| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K912875 |
08/20/1991 |
AVI MODEL 270CI INFUSION PUMP |
3M AVI, INC. |
VON BUSCH |
| K912738 |
08/12/1991 |
AVI VOLUMETRIC INFUSION PUMPS-VARIOUS MODELS |
3M AVI, INC. |
VON BUSCH |
| K912871 |
08/09/1991 |
INSIDE JOB |
3M HEALTH CARE, LTD. |
WILLARD D LARSON |
| K912078 |
08/20/1991 |
SARNS SM03 MEMBRANE OXYGENATOR, MODIFICATION |
3M HEALTH CARE, SARNS |
CATHY L SIMPSON |
| K911049 |
08/07/1991 |
DIGITAL SPHYGMOIMANOMETER, MODEL UA-830 |
A & D ENGINEERING, INC. |
ALBERT J PINZA |
| K912118 |
08/07/1991 |
DIGITAL SPHYGMOMANOMETER MODEL UA-833 |
A & D ENGINEERING, INC. |
ALBERT J PINZA |
| K912119 |
08/07/1991 |
DIGITAL SPHYGMOMANOMETER MODEL UB-211 AND 212 |
A & D ENGINEERING, INC. |
ALBERT J PINZA |
| K911815 |
08/02/1991 |
3RD HAND HELPER |
AARON MEDICAL INDUSTRIES |
ROBERT SARON |
| K910382 |
08/07/1991 |
FLEXIFLO ENTERAL FEEDING TUBE |
ABBOTT LABORATORIES |
MICHAEL H HANEY |
| K912928 |
08/26/1991 |
LIFECARE 4100 PCA INFUSER PLUS II |
ABBOTT LABORATORIES |
FREDERICK GUSTAFSON |
| K912092 |
08/02/1991 |
MODIFIED LIFECARE MODEL 175 INFUSER |
ABBOTT LABORATORIES |
FREDERICK GUSTAFSON |
| K911964 |
08/02/1991 |
MODIFIED PANCRETEC PROVIDER ONE INFUSION SYSTEM |
ABBOTT LABORATORIES |
FREDERICK GUSTAFSON |
| K912365 |
08/16/1991 |
TDX(R)/TDXFLX(TM) & ADX(R) PROPOXPHENE ASSAYS |
ABBOTT LABORATORIES |
CAROL M COOPER |
| K913400 |
08/21/1991 |
MODEL SCR-1000 |
ACCUCORE, INC. |
WILLIAM C MCBRIDE |
| K910785 |
08/22/1991 |
TITANIUM CATHETER EXTENDER |
ACCURATE SURGICAL INSTRUMENTS CO. |
HELEN MORELAND |
| K910787 |
08/15/1991 |
TITANIUM CONNECTOR (2 PART) |
ACCURATE SURGICAL INSTRUMENTS CO. |
HELEN MORELAND |
| K910193 |
08/23/1991 |
HUENE FIXATION SCREW |
ACU-MED, INC. |
RANDALL HUEBNER |
| K904435 |
08/29/1991 |
VENTROFIL TENSION RELIEF SUTURE SET |
AESCULAP, INC. |
ROBIN BUSH |
| K912130 |
08/09/1991 |
TBD KERATOSCOPE |
ALCON LABORATORIES |
DAVID KRAPF |
| K912197 |
08/20/1991 |
SKIN SAVER(TM) TUBING HOLDER, MODEL 467 |
ALPINE SPECIALTIES, INC. |
ROBIN J PASQUAROSA |
| K913272 |
08/22/1991 |
EMS/400 |
ALTOONA MEDICAL SUPPLY |
DONALD A MACKENZIE |
| K913091 |
08/26/1991 |
BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY |
AMERICAN LABORATORY PRODUCTS CO., LTD. |
JANET F CONLEY |
| K912964 |
08/29/1991 |
API UNISCEPT MIC/UNISCEPT MICRO-MIC |
ANALYTAB PRODUCTS, INC. |
FRANCIS P.CANONICA, |
| K912102 |
08/09/1991 |
ACS LIQUID THROMBOPLASTIN |
ANALYTICAL CONTROL SYSTEMS, INC. |
PAULINE W BONDERMAN |
| K911520 |
08/02/1991 |
ARTHROBOT(TM) 75" (190 CM) GENERAL PURPOSE DRAPE |
ANDRONIC DEVICES, LTD. |
MICHAEL CLHAN |
| K911521 |
08/02/1991 |
ARTHROBOT(TM) 96" (240 CM) DRAPE WITH 1 STRAP |
ANDRONIC DEVICES, LTD. |
MICHAEL CHAN |
| K904873 |
08/29/1991 |
STERILE SURGICAL PACK |
ANGELICA HEALTHCARE SERVICES |
MICHAEL ZOZAYA |
| K912903 |
08/16/1991 |
PERCUTANEOUS RETRACTOR KIT |
APPLIED UROLOGY, INC. |
JO STEGWELL |
| K912765 |
08/12/1991 |
STASIS BUTTON PRSSURE DEVICE |
ARCH DEVELOPMENT GROUP |
ROBERT A ROTH |
| K912929 |
08/13/1991 |
DASH IV |
ASTRO-MED, INC. |
DONNA J RAY |
| K912034 |
08/22/1991 |
VENETO COLLECTION |
ATLANTIC OPTICAL CO., INC. |
MEL HOFFMAN |
| K912704 |
08/26/1991 |
ATRIUM 2000 CHEST DRAIN |
ATRIUM MEDICAL CORP. |
TED DARWOSKI |
| K913000 |
08/02/1991 |
HEART NEBULIZER POLE CLAMP |
B & B MEDICAL TECHNOLOGIES, INC. |
STEPHEN W BRIGGS |
| K913229 |
08/29/1991 |
BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYM IMMUN |
BAXTER DIAGNOSTICS, INC. |
SCOTT DENNIS |
| K912455 |
08/12/1991 |
DADE IAC-X COMPREHENSIVE IMMUNOASSAY CONTROL |
BAXTER HEALTHCARE CORP. |
NANCY A HORNBAKER |
| K911051 |
08/22/1991 |
MONARCH SYSTEM |
BAXTER HEALTHCARE CORP. |
JACK P DOUGLAS |
| K913236 |
08/16/1991 |
STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY |
BAXTER HEALTHCARE CORP. |
NANCY A HORNBAKER |
| K910453 |
08/13/1991 |
TOPS NEEDLE TIP PROBE & PVC TIP PROBE |
BAXTER HEALTHCARE CORP. |
NANCY E SHADFORTH |
| K912480 |
08/23/1991 |
BBL(R) DMACA INDOLE REAGENT DROPPERS |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
J ARNSBERGER |
| K912170 |
08/09/1991 |
RADIOACTIVE IODINE-125 SOURCES |
BEST INDUSTRIES |
SANKARA I RAMASWAMY |
| K912320 |
08/22/1991 |
BIOPHYSIOMETER POSITIONING CHAIR |
BI-DYNAMICS, INC. |
PATRICIA B SHRADER |
| K912032 |
08/20/1991 |
SILON(TM) TRANSPARENT WOUND DRESSING |
BIO MED SCIENCES, INC. |
MARK E DILLON |
| K911351 |
08/22/1991 |
BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBP |
BIOCHEM INTERNATIONAL, INC. |
DAVID A UHEN |
| K910381 |
08/22/1991 |
BIOCHEM TEMPERATURE/ FIO2 MODULE |
BIOCHEM INTERNATIONAL, INC. |
DAVID A UHEN |
| K911213 |
08/07/1991 |
CUFFABLE |
BIOMEDICAL DYNAMICS, INC. |
MATTHEW BELLIN |
| K900343 |
08/22/1991 |
GAP-IGG |
BIOMERICA, INC. |
PERRY G RUCKER |
| K912245 |
08/19/1991 |
AGC REVISION KNEE PROTHESIS |
BIOMET, INC. |
PATRICIA M SANDBORN |
| K913051 |
08/20/1991 |
SPECTRAL EEG MONITOR MODEL B500 |
BIOMETRAK CORP. |
LYNNE ARONSON |
| K912025 |
08/22/1991 |
SPECTROLYSE PLASMINOGEN SK KIT |
BIOPOOL AB |
BARBARA A KILLACKEY |
| K912129 |
08/07/1991 |
DOBBHOFF(R) BIPOLAR HEMOSTATIC PROBE |
BIOSEARCH MEDICAL PRODUCTS, INC. |
MATTHEW W LESNIESKI |
| K912795 |
08/12/1991 |
BIOTROL UIBC REAGENT |
BIOTROL, USA, INC. |
ALLAN C.MURPHY |
| K911142 |
08/09/1991 |
LEAD TERMINAL PIN CAPS, VARIOUS MODELS |
BIOTRONIK, GMBH & CO. |
SCOTT J MINDREBO |
| K910609 |
08/28/1991 |
PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIP |
BIOTRONIK, GMBH & CO. |
SCOTT J MINDREBO |
| K910889 |
08/29/1991 |
ABC LAPAROSCOPIC HANDPROBE |
BIRTCHER MEDICAL SYSTEMS, INC. |
WILLIAM E MCKAY |
| K913270 |
08/09/1991 |
BIVONA FOME-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE |
BIVONA MEDICAL TECHNOLOGIES |
HARRY M KAUFMAN |
| K912212 |
08/28/1991 |
PROACT CHOLESTEROL SYSTEMS |
BOEHRINGER MANNHEIM CORP. |
CYNTHIA A.SPAIN |
| K913105 |
08/12/1991 |
REFLOTRON CREATININE TEST TABS |
BOEHRINGER MANNHEIM CORP. |
CYNTHIA A SPAIN |
| K912290 |
08/26/1991 |
HEALY/MONTGOMERY STENT SYSTEM (HMS SYSTEM(TM)) |
BOSTON MEDICAL PRODUCTS, INC. |
STUART K MONTGOMERY |
| K900205 |
08/20/1991 |
DRAINAGE CATHETERS W/A DISSOLVABLE TIP |
BOSTON SCIENTIFIC CORP. |
LEO L BASTA |
| K905198 |
08/28/1991 |
DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535 |
BRUEL & KJAER |
AAGE RUBY |
| K911603 |
08/07/1991 |
HEMOSPAL KIT B22 |
C.G.H. MEDICAL, INC. |
JEFFREY R SHIDEMAN |
| K910195 |
08/09/1991 |
BARD HYDROGEL-COATED FOLEY CATHETERS |
C.R. BARD, INC. |
DONNA J WILSON |
| K910846 |
08/16/1991 |
BARD LATEX URINARY CATHETERS DRAINS- DESIGNS MODIF |
C.R. BARD, INC. |
DONNA J WILSON |
| K910190 |
08/16/1991 |
BARD MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT |
C.R. BARD, INC. |
DONNA J WILSON |
| K910822 |
08/29/1991 |
BARD PERIPHERAL BALLOON DILATATION CATHETER |
C.R. BARD, INC. |
CATHERINE V BEATH |
| K910197 |
08/09/1991 |
HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS |
C.R. BARD, INC. |
DONNA J WILSON |
| K912827 |
08/12/1991 |
SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3 |
CALA DIAGNOSTICS |
JAMES F GODFREY |
| K912341 |
08/26/1991 |
MULTICAM I 8X10 |
CAMTRONICS, LTD. |
SCOTT J PEASE |
| K912443 |
08/16/1991 |
CANDELA INTRODUCER SHEATH SYSTEM |
CANDELA LASER CORP. |
GEORGE CHO |
| K910917 |
08/02/1991 |
CATHLAB SILICONE BILIARY BALLOON CATHETER |
CATHLAB CORP. |
DANIEL R LUCAS |
| K912152 |
08/12/1991 |
CELLABS GIARDIA CEL I.F. TEST |
CELLTECH DIAGNOSTICS LTD. |
BRUCE F MACKLER |
| K912583 |
08/12/1991 |
MAGIC LITE TSH (HS) IMMUNOASSAY |
CIBA CORNING DIAGNOSTICS CORP. |
WILLIAM J PIGNATO |
| K912490 |
08/16/1991 |
CITATION MEDICAL SCOPE PROCEDURE PACK |
CITATION MEDICAL CORP. |
EDWARD F WADDELL |
| K910938 |
08/16/1991 |
CODMAN EXTERNAL DRAINAGE SYSTEM II (EDS II) |
CODMAN & SHURTLEFF, INC. |
JEANETTE G CLOUTIER |
| K911772 |
08/26/1991 |
GARDNER PINS (ADULT & CHILD) |
CODMAN & SHURTLEFF, INC. |
THOMAS J COURAGE |
| K912029 |
08/13/1991 |
ULTRAPULSE(TM) CARBON DIOXIDE SURGICAL LASER |
COHERENT MEDICAL GROUP |
VIRGINIA SINGER |
| K912338 |
08/07/1991 |
TUBE HOUSING ASSEMBLIES |
COMET LTD. C/O RADIOLOGY RESOURCES, INC. |
FREY |
| K913301 |
08/28/1991 |
MCS 50MO X-RAY TUBE INSERT/MXS 50MO TUBE HOU ASSEM |
COMET NORTH AMERICA, INC. |
SUFFREDINI |
| K911809 |
08/26/1991 |
NEW-VENT |
CONCORD/PORTEX |
ROBERT WHEELER |
| K912124 |
08/16/1991 |
TRACHEOSTOMY TUBE AND CUFF |
CONCORD/PORTEX |
ROBERT WHEELER |
| K913121 |
08/16/1991 |
OMNIFLEX OVERHEAD TUBECRANE CAT.#S-9108/#6713.400 |
CONTINENTAL X-RAY CORP. |
OSCAR KHUTORYANSKY |
| K912550 |
08/14/1991 |
DUODERM(R) ADHESIVE COMPRESSION BANDAGE, MODIFIED |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
MARILYN DREYLING |
| K912823 |
08/16/1991 |
HIGH DENSITY LIPOPROTEIN CHOLESTEROL |
CREATIVE LABORATORY PRODUCTS, INC. |
GARY J PROKSCH |
| K912148 |
08/12/1991 |
CHOLINESTERASE TEST KIT |
CRESTAT DIAGNOSTICS, INC. |
MIKE MUKAI |
| K912914 |
08/22/1991 |
DANBY-DCR VOLUMETRIC INFUSION PUMP |
DANBY MEDICAL LTD. |
TOBY JOHNSTON |
| K912319 |
08/22/1991 |
DAVIS & GECK CHROMIC & PLAIN GUT LIGATURE CARRIER |
DAVIS & GECK, INC. |
BLANCHE PARZUCHOWSKI |
| K912493 |
08/20/1991 |
DEGUBOND LITE |
DEGUSSA AG |
HOLGER MEINICKE |
| K912999 |
08/13/1991 |
DENTA SAFE(TM) LATEX EXAMINATION GLOVES |
DENTAL CARE INTL., INC. |
ACHARYA |
| K912824 |
08/26/1991 |
DEVON SPONGE COUNTER BAGS |
DEVON INDUSTRIES, INC. |
RUDY GABA |
| K912750 |
08/02/1991 |
MONOSCOPY(TM) BRAND, DUAL SUCTION/IRRIGATION CONTR |
DEXIDE, INC. |
KEITH JUNG |
| K912862 |
08/12/1991 |
MONOSCOPY(TM) BRANK, HOOK DISSECTOR |
DEXIDE, INC. |
KEITH JUNG |
| K912541 |
08/12/1991 |
MILENIA TOTAL T4, CATALOG: MKT41,5 |
DIAGNOSTIC PRODUCTS CORP. |
KENNETH B ASARCH |
| K912173 |
08/13/1991 |
DSL BETA 2 MICROGLOBULIN (DSL 6100) |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
JOHNNY R WILLIS |
| K911166 |
08/15/1991 |
DIAGNOSTIC ULTRASOUND/URO-GYN UD 511 |
DIAGNOSTIC ULTRASOUND CORP. |
GERALD MCMORROW |
| K911125 |
08/15/1991 |
DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020 |
DIAGNOSTIC ULTRASOUND CORP. |
GERALD MCMORROW |
| K912010 |
08/19/1991 |
I.V. SKY-HOOK |
DINA - INDUSTRIA, COMERCIO E EXPORTACAO LTD. |
VON SPERLING |
| K912400 |
08/09/1991 |
MOBILE X-RAY FLOOR STAND |
DNTL CORP. |
ROBERT GIVAN |
| K912284 |
08/19/1991 |
BIOVISION ENDOCULAR PROBE ACCESS DELIV SYST, MODIF |
DOUGLAS JAMES DONALDSON COMPLIANCE SERVICES |
DOUGLAS DONALDSON |
| K912820 |
08/21/1991 |
POLYESTER RESIN HAND MOLDED TRAY |
E&D DENTAL PRODUCTS, INC. |
EDWARD SPEHAR |
| K913195 |
08/26/1991 |
KODAK EKTACHEM DT SLIDES (ALB) |
EASTMAN KODAK COMPANY |
NORMAN H GEIL |
| K913198 |
08/26/1991 |
KODAK EKTACHEM DT SLIDES (CHE) |
EASTMAN KODAK COMPANY |
NORMAN H GEIL |
| K913197 |
08/26/1991 |
KODAK EKTACHEM DT SLIDES (LAC) |
EASTMAN KODAK COMPANY |
NORMAN H GEIL |
| K910871 |
08/29/1991 |
EDENTEC DIGITAL CHARTER MODEL 3710 |
EDENTEC CORP. |
GARY SYRING |
| K910870 |
08/29/1991 |
EDENTEC MODEL 3711 DIGITAL RECORDER |
EDENTEC CORP. |
GARY SYRING |
| K912809 |
08/12/1991 |
ABBOTT QUICKSTART PHOSPHORUS(PHOS) ITEM #5A14 |
EM DIAGNOSTIC SYSTEMS, INC. |
ANNA G BENTLEY |
| K911155 |
08/07/1991 |
OVAL CUP BIOPSY FORCEP |
ENDOVATIONS |
JANE E PREDIX |
| K912896 |
08/26/1991 |
DIGISTORE 2100 |
ENHANCED IMAGING TECHNOLOGIES, INC. |
RICHARD L ADAMEK |
| K911692 |
08/16/1991 |
ENZYMATICS, INC., TOTAL CHOLESTEROL TEST |
ENZYMATICS C/O BURDITT,BOWLES,RADZIUS & RUBERRY |
CHRISTOPHER ZALESKY |
| K911829 |
08/28/1991 |
ENDOSTAPLE |
ETHICON, INC. |
JOHN PAULSON |
| K903774 |
08/29/1991 |
LP-PLUS |
FIDELITY MEDICAL, INC. |
AMIR RIPPEL |
| K912394 |
08/30/1991 |
TRANSDUCER PROTECTOR |
FILTERTEK, INC. |
LARRY LARKIN |
| K912448 |
08/28/1991 |
CSP |
FISCHER IMAGING CORP. |
THOMAS H GALLINGER |
| K912449 |
08/28/1991 |
MICRO-X 15 HF |
FISCHER IMAGING CORP. |
THOMAS H GALLINGER |
| K912586 |
08/02/1991 |
TANGENT IV |
FISCHER IMAGING CORP. |
THOMAS H GALLINGER |
| K912022 |
08/02/1991 |
FRASTEC DRYNET, BRIDAL VEIL, VARIOUS SIZES |
FRAASS SURVIVAL SYSTEMS, INC. |
COLIN OFFENHARTZ |
| K910821 |
08/12/1991 |
TRANSDUCER PROTECTOR |
GELMAN SCIENCES, INC. |
HARWOOD GREEN |
| K912132 |
08/07/1991 |
OPERAND LUBRICATING JELLY |
GENERAL MEDICAL CO. |
RICHARD J MARSHALL |
| K911326 |
08/14/1991 |
OBSTETRICAL VACUUM CUP |
GESCO INTL., INC. |
CLYDE N BAKER |
| K913373 |
08/29/1991 |
GLOBALCARE ELECTRODE |
GLOBALCARE INTL., INC. |
JOHN DUNN |
| K911746 |
08/16/1991 |
H.I.STANDARD CALIBRE UPGRADE |
HEALTH IMAGES, INC. |
BRUCE STEVENSON |
| K905677 |
08/09/1991 |
JEJUNO-CATH KIT |
HEALTH IMPROVEMENT ASSOC. |
ALEXANDER BOMMARITO |
| K912774 |
08/22/1991 |
ARACHIDONIC ACID |
HELENA LABORATORIES |
PAT FRANKS |
| K912201 |
08/16/1991 |
PACKS-4 (TM) ANALYZER |
HELENA LABORATORIES |
PAT FRANKS |
| K911777 |
08/22/1991 |
ROCKET REFERENCE PLASMA, CAT. NO. 5188, MODIFIED |
HELENA LABORATORIES |
PAT FRANKS |
| K911987 |
08/13/1991 |
LUXUS 132 ND: YAG SURGICAL LASER SYSTEM |
HERAEUS LASERSONICS, INC. |
ROBERT MILDER |
| K912566 |
08/20/1991 |
MINITROP AEROSOL UNIT |
HEYER AMERICA, INC. |
STUART M PAPE |
| K910272 |
08/09/1991 |
HGM COMBINATION ND:YAG & SOLID STATE GREEN |
HGM MEDICAL LASER SYSTEMS, INC. |
DENNIS REIGLE |
| K912363 |
08/27/1991 |
ELECTRONIC ULTRASOUND SCAN MODELS EUP-U12/012T/TC3 |
HITACHI MEDICAL CORP. OF AMERICA |
TAKGUCHI |
| K911195 |
08/12/1991 |
DUNLAP HEAT PAD |
HOME HEALTHCARE PRODUCTS, INC. |
ERIC FLAM |
| K912426 |
08/21/1991 |
UHMWP ACETABULAR COMPONENT |
HOWMEDICA CORP. |
MARGARET F CROWE |
| K912439 |
08/28/1991 |
TANDEM-E TSH CALIBRATION VERIFICATION CONTROL SET |
HYBRITECH, INC. |
JOANNE MARTINIS |
| K912540 |
08/23/1991 |
CONTOUR-PORT |
IDEAL MEDICAL, INC. |
LORNA K LINVILLE |
| K912211 |
08/09/1991 |
INTRAVASCULAR CATHETER SECURMENT DEVICE |
INMAN LIEBELT CORP. |
H.CLAY WILSON |
| K913522 |
08/28/1991 |
SOLITENS MODIFIED |
INNOVATIVE DESIGNER PRODUCTS, INC. |
SAUL LISS |
| K904926 |
08/02/1991 |
SMART-EP |
INTELLIGENT HEARING SYSTEMS |
EDWARD MISKIEL |
| K911427 |
08/26/1991 |
BREATHING FILTERS |
INTERSURGICAL, INC. |
THOMAS R GUERMAN |
| K911328 |
08/15/1991 |
UNIVERSAL VOLUME VENTILATOR CIRCUIT, MODIFICATION |
INTERTECH RESOURCES, INC. |
DEBRA E ROGERS |
| K913186 |
08/30/1991 |
INNOFLUOR(TM) DIGITOXIN CALIBRATOR SET |
INTL. BIOCLINICAL, INC. |
CRAIG SMART |
| K912918 |
08/23/1991 |
IRIS OCULIGHT DIODE LASER ADDING SLIT LAMP ADAPTER |
IRIDERM DIV. |
THEODORE BOUTACOFF |
| K912171 |
08/13/1991 |
PREDISPENSED ORTHODONTIC CERAMIC BRACKET ADHESIVE |
JACK JAMES |
AN-SHIH CHENG |
| K912885 |
08/30/1991 |
KAPS 90 DEGREE FIBEROPTIC ADAPTOR |
JEDMED INSTRUMENT CO. |
CRAIG RAPP |
| K913046 |
08/28/1991 |
FRAMES (EYE GLASSES) |
JIUH CHYI ENT. CO., LTD. |
ROBERT GRANOFF |
| K911199 |
08/28/1991 |
JMS AV FISTULA NEEDLES |
JMS CO., LTD. |
SAKAE OGATA |
| K912232 |
08/14/1991 |
ULCERCARE |
JOBST INSTITUTE, INC. |
ANGELO R PEREIRA |
| K910968 |
08/26/1991 |
P.F.C. UNICONDYLAR KNEE SYSTEM |
JOHNSON & JOHNSON ORTHOPAEDICS, INC. |
MARSHA J STONE |
| K910789 |
08/26/1991 |
KAVOKLAVE STEAM AUTOCLAVE |
KAVO AMERICA |
CHRIS THOMAS |
| K912295 |
08/12/1991 |
KINAMED ATH 28MM ALUMINA CERAMIC LONG-NECK BALL |
KINAMED, INC. |
DANIEL J MANELLI |
| K912707 |
08/20/1991 |
CLEARFIL LINER BOND SYSTEM |
KURARAY CO. |
TOHRU SHIMIZU |
| K912708 |
08/20/1991 |
CLEARFIL PHOTO ANTERIOR & LINER BOND SYSTEM |
KURARAY CO. |
TOHRU SHIMIZU |
| K910806 |
08/30/1991 |
METROLAB MODEL 1500 |
LABORATORIO RODRIGUEZ CORSWANT S.R.L. |
ROBERTO J RODRIGUEZ |
| K912988 |
08/02/1991 |
LATEX EXAMINATION GLOVES |
LAGLOVE (M) SDN. BHD. |
LOT 478 |
| K910062 |
08/16/1991 |
02-10,001 |
LASER ENGINEERING, INC. |
ROBERT I RUDKO |
| K911830 |
08/14/1991 |
LASERSCOPE(R) KTP/532 AND KTP/YAG SURGICAL LASER |
LASERSCOPE |
CHARLES L ROSE |
| K912450 |
08/28/1991 |
TRACETS SME 5000 |
LECTEC CORP. |
DAVID A MONTECALVO |
| K911985 |
08/02/1991 |
LUMATAG T4 CHEMILUMINESCENCE ASSAY |
LONDON DIAGNOSTICS, INC. |
RAMAKRISHNAN |
| K905291 |
08/09/1991 |
LATERAL SPINE DETERMAINATIONS DPX/DPX-L/DPX-ALPHA |
LUNAR |
RICHARD B MAZESS |
| K910982 |
08/26/1991 |
INNERVISION IRRIGATION PUMP |
M.D. ENGINEERING, INC. |
ANDREW HALSEY |
| K912240 |
08/22/1991 |
CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEM |
MALLINCKRODT ANESTHESIA PRODUCTS |
LYNN C STIMPSON |
| K912074 |
08/28/1991 |
BONE MARROW BIOPSY TRAY |
MANAN MEDICAL PRODUCTS, INC. |
MANFRED MITTERMEIER |
| K912661 |
08/21/1991 |
MATRX, PYRAMID TRIANGLE BANDAGE |
MATRIX MEDICA, INC. |
JOHN M WYNNE |
| K913350 |
08/09/1991 |
VITAL-PORT(R) PETITE VASCULAR ACCESS SYSTEM |
MED INSTITUTE, INC. |
NEAL E FEARNOT |
| K911691 |
08/09/1991 |
XYZ CRANK IMAGING TABLE |
MED-TRON PRODUCTS, INC. |
KATHERINE MAGUILL |
| K911665 |
08/29/1991 |
ESCORT 300 SERIES |
MEDICAL DATA ELECTRONICS |
CHIP HARLOW |
| K912106 |
08/29/1991 |
ARTHROSCOPY TRAY |
MEDICAL DEVICE INSPECTION CO., INC. |
ALAN P SCHWARTZ |
| K912105 |
08/29/1991 |
EYE TRAY |
MEDICAL DEVICE INSPECTION CO., INC. |
ALAN P SCHWARTZ |
| K912052 |
08/20/1991 |
HEART CATH TRAY |
MEDICAL DEVICE INSPECTION CO., INC. |
ALAN P.SCHWARTZ |
| K912117 |
08/09/1991 |
LACERATION TRAY |
MEDICAL DEVICE INSPECTION CO., INC. |
ALAN P SCHWARTZ |
| K912104 |
08/09/1991 |
MAJOR BASIN TRAY |
MEDICAL DEVICE INSPECTION CO., INC. |
ALAN P SCHWARTZ |
| K912159 |
08/29/1991 |
MAJOR SET-UP TRAY |
MEDICAL DEVICE INSPECTION CO., INC. |
ALAN P SCHWARTZ |
| K912053 |
08/26/1991 |
OPEN HEART TRAY |
MEDICAL DEVICE INSPECTION CO., INC. |
ALAN P.SCHWARTZ |
| K913330 |
08/26/1991 |
URINE COLLECTION KIT/DEVICE |
MEDICAL IMPLEMENTS, INC. |
JAMES M PARRISH |
| K912089 |
08/12/1991 |
MODIFIED SERIES 2100 ENDOSCOPES |
MEDICAL LASER, INC. |
GREGORY J MATHISON |
| K913329 |
08/23/1991 |
V-ACCI-GUARD(TM) REUSABLE HOLDER |
MEDICAL SAFETY PRODUCTS, INC. |
E SAGSTETTER |
| K911129 |
08/07/1991 |
MMG BILE BAG |
MEDICAL TECHNOLOGIES OF GEORGIA |
TIMOTHY D GOLDEN |
| K902772 |
08/14/1991 |
PLEASURE PLUS |
MEDIMIX PRODUCTS, INC. |
MARTIN J HAHN |
| K910342 |
08/19/1991 |
SONOACE 4500 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM |
MEDISON CO., LTD. |
ROBERT D WAXHAM |
| K913594 |
08/23/1991 |
DYNEX IIIB, MODEL 89002026 |
MEDTRONIC VASCULAR |
DARYLE PETERSEN |
| K912415 |
08/16/1991 |
MEDICAL SAFETY CABLE AND LEAD SYSTEM |
MEDTRONIC VASCULAR |
JANICE M PEVIDE |
| K897068 |
08/28/1991 |
MEDTRONIC MINIMAX HOLLOW FIBER OXYGENATOR |
MEDTRONIC VASCULAR |
LOWE, PHD |
| K911790 |
08/12/1991 |
MINIMAX (TM) COLLAPSIBLE VENOUS RESERVOIR BAG |
MEDTRONIC VASCULAR |
NORMA L.LOWE |
| K911789 |
08/20/1991 |
MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT |
MEDTRONIC VASCULAR |
NORMA L.LOWE |
| K903434 |
08/09/1991 |
SELECT NEUROMUSCULAR STIMULATORS |
MEDTRONIC VASCULAR |
LINDA S ALEXANDER |
| K913281 |
08/16/1991 |
E-Z CLEAN LAPAROSCOPIC ELECTRODE |
MEGADYNE MEDICAL PRODUCTS, INC. |
DREW D WEAVER |
| K912337 |
08/16/1991 |
ELECTROSURGICAL CUT & COAGULATION DEVICE & ACCESS |
MEGADYNE MEDICAL PRODUCTS, INC. |
DREW D WEAVER |
| K910945 |
08/15/1991 |
HORIZON 2000 EEG MONITORING OPTION |
MENNEN MEDICAL, INC. |
RICHARD G WHITEHEAD |
| K911257 |
08/19/1991 |
MR-5200 FULL DISCLOSURE SYSTEM |
MENNEN MEDICAL, INC. |
RICHARD WHITEHEAD |
| K912721 |
08/20/1991 |
AUROFILM MP |
METALOR DENTAL USA CORP. |
BRIAN F SCHILLER |
| K911669 |
08/16/1991 |
CERAPALL 6 |
METALOR DENTAL USA CORP. |
BRIAN F.SCHILLER |
| K911674 |
08/16/1991 |
CERAPLUS |
METALOR DENTAL USA CORP. |
BRIAN SCHILLER |
| K912435 |
08/28/1991 |
DENTAL CONNECTOR PRECISION ATTACHMENT |
METALOR DENTAL USA CORP. |
BRIAN F SCHILLER |
| K912720 |
08/20/1991 |
ENDO-CORE |
METALOR DENTAL USA CORP. |
BRIAN F SCHILLER |
| K912313 |
08/09/1991 |
SOLCHROM-PAL |
METALOR DENTAL USA CORP. |
BRIAN F SCHILLER |
| K912305 |
08/09/1991 |
STANDARD S3 |
METALOR DENTAL USA CORP. |
BRIAN F SCHILLER |
| K912307 |
08/09/1991 |
STANDARD S31 |
METALOR DENTAL USA CORP. |
BRIAN F SCHILLER |
| K912308 |
08/09/1991 |
STANDARD S32 |
METALOR DENTAL USA CORP. |
BRIAN F SCHILLER |
| K912302 |
08/09/1991 |
VACU 2 |
METALOR DENTAL USA CORP. |
BRIAN F SCHILLER |
| K912206 |
08/16/1991 |
MICRO-AIRE ARTHROS SURG BLADES-VARIOUS CO PROD NO. |
MICROAIRE |
FRANS LIMONTA |
| K912205 |
08/16/1991 |
MICRO-AIRE ARTHROS SURG BLADES-VARIOUS DYS PROD NO |
MICROAIRE |
FRANS LIMONTA |
| K912767 |
08/13/1991 |
FIBER OPTIC UNIVERAL CABLES, SCOPE ADAP., LT.SOURC |
MICROAIRE ADVANCED SURGICAL PRODUCTS |
SIDDHARTH DESAI |
| K912332 |
08/21/1991 |
MICROSURGE LASER FIBER HOLDER |
MICROSURGE, INC. |
LYNN ARONSON |
| K911322 |
08/26/1991 |
MODEL #M9 ULTRACLAVE STEAM STERILIZER |
MIDMARK CORP. |
JOHN OLDIGES |
| K904961 |
08/30/1991 |
ARTIFICIAL SCLERAL SHELL |
MIDWEST EYE LABORATORIES, INC. |
MICHAEL BARRETT |
| K904962 |
08/30/1991 |
EYE ARTIFICIAL CUSTOM |
MIDWEST EYE LABORATORIES, INC. |
MICHAEL BARRETT |
| K911841 |
08/26/1991 |
MINXRAY P300 X-RAY SYSTEM |
MINXRAY, INC. |
KEITH R KRETCHMER |
| K911263 |
08/19/1991 |
22MM ID/OD ADAPTER |
MONAGHAN MEDICAL CORP. |
JAMES A COCHIE |
| K911749 |
08/20/1991 |
L-LINEX-RAY FLUORESCENCE |
MONTIFORE MEDICAL CENTER |
JOHN F.ROSEN |
| K911097 |
08/07/1991 |
PR4 |
MORTARA INSTRUMENT, INC. |
RODNEY CAMBRE |
| K912608 |
08/21/1991 |
STAR*SHADES(TM) SUNGLASSES |
NALPAC LTD. |
RALPH CAPLAN |
| K910611 |
08/16/1991 |
NOBELPHARMA CERAONE ABUTMENT SYSTEM |
NOBELPHARMA USA, INC. |
THOMAS J MULDOON |
| K912086 |
08/07/1991 |
FMA TRANSLATOR |
NORMANDIE GROUP, INC. |
WILLIAM L MCCARTY |
| K910691 |
08/15/1991 |
NORTEC URETERAL STENT |
NORTH AMERICAN STERILIZATION & PACKAGING CO. |
HARRY A SCHLAKMAN |
| K911430 |
08/07/1991 |
IDEIA(TM) CHLAMYDIA, MODIFICATION |
NOVO NORDISK DIAGNOSTICS, LTD. |
STEPHEN A ABBOTT |
| K911932 |
08/26/1991 |
J105 JAMES SURGICAL SYSTEM I/A PACK |
O.R. SPECIALTIES, INC. |
JACK W HOWARD |
| K912836 |
08/28/1991 |
CANNULA AND TROCAR |
OCEANSIDE BIOMEDICS |
LOUIE POLONI |
| K912253 |
08/07/1991 |
LANDERS 3 STRUT IRRIGATING VITRECTOMY LENS RING |
OCULAR INSTRUMENTS, INC. |
TAMSIN J ERICKSON |
| K912269 |
08/07/1991 |
LANDERS NOTCHED IRRIGATING VITRECTOMY LENS RING |
OCULAR INSTRUMENTS, INC. |
TAMSIN J ERICKSON |
| K912268 |
08/07/1991 |
LANDERS NOTCHED VITRECTOMY LENS RING |
OCULAR INSTRUMENTS, INC. |
TAMSIN J ERICKSON |
| K910828 |
08/21/1991 |
LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS |
OCULAR INSTRUMENTS, INC. |
TAMSIN J ERICKSON |
| K911193 |
08/02/1991 |
OHMEDA MODEL 4700 OXICAP |
OHMEDA MEDICAL |
KEVIN MORNINGSTAR |
| K912120 |
08/07/1991 |
URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHOFIBERSCOPE |
OLYMPUS CORP. |
DANIEL J DILLON |
| K911745 |
08/09/1991 |
SIMPLATE PEDIATRIC |
ORGANON TEKNIKA CORP. |
ANN M QUINN |
| K912266 |
08/20/1991 |
MODIFICATION AXIOM TOTAL KNEE SYST, PATELLAR COMP |
OROTHMET, INC. |
DENNIS H CRANE |
| K912736 |
08/12/1991 |
ERECAID(R) SYSTEM PLUS |
OSBON MEDICAL SYSTEMS, LTD. |
JULIAN W OSBON |
| K911936 |
08/21/1991 |
OSTEOMED SBF SYSTEM (SBF) |
OSTEOMED CORP. |
RICK A BUSS |
| K912654 |
08/16/1991 |
OMNIFIT EPF DUAL GEOMETRY ACETABULAR CUP |
OSTEONICS CORP. |
ROBERT A KOCH |
| K911728 |
08/16/1991 |
OMNIFIT(R) EPF DUAL GEOMTRY/RADIUS/THREAD ACETAB C |
OSTEONICS CORP. |
PAT KRAMER |
| K912147 |
08/13/1991 |
OSTEONICS 7000 SERIES STAND TOTAL KNEE FEMOR COMP |
OSTEONICS CORP. |
ROBERT A KOCH |
| K913134 |
08/22/1991 |
MODEL 4220 |
PACE MEDICAL |
ROBERT C.MACE |
| K910924 |
08/28/1991 |
ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE |
PACESETTER SYSTEMS |
NESTOR KUSNIERZ |
| K904639 |
08/13/1991 |
GENOX MODEL CT-1 |
PACIFIC CONSOLIDATED INDUSTRIES |
LEE W SMITH |
| K912860 |
08/28/1991 |
INTRAVASCULAR ADMINISTRATION SETS |
PACIFIC DEVICE, INC. |
JIM CAPUTO |
| K913664 |
08/30/1991 |
ROSYS MODELS 100 AND 200 |
PACKARD INSTRUMENT CO., INC. |
DOROTHY MRKVICKA |
| K912804 |
08/12/1991 |
FSH IRMA IMMUNOMAG |
PANTEX, DIV. BIO-ANALYSIS, INC. |
NEIL Y.CHIAMORI,PH.D |
| K913280 |
08/16/1991 |
OPUS(R) PROLACTIN TEST SYSTEM |
PB DIAGNOSTIC SYSTEMS, INC. |
LORI BARANAUSKAS |
| K911834 |
08/12/1991 |
OPUS(R) ROZO |
PB DIAGNOSTIC SYSTEMS, INC. |
KATHLEEN DRAY-LYONS |
| K912352 |
08/02/1991 |
PEACE MODEL 100 CUFF MONITOR |
PEACE MEDICAL, INC. |
KEVIN FEGAN |
| K910676 |
08/21/1991 |
INTRAORAL DENTAL WAX |
PEMACO, INC. |
RICHARD L PERKOWSKI |
| K911938 |
08/02/1991 |
DYNAVISION 2000 |
PERFORMANCE ENT. |
PHIL JONES |
| K912354 |
08/16/1991 |
OLYMOUS XLS XENON LIGHT SOURCE |
PERKIN ELMER OPTOELECTRONICS |
SCHUDA PH.D. |
| K911637 |
08/02/1991 |
STAYFREE, UNSCENTED/SCENTED/SCENTED DEODOR MEN PAD |
PERSONAL PRODUCTS CO. |
L. J RUBER |
| K911656 |
08/13/1991 |
PLEUR-EVAC PLUS CONTIN. REINFUS. & AUTOINFUS. SYST |
PFIZER HOSPITAL PRODUCTS GROUP, INC. |
MICHEAL SANTALUCIA |
| K911903 |
08/12/1991 |
ALLERGANS PHARMACIA CAP SYS.RAST RIA/FEIA |
PHARMACIA, INC. |
ALBERT P.MAYO |
| K913390 |
08/26/1991 |
M32 IN-THE-EAR HEARING AID |
PHILIPS HEARING INSTRUMENTS CO. |
ROBERT MARTIN |
| K913389 |
08/26/1991 |
PHILIPS S1594 OTB HEARING AID |
PHILIPS HEARING INSTRUMENTS CO. |
ROBERT MARTIN |
| K912470 |
08/07/1991 |
PHILIPS DIAGNOST 96 |
PHILIPS MEDICAL SYSTEMS, INC. |
WILLIAM G MCMAHON |
| K912356 |
08/15/1991 |
GROUP AUDITORY TRAINER,FM RECEIVER |
PHONIC EAR, INC. |
ROBERT L.REINKE |
| K913544 |
08/29/1991 |
DUKKI |
PIN DOT PRODUCTS, INC. |
|
| K913512 |
08/29/1991 |
IMPALA |
PIN DOT PRODUCTS, INC. |
|
| K913552 |
08/29/1991 |
PIN DOT FOOTREST PRODUCTS |
PIN DOT PRODUCTS, INC. |
|
| K912002 |
08/12/1991 |
PLAYTEX NON-DEODORANT/DEODORANT TAMPONS |
PLAYTEX FAMILY PRODUCTS, INC. |
IRWIN BUTENSKY |
| K911886 |
08/12/1991 |
PMT METAL LOCATOR, MODEL 3630-1 |
PMT CORP. |
JAMES COX |
| K912073 |
08/28/1991 |
POLAROID HELIOS LASER IMAGER |
POLAROID MEDICAL CORP. |
HOWARD M HOLSTEIN |
| K911649 |
08/07/1991 |
MITRASHEER TRANSPLANT DRESSING |
POLYMINT INDUSTRIAL CO. LTD. |
ANDREW M REED |
| K910528 |
08/09/1991 |
BIPOLAR SUTURELESS MYOCARDIAL PACING LEADS |
POSSIS MEDICAL, INC. |
MICHAEL G SCHULTZ |
| K912853 |
08/20/1991 |
PLP EVACUATION CONTROL SYSTEM 1 MICRO (ECS.1UM) |
PRECISION LASER PRODUCTS, INC. |
PERK CROOK |
| K913370 |
08/26/1991 |
MODIFICATION MANUAL RESUSCITATOR (PMR 2) |
PURITAN BENNETT CORP. |
MARSHALL SMITH |
| K911971 |
08/09/1991 |
MODIFIED SINGLE PATIENT USE DISP. MANUAL RESUSCIT. |
PURITAN BENNETT CORP. |
MARSHALL SMITH |
| K912428 |
08/09/1991 |
PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT |
PURITAN BENNETT CORP. |
STEPHAN NORSTED |
| K913122 |
08/16/1991 |
DIRECTIGEN 1-2-3(TM) HCG TEST |
QUIDEL CORP. |
CRAIG E WATSON |
| K912868 |
08/07/1991 |
GROUP A STREP POSITIVE AND NEGATIVE CONTROLS |
QUIDEL CORP. |
CRAIG E WATSON |
| K912227 |
08/07/1991 |
MONARK ERGOMETERS |
QUINTON, INC. |
RON R DUCK |
| K913033 |
08/07/1991 |
LATEX EXAMINATION GLOVES |
REAGENT HOSPITAL PROD. LTD. |
WAYNE H.MATELSKI |
| K912410 |
08/13/1991 |
COXEL FLINGER 2500/5000 3-D IMAGING SYSTEM |
REALITY IMAGING CORP. |
CARL J HOWE |
| K912832 |
08/22/1991 |
BACTI-SWAB(TM) NPG |
REMEL CO. |
ANN SILVIUS |
| K911856 |
08/09/1991 |
RESPIRONICS REMSTAR WITH REMOTE AND RAMP |
RESPIRONICS, INC. |
RICHARD G CONFER |
| K912574 |
08/12/1991 |
ABUSCREEN ONLINE FOR THC (50 AND 100) |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
CAROL L KRIEGER |
| K912755 |
08/26/1991 |
ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
CAROL L KRIEGER |
| K913335 |
08/26/1991 |
ABUSCREEN(R) ONLINE(TM) CALIBRATORS |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
CAROL L KRIEGER |
| K913336 |
08/26/1991 |
ABUSCREEN(R) ONLINE(TM) CONTROLS |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
CAROL L KRIEGER |
| K913107 |
08/12/1991 |
ABUSCREEN(R) ONTRAK(R) POSITIVE REF CONT BENZODIAZ |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
CAROL L KRIEGER |
| K913124 |
08/12/1991 |
ROCHE REAGENT FOR AMMONIA |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
CAROL L KRIEGER |
| K913125 |
08/12/1991 |
ROCHE REAGENT FOR ETHANOL |
ROCHE DIAGNOSTIC SYSTEMS, INC. |
CAROL L KRIEGER |
| K912555 |
08/02/1991 |
GAMMAMED 12IT HIGH DOSE RATE REMOTE AFTERLOADER |
RTS TECHNOLOGY, INC. |
MUNRO III |
| K911264 |
08/02/1991 |
CALIBRATION KIT |
S & W MEDICO TEKNIK |
LISBETH ISBRANDT |
| K912317 |
08/22/1991 |
SCHNEIDER MONORAIL 421 PERCU TRANS ANGIO PTA CATH |
SCHNEIDER INTL., LTD. |
ROBERT L ULLEN |
| K912788 |
08/23/1991 |
CURAY SUPPORT |
SCIENTIFIC PHARMACEUTICALS, INC. |
DR.JAN A.ORLOWSKI |
| K913364 |
08/30/1991 |
SCIMED 7 FR. & 8 FR. |
SCIMED LIFE SYSTEMS, INC. |
MERCEDES P BAYANI |
| K911870 |
08/12/1991 |
SCIMED OPTAMUM OPERATIVE PERIPHERAL ANGIOPLAS CATH |
SCIMED LIFE SYSTEMS, INC. |
DAVID A TEICHER |
| K912613 |
08/22/1991 |
GENTAMICIN 500 UG/ML TO BE INCLUDED IN JUSTONE(TM) |
SENSITITRE MICROBIOLOGY A DIV. OF RADIOMETER |
KATHLEEN M ONTKO |
| K912846 |
08/22/1991 |
JUSTONE(TM) |
SENSITITRE MICROBIOLOGY A DIV. OF RADIOMETER |
LAURA K BASISTA |
| K913562 |
08/30/1991 |
QMS - DIGOXIN |
SERADYN, INC. |
MICHAEL SULLIVAN |
| K911217 |
08/16/1991 |
SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE) |
SERONO-BAKER DIAGNOSTICS, INC. |
DAVID THOMAS |
| K912792 |
08/29/1991 |
SHARPLAN ND:YAG SURG.LASER,MODEL 3040 SHARPLASER |
SHARPLAN LASERS, INC. |
DOUGLAS MEAD |
| K905040 |
08/21/1991 |
ALGINATE FIBER |
SHEPHERD MEDICAL CORP. |
GEORGE R SCHERR |
| K911876 |
08/09/1991 |
SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200 |
SHILEY, INC. |
ALLAN L ABATI |
| K912286 |
08/02/1991 |
CARDIAC SPECT PALLET |
SIEMENS GAMMASONICS, INC. |
IRENA M KRUTULIS |
| K912481 |
08/02/1991 |
ECT CARBON FIBER PALLET, MODIFICATION |
SIEMENS GAMMASONICS, INC. |
IRENA M KRUTULIS |
| K913252 |
08/26/1991 |
LITEBOX |
SIEMENS GAMMASONICS, INC. |
DENNIS W HENKELMAN |
| K912095 |
08/09/1991 |
MAGNETIC RESONANCE DIAGNOSTIC DEVICE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
STEPHEN K DEOL |
| K913120 |
08/16/1991 |
POLYSTAR ANGIOGRAPHIC X-RAY SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
STEPHEN K DEOL |
| K912739 |
08/28/1991 |
SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE |
SITE MICROSURGICAL SYSTEMS, INC. |
JAMES K MCCRACKEN |
| K912453 |
08/26/1991 |
INTELIJET TM FLUID MANAGEMENT SYSTEM |
SMITH & NEPHEW DYONICS, INC. |
ERIC BANNON |
| K912162 |
08/14/1991 |
INTRAMEDULLARY HIP SCREW, MODIFICATION |
SMITH & NEPHEW RICHARDS, INC. |
ROBERT F GAMES |
| K911567 |
08/02/1991 |
DUAL COMPARTMENT TPN BAG 3 LITER |
STEDIM, INC. |
BRYAN KRAUSE |
| K905125 |
08/05/1991 |
GUARANTY HAIR REMOVAL SYSTEM |
STEPHENS MFG. CO. |
JONATHAN S KAHAN |
| K912190 |
08/29/1991 |
STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST |
STRYKER CORP. |
HARMON H WOODWORTH |
| K912479 |
08/09/1991 |
MOTOR MASSAGE PILLOW |
SUPREME IMPORT LTD. |
MICHAEL MATRAS |
| K912422 |
08/12/1991 |
SURG/ASSIST MODEL SA-1 |
SURG-ASSIST, INC. |
ANDREW P FRISQUE |
| K912524 |
08/15/1991 |
EXPANDACEL NASAL TAMPONS, MODIFICATION |
SURGITREND, LTD. |
RON SHIPPERET |
| K904625 |
08/20/1991 |
SYNECTICS LIBERTY SYSTEM, PC POLYGRAF AND POLYGRAM |
SYNECTICS-DANTEC |
ANNA PETTERSSON |
| K913190 |
08/26/1991 |
EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORS |
SYVA CO. |
PAUL L ROGERS |
| K913429 |
08/26/1991 |
EMIT(R) 2000 PHENYTOIN ASSAY/CALIBRATORS |
SYVA CO. |
PAUL L ROGERS |
| K910926 |
08/02/1991 |
TECNADYNE SURGI-SQUEEZE INFUSION PUMP |
TECNADYNE SCIENTIFIC, INC. |
JOHN R GARRETT |
| K913043 |
08/23/1991 |
MODIFICATION TECNOL FLUIDSHIELD SURGICAL MASKS |
TECNOL NEW JERSEY WOUND CARE, INC. |
RUTH L JONES |
| K911165 |
08/20/1991 |
SCREW, BONE, MAXILLOFACIAL |
TEKNO-MEDICAL |
GEORGE O SHECTER |
| K911273 |
08/28/1991 |
100 CM PERMANENT PACING LEAD MODELS |
TELECTRONICS PACING SYSTEMS, INC. |
DUANE A SCHULTZ |
| K910558 |
08/07/1991 |
TERUMO(R) ARTERIAL AND VENOUS BLOOD LINE SET |
TERUMO MEDICAL CORP. |
GEORGE S MOMODA |
| K911334 |
08/29/1991 |
MASK, SURGICAL APPAREL |
THAI HOSPITAL PRODUCTS CO., LTD. |
THAWATCHAI MATURAPOR |
| K905415 |
08/12/1991 |
BRAIDED HIGH PRESSURE CATHETER CONNECTOR |
THE R GROUP |
MARK J KAHN |
| K912179 |
08/28/1991 |
THE SPRITZ BATH |
THE SPRITZ CO. |
DONNA L VALVERDE |
| K912537 |
08/16/1991 |
JACE MODEL K200 KNEE CPM DEVICE, MODIFICATION |
THERA KINETICS, INC. |
MARK KOZAK |
| K913227 |
08/16/1991 |
JACE MODEL T300 TOE CPM DEVICE |
THERA KINETICS, INC. |
MARK KOZAK |
| K912249 |
08/30/1991 |
PATIENT DOSE MONITOR |
THETA SYSTEMS, INC. |
KEVIN RUSSELL |
| K911658 |
08/12/1991 |
DIALYSIS TRANDSDUCER PROTECTOR |
TICO MEDICAL INSTRUMENTS, INC. |
E. J SIMICICH |
| K910838 |
08/07/1991 |
TREATMENT TABLE |
TRI W-G, INC. |
DAVID KESLER |
| K911290 |
08/19/1991 |
EAGLE NUCLEAR IMAGING SYSTEM |
TRIONIX RESEARCH LABORATORY, INC. |
KEVIN M MURROCK |
| K911485 |
08/14/1991 |
COLOR VIDEO CAMERA |
UNITED STATES ENDOSCOPY GROUP, INC. |
DEAN SECREST |
| K911492 |
08/14/1991 |
ENDOSCOPIC LIGHT SOURCE |
UNITED STATES ENDOSCOPY GROUP, INC. |
DEAN SECREST |
| K911477 |
08/14/1991 |
LAPAROSCOPIC BASKET FLEXIBLE AND RIGID |
UNITED STATES ENDOSCOPY GROUP, INC. |
DEAN SECREST |
| K911487 |
08/14/1991 |
LAPAROSCOPIC CHOLANGIOCATH |
UNITED STATES ENDOSCOPY GROUP, INC. |
DEAN SECREST |
| K910921 |
08/26/1991 |
AUTO SUTURE SURGIPORT TISSUE GRIP DISPOSABLE SLEEV |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
CURTIS RAYMOND |
| K911105 |
08/07/1991 |
SUCTION/IRRIGATION DEVICE WITH HYDRO-DISSECTION |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
STEVE REITZLER |
| K905223 |
08/16/1991 |
OCTA-HEX (TM) IMPLANT RESTORATION SYSTEMS |
UNIVERSAL IMPLANT SYSTEMS, INC. |
GERALD MARLIN |
| K905107 |
08/19/1991 |
UTS ELECTRICAL MUSCLE STIMULATION DEVICE-PGS 1500 |
UNIVERSAL TECHNOLOGY SYSTEMS, INC. |
THOMAS J MCENANY |
| K912109 |
08/12/1991 |
URESIL GENERAL PURPOSE DRAINAGE CATHETER |
URESIL CORP. |
LEV MELINYSHYN |
| K901281 |
08/28/1991 |
THERMO KOR-CONTINUOUS PULMONARY ARTERY THERMOMETER |
VAL-MARK MEDICAL, INC. |
STEVEN V BUSH |
| K911565 |
08/09/1991 |
CUSTOM PROCEDURE TRAY |
VANGUARD MEDICAL CONCEPTS, INC. |
CHUCK MASEK |
| K913112 |
08/16/1991 |
OPTI-PLAST 5F PTA CATHETERS |
VAS-CATH, INC. |
MARCO A GUILLEN |
| K912984 |
08/13/1991 |
OPTI-PLAST 5F PTA CATHETERS, MODIFICATION |
VAS-CATH, INC. |
MARCO A GUILLEN |
| K911763 |
08/13/1991 |
LASERFLO(R) BLOOD PERFUSION MONITOR (MODEL BPM2) |
VASAMEDICS, L.L.C. |
CONSTANCE G BUNDY |
| K910139 |
08/15/1991 |
VER-MED A10014 "RESTING EKG ELECTRODE" & A10021 |
VERMONT MEDICAL, INC. |
DAVID LOVELL |
| K911340 |
08/26/1991 |
AUTOCOMP |
VICTOREEN, INC. |
GLASSER |
| K912650 |
08/16/1991 |
1.1, 1.2, 1.3 TEMPERATURE PROBES |
VITAL SIGNS, INC. |
ALBERTO VELEZ |
| K912626 |
08/02/1991 |
BOLUS XENON CIRCUIT |
VITAL SIGNS, INC. |
ALBERTO VELEZ |
| K912625 |
08/02/1991 |
MOUTH TO MASK RESUSCITATOR |
VITAL SIGNS, INC. |
ALBERTO VELEZ |
| K910950 |
08/02/1991 |
HMS-4000 MULTICHANNEL PHYSIO MONIT SYST, MODIFIED |
VITALOG MONITORING,INC. |
LAUGHTON E MILES |
| K910230 |
08/30/1991 |
LYME-SPOT IF KIT |
VITEK SYSTEMS, INC. |
CHERYL WINTERS-HEAD |
| K910210 |
08/12/1991 |
SLIDEX MENINGITE-KIT 5 |
VITEK SYSTEMS, INC. |
DAVID K BROADWAY |
| K911444 |
08/30/1991 |
RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM |
WAMPOLE LABORATORIES |
KAREN VUKOBRATOVICH |
| K911207 |
08/26/1991 |
OXICOMPLUS |
WATERS INSTRUMENTS, INC. |
STEVE BOUTELLE |
| K912850 |
08/12/1991 |
SHBG |
WIEN LABORATORIES, INC. |
BRET G WIEN |
| K912989 |
08/16/1991 |
PLANUSTAR AND DENS NOBILIS DENTURE TEETH |
WILDE-USA, INC. |
ROBERT W BAUER |
| K904290 |
08/20/1991 |
NOZOVENT, NASAL DILATOR |
WPM INTL AB INTL TRADE & MANAGEMET CONSULTING |
PETRUSON, M.D. |
| K912416 |
08/28/1991 |
ANGIOGRAPHIC OR FLUOROSCOPIC X-RAY SYSTEM |
XRE CORP. |
THOMAS F FLYNN |
| K912263 |
08/29/1991 |
HA ANATOMIC HIP PROSTH W/ TI-NIDIUM SURF HARD PROC |
ZIMMER, INC. |
CHRISTOPHER PETERSON |
