FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K810317 |
05/27/1981 |
NITROGLYCERINE IV SET |
ABBOTT LABORATORIES |
|
K810835 |
05/05/1981 |
RUBAZYME - M |
ABBOTT LABORATORIES |
|
K811263 |
05/29/1981 |
TOX TM ANALYZER |
ABBOTT LABORATORIES |
|
K810239 |
05/29/1981 |
VENTED PRIMARY PIGGYBACK VENOSET DUAL |
ABBOTT LABORATORIES |
|
K803154 |
05/11/1981 |
INSTRUMENT CLEANER LIQUID CONCENTRATE |
ABCO DEALERS, INC. |
|
K811120 |
05/05/1981 |
SURGICAL STAPLE REMOVER |
ACME UNITED CORP. |
|
K811134 |
05/05/1981 |
ACU-DESOXYCHOLATE AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811359 |
05/29/1981 |
AGAR, BACTERIOLOGICAL |
ACUMEDIA MANUFACTURERS, INC. |
|
K811043 |
05/05/1981 |
BISMUTH SULFITE AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811055 |
05/05/1981 |
BLOOD AGAR BASE PH 7.4 |
ACUMEDIA MANUFACTURERS, INC. |
|
K811332 |
05/29/1981 |
BRAIN HEART CC AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811353 |
05/29/1981 |
BRAIN HEART INFUSION W/O DEXTROSE |
ACUMEDIA MANUFACTURERS, INC. |
|
K811041 |
05/05/1981 |
BRILLIANT GREEN AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811128 |
05/05/1981 |
BRUCELLA AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811040 |
05/05/1981 |
CETRIMEDE AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811135 |
05/05/1981 |
COLUMBIA BLOOD AGAR BASE |
ACUMEDIA MANUFACTURERS, INC. |
|
K811137 |
05/05/1981 |
COLUMBIA CNA AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811358 |
05/29/1981 |
DEHYDRATED BILE |
ACUMEDIA MANUFACTURERS, INC. |
|
K811333 |
05/29/1981 |
EC MEDIUM |
ACUMEDIA MANUFACTURERS, INC. |
|
K811133 |
05/05/1981 |
EOSIN-METHYLENE BLUE AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811132 |
05/05/1981 |
EUGON BROTH |
ACUMEDIA MANUFACTURERS, INC. |
|
K811047 |
05/05/1981 |
FLUID THIOGLYCOLLATE MEDIUM |
ACUMEDIA MANUFACTURERS, INC. |
|
K811354 |
05/29/1981 |
GN BROTH (HAJNA) |
ACUMEDIA MANUFACTURERS, INC. |
|
K811131 |
05/05/1981 |
HEKTOEN ENTERIC AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811357 |
05/29/1981 |
HEMOGLOBIN POWDER |
ACUMEDIA MANUFACTURERS, INC. |
|
K811130 |
05/05/1981 |
LACTOSE BROTH |
ACUMEDIA MANUFACTURERS, INC. |
|
K811129 |
05/05/1981 |
LAURYL SULFATE BROTH |
ACUMEDIA MANUFACTURERS, INC. |
|
K811045 |
05/05/1981 |
LEVIN EOSIN-METHYLENE BLUE AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811355 |
05/29/1981 |
LYSINE IRON AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811336 |
05/29/1981 |
M-GREEN YEAST & MOLD BROTH |
ACUMEDIA MANUFACTURERS, INC. |
|
K811048 |
05/05/1981 |
MACCONKEY AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811136 |
05/05/1981 |
MUELLER HINTON BROTH |
ACUMEDIA MANUFACTURERS, INC. |
|
K811334 |
05/29/1981 |
MYCOSEL |
ACUMEDIA MANUFACTURERS, INC. |
|
K811138 |
05/05/1981 |
NUTRIENT AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811323 |
05/28/1981 |
NUTRIENT BROTH |
ACUMEDIA MANUFACTURERS, INC. |
|
K811361 |
05/29/1981 |
PANCREATIC HYDROLYSATE OF HEART MUSCLE |
ACUMEDIA MANUFACTURERS, INC. |
|
K811324 |
05/28/1981 |
PHENYLETHANOL AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811322 |
05/28/1981 |
POTATO DEXTROSE AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811325 |
05/28/1981 |
SABOURAUD DEXTROSE AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811326 |
05/28/1981 |
SABOURAUD LIQUID, BROTH MODIFIED |
ACUMEDIA MANUFACTURERS, INC. |
|
K811327 |
05/28/1981 |
SALMONELLA SHIGELLA AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811328 |
05/28/1981 |
SCHAEDLER AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811329 |
05/29/1981 |
SCHAEDLER BROTH |
ACUMEDIA MANUFACTURERS, INC. |
|
K811331 |
05/29/1981 |
SF BROTH |
ACUMEDIA MANUFACTURERS, INC. |
|
K811330 |
05/29/1981 |
SIM MEDIUM |
ACUMEDIA MANUFACTURERS, INC. |
|
K811321 |
05/28/1981 |
STANDARD METHODS AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811046 |
05/05/1981 |
STERILITY TEST BROTH |
ACUMEDIA MANUFACTURERS, INC. |
|
K811362 |
05/29/1981 |
TCBS AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811337 |
05/29/1981 |
TERGITOL 7 AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811335 |
05/29/1981 |
THIOGLYCOLLATE GELATIN MEDIUM |
ACUMEDIA MANUFACTURERS, INC. |
|
K811340 |
05/29/1981 |
THIOGLYCOLLATE MEDIUM W/OUT INDICATOR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811339 |
05/29/1981 |
TODD HEWITT BROTH |
ACUMEDIA MANUFACTURERS, INC. |
|
K811044 |
05/05/1981 |
TRIPLE SUGAR IRON AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811052 |
05/01/1981 |
TRYPTIC SOY AGAR W/LECITHIN & TWEEN 80 |
ACUMEDIA MANUFACTURERS, INC. |
|
K811356 |
05/29/1981 |
TRYPTONE AZOLECITHIN TWEEN |
ACUMEDIA MANUFACTURERS, INC. |
|
K811338 |
05/29/1981 |
VIOLET RED BILE AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811039 |
05/05/1981 |
VOGEL & JOHNSON AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811042 |
05/05/1981 |
XLD AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811360 |
05/29/1981 |
YEAST EXTRACT |
ACUMEDIA MANUFACTURERS, INC. |
|
K802297 |
05/01/1981 |
PORTADIAL CARRY-ON KIDNEY MACHINE |
ALAN P. KENDAL, PH.D. |
|
K811260 |
05/27/1981 |
BARALYME CO2 ABSORBENT |
ALLIED HEALTHCARE PRODUCTS, INC. |
|
K811075 |
05/13/1981 |
BALANCE ARTICULATOR |
ALMORE INTL., INC. |
|
K811152 |
05/15/1981 |
DADE RPR CARD TEST |
AMERICAN DADE |
|
K810894 |
05/15/1981 |
FOGARTY FLEXIBLE CALIBRATOR |
AMERICAN EDWARDS LABORATORIES |
|
K810683 |
05/08/1981 |
CAPD CATHETER ADAPTER |
AMERICAN MCGAW |
|
K811181 |
05/13/1981 |
MODEL FBS-1, FLEXIBLE BRONCHOSCOPE |
AMERICAN OPTICAL CORP. |
|
K811180 |
05/15/1981 |
ULTRAMATIC PROJECT-O-CHART OPHTH. PROJ |
AMERICAN OPTICAL CORP. |
|
K810399 |
05/15/1981 |
APC IMPLANTABEL PACING LEAD, MODEL 3264 |
AMERICAN PACEMAKER CORP. |
|
K810398 |
05/15/1981 |
APC IMPLANTABLE PACING LEAD, MODEL 3266 |
AMERICAN PACEMAKER CORP. |
|
K810396 |
05/15/1981 |
APC IMPLANTABLE PACING LEAD, TINED #3262 |
AMERICAN PACEMAKER CORP. |
|
K810397 |
05/15/1981 |
APC IMPLANTABLE PACING LEAD-FLANGE #3260 |
AMERICAN PACEMAKER CORP. |
|
K811004 |
05/08/1981 |
MANIFOLD |
AMERICAN PHARMASEAL DIV. AHSC |
|
K811301 |
05/27/1981 |
TUBMATE |
AMERICAN STAIR-GLIDE CORP. |
|
K810937 |
05/15/1981 |
ANIS IRRIGATING SPATULA |
AMERICAN V. MUELLER |
|
K811169 |
05/15/1981 |
PROSTATIC ACID PHOSPHATASE (PAP) RDA KIT |
AMERSHAM CORP. |
|
K811242 |
05/21/1981 |
DISPOSABLE STERILIZATION WRAP |
AMSCO CO. |
|
K811016 |
05/01/1981 |
CC-100 |
ANTHRO-METRICS CORP. |
|
K810868 |
05/13/1981 |
ARALUEN HEAD SHIELD |
ARALUEN, INC. |
|
K811371 |
05/29/1981 |
NATAL-TEC ESTRIOL |
ARMKEL, LLC. |
|
K811370 |
05/29/1981 |
NATAL-TEC HPL |
ARMKEL, LLC. |
|
K811369 |
05/29/1981 |
NATAL-TEC PROGESTERONE |
ARMKEL, LLC. |
|
K811111 |
05/08/1981 |
AUTOMATIC ELISA READER |
ARTEK SYSTEMS CORP. |
|
K811060 |
05/01/1981 |
POLYETHYLENE MEDULLARY PLUG |
ARTHUR A. CHECCHI, INC. |
|
K810880 |
05/27/1981 |
AR-1 PHYSIOLOGICAL PRODESSOR |
ATLAS RESEARCHES LTD. |
|
K810882 |
05/27/1981 |
ASR-3520 SKIN RESPONSE MONITOR;ASR-3520A |
ATLAS RESEARCHES LTD. |
|
K810881 |
05/27/1981 |
EMG 3510/EMG 3510D MYOFEEDBACK MONITORS |
ATLAS RESEARCHES LTD. |
|
K810856 |
05/05/1981 |
DIRECT IMMUNOFLUOR. ANTIBODY TEST KIT |
BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. |
|
K810969 |
05/05/1981 |
ISOSIT C & B MATERIAL |
BAUER, CHENG & ASSOCIATES, INC. |
|
K810970 |
05/05/1981 |
ISOSIT TEETH |
BAUER, CHENG & ASSOCIATES, INC. |
|
K810972 |
05/05/1981 |
THE GNATHOMETER-M |
BAUER, CHENG & ASSOCIATES, INC. |
|
K810971 |
05/05/1981 |
THE GNATOMET |
BAUER, CHENG & ASSOCIATES, INC. |
|
K811144 |
05/15/1981 |
ARIA II INSULIN RIA |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K811273 |
05/27/1981 |
CYCLIC AMP RADIOIMMUNOASSAY KIT [125I] |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K811274 |
05/27/1981 |
PROSTATIC ACID PHOSPHATASE RADIOIMM. KIT |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K811348 |
05/29/1981 |
CARDIOPULMONARY BYPASS ACCESSORY EQUIP. |
BENTLEY LABORATORIES, INC. |
|
K810735 |
05/08/1981 |
DISPOSABLE, STERILE TRANSDUCER DOMES |
BIO-MED CORP. |
|
K811177 |
05/15/1981 |
QUANTA PHASE VITAMIN B-12/FOLATE RAD |
BIO-RAD |
|
K811223 |
05/21/1981 |
VASOVASOSTOMY STABILIZER PLATFORM DEV |
BIOMET, INC. |
|
K811251 |
05/21/1981 |
CITRATE BUFFER |
BIOSCIENTIFIC |
|
K811194 |
05/27/1981 |
HITACHI 705 AUTOMATIC BLOOD CHEMISTRY |
BOEHRINGER MANNHEIM CORP. |
|
K810978 |
05/05/1981 |
MONTGOMERY SILICONE TRACHEAL T-TUBE |
BOSTON MEDICAL PRODUCTS, INC. |
|
K811232 |
05/21/1981 |
DISPOSABLE UNDERPADS |
BURINA |
|
K811062 |
05/29/1981 |
CAMPBRIDGE COMPUTRACE |
CAMBRIDGE INSTRUMENTS, INC. |
|
K810945 |
05/08/1981 |
SCANEL 100 |
CGR MEDICAL CORP. |
|
K810722 |
05/27/1981 |
GASTRIN RADIOIMMUNOASSAY TEST |
CLINICAL ASSAYS, INC. |
|
K810636 |
05/01/1981 |
VARIODRAIN |
COLMED, LTD. |
|
K810895 |
05/13/1981 |
ESOPHAGEAL PILL ELECTRODE |
CON MED EQUIPMENT, INC. |
|
K810995 |
05/21/1981 |
PREFILLED PULSATOR SYRINGE |
CONCORD LABORATORIES, INC. |
|
K811222 |
05/21/1981 |
INORGANIC PHOSPHORUS REAGENTS |
CONNECTICUT DIAGNOSTICS, LTD. |
|
K810808 |
05/15/1981 |
CORATOMIC MODEL OVALITH-920 |
CORATOMIC, INC. |
|
K811000 |
05/08/1981 |
ABNORMAL GLYCOSYLATED HEMOGLOBIN CONTROL |
CORNING MEDICAL & SCIENTIFIC |
|
K811257 |
05/27/1981 |
CORNING 965 CARBON DIOXIDE ANALYZER |
CORNING MEDICAL & SCIENTIFIC |
|
K811088 |
05/08/1981 |
DRESSING TRAY MERCY HOSPITAL |
CUNNINGHAM WOODLAND, INC. |
|
K811090 |
05/08/1981 |
MAJOR DRESSING TRAY |
CUNNINGHAM WOODLAND, INC. |
|
K811087 |
05/01/1981 |
MIKA SKIN SCRUB TRAY PRE OPERATIVE W/GEL |
CUNNINGHAM WOODLAND, INC. |
|
K811091 |
05/08/1981 |
MINOR DRESSING TRAY |
CUNNINGHAM WOODLAND, INC. |
|
K811089 |
05/08/1981 |
ONE STEP PREP KIT |
CUNNINGHAM WOODLAND, INC. |
|
K811086 |
05/01/1981 |
SUTURE REMOVAL SET(DISPLSABLE) |
CUNNINGHAM WOODLAND, INC. |
|
K810837 |
05/05/1981 |
CYBER 80 HEMODIALYZER |
CYBEREX CORP. |
|
K811226 |
05/13/1981 |
DAHLBERG MODEL AM |
DAHLBERG ELECTRONICS, INC. |
|
K803249 |
05/21/1981 |
FLUID WARMER |
DATACHEM, INC. |
|
K810297 |
05/06/1981 |
DATASCOPE PERCOR=DL DUAL-LUMEN INTRA |
DATASCOPE CORP. |
|
K811030 |
05/27/1981 |
APPOSE SKIN STAPLER |
DAVIS & GECK, INC. |
|
K811191 |
05/27/1981 |
DAVIS & GECK NEEDLE/SHARPS COUNTER |
DAVIS & GECK, INC. |
|
K811023 |
05/05/1981 |
ROOT CANAL KIT |
DENTSPLY INTL. |
|
K810847 |
05/01/1981 |
PRITCHARD SURFACE REPLACEMENT ELBOW |
DEPUY, INC. |
|
K811343 |
05/28/1981 |
HUMERAL FRACTURE CAST BRACE |
DESERET MEDICAL, INC. |
|
K810655 |
05/05/1981 |
DISPOSABLE SCRUB BRUSH |
DEXIDE, INC. |
|
K810793 |
05/05/1981 |
MOUTHPIECE, BREATHING |
DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. |
|
K811315 |
05/27/1981 |
COAT-A-COUNT T4 RIA KIT |
DIAGNOSTIC PRODUCTS CORP. |
|
K811017 |
05/27/1981 |
HUCKSTEP INTRAMEDULLARY NAIL |
DOWNS SURGICAL LTD. |
|
K810783 |
05/13/1981 |
ALSEVER'S SOLUTION (MODIFIED) |
DUTCHLAND LABORATORIES, INC. |
|
K810778 |
05/13/1981 |
BASAL MEDIUM EAGLE (MOD.) W/EARLE'S SALT |
DUTCHLAND LABORATORIES, INC. |
|
K810773 |
05/13/1981 |
BASAL MEDIUM EAGLE W/HANKS' SALTS |
DUTCHLAND LABORATORIES, INC. |
|
K810779 |
05/13/1981 |
EARLE'S BALANCED SALTS SOULTION |
DUTCHLAND LABORATORIES, INC. |
|
K810775 |
05/08/1981 |
GOAT SERUM-STERILE |
DUTCHLAND LABORATORIES, INC. |
|
K810766 |
05/08/1981 |
HANKS' BALANCED SALT SOLUTION W/O CA-MG |
DUTCHLAND LABORATORIES, INC. |
|
K810777 |
05/08/1981 |
HANKS' BALANCED SALTS SOLUTION (MODIF.) |
DUTCHLAND LABORATORIES, INC. |
|
K810771 |
05/13/1981 |
L-15 MEDIUM (MODIFIED) |
DUTCHLAND LABORATORIES, INC. |
|
K810781 |
05/13/1981 |
L-GLUTAMINE |
DUTCHLAND LABORATORIES, INC. |
|
K810770 |
05/13/1981 |
MED. 199(MODIFIED) W/HANKS' SALTS |
DUTCHLAND LABORATORIES, INC. |
|
K810772 |
05/13/1981 |
MEDIUM 199 W/EARLE'S SALTS & GLUTAMINE |
DUTCHLAND LABORATORIES, INC. |
|
K810769 |
05/13/1981 |
MINIMUM ESSENTIAL MEDIUM EAGLE W/EARLE |
DUTCHLAND LABORATORIES, INC. |
|
K810768 |
05/13/1981 |
MINIMUM ESSENTIAL MEDIUM EAGLE W/HANKS |
DUTCHLAND LABORATORIES, INC. |
|
K810776 |
05/13/1981 |
PENICILLIN-STREPTOMYCIN MIXTURE |
DUTCHLAND LABORATORIES, INC. |
|
K810767 |
05/08/1981 |
RPMI 1640 MEDIUM |
DUTCHLAND LABORATORIES, INC. |
|
K810780 |
05/13/1981 |
SODIUM BICARBONATE (7.5%) SOLUTION |
DUTCHLAND LABORATORIES, INC. |
|
K810782 |
05/13/1981 |
TRYPAN BLUE (0.5% IN NORMAL SALINE) |
DUTCHLAND LABORATORIES, INC. |
|
K810774 |
05/13/1981 |
WATER-TISSUE CULTURE GRADE |
DUTCHLAND LABORATORIES, INC. |
|
K811157 |
05/27/1981 |
BLADE, TONGUE |
DYN-A-MED PRODUCTS |
|
K811001 |
05/01/1981 |
MICROERMA SYSTEM |
DYNATECH CORP. |
|
K811159 |
05/27/1981 |
DYNASOUND 801 |
DYNAWAVE, CORP. |
|
K811163 |
05/21/1981 |
SUR-FIT DISPOSABLE FANGE CAP |
E. R. SQUIBB & SONS, INC. |
|
K810142 |
05/29/1981 |
ELA MEDICAL UNILITH PULSE GENERATOR |
ELA MEDICAL, INC. |
|
K810489 |
05/29/1981 |
MULTILITH PULSE GENERATOR #1140 |
ELA MEDICAL, INC. |
|
K811093 |
05/05/1981 |
BRAEGEN EEG TRANSMITTER/RECEIVER SYS |
ELECTRO-BIO-MEDICAL SERVICES, INC. |
|
K810860 |
05/05/1981 |
ENI ANTIBODY TO EPSTEIN-BARR VIRUS |
ELECTRO-NUCLEONICS LABORATORIES, INC. |
|
K810843 |
05/08/1981 |
EPILATRON |
ELECTROLA |
|
K811199 |
05/21/1981 |
MARZ-175 |
EMDE CORP. |
|
K811206 |
05/21/1981 |
SELF HEATING DISPOSABLE HEAT PAD |
ENSAR CORP. |
|
K811182 |
05/15/1981 |
MULTIANALYTE CONTROLS, ALL KINDS |
FISHER SCIENTIFIC CO., LLC. |
|
K811179 |
05/15/1981 |
OSMOMETER MODEL OM-6010 |
FISKE MED SCIENCE |
|
K810437 |
05/01/1981 |
BREATH METER |
FRED SAMMONS, INC. |
|
K811068 |
05/27/1981 |
BYPASS COIL |
G.D. SEARLE AND CO. |
|
K811071 |
05/05/1981 |
VENOUS OXYGEN PROBE |
G.D. SEARLE AND CO. |
|
K811100 |
05/01/1981 |
GELMAN ELECTROPHORESIS CONTROL |
GELMAN SCIENCES, INC. |
|
K810961 |
05/05/1981 |
CAMPYLOBACTER MED. (PLATE) |
GRANITE DIAGNOSTICS, INC. |
|
K811155 |
05/05/1981 |
MODEL RXO2 OXYGEN RICH AIR SUPPLY |
GREENE & KELLOGG, INC. |
|
K810711 |
05/08/1981 |
HAEMONETICS 600 ML. COMPONENT BAG |
HAEMONETICS CORP. |
|
K811202 |
05/27/1981 |
ULTRACHEM GLUC-DH, ITEM NO. 65048 |
HARLECO |
|
K810488 |
05/08/1981 |
HOME HEALTH CHEKUP KIT |
HEALTHKIT |
|
K810608 |
05/01/1981 |
TRANSMITTER & RECEIVERS, TELEPHONE, ELEC |
HEART CHECK SYSTEMS, INC. |
|
K811164 |
05/27/1981 |
URETHANE ORTHOPAEDIC CASTING TAPE |
HEXCEL MEDICAL |
|
K811116 |
05/13/1981 |
HCG RADIOIMMUNOASSAY |
HOFFMANN-LA ROCHE, INC. |
|
K811151 |
05/15/1981 |
COLLARLESS TOTAL HIP FEMORAL COMP. SYS |
HOWMEDICA CORP. |
|
K811317 |
05/29/1981 |
HOWMEDICA FEMORAL PRESSURING SEAL |
HOWMEDICA CORP. |
|
K811154 |
05/13/1981 |
HOYT ECONO-TRAY |
HOYT LABORATORIES |
|
K802913 |
05/29/1981 |
TAN DEM* - IGE KIT |
HYBRITECH, INC. |
|
K811125 |
05/08/1981 |
AIM SYSTEM (FOR IGA) |
ICL SCIENTIFIC |
|
K811126 |
05/08/1981 |
AIM SYSTEM (FOR IGG) |
ICL SCIENTIFIC |
|
K811124 |
05/08/1981 |
AIM SYSTEM (FOR IGM) |
ICL SCIENTIFIC |
|
K811219 |
05/21/1981 |
KOVA STRIP 6 |
ICL SCIENTIFIC |
|
K811398 |
05/29/1981 |
EARLY PREGNANCY DETECTION |
IMMUCHEM CORP. |
|
K811024 |
05/08/1981 |
LUTEINIZING HORMONE DIRECT RIA KIT 125/I |
IMMUNALYSIS CORPORATION |
|
K811212 |
05/21/1981 |
DIGOXIN (RIA) KIT |
IMMUNO ASSAY CORP. |
|
K811213 |
05/29/1981 |
T3 (RIA) KIT |
IMMUNO ASSAY CORP. |
|
K810984 |
05/01/1981 |
ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST |
IMMUNO-PRODUCTS INDUSTRIES |
|
K810985 |
05/01/1981 |
ANTINUCLEAR ANTIBODY IMMUNOFLUORESCENT |
IMMUNO-PRODUCTS INDUSTRIES |
|
K810983 |
05/01/1981 |
ANTISMOOTH MUSCLE ANTIBODY TEST SYS |
IMMUNO-PRODUCTS INDUSTRIES |
|
K810982 |
05/01/1981 |
ANTITHYROID ANTIBODY IMMUNOFLUORESCENT |
IMMUNO-PRODUCTS INDUSTRIES |
|
K811143 |
05/13/1981 |
PH/BLOOD GAS CONTROL (ABC) |
INSTRUMENTATION LABORATORY CO. |
|
K811221 |
05/27/1981 |
INTERMEDICS CYBERLITH BIPOLAR CARDIAC |
INTERMEDICS, INC. |
|
K811106 |
05/27/1981 |
INTERMEDICS POLY FLEX ENDOCARDIAL PACING |
INTERMEDICS, INC. |
|
K810800 |
05/01/1981 |
MODEL 230-05 CYBERLITH I BIPOL. PULSE G. |
INTERMEDICS, INC. |
|
K811066 |
05/01/1981 |
MODEL 230-06 CYBERLITH TM I BIPOLAR IN |
INTERMEDICS, INC. |
|
K810752 |
05/01/1981 |
THINLITH III UNIPOLAR CARDIAC PULSE GEN. |
INTERMEDICS, INC. |
|
K810989 |
05/01/1981 |
IBM 5880 ACQUISITION & ANALYSIS CART TEL |
INTL. BUSINESS MACHINES |
|
K810988 |
05/01/1981 |
IBM 5885 DIGITAL ECG ACQUISITION CART |
INTL. BUSINESS MACHINES |
|
K810976 |
05/29/1981 |
ALPHA-THAL SCREEN TM CONTROL |
ISOLAB, INC. |
|
K810875 |
05/01/1981 |
FECAL STAINING KIT |
JAYCO PHARMACEUTICALS |
|
K811085 |
05/01/1981 |
VENES II |
JUNG PRODUCTS, INC. |
|
K810641 |
05/13/1981 |
K-MED "ENCOURAGER" INCENTIVE SPIROMETER |
K-MED, INC. |
|
K811367 |
05/29/1981 |
KALLESTAD ANTISERA TO PHENOBARBITAL |
KALLESTAD LABORATORIES, INC. |
|
K810403 |
05/13/1981 |
KEELER/KONAN SPECULAR MICROSCOPE |
KEELER OPTICAL PRODUCTS LTD. |
|
K811175 |
05/27/1981 |
RECOH ROOT CANAL IRRIGATOR |
KOEI INTERNATIONAL, INC. |
|
K811020 |
05/05/1981 |
REVERSIBLE HYDROCOLLOID IMPRESSION |
KOTTLER LABORATORIES |
|
K811162 |
05/08/1981 |
FLOWLOCK OXYGEN METER |
LIFEGUARD MEDICAL PRODUCTS, INC. |
|
K810915 |
05/08/1981 |
THE SCOTT DIALMENZENSERT |
LONE STAR MEDICAL PRODUCTS, INC. |
|
K811150 |
05/15/1981 |
URINE PREGNANCY TEST STANDARD/CONTR. PK |
MALLINCKRODT CRITICAL CARE |
|
K810845 |
05/08/1981 |
DOUBLE VELOUR GRAFTS |
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. |
|
K810155 |
05/01/1981 |
DOP 84 |
MEDLOG GMBH MARKETING SERVICES |
|
K811187 |
05/27/1981 |
MEDTRONIC A2 CLINICAL IMAGING SYSTEM |
MEDTRONIC VASCULAR |
|
K811123 |
05/27/1981 |
MEDTRONIC PULSE GENERATOR |
MEDTRONIC VASCULAR |
|
K810677 |
05/27/1981 |
MODELS 5976/5977 PACEMAKER PULSE GENER |
MEDTRONIC VASCULAR |
|
K810734 |
05/15/1981 |
MODELS 8420 THRU 8423 PACEMAKER GENER |
MEDTRONIC VASCULAR |
|
K811178 |
05/15/1981 |
HUMAN IGG-ALBUMIN TEST KIT |
MELOY LABORATORIES, INC. |
|
K811190 |
05/08/1981 |
THREE MODELS OF TABLES, STOOLS, & LIGHTS |
MIDMARK CORP. |
|
K811392 |
05/29/1981 |
AMES SERA-PAK GLUCOSE REAGENT |
MILES LABORATORIES, INC. |
|
K810920 |
05/01/1981 |
NDM DIATEMP INFANT ELECTROSURG. DISP. P. |
NDM CORP. |
|
K810513 |
05/11/1981 |
ELECTRODYN CII-INTERFERENTIAL MUSCLE |
NEMECTRON MEDICAL, INC. |
|
K811188 |
05/15/1981 |
NORELCO BLOOD PRESSURE METER |
NORTH AMERICAN PHILIPS CORP. |
|
K811289 |
05/27/1981 |
NOVA 5 |
NOVA BIOMEDICAL CORP. |
|
K811158 |
05/27/1981 |
OMNI |
OMNI HEARING SYSTEMS |
|
K811297 |
05/27/1981 |
CERVICAL SUPPORT |
ORTHOMEDICS |
|
K811298 |
05/27/1981 |
EXECUTIVE COLLAR |
ORTHOMEDICS |
|
K811015 |
05/15/1981 |
POSITIVE CLOSURE ANESTHETIC VALVE |
ORTHOPEDIC SYSTEMS, INC. |
|
K810986 |
05/05/1981 |
EARETTE HEARING AID OTICON #E25F |
OTICON CORP. |
|
K810987 |
05/05/1981 |
EARETTE HEARING AID OTICON #E27F |
OTICON CORP. |
|
K811059 |
05/27/1981 |
PENTAX BRONCHOFIBERSCOPE #FB-15A |
PENTAX PRECISION INSTRUMENT CORP. |
|
K811214 |
05/21/1981 |
ASSURE NATURAL FIT TAMPON |
PERSONAL PRODUCTS CO. |
|
K810584 |
05/13/1981 |
PHADEBAS ISOAMYLASE TEST |
PHARMACIA, INC. |
|
K810973 |
05/21/1981 |
SYSTEM 400 |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
|
K811171 |
05/27/1981 |
VASCULON II I.V. CATHETER |
PIONEER VIGGO, INC. |
|
K811082 |
05/21/1981 |
BETA I & BETA II |
PORTA RAY, INC. |
|
K810977 |
05/13/1981 |
ENDODONTIC POST SYSTEMS |
PREAT CORP. |
|
K810918 |
05/21/1981 |
ROLL-A-SET |
PRINCIPLE BUSINESS ENT. |
|
K810921 |
05/21/1981 |
MALE LUER LOCK PLUGS |
PROCEDURE PRODUCTS, INC. |
|
K811098 |
05/05/1981 |
SERO-STAT STAPHYLOCOCCUS TEST |
SCOTT LABORATORIES, INC. |
|
K810635 |
05/08/1981 |
ELECTRODE BLOOD PRESSURE MONITOR |
SEARS, ROEBUCK & CO. |
|
K811205 |
05/21/1981 |
MOLDED POLYSULFONE TRIAL PROSTHESIS |
SHANNON GROUP |
|
K810638 |
05/08/1981 |
LANCER GLYCOSYLATED HEMOGLOBIN |
SHERWOOD MEDICAL CO. |
|
K810714 |
05/08/1981 |
LANCER GLYCOSYLATED HEMOGLOBIN ASSAY |
SHERWOOD MEDICAL CO. |
|
K811065 |
05/05/1981 |
PISTON SYRINGE |
SHERWOOD MEDICAL CO. |
|
K811204 |
05/21/1981 |
BRONCHEK-SHILEY CARDIAC JACKET & BSC J |
SHILEY, INC. |
|
K811033 |
05/13/1981 |
SHILEY LOW PRESSURE THIN-CUFFED TRACH |
SHILEY, INC. |
|
K803208 |
05/27/1981 |
SIRECUST 358 |
SIEMENS CORP. |
|
K810858 |
05/13/1981 |
XIMATRON V |
SIEMENS CORP. |
|
K811102 |
05/05/1981 |
SIEMENS-ELEMA AB SERVO VENTILATOR 900 C |
SIEMENS ELEMA AB |
|
K810974 |
05/13/1981 |
GAMMA CAMERA |
SIEMENS GAMMASONICS, INC. |
|
K811011 |
05/15/1981 |
HISTOCHEMICAL DEMONSTRATION OF LEUKOCYTE |
SIGMA CHEMICAL CO. |
|
K810914 |
05/08/1981 |
5CM SMALL PARTS SCANNER |
SMITH KLINE DIAGNOSTICS, INC. |
|
K811241 |
05/27/1981 |
BODAI SUCTION -SAFE 4 |
SONTEK INDUSTRIES, INC. |
|
K811203 |
05/21/1981 |
SAF SINGLE-USE AEROSOL FILTER |
SORENSEN RESEARCH |
|
K811184 |
05/20/1981 |
SPENCO DERMAL PADS |
SPENCO MEDICAL CORP. |
|
K811167 |
05/21/1981 |
FOCUS STERILE SYRINGES |
STANFORD LABORATORIES |
|
K811304 |
05/27/1981 |
LIQUID CHROMATOGRAPHY COLUMNS |
SUPELCO, INC. |
|
K811034 |
05/01/1981 |
EMIT-CAD N-ACETYLPROCAINAMIDE ASSAY |
SYVA CO. |
|
K810899 |
05/05/1981 |
TECHNICON AUTOGROUPER 16-C SYSTEM |
TECHNICON INSTRUMENTS CORP. |
|
K811249 |
05/21/1981 |
TECHNICON SMAC II SYSTEM & ACCESSORIES |
TECHNICON INSTRUMENTS CORP. |
|
K810872 |
05/01/1981 |
EEG TELEPHONE RECEIVER MODEL #AFR-J |
TELEDIAGNOSTIC SYSTEMS, INC. |
|
K811176 |
05/15/1981 |
TIGGES SPINAL |
THE TIGGS CO. |
|
K810853 |
05/29/1981 |
CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT |
THE UPJOHN CO. |
|
K810332 |
05/18/1981 |
SC/TEMP 300 |
THOUGHT TECHNOLOGY LTD. |
|
K802828 |
05/08/1981 |
LIXIVITRON |
UNITED MEDICAL |
|
K811174 |
05/13/1981 |
HEARING AID, UNITRON MODEL C5-H |
UNITRON INDUSTRIES, INC. |
|
K810801 |
05/27/1981 |
DENTMED V-PACKS |
UNIV. OF BRISTOL DENTAL SCHOOL |
|
K811236 |
05/13/1981 |
DISPOSABLE HOLDER FOR HANCOCK AORTIC |
VASCOR, INC. |
|
K811235 |
05/13/1981 |
DISPOSABLE HOLDER FOR HANCOCK MITRAL |
VASCOR, INC. |
|
K810043 |
05/15/1981 |
GOAT ANTI-HERPES SIMPLEX VIRUS TYPE I |
VIBAC CORP. |
|
K810645 |
05/05/1981 |
SELECT-A-FLOW COLLECTOR |
WENMAR INTL. CORP. |
|
K811208 |
05/21/1981 |
MODEL 1100 SPHYGMOMANOMETER |
Y |
|
K811262 |
05/27/1981 |
EPSTEIN-BARR VIRUS CAPSID ANTIGEN ANTI |
ZEUS SCIENTIFIC, INC. |
|
K811201 |
05/21/1981 |
EFTEKHAR ACETABULAR STANDOFF |
ZIMMER, INC. |
|