOSTICS, INC. |
DI TULLIO |
| K921353 |
06/11/1992 |
NASOPHARYNGEAL AIRWAY |
COAST MEDICAL CORP. |
DOYGLAS R MONGEON |
| K915204 |
06/04/1992 |
MULTI USE LAPAROSCOPY ELECTROSURGICAL INSTRUMENT |
CONMED CORP. |
FORTE, JR. |
| K921820 |
06/16/1992 |
RENAMEL ESTHETIC RESTORATIVE SYSTEM, MODIFICATION |
COSMEDENT, INC. |
MICHAEL O'MALLEY |
| K920779 |
06/03/1992 |
FAST-CATH HEMOSTASIS INTRODUCER |
DAIG CORP. |
JOHN J FLEISCHHACKE |
| K920659 |
06/05/1992 |
DAVOL ENDO-FLO LASER PROBE AND ACCESSORIES |
DAVOL, INC. |
ROBIN M DRAGO |
| K921479 |
06/22/1992 |
DUCERATIN/DUCERAM LFC DENTAL PORCELAIN |
DEGUSSA AG |
HOLGER MEINICKE |
| K922380 |
06/16/1992 |
BITE RIM WAX |
DENTSPLY INTL. |
JEFFERY LEHN |
| K921232 |
06/09/1992 |
KEANE UNI KNEE SYSTEM WITH POROCOAT |
DEPUY, INC. |
DAVID A KOTKOVETZ |
| K914746 |
06/17/1992 |
DERMAGRAN WET DRESSING |
DERMA SCIENCES, INC. |
MARY G CLARK |
| K921614 |
06/25/1992 |
MILENIA FOLIC ACID |
DIAGNOSTIC PRODUCTS CORP. |
KENNETH B ASARCH |
| K915342 |
06/10/1992 |
UD 2000 VIDEO OPTION |
DIAGNOSTIC ULTRASOUND CORP. |
GERALD MCMORROW |
| K921583 |
06/19/1992 |
DRYSLIDE(TM), PYR |
DIFCO LABORATORIES, INC. |
DAVID W GATES |
| K920788 |
06/04/1992 |
BLOOD ADMINISTRATION SET |
DOUGLAS MEDICAL PRODUCTS CORP. |
DOUGLAS JOHNSON |
| K921128 |
06/02/1992 |
ENDOTRACHEAL TUBE STYLET |
EASTMED ENTERPRISES INC. |
RATHIN PUTATUNDA |
| K915378 |
06/29/1992 |
WECK TROCAR |
EDWARD WECK, INC. |
GLENN MATTEI |
| K921250 |
06/04/1992 |
SYNELISA CARDIOLIPIN ANTIBODIES |
ELIAS USA, INC. |
GOTTFRIED KELLERMANN |
| K915679 |
06/24/1992 |
EXCEL DUOPAULSE MODEL 2000 |
EXCEL TECH. LTD. |
RAMA RAO |
| K920875 |
06/16/1992 |
PROLONGED OCCLUSION DRESSING I |
FERNDAL LABORATORIES |
DONALD R STONE |
| K920874 |
06/16/1992 |
PROLONGED OCCLUSION DRESSING II |
FERNDAL LABORATORIES |
DONALD R STONE |
| K913367 |
06/25/1992 |
MODELS MR410 & MR480 RESPIRATORY HUMIDIFIER/ACCESS |
FISHER & PAYKEL ELECTRONICS LTD. |
RICHARD BELGRAVE |
| K915739 |
06/30/1992 |
#903 SILAFLEX II |
FLENTS PRODUCTS CO., INC. |
PETER C KOHN |
| K920789 |
06/25/1992 |
B3000/B3000M MAGNETIC RESONANCE IMAGING SCANNER |
FONAR CORP. |
ANTHONY GIAMBALVO |
| K914846 |
06/19/1992 |
CD2 MONOCLONAL ANTIBODIES |
GEN TRAK, INC. |
DEBORAH L.LINDEMUTH |
| K914848 |
06/19/1992 |
CD4 MONOCLONAL ANTIBODIES |
GEN TRAK, INC. |
DEBORAH L.LINDMOUTH |
| K914847 |
06/19/1992 |
CD8 MONOCLONAL ANTIBODIES |
GEN TRAK, INC. |
DEBORAH L.LINDMOUTH |
| K914588 |
06/11/1992 |
GRIESHABER SNARE INSTRUMENT AND SNARE CARTRIDGE |
GRIESHABER & CO. |
JOHN E RICHMOND |
| K920719 |
06/29/1992 |
IVOS ANALYZER |
HAMILTON THORNE RESEARCH |
DOUGLAS-HAMILTON |
| K921363 |
06/09/1992 |
CASCADE 480 |
HELENA LABORATORIES |
PAT FRANKS |
| K921465 |
06/29/1992 |
CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V) |
HELENA LABORATORIES |
PAT FRANKS |
| K921305 |
06/09/1992 |
GLYCO-TEK AFFINITY COLUMN KIT |
HELENA LABORATORIES |
PAT FRANKS |
| K920927 |
06/19/1992 |
KEMTROL SERUM CONTROL-NORMAL CAT NO. 7024 |
HELENA LABORATORIES |
PAT FRANKS |
| K915786 |
06/30/1992 |
BLOM-SINGER HUMID/FIL SYST INHEALTH IN-LINE HUMID. |
HELIX MEDICAL, INC. |
CHRISTINE EMANUEL |
| K921701 |
06/09/1992 |
DURAFILL BOND |
HERAEUS KULZER, INC. |
SHARON PARKER |
| K915578 |
06/15/1992 |
ND;YAG SURGICAL LASER SYSTEMS |
HERAEUS LASERSONICS, INC. |
ROBERT MILDER |
| K921807 |
06/18/1992 |
ULTRALINE STERILE DISPOSABLE FIBER |
HERAEUS LASERSONICS, INC. |
ROBERT MILDER |
| K915437 |
06/11/1992 |
CRITICAL CARE HOSPITAL BED (ICU/CCU) |
HILL-ROM, INC. |
FORD WILDER |
| K921384 |
06/25/1992 |
PCA ACETABULAR INSERT II |
HOWMEDICA CORP. |
DENISE E MURPHY |
| K921383 |
06/25/1992 |
PRECISION STRATA TOTAL HIP STEM |
HOWMEDICA CORP. |
MARY C SPICER |
| K915086 |
06/17/1992 |
HPI BROWN NITRILE SENSI-GRIP SURGICAL GLOVES |
HPI, INC. |
CAROL ESSARY |
| K921763 |
06/09/1992 |
TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY |
HYBRITECH, INC. |
JOANNE MARTINIS |
| K915646 |
06/15/1992 |
VIVUS 50 AND VIVUS 100 PERSONAL INFUSER |
I-FLOW CORP. |
ROBERT BARD |
| K920608 |
06/19/1992 |
AMERICA SYSTEM |
I. KLIMOV CO. |
GRICHENER |
| K914416 |
06/23/1992 |
BREATH-EASY, MODIFICATION |
ICOR AB |
ANDRAS GEDEON |
| K921527 |
06/24/1992 |
STATVIEW |
IMAGE DATA CORP. |
LARRY BUERK |
| K921378 |
06/09/1992 |
IMED MODEL PC-4 VOLUMETRIC INFUSION PUMP/CONTROLLE |
IMED CORP. |
RALPH JARBOE |
| K915662 |
06/25/1992 |
BARRIER INTEGRITY MONITOR |
INCOMED, INC. |
ROBERT L DONNELL |
| K911804 |
06/11/1992 |
INFRASONICS VENTILATOR "ADULT STAR", MODIFICATION |
INFRASONICS CORP. |
JIM HITCHIN |
| K920007 |
06/16/1992 |
IL TEST COMPLEMENT 3 |
INSTRUMENTATION LABORATORY CO. |
MURACA, JR. |
| K920014 |
06/16/1992 |
IL TEST IMMUNOGLOBULIN A |
INSTRUMENTATION LABORATORY CO. |
MURACA, JR. |
| K920373 |
06/24/1992 |
MAESTRO DIGITAL VIDEO SYSTEM |
INTERNATIONAL IMAGING ELECTRONICS |
JOHN MIERS |
| K921246 |
06/22/1992 |
IMZ SURGICAL INSTRUMENT TRAY |
INTERPORE INTL. |
WILLIAM FRANKLIN |
| K921511 |
06/17/1992 |
CATHETER MOUNTS -- MODIFICATION |
INTERSURGICAL, INC. |
THOMAS R GUNERMAN |
| K921512 |
06/17/1992 |
ENTENDED LINE ACCESSORIES & CONNECTORS |
INTERSURGICAL, INC. |
THOMAS R GUNERMAN |
| K921624 |
06/30/1992 |
DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITS |
INTERTECH RESOURCES, INC. |
ALYCE P MARSHALL |
| K915625 |
06/03/1992 |
INTRODUCER CATHETER |
INTERVENTIONAL THERAPEUTICS CORP. |
LUANNE TERMEER |
| K922203 |
06/03/1992 |
IPT CAPSULE MIXER |
IPT TECHNOLOGIES, INC. |
INGOLF V JANERUS |
| K922185 |
06/11/1992 |
JACE KNEE EXTENSION SYSTEM -- MODIFICATION |
JACE SYSTEMS, INC. |
RICK ROSATI |
| K921562 |
06/22/1992 |
JOBST EXTREMITY PUMP SYSTEM 7500 |
JOBST INSTITUTE, INC. |
ANGELO R PEREIRA |
| K921710 |
06/29/1992 |
MOVIT DEVICE |
JOHN J. NAVAR, M.D. |
|
| K914698 |
06/05/1992 |
SETUP COMPUTER WITH SOFTWARE V-1261,62 AND 63 |
K.S., INC. |
VIVIAN DENTON |
| K915328 |
06/29/1992 |
GEL-TAC |
KATECHO, INC. |
LORNE SCHARNBERG |
| K915776 |
06/11/1992 |
KNEE PROSTHESIS DRIVER |
KIM-MED, INC. |
WILLIAM W BOHN |
| K922109 |
06/04/1992 |
KING DIAGNOSTICS ALT (GPT) REAGENT |
KING DIAGNOSTICS, INC. |
FRANCES LOH |
| K920207 |
06/09/1992 |
HERMLE Z230H |
LABNET INTL., INC. |
WALTER DEMSIA |
| K915631 |
06/15/1992 |
LPI ML 100/532 AND ML 532 SURGICAL LASER |
LASER PHOTONICS, INC. |
ROBERT ANSELMO |
| K921380 |
06/25/1992 |
LASERSCOPE'S DISPOSABLE LAPAROSTAT W/ FIBER DIVER |
LASERSCOPE |
DONNA PAGE |
| K904385 |
06/10/1992 |
JANUS ATAC ENG ANALYSIS SYSTEM |
LIFE-TECH INTL., INC. |
ALFRED COATS |
| K920471 |
06/23/1992 |
LEVY ARTICULATING RETRACTOR |
LIFEGUARD MEDICAL PRODUCTS, INC. |
DOUGLAS HULFISH |
| K910447 |
06/09/1992 |
DURA MATER |
LIFELINK FOUNDATION TISSUE BANK |
DAVE SHIRES |
| K922253 |
06/19/1992 |
KERATOREF L60 |
LUNEAU OPHTALMOLOGIE SA |
JEAN-NOEL YOUNG |
| K921214 |
06/11/1992 |
OPHTHALMIC PROJECTOR |
LUNEAU OPHTALMOLOGIE SA |
YOUNG |
| K921402 |
06/04/1992 |
SURGICAL INSTRUMENT, DISPOSABLE |
MACRO MEDICAL, INC. |
SHERRY MCPHILLIPS |
| K921316 |
06/22/1992 |
MG-1001 TUBE HOUSING ASSEMBLY |
MAGMA CORP. |
MICHAEL RINGART |
| K920127 |
06/10/1992 |
ELECTROENCEPHALOGRAPH RECORDING SYSTEM |
MEDELEC INTL. CORP. |
HOLLOWAY |
| K921418 |
06/19/1992 |
ULTRA-CORE BIOPSY NEEDLES |
MEDICAL DEVICE TECHNOLOGIES, INC. |
PAUL BAKER |
| K915694 |
06/18/1992 |
MEDITRON ELECTRONIC LAPAROSCOPIC INSUFFLATOR |
MEDICAL DEVICES, INC. |
SAMUEL DICKSTEIN |
| K921556 |
06/29/1992 |
MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM |
MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. |
DAVID A WALL |
| K913320 |
06/16/1992 |
MIL CM-II COAGULATION MACHINE |
MEDICAL INNOVATIONS CORP. |
RAYMOND CHAN |
| K921876 |
06/25/1992 |
MKS BEAM OUTLINE PROJECTOR |
MEDICAL KNOWLEDGE SYSTEMS, INC. |
DON P RAGAN |
| K921700 |
06/29/1992 |
TSH ENZYME IMMUNOASSAY TEST KIT CAT. NO. KIF4093 |
MEDIX BIOTECH, INC. |
JOHN CHEN |
| K915351 |
06/29/1992 |
SHERPA GUIDING CATHETER WITH CATHETER INTRODUCER |
MEDTRONICS INTERVENTIONAL VASCULAR |
KIRK DALY |
| K912904 |
06/11/1992 |
MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM |
MENTOR O & O, INC. |
RICHARD L FOLLETT |
| K914998 |
06/02/1992 |
MICROAIRE(R) FACIAL BONE PLATING SYSTEM |
MICRO SURGICAL INSTRUMENTS CORP. |
MOE KHOSRAVI |
| K912565 |
06/11/1992 |
MICRO-COLL COLLAGEN WOUND SPRAY |
MICRO-COLL |
VINAY K SHARMA |
| K920318 |
06/04/1992 |
CEDIA FERRITIN ASSAY |
MICROGENICS CORP. |
PATRICIA M.KLIMLEY |
| K921689 |
06/16/1992 |
CEDIA RED BLOOD CELL FOLATE REAGENT PACK |
MICROGENICS CORP. |
PATRICIA M KLIMLEY |
| K921873 |
06/09/1992 |
QUICKANCHOR, MODIFICATION |
MITEK SURGICAL PRODUCTS, INC. |
ROBERT P ZOLETTI |
| K921568 |
06/09/1992 |
ORS-100 |
MNLASE, INC. |
BRUCE HEYMANN |
| K921569 |
06/09/1992 |
ORS-200 |
MNLASE, INC. |
BRUCE HEYMANN |
| K921633 |
06/02/1992 |
ORS-2000 SERIES |
MNLASE, INC. |
BRUCE HEYMANN |
| K921570 |
06/09/1992 |
ORS-300 |
MNLASE, INC. |
BRUCE HEYMANN |
| K922305 |
06/19/1992 |
COYOTE ELECTRIC SCOOTER-3WHEELED |
MOBILITY MFG. CO. |
ROBERT MAGINEL |
| K922304 |
06/19/1992 |
ROADRUNNER ELECTRIC SCOOTER-3 WHEELED |
MOBILITY MFG. CO. |
ROBERT MAGINEL |
| K915279 |
06/10/1992 |
NEOPROBE PORTABLE RADIOSCOPE DETECTOR |
NEOPROBE CORP. |
ROGER P.KAMINSKI |
| K920764 |
06/25/1992 |
SUNGLASSES AND EYEGLASS FRAMES |
NEW OPTIC SRL |
PHILIPPE RADLEY |
| K913324 |
06/22/1992 |
MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT |
NEWARD ENTERPRISES, INC. |
JOHN T MURRAY |
| K910077 |
06/02/1992 |
CRIT-SCAN |
NONINVASIVE MEDICAL TECHNOLOGY CORP. |
ROBERT R STEUER |
| K915078 |
06/10/1992 |
MORSE HEMOSTATIC CATHETER INTRODUCER SET |
NORTH AMERICAN INSTRUMENT CORP. |
JAMES WELSH |
| K915051 |
06/04/1992 |
MODIFICATION MODEL 7201 INSUFFLATOR |
NORTHGATE TECHNOLOGIES, INC. |
PETER A MANZIE |
| K914517 |
06/30/1992 |
SD-200IEHL(TM) |
NORTHGATE TECHNOLOGIES, INC. |
SCOTT K GILCHRIST |
| K915375 |
06/03/1992 |
ODONTIT OSSEOINTEGRATED IMPLANTS SYSTEM |
ODONTIT SYSTEME |
NEAL DUNNING |
| K914784 |
06/05/1992 |
PAPILLION PROCTOSCOPE |
OLDELFT CORP. OF AMERICA |
CHARLES PATTIE |
| K920423 |
06/11/1992 |
OLYMPIC SMART SCALE CARE CENTER |
OLYMPIC MEDICAL CORP. |
JOSEPH P STEFANILE |
| K922220 |
06/25/1992 |
OLYMPUS AU5200 CLINICAL CHEMISTRY ANALYZER |
OLYMPUS CORP. |
LAURA STORMS-TYLER |
| K920942 |
06/10/1992 |
OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZER |
OLYMPUS CORP. |
LAURA STORMS-TYLER |
| K922230 |
06/25/1992 |
OLYMPUS GGT REAGENT |
OLYMPUS CORP. |
LAURA STORMS-TYLER |
| K915116 |
06/12/1992 |
TROCAR SHEATH ANCHOR |
ORIGIN MEDSYSTEMS, INC. |
RICHARD RUSH |
| K920412 |
06/22/1992 |
MODIFIED ORTHO EBV VCA-IGG ELISA |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
KIN W GRAY |
| K915890 |
06/24/1992 |
AUTOCLAVABLE THERA-MIST HUMIDIFIER P3600, MODIFIED |
PEGASUS RESEARCH CORP. |
WILLIAM BURKE |
| K921438 |
06/23/1992 |
DISPOSABLE LATEX EXAMINATION GLOVES |
PERLINK USA, INC. |
KANWAR |
| K920831 |
06/10/1992 |
PCA TOTAL HIP SYSTEM (CEMENTLESS USE) |
PFIZER HOSPITAL PRODUCTS GROUP, INC. |
ROBERT SMITH |
| K912067 |
06/16/1992 |
POLARIS, GYNECOLOGY INDICATIONS |
PFIZER LASER SYSTEMS |
COLETTE COZEAN |
| K921609 |
06/15/1992 |
VISTA HP/HPQ SYSTEM |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ELAINE K KEELER |
| K920686 |
06/11/1992 |
ORTHO-PLEX-REHABILITATION SYSTEM |
PLEXUS INTL., INC. |
CARL H DUKE |
| K915773 |
06/24/1992 |
P-300 CAPNOGRAPH AND PULSE OXIMETER |
PRYON CORP. |
SANDRA L SCHICK |
| K920501 |
06/02/1992 |
SILCLAMPS DEGANIA SILICONE |
PURITAS HEALTH CARE, INC. |
ARCOVIO, JR. |
| K912462 |
06/04/1992 |
Q-MS NEUROMUSCULAR STIMULATOR |
QUANTITATIVE MEDICINE, INC. |
YORK MCGAVIN |
| K913267 |
06/05/1992 |
R-GROUP INTL. ONE WALL PUNCTURE NEEDLE |
R-GROUP INTL. |
MARK J KAHN |
| K921323 |
06/03/1992 |
CERVICAL PASSIVE MOTION |
REHABILITATIVE RESOURCES, INC. |
ERNIE RIDDLE |
| K920974 |
06/19/1992 |
BACTIDROP ACRIDINE ORANGE |
REMEL CO. |
ANN SILVIUS |
| K920975 |
06/09/1992 |
BACTIDROP CALCOFLUOR WHITE |
REMEL CO. |
ANN SILVIUS |
| K920976 |
06/09/1992 |
BACTIDROP INDIA INK |
REMEL CO. |
ANN SILVIUS |
| K920973 |
06/19/1992 |
BACTIDROP INDOLE (ERLICH'S) |
REMEL CO. |
ANN SILVIUS |
| K920970 |
06/09/1992 |
BACTIDROP KOH (10%) |
REMEL CO. |
ANN SILVIUS |
| K920143 |
06/09/1992 |
TB SUSCEPTIBILITY QUADS I AND II |
REMEL CO. |
ANN SILVIUS |
| K920254 |
06/22/1992 |
COILS FOR RX4000 & RX5000 MRI SYSTEMS |
RESONEX, INC. |
BRUNCE FLOYD |
| K921510 |
06/11/1992 |
GAS SAMPLING KIT MODIFICATION |
RESPIRATORY SUPPORT PRODUCTS, INC. |
ANTHONY V BERAN |
| K922371 |
06/04/1992 |
SPINAL POSITIONING FRAME |
RHINO MFG. |
SHANE FISK |
| K920829 |
06/19/1992 |
COBAS CORE FERRITIN EIA |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
CAROL L KRIEGER |
| K922043 |
06/16/1992 |
ROCHE CALIBRATOR SERUM |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
CAROL L KRIEGER |
| K914459 |
06/24/1992 |
AUTOMATIC TUBING CLAMP |
ROCKY MOUNTAIN RESEARCH, INC. |
THERESE DAVY |
| K912183 |
06/23/1992 |
TYPE 9050/NEO |
S & W MEDICO TEKNIK |
LISBETH ISBRANDT |
| K914327 |
06/09/1992 |
SEROELISA(TM) CHLAMYDIA IGA TEST KIT |
SAVYON DIAGNOSTICS, LTD. |
YAKIR |
| K921943 |
06/17/1992 |
SCHNEIDER MONORAIL 421 PERCU TRANS ANGIO (PTA) BAL |
SCHNEIDER INTL., LTD. |
ROBERT L ULLEN |
| K914194 |
06/09/1992 |
SCIMED(R) CONTROLWIRE(TM) GUIDE WIRE |
SCIMED LIFE SYSTEMS, INC. |
DARLENE A THOMETZ |
| K921376 |
06/15/1992 |
PATIENT EXAMINATION GLOVES |
SEAL POLYMER INDUSTRIES BHD. |
K. Y CHEAH |
| K921834 |
06/15/1992 |
AUTOMATES COMA COCAINE METABOLITE ASSAY |
SEREX, INC. |
VICTOR LEE-OWN |
| K921146 |
06/08/1992 |
SHARPLAN CO2 SURG. LASER, MO. 1039 SURGICENTER 40 |
SHARPLAN LASERS, INC. |
DOUGLASS MEAD |
| K921183 |
06/19/1992 |
DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT |
SHIELD DIAGNOSTICS, LTD. |
GEORGE ZAJICEK |
| K922011 |
06/10/1992 |
SHIMADZU IMAGE AMPLIFIER IA-12VDA SERIES |
SHIMADZU MEDICAL SYSTEMS |
DE MINT |
| K922013 |
06/10/1992 |
SHIMADZU IMAGE AMPLIFIER IA-12VMA SERIES |
SHIMADZU MEDICAL SYSTEMS |
DE MINT |
| K922012 |
06/16/1992 |
SHIMADZU IMAGE AMPLIFIER IA-12VSA SERIES |
SHIMADZU MEDICAL SYSTEMS |
DE MING |
| K922307 |
06/16/1992 |
SHOWERFLOSS ORAL IRRIGATION UNIT |
SHOWERFLOSS, INC. |
CLYDE F STEWART |
| K913813 |
06/01/1992 |
JIFFI CONDOM (RUBBER) CONTRACEPTIVE |
SIME HEALTH, LTD. |
HELEN I MARIESKIND |
| K921135 |
06/03/1992 |
IOLAB POWER I.V. POLE |
SITE MICROSURGICAL SYSTEMS, INC. |
JAMES K MCCRACKEN |
| K914963 |
06/04/1992 |
SMITH & NEPHEW DYONICS TMJ ARTHROSCOPY INFLOW SET |
SMITH & NEPHEW DYONICS, INC. |
ERIC BANNON |
| K920986 |
06/04/1992 |
SNOWDEN-PENCER HIGH FLOW INSUFFLATOR, SP/88-9700 |
SNOWDEN-PENCER |
BLACK, III |
| K920985 |
06/09/1992 |
SNOWDEN-PENCER IRRIGATION PUMP |
SNOWDEN-PENCER |
BLACK, III |
| K914306 |
06/19/1992 |
TSRH(TM) LATERAL OFFSET PLATE |
SOFAMOR DANEK MFG., INC. |
RICHARD W TREHARNE |
| K921275 |
06/10/1992 |
SONY LASER VIDEODISC RECORDING SYSTEM |
SONY MEDICAL SYSTEMS |
CYNTHIA A SINCLAIR |
| K920597 |
06/04/1992 |
HANDI-LASE CO2 SURGICAL LASER INSTRUMENT |
SORENSON LABORATORIES, INC. |
CHARLES L ROSE |
| K920287 |
06/29/1992 |
POWERED VACUUM ASPIRATOR 1110-G-030 |
STIRN INDUSTRIES |
ROBERT W HARRINGTON |
| K920288 |
06/29/1992 |
POWERED VACUUM ASPIRATOR 1110-G-062 |
STIRN INDUSTRIES |
ROBERT W HARRINGTON |
| K921229 |
06/09/1992 |
STERILE/SINGLE USE OPHTHALMIC CONFORMERS |
STORZ INSTRUMENT CO. |
JANET LACAVICH |
| K920223 |
06/10/1992 |
CHEM CHEX THEOPHYLLINE CONTROL |
STRECK LABORATORIES, INC. |
ROBERT M LACHOWIEZ |
| K920231 |
06/08/1992 |
OMNIFIT M-HA HIP STEM SERIES |
STRYKER CORP. |
ROBERT A KOCH |
| K920193 |
06/08/1992 |
OMNIFLEX M-HA HIP STEM SERIES |
STRYKER CORP. |
ROBERT A KOCH |
| K915651 |
06/15/1992 |
OMNIMED HOLMIUM LASER AND DELIVERY SYSTEM |
SUMMIT TECHNOLOGY, INC. |
MAUREEN O'CONNELL |
| K921671 |
06/18/1992 |
SURGILASE FIBERLASE VCO2 LASER WAVEGUIDE |
SURGICAL PRODUCTS CORP. |
LYNNNE ARONSON |
| K913817 |
06/11/1992 |
MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION |
SYNECTICS-DANTEC |
ANNA PETTERSSON |
| K915895 |
06/04/1992 |
STEALTH DILATION CATHETER SYSTEM (MODIFIED) |
TARGET THERAPEUTICS |
THERESA NAZAROFF |
| K920183 |
06/15/1992 |
TECH DYNE - HP-2000, SKREEN TEST, RMS-200 |
TECH DYNE GROUP |
HOWARD A MAHONEY |
| K921131 |
06/08/1992 |
CKS OSCILLATING SAW BLADE |
TECHMEDICA, INC. |
DAVID SAMSON |
| K920746 |
06/30/1992 |
VFC UNIT |
TILANE CORP. |
TIMOTHY LANE |
| K920098 |
06/09/1992 |
ACCESS QD HEAD COIL |
TOSHIBA AMERICA MRI, INC. |
BEN KHOSRAVI |
| K921904 |
06/24/1992 |
THYROXINE (FPIA) KIT |
TUDOR LABORATORIES, INC. |
ROBERT DOWMAN |
| K921601 |
06/16/1992 |
ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINE |
ULTRADENT PRODUCTS, INC. |
LINDA CHATWIN |
| K914753 |
06/11/1992 |
AUTO SUTURE(R) ARTICULATING ENDOSCOPIC CLAMP |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
STEVE REITZLER |
| K914752 |
06/11/1992 |
AUTO SUTURE(R) ARTICULATING ENDOSCOPIC SCISSORS |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
STEVE REITZLER |
| K921251 |
06/12/1992 |
CUSA SYSTEM 200C AND 200T ULTRASONIC ASPIRATOR |
VALLEYLAB, INC. |
PEGGY WALLINE |
| K920938 |
06/17/1992 |
VJW2919 PNEUMATIC COMPRESSION UPGRADE |
VARIAN CANADA, INC. |
ANTHONY B BAILEY |
| K913912 |
06/16/1992 |
VERIMED PERINEOMETER |
VERIMED HOLDINGS, INC. |
DOUGLAS MEE |
| K915831 |
06/08/1992 |
THERMAL PROBE COVER |
VERMONT MEDICAL, INC. |
PAMELA SOPCZYK |
| K913644 |
06/22/1992 |
VITA IN-CERAM |
VIDENT |
RAY E MORROW |
| K921474 |
06/18/1992 |
VITA OMEGA PORCELAIN |
VIDENT |
RAY E MORROW |
| K921618 |
06/29/1992 |
COXSACKIE VIRUS B1-B6 CF ANTIGENS |
VIRION (U.S.), INC. |
WILLIAM J HAUSLER |
| K920998 |
06/03/1992 |
GORE TUNNELER, MODIFICATION |
W.L. GORE & ASSOCIATES,INC |
SAMMY EMRICH |
| K922708 |
06/30/1992 |
WIDEX MODEL D32 |
WIDEX HEARING AID CO., INC. |
RON MELTSNR |
| K915063 |
06/03/1992 |
IVAC PC ANIFUSER |
Y |
JUDITH A.FAIRCHILD |
| K915711 |
06/10/1992 |
IN THE EAR HEARING AID |
ZENITH-OMNI H.C., INC. |
RICHARD E MCMAHON |
