FDA 510(k) Decisions During May, 1981  

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.


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