FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K801940 |
01/07/1981 |
3M AJ-12 GLENOID RESURFACE/NEER II PROS |
3M COMPANY |
|
K812867 |
11/02/1981 |
STERI-VAC #400C GAS STERILIZER |
3M COMPANY |
|
K810079 |
01/30/1981 |
SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS |
3M HEALTH CARE, SARNS |
|
K803219 |
01/21/1981 |
ADC-500 AUTOMATED DIFFER. CELL CNTR. SY. |
ABBOTT LABORATORIES |
|
K812926 |
11/06/1981 |
ALT-QUANTICHROM |
ABBOTT LABORATORIES |
|
K803236 |
01/28/1981 |
CYBREX VALPROIC ACID |
ABBOTT LABORATORIES |
|
K803300 |
01/29/1981 |
INPERSOL CAPD BAG PORT CLAMP |
ABBOTT LABORATORIES |
|
K812874 |
11/02/1981 |
PEDIATRIC MICROAGGREGATE BLOOD FILTER |
ABBOTT LABORATORIES |
|
K812865 |
11/10/1981 |
QUANTUMATIC DUAL-WAVELENGTH SPECTRO |
ABBOTT LABORATORIES |
|
K810029 |
01/06/1981 |
REGULATOR VENOSET W/0.22 MICRON IVEX |
ABBOTT LABORATORIES |
|
K803261 |
01/15/1981 |
T3 RIABEAD DIAGNOSTIC KIT |
ABBOTT LABORATORIES |
|
K813175 |
11/27/1981 |
20CC GLASS CONTROL SYRINGE |
ABCO DEALERS, INC. |
|
K803153 |
01/28/1981 |
ELASTIC ADHESIVE BANDAGES |
ABCO DEALERS, INC. |
|
K803188 |
01/15/1981 |
GAUZE SPONGES |
ABCO DEALERS, INC. |
|
K812887 |
11/17/1981 |
ROBINSON CATHETERS NON-STERILE |
ABCO DEALERS, INC. |
|
K812809 |
11/06/1981 |
STERILE ADHERENT DRAPES |
ABCO DEALERS, INC. |
|
K812845 |
11/16/1981 |
SURGICAL SUCTION INSTRUMENTS-DISPOS. |
ABCO DEALERS, INC. |
|
K810063 |
01/26/1981 |
AUTOMATIC BIOCHEMICAL ANALYZER |
ACCULAB |
|
K802885 |
01/15/1981 |
L.A.F. ISOLATION PACK |
ACTION MEDICAL SYSTEMS, INC. |
|
K802806 |
01/23/1981 |
VISECERA RETAINER |
ADEPT-MED INTL., INC. |
|
K812301 |
11/16/1981 |
VARIABLE FOCUS 3.5 MHZ TRANSDUCER |
ADR ULTRASOUND |
|
K812977 |
11/16/1981 |
RESPIRATORY CARE MONITOR |
ADVANCED MEDICAL EQUIPMENT, INC. |
|
K802437 |
01/15/1981 |
MARK III ULTRASONIC SCANNING SYSTEM |
ADVANCED TECHNOLOGY LABORATORIES, INC. |
|
K802917 |
01/16/1981 |
MARK III ULTRASONIC SCANNING SYSTEM |
ADVANCED TECHNOLOGY LABORATORIES, INC. |
|
K802438 |
01/21/1981 |
MARK V DUPLEX ULTRASONIC SCAN SYS. |
ADVANCED TECHNOLOGY LABORATORIES, INC. |
|
K803309 |
01/16/1981 |
VITASTAT ECG-1/ECG-3 ELECTROCARDIOGRAPH |
ADVANCED TECHNOLOGY LABORATORIES, INC. |
|
K813034 |
11/27/1981 |
POLYSTAN HEART LUNG MACHINE SYS |
ADVOCACY INTERNATIONAL, LTD. |
|
K813035 |
11/27/1981 |
POLYSTAN VERTICLUDE BLOOD PUMP |
ADVOCACY INTERNATIONAL, LTD. |
|
K803129 |
01/08/1981 |
"GO-BETWEEN" |
AGRI HORT |
|
K812880 |
11/24/1981 |
OHIO NON-REUSABLE TRACHEAL TUBE MAJILL |
AIRCO/OHIO MEDICAL PRODUCTS |
|
K812879 |
11/24/1981 |
OHIO NON-REUSABLE TRACHEAL TUBE MURPHY |
AIRCO/OHIO MEDICAL PRODUCTS |
|
K810011 |
01/28/1981 |
GAMMA STICK 125-1 TOBRAMYCIN RIA KIT |
ALPHA GAMMA LABORATORY |
|
K803214 |
01/15/1981 |
ACMI BIPOLAR HEMOSTATIC ELECTRODE |
AMERICAN CYSTOCOPE MAKERS, INC. |
|
K812556 |
11/02/1981 |
DADE IMMU-TRACE TRI-RAC R TRI-LEVEL R.C |
AMERICAN DADE |
|
K803044 |
01/02/1981 |
IMMU-TRACE T3 UPTAKE (T3U) REAGENTS |
AMERICAN DADE |
|
K803046 |
01/02/1981 |
IMMU-TRACE T4 RIA PROCEDURE |
AMERICAN DADE |
|
K812969 |
11/06/1981 |
S/P CAPILLARY TUBES, HEPARINIZED (2A) |
AMERICAN DADE |
|
K812970 |
11/06/1981 |
S/P CAPILLARY TUBES, HEPARINIZED (3A) |
AMERICAN DADE |
|
K812921 |
11/06/1981 |
S/P SURE-CAP |
AMERICAN DADE |
|
K812922 |
11/06/1981 |
S/P SURE-CAP C |
AMERICAN DADE |
|
K812923 |
11/06/1981 |
S/P SURE-CAP N |
AMERICAN DADE |
|
K813148 |
11/24/1981 |
S/P VORTEX MIXER |
AMERICAN DADE |
|
K813149 |
11/24/1981 |
S/P VORTEX MIXER JR. |
AMERICAN DADE |
|
K803098 |
01/09/1981 |
TRI-LEVEL RADIOASSAY CONTROL SERA |
AMERICAN DIAGNOSTIC CORP. |
|
K803222 |
01/13/1981 |
ADVANCEMED CCU DOCUMENTOR |
AMERICAN EDWARDS LABORATORIES |
|
K803225 |
01/13/1981 |
ADVANCEMED EXAMINER |
AMERICAN EDWARDS LABORATORIES |
|
K803224 |
01/13/1981 |
ADVANCEMED HOLTER RECORDERS |
AMERICAN EDWARDS LABORATORIES |
|
K803223 |
01/13/1981 |
ADVANCMED ELIMINATOR |
AMERICAN EDWARDS LABORATORIES |
|
K803057 |
01/13/1981 |
FOGARTY BALLON ANGIOPLASTY CATHETERS |
AMERICAN EDWARDS LABORATORIES |
|
K812935 |
11/16/1981 |
FOGARTY FLEXIBLE PROBE |
AMERICAN EDWARDS LABORATORIES |
|
K803058 |
01/16/1981 |
SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH. |
AMERICAN EDWARDS LABORATORIES |
|
K803115 |
01/06/1981 |
DRESSING CHANGE FOR "G" TUBE |
AMERICAN MEDICAL DISPOSABLE, INC. |
|
K803116 |
01/28/1981 |
HEAVY DRAINAGE PACK |
AMERICAN MEDICAL DISPOSABLE, INC. |
|
K813069 |
11/16/1981 |
PERITONEAL DIALYSIS CYCLER SET |
AMERICAN MEDICAL PRODUCTS, INC. |
|
K803135 |
01/09/1981 |
"PARALLEL" CHEMICAL ANALYZER |
AMERICAN MONITOR CORP. |
|
K813076 |
11/16/1981 |
PHOSPHOTUNGSTATE REDUCTION, URIC ACID |
AMERICAN MONITOR CORP. |
|
K812965 |
11/02/1981 |
MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE |
AMERICAN OPTICAL CORP. |
|
K812567 |
11/10/1981 |
"RELIEF" |
AMERICAN PHARMACEUTICAL CO., INC. |
|
K812927 |
11/06/1981 |
ARTERIOGRAM TRAY |
AMERICAN PHARMASEAL DIV. AHSC |
|
K802390 |
01/09/1981 |
EMG-UT 30 |
AMERICAN SCIENTIFIC CORP. |
|
K802391 |
01/09/1981 |
EMG-UT 40 |
AMERICAN SCIENTIFIC CORP. |
|
K812895 |
11/02/1981 |
YARMO NASAL CARTILAGE SOFTENER |
AMERICAN V. MUELLER |
|
K812979 |
11/24/1981 |
VITAMIN B12/FOLATE DUAL RADIOASSAY KITS |
AMERSHAM CORP. |
|
K812945 |
11/06/1981 |
LIQUILYME BUN REAGENT |
AMRESCO, INC. |
|
K803297 |
01/16/1981 |
LUQUIZYME TRIGLYCERIDE REAGENT SET |
AMRESCO, INC. |
|
K802113 |
01/22/1981 |
SIRECUST 400 SYSTEM PATIENT MONITORING |
ANALOGIC CORP. |
|
K810089 |
01/26/1981 |
6% ORTHO LOLIUDINE REAGENT IN GLACID ACI |
ANCO MEDICAL REAGENTS & ASSOC. |
|
K810090 |
01/26/1981 |
CHOLESTEROL REAGENT |
ANCO MEDICAL REAGENTS & ASSOC. |
|
K810091 |
01/26/1981 |
GLUCOSE STANDARD |
ANCO MEDICAL REAGENTS & ASSOC. |
|
K812841 |
11/27/1981 |
TOTAL & DIRECT BILIRUBIN REAGENT SET |
ANCO MEDICAL REAGENTS & ASSOC. |
|
K812833 |
11/27/1981 |
TOTAL PROTEIN REAGENT SET |
ANCO MEDICAL REAGENTS & ASSOC. |
|
K812878 |
11/02/1981 |
THE NEW 1600 ELECTRODE |
ANDOVER MEDICAL, INC. |
|
K802312 |
01/07/1981 |
CC101 ECG MONITORING SYSTEM |
ANTHRO-METRICS CORP. |
|
K803186 |
01/21/1981 |
NORMAL AND ELEVATED CONTROL FOR GLYCO. |
APPLIED CLINICAL RESEARCH LABORATORIES |
|
K802406 |
01/15/1981 |
CYTOTRAN I BONE MARROW ASPIRATION SYSTEM |
APPLIED MEDICAL DEVICES, INC. |
|
K812924 |
11/02/1981 |
ANSWER (R) |
ARMKEL, LLC. |
|
K813013 |
11/27/1981 |
GEL ELECTRODE |
ARNDT AUTOMATION & ASSOC. |
|
K810004 |
01/26/1981 |
STERILE DISPOSABLE INSTRUMENT TRAYS |
ASCEP, INC. |
|
K810103 |
01/29/1981 |
ADULT ECG ELECTRODE #60-0724 |
ASPEN LABORATORIES, INC. |
|
K810102 |
01/29/1981 |
INFANT ECG ELECTRODE #60-1029 |
ASPEN LABORATORIES, INC. |
|
K810101 |
01/29/1981 |
WATER RESISTANT FOOTSWITCH W/CABLE |
ASPEN LABORATORIES, INC. |
|
K802964 |
01/05/1981 |
AMPCO-DRESSING CHANGE TRAY-MAJOR DC |
ASSOCIATED MEDICAL PRODUCTS CO. |
|
K802965 |
01/05/1981 |
AMPCO-DRESSING CHANGE TRAY-MAJOR DC 7418 |
ASSOCIATED MEDICAL PRODUCTS CO. |
|
K810034 |
01/15/1981 |
FOOT BATHS & HAND MASSAGERS |
ASSOCIATED MILLS, INC. |
|
K810057 |
01/23/1981 |
GALVANATOR 725 |
AVRATRONICS CORP. |
|
K802878 |
01/02/1981 |
K-KATH URETHRAL CATHETER INTRODUCER |
B&K MEDICAL |
|
K813099 |
11/24/1981 |
BACK RIE |
BACK RITE |
|
K813025 |
11/10/1981 |
STANDING FRAME |
BARNETT MEDICAL |
|
K802527 |
01/05/1981 |
TEST KIT FOR DETECTION OF ANTINUCLEAR |
BARTELS & STOUT, INC. |
KEVIN T MCGOURTY |
K802966 |
01/07/1981 |
I.V. ADDITIVE CAP |
BAXA CORP., SUB. OF COOK GROUP, INC. |
|
K812137 |
11/06/1981 |
B-D HEPARINIZED LONGDWEL I.V. CATHETER |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K810042 |
01/28/1981 |
BACTEC BACTERIAL DETECTION SYSTEM: #5 |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K812315 |
11/10/1981 |
BACTEC RESIN CULTURE MED. 16A |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K803212 |
01/08/1981 |
BAUER & BLACK ARM SLING W/DETACH. POUCH |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K803185 |
01/05/1981 |
NON-CONDUCTIVE ANESTHESIA FACE MASK |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K803267 |
01/16/1981 |
AUTOMATED IMMUOCHEMISTRY SYSTEM |
BECKMAN INSTRUMENTS, INC. |
|
K803254 |
01/09/1981 |
LIQUID-STAT REAGENT FOR ASSAY OF CHOLES. |
BECKMAN INSTRUMENTS, INC. |
|
K802826 |
01/09/1981 |
PARAGON ELECTRO. CREATINE KINASE TEST KI |
BECKMAN INSTRUMENTS, INC. |
|
K803043 |
01/02/1981 |
RIAPHASE (125I) PROST. ACID PHOSPH. KIT |
BECKMAN INSTRUMENTS, INC. |
|
K810024 |
01/23/1981 |
BONNER BRACE |
BEE ENT. |
|
K810104 |
01/29/1981 |
ECG ARRHYTHMIA STIMULATOR |
BELMONT INSTRUMENT CORP. |
|
K803206 |
01/21/1981 |
SUCTION PROBE |
BEMIS HEALTH CARE |
|
K813053 |
11/16/1981 |
DISPOSABLE BLOOD PRESSURE TRANSDUCER DOM |
BENTLEY LABORATORIES, INC. |
|
K812389 |
11/16/1981 |
SURGICAL LOOPS |
BERKELEY MEDEVICES |
|
K812388 |
11/16/1981 |
SURGICAL PAWS |
BERKELEY MEDEVICES |
|
K810082 |
01/26/1981 |
ALKALINE PHOSPH., LIQUID ENZY., KIN. KIT |
BIO-ANALYTICS LABORATORIES, INC. |
|
K810086 |
01/28/1981 |
IRON & TICB |
BIO-ANALYTICS LABORATORIES, INC. |
|
K810085 |
01/28/1981 |
IRON KIT |
BIO-ANALYTICS LABORATORIES, INC. |
|
K810083 |
01/28/1981 |
LDH-L LIQUID ENZYMATIC, KINETIC KIT |
BIO-ANALYTICS LABORATORIES, INC. |
|
K810084 |
01/26/1981 |
MAGNESIUM KIT |
BIO-ANALYTICS LABORATORIES, INC. |
|
K810088 |
01/28/1981 |
URIC ACID (TPTZ) COLORINMETRIC |
BIO-ANALYTICS LABORATORIES, INC. |
|
K812980 |
11/06/1981 |
MA-2 VENTILATOR |
BIO-MEDICAL REPAIR, INC. |
|
K812643 |
11/16/1981 |
LIFESPAN CO2 |
BIOCHEM INTERNATIONAL, INC. |
|
K813089 |
11/20/1981 |
CEMENT RING |
BIOMET, INC. |
|
K812946 |
11/06/1981 |
TRONZO HIP |
BIOMET, INC. |
|
K812111 |
11/16/1981 |
PRUITT ARTERIAL OCCLUSION CHOLANG. CATH |
BIONOMY, INC. |
|
K802299 |
01/29/1981 |
K/K (ASMA/ANA) UNIVERSAL BIOPAK |
BIOWARE PRODUCTS |
|
K812982 |
11/24/1981 |
BLOM-SINGER VOICE PROSTHESIS |
BIVONA MEDICAL TECHNOLOGIES |
|
K812437 |
11/02/1981 |
150 DRIVER REAMER |
BLACK & DECKER(TM) |
|
K812436 |
11/02/1981 |
450/800 DRILL |
BLACK & DECKER(TM) |
|
K812439 |
11/02/1981 |
DUAL MPC CHARGER |
BLACK & DECKER(TM) |
|
K812440 |
11/02/1981 |
POWER PACK |
BLACK & DECKER(TM) |
|
K812438 |
11/02/1981 |
SAGITTAL SAW |
BLACK & DECKER(TM) |
|
K811114 |
11/23/1981 |
MODEL P-8 PROFESSIONAL |
BLOOMEX INTERNATIONAL, INC. |
|
K812978 |
11/06/1981 |
URIC ACID SYSTEM PACK TEST |
BOEHRINGER MANNHEIM CORP. |
|
K810064 |
01/26/1981 |
PULSARII, HIGH VOLT. GALVANIC MUSC. STIM |
BOMED MEDICAL MFR., LTD. |
|
K802882 |
01/28/1981 |
HYDROCOLLOID COMPATIBLE CREAM ALGINATE |
BUFFALO DENTAL MFG. CO., INC. |
|
K803111 |
01/23/1981 |
ERECTAID |
BURDITT & CALKINS-SIEMENS-ELEMA |
FRANK GEROW |
K813085 |
11/20/1981 |
HEPAFIX BIOPSY NEEDLE SET |
BURRON MEDICAL PRODUCTS, INC. |
|
K813083 |
11/16/1981 |
VENOFIX SCALP VEIN SET |
BURRON MEDICAL PRODUCTS, INC. |
|
K812960 |
11/16/1981 |
EAST VENTILARM PRESSURE MONITOR ALARM S. |
CAIRCO LTD. |
|
K812953 |
11/27/1981 |
RADCLIFFE VENTILATOR MARK 5 |
CAIRCO LTD. |
|
K803229 |
01/13/1981 |
4-CHANNEL ECG TELEMETRY MON. SYST. #3045 |
CAMBRIDGE INSTRUMENTS, INC. |
|
K812702 |
11/05/1981 |
TECHNICATOR |
CAMERON-MILLER, INC. |
|
K811101 |
11/20/1981 |
HYDROXYLAPATITE |
CARBOMEDICS, INC. |
|
K812917 |
11/06/1981 |
PORTABLE LIDOCAINE INFUSION PUMP |
CARDIAC PACEMAKERS, INC. |
|
K803255 |
01/28/1981 |
AUTOMATED PULMONARY FUNCTION LABORATORY |
CARDIO PULMONARY INSTRUMENTS |
|
K813051 |
11/24/1981 |
COMPTAR III |
CGR MEDICAL CORP. |
|
K812963 |
11/24/1981 |
IBIS II |
CGR MEDICAL CORP. |
|
K812908 |
11/24/1981 |
ELECTRO-GONIOMETER |
CHATTANOOGA GROUP, INC. |
|
K812899 |
11/06/1981 |
MED-EX |
CHATTANOOGA GROUP, INC. |
|
K802972 |
01/15/1981 |
DUAL-TROL |
CIMARRON INSTRUMENTS, INC. |
|
K803074 |
01/08/1981 |
FERNORAL HIP PROSTHESIS |
CINTOR ORTHOPAEDIC DIV. |
|
K813185 |
11/24/1981 |
SALICYLATE STAT-PAK |
CLINTECH DIAGNOSTICS CORP. |
|
K813123 |
11/27/1981 |
EPC FILTER |
CODMAN & SHURTLEFF, INC. |
|
K812722 |
11/05/1981 |
SAFE GUARD |
CONCEPT, INC. |
|
K803147 |
01/08/1981 |
CONPHAR ADJUSTABLE CERVICAL COLLAR |
CONPHAR, INC. |
|
K803139 |
01/08/1981 |
CONPHAR ARM SLINGS |
CONPHAR, INC. |
|
K803141 |
01/09/1981 |
CONPHAR CAST HEELS |
CONPHAR, INC. |
|
K803140 |
01/08/1981 |
CONPHAR CRUTCH GRIPS |
CONPHAR, INC. |
|
K803144 |
01/08/1981 |
CONPHAR CRUTCH PADS |
CONPHAR, INC. |
|
K803136 |
01/08/1981 |
CONPHAR CRUTCH TIPS |
CONPHAR, INC. |
|
K803137 |
01/08/1981 |
CONPHAR INVALID RING |
CONPHAR, INC. |
|
K803148 |
01/08/1981 |
CONPHAR PERCUSSION HAMMER(TAYLOR) |
CONPHAR, INC. |
|
K803142 |
01/13/1981 |
CONPHAR VELCRO TOUNIGUER |
CONPHAR, INC. |
|
K802941 |
01/09/1981 |
CINESCOPE III RADIOGRAPHIC GENERATOR |
CONTROTEC, INC. |
|
K812832 |
11/05/1981 |
MODEL 325C UNIPOLAR CARDIAC PULSE GEN. |
COOK PACEMAKER CORP. |
|
K802613 |
01/07/1981 |
C-PAK MODEL 12 ARTIFICIAL KIDNEY |
CORDIS CORP. |
|
K803258 |
01/15/1981 |
CORDIS HAKIM ASCITES VALVE SYSTEM |
CORDIS CORP. |
|
K803242 |
01/28/1981 |
SEROCLUSTER EIA PLATES |
CORNING COSTAR CORP. |
|
K803243 |
01/28/1981 |
SEROCLUSTER FLEXIBLE VINYL "U" & "V" PL. |
CORNING COSTAR CORP. |
|
K803273 |
01/16/1981 |
PROLACTIN (125) RADIOIMMUNAOASSAY |
CORNING MEDICAL & SCIENTIFIC |
|
K802220 |
01/09/1981 |
VITAMIN B12 (57CO) RADIOIMMUNOASSAY |
CORNING MEDICAL & SCIENTIFIC |
|
K803078 |
01/28/1981 |
SIMPLICITY INFUSION PUMP MODEL 2100A |
CRITIKON COMPANY,LLC |
|
K803233 |
01/12/1981 |
MEUROMETRICS MONITOR |
DADE MEDICAL, INC. |
|
K802552 |
01/16/1981 |
PERM. ENDOCARDIAL UNIPOLAR TINED/WEDGE |
DAIG CORP. |
|
K802553 |
01/16/1981 |
PERM. ENDOCARDIAL UNIPOLAR WEDGE URETHAN |
DAIG CORP. |
|
K802547 |
01/16/1981 |
PERMANENT & TEMP. PACEMAKER ELECTRODE |
DAIG CORP. |
|
K812937 |
11/06/1981 |
BEHIND-THE-EAR MODEL 115 |
DANAVOX, INC. |
|
K812939 |
11/06/1981 |
IN-THE-EAR MODEL 101M |
DANAVOX, INC. |
|
K812938 |
11/06/1981 |
IN-THE-EAR MODEL 821 |
DANAVOX, INC. |
|
K803239 |
01/09/1981 |
SOFTGOOD PRODUCTS AND SPLINTS |
DANEK MEDICAL, INC. |
|
K803315 |
01/22/1981 |
CRITERION II RHYTHM PROFILE MONITOR |
DART MEDICAL EQUIPMENT |
|
K801601 |
01/13/1981 |
DATASCOPE/AVCO CONNECTOR |
DATASCOPE CORP. |
|
K812828 |
11/16/1981 |
MODEL 2000 MONITOR |
DATASCOPE CORP. |
|
K802167 |
01/13/1981 |
PERCOR DATASCOPE INTRA-AORTIC BALLOON |
DATASCOPE CORP. |
|
K802755 |
01/07/1981 |
ARTERIAL BLOOD FILTER BF-37 |
DELTA MEDICAL INDUSTRIES |
|
K810068 |
01/22/1981 |
PEDIATRIC ARTERIAL BLOOD FILTER |
DELTA MEDICAL INDUSTRIES |
|
K802975 |
01/14/1981 |
ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE |
DENTSPLY INTL. |
|
K803269 |
01/15/1981 |
CAPSULE DENTAL AMALGAM |
DENTSPLY INTL. |
|
K802921 |
01/08/1981 |
ICLH TIBIAL PLATEAU |
DEPUY, INC. |
|
K810001 |
01/16/1981 |
'NO-BOIL' DUALCOUNT KIT |
DIAGNOSTIC PRODUCTS CORP. |
|
K810003 |
01/21/1981 |
'NO-BOIL' FOLIC ACID KIT |
DIAGNOSTIC PRODUCTS CORP. |
|
K810002 |
01/16/1981 |
'NO-BOIL' VITAMIN B12 KIT |
DIAGNOSTIC PRODUCTS CORP. |
|
K812638 |
11/16/1981 |
DIAGNOSTIC MEDICAL COMPUTER |
DIAGNOSTIC RESOURCES, INC. |
|
K802979 |
01/22/1981 |
DIASONICS SMALL PARTS SCANNER |
DIASONICS, INC. |
|
K812973 |
11/16/1981 |
PERCUTANEOUS INTRODUCER COURNAND STYLE |
DIP, INC. |
|
K813019 |
11/16/1981 |
PERCUTANEOUS INTRODUCER: SELDINGER STYLE |
DIP, INC. |
|
K812852 |
11/02/1981 |
SET FOR ASEPTIC DECANTING OF A FLEX I.V |
DIP, INC. |
|
K802778 |
01/09/1981 |
LIQUID CRYSTAL THERM. 8 EVENT MONITOR |
DJINNII INDUSTIRES, INC. |
|
K812864 |
11/24/1981 |
SILASTIC VOICE PROSTHESIS |
DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS |
|
K803162 |
01/28/1981 |
X-RAY STAND & OPERATING CHAIR |
DOWNS SURGICAL LTD. |
|
K802905 |
01/15/1981 |
MULTI-IMAGE CAMERA-#627 TLC |
DUNN SYSTEMS, INC. |
|
K812885 |
11/24/1981 |
DULBECCO MINIMUM ESSENTIAL MED NO GLUTAM |
DUTCHLAND LABORATORIES, INC. |
|
K810039 |
01/28/1981 |
MIC-2000 INOCULUM TRAY LID |
DYNATECH CORP. |
|
K810022 |
01/26/1981 |
SRD III |
DYNATECH CORP. |
|
K803100 |
01/08/1981 |
STOMAHESIVE PASTE PROTECTIVE SKIN BARR |
E. R. SQUIBB & SONS, INC. |
|
K812626 |
11/24/1981 |
ACA ANTITHROMBIN III PLASMINOGEN CALIB |
E.I. DUPONT DE NEMOURS & CO., INC. |
|
K812628 |
11/24/1981 |
ACA FIBRINOGEN CALIBRATOR |
E.I. DUPONT DE NEMOURS & CO., INC. |
|
K803305 |
01/16/1981 |
DUPONT 'ACA' CREATINE KINASE VERIFIERS |
E.I. DUPONT DE NEMOURS & CO., INC. |
|
K813005 |
11/24/1981 |
KODAK CINEFLUOROGRAPHIC FILM SO-274 |
EASTMAN KODAK COMPANY |
|
K812902 |
11/10/1981 |
"ACUPRESS" VIBRATOR |
EICONA CORP. |
|
K770791 |
01/26/1981 |
DEPILATOR, DERMA-I & DERMA-II |
ELECTRO-KINETIC ENG/MFG |
|
K803277 |
01/13/1981 |
TYGON TUBING |
ELECTROMEDICS, INC. |
|
K813018 |
11/06/1981 |
OXYTRON OXYGEN GENERATOR |
ELMORE TECHNOLOGY CORP. |
|
K803089 |
01/02/1981 |
GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT) |
ENVIRONMENTAL CHEMICAL SPECIALTIES |
|
K803209 |
01/14/1981 |
ELIPAR LIGHT SOURCE |
ESPE-PREMIER SALES CO. |
|
K803227 |
01/14/1981 |
VISIO-DISPERS |
ESPE-PREMIER SALES CO. |
|
K812819 |
11/20/1981 |
ETHICON* SURGICAL SUTURES W/COMPRESS BOL |
ETHICON, INC. |
|
K812323 |
11/16/1981 |
PDS* ABSORBABLE LIGATING CLIPS |
ETHICON, INC. |
|
K803190 |
01/09/1981 |
ETHOX/BARRON #2000 FOOD PUMP-ENTERAL FED |
ETHOX CORP. |
|
K813143 |
11/27/1981 |
DESILET |
EXCO, INC. |
|
K813144 |
11/27/1981 |
INTRAFLON, INTRAFLUX, INTRAVALVE |
EXCO, INC. |
|
K813142 |
11/27/1981 |
LEADER-CATH |
EXCO, INC. |
|
K813140 |
11/27/1981 |
VYGON EXTENSION TUBES & CONNECTORS |
EXCO, INC. |
|
K813141 |
11/27/1981 |
VYGON STOPCOCKS & RAMPS(MANIFOLDS) |
EXCO, INC. |
|
K802364 |
01/29/1981 |
EXTRACORPOREAL'S EXP 400 PARALLEL PLATE |
EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
|
K811972 |
11/16/1981 |
EXTRASENSR ULTRAFILTRATION MONITOR |
EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
|
K803003 |
01/22/1981 |
INTERPULSE MEMBRANE OXYGENATION SYSTEM |
EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
|
K812398 |
11/10/1981 |
LINUS |
FISCHER IMAGING CORP. |
|
K812623 |
11/02/1981 |
CLEANING SOLUTION FOR RADIOMETER OSM2 |
FISHER SCIENTIFIC CO., LLC. |
|
K812831 |
11/06/1981 |
SURGICAL DRESSINGS |
FOREIGN TRADE ZONE OF WISCONSIN |
|
K802943 |
01/15/1981 |
POSITIVE END EXPIRATORY PRESSURE VALVE |
FRASER HARLAKE, INC. |
|
K812888 |
11/10/1981 |
SYRINGE, PISTON |
FRISCO PRODUCTS, INC. |
|
K811752 |
11/02/1981 |
FE-CULT PLUS |
GAMMA BIOLOGICALS, INC. |
|
K802765 |
01/21/1981 |
ACRODISC FILTER ASSEMBLY |
GELMAN SCIENCES, INC. |
|
K812916 |
11/06/1981 |
MEZLOCILLIN 75MCG ANTIMICROB. SUSCEPT. D |
GENERAL DIAGNOSTICS |
|
K812993 |
11/10/1981 |
MOXALACTOM 30MCG ANTIMICROBIAL SUS. DISK |
GENERAL DIAGNOSTICS |
|
K812929 |
11/24/1981 |
3.5 MHZ BIOPSY TRANSDUCER |
GENERAL ELECTRIC CO. |
|
K812966 |
11/24/1981 |
400T ECT SOFTWARE |
GENERAL ELECTRIC CO. |
|
K802695 |
01/07/1981 |
DATASON RTL II |
GENERAL ELECTRIC CO. |
|
K802953 |
01/09/1981 |
DIGITAL FLUOROGRAPHIC X-RAY SYSTEM |
GENERAL ELECTRIC CO. |
|
K812775 |
11/06/1981 |
FLUORICON L300 IMAGE INTENSIFIER |
GENERAL ELECTRIC CO. |
|
K802801 |
01/15/1981 |
GE RT/PLAN MAGNETIC TAPE DRIVE OPTION |
GENERAL ELECTRIC CO. |
|
K812915 |
11/24/1981 |
MX 125 |
GENERAL ELECTRIC CO. |
|
K812913 |
11/24/1981 |
OMEGA II ANGIOGRAPHIC TABLE |
GENERAL ELECTRIC CO. |
|
K803181 |
01/28/1981 |
SCANNER, COMPUTERIZED TOMOGRAPHIC |
GENERAL ELECTRIC CO. |
|
K802708 |
01/07/1981 |
SYSTEM, ECHO, PULSED ULTRASONIC DIAG. |
GENERAL ELECTRIC CO. |
|
K802940 |
01/15/1981 |
SUPER-SPIKE TRANSFER SET |
GENEVA LABORATORIES, INC. |
|
K812911 |
11/06/1981 |
BCYE MEDIUM |
GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. |
|
K812787 |
11/27/1981 |
EIA RUBELLA |
GILFORD |
|
K803301 |
01/16/1981 |
CREATINE KINASE REAGENT |
GILFORD DIAGNOSTICS |
|
K812912 |
11/02/1981 |
GILCHEM ALP REAGENT |
GILFORD DIAGNOSTICS |
|
K803210 |
01/28/1981 |
MENSTRUAL ASPIRATION KITS |
GYNEMETRICS, INC. |
|
K802313 |
01/12/1981 |
UTERINE CURETTE |
GYNEMETRICS, INC. |
|
K802315 |
01/12/1981 |
UTERINE SOUND |
GYNEMETRICS, INC. |
|
K802674 |
01/08/1981 |
RESERVOIR FOR AUTOLOGOUS BLOOD TRANSFUS. |
HAEMONETICS CORP. |
|
K812820 |
11/10/1981 |
CHANG MEDIUM |
HANA BIOLOGICS, INC. |
|
K803168 |
01/09/1981 |
CARDIO ZYME PLUS CK-MB #65045 |
HARLECO |
|
K803169 |
01/09/1981 |
CARDIOZYME PLUS CK-TOTAL #65046 |
HARLECO |
|
K813044 |
11/10/1981 |
ULTRACHEM ALB, ITEM #64970 |
HARLECO |
|
K813040 |
11/10/1981 |
ULTRACHEM CA, ITEM #64975 |
HARLECO |
|
K813043 |
11/10/1981 |
ULTRACHEM CREA ITEM #64972 |
HARLECO |
|
K813039 |
11/10/1981 |
ULTRACHEM E-CHOL, ITEM #65025 |
HARLECO |
|
K813042 |
11/10/1981 |
ULTRACHEM GLUC-DH SET, ITEM #65048 |
HARLECO |
|
K813038 |
11/10/1981 |
ULTRACHEM TP, ITEM #64974 |
HARLECO |
|
K813041 |
11/10/1981 |
ULTRAZYME-GT, ITEM #64959 & 65032 |
HARLECO |
|
K810132 |
01/28/1981 |
MODEL 2 FLOWMETER |
HARRIS CALORIFIC |
|
K810030 |
01/14/1981 |
POST-AURICULAR HEARING AID (#PE830) |
HC ELECTRONICS |
|
K803281 |
01/16/1981 |
AUTOMATED ELECTROPHORESIS SYSTEM |
HELENA LABORATORIES |
|
K803108 |
01/09/1981 |
HELENA HBA2 QUIK COLUMN METHOD |
HELENA LABORATORIES |
|
K803123 |
01/13/1981 |
CRT DISPLAY #1310B |
HEWLETT-PACKARD CO. |
|
K802717 |
01/22/1981 |
HP MODEL 4710A ECG TRANSMITTER |
HEWLETT-PACKARD CO. |
|
K812700 |
11/05/1981 |
URICAR |
HI CHEM, INC. |
|
K810062 |
01/26/1981 |
BI-CENTRIC BI-POLAR ENDOPROSTHESIS |
HOWMEDICA CORP. |
|
K803125 |
01/15/1981 |
BONE-DRI SURGICAL SPONGE |
HOWMEDICA CORP. |
|
K810061 |
01/23/1981 |
CURVED SHERMAN BONE PLATE |
HOWMEDICA CORP. |
|
K803166 |
01/09/1981 |
DOUBLE BALL JOINT |
HOWMEDICA CORP. |
|
K803093 |
01/08/1981 |
SLIT CATHETER SYSTEM |
HOWMEDICA CORP. |
|
K813080 |
11/17/1981 |
WOUND DRAINAGE MANAGEMENT SYSTEMS |
HOWMEDICA CORP. |
|
K802610 |
01/05/1981 |
ALERT A,HDL-APOLIPOROTEIN A, TEST KIT |
HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES |
|
K810077 |
01/28/1981 |
OMEGA THERAPEUTIC DRUG MONIT. CONTROL S. |
HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES |
|
K803251 |
01/26/1981 |
AIP SYSTEM-METHOD FOR IGM |
ICL SCIENTIFIC |
|
K803272 |
01/26/1981 |
AUTOMATED IMMUNOPRECIPITIN METHOD/ICG |
ICL SCIENTIFIC |
|
K803274 |
01/26/1981 |
AUTOMATED IMMUNOPRECIPITIN METHOD/IGA |
ICL SCIENTIFIC |
|
K803276 |
01/26/1981 |
ANA-IFA TEST SYSTEM |
IMMUNO CONCEPTS, INC. |
|
K803279 |
01/16/1981 |
FOLLICE STIMULATING HORMONE-RADIOIMM. KT |
IMMUNO NUCLEAR CORP. |
|
K812727 |
11/05/1981 |
GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT |
IMMUNO NUCLEAR CORP. |
|
K803280 |
01/16/1981 |
HUMAN GROWTH HORMONE-RADIOIMM. KIT |
IMMUNO NUCLEAR CORP. |
|
K803278 |
01/21/1981 |
LUTEINIZING HORMONE RADIOIMMUNOASSAY KIT |
IMMUNO NUCLEAR CORP. |
|
K811021 |
11/05/1981 |
HERPES |
IMMUNO-DIAGNOSTIC PRODUCTS, INC. |
|
K803296 |
01/16/1981 |
ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT |
IMMUNOTECH CORP. |
|
K813026 |
11/17/1981 |
GUIDE WIRE |
INMED CORP. |
|
K810107 |
01/26/1981 |
RESPA-TROL |
INTENSIVE TECHNOLOGY, INC. |
|
K801338 |
01/07/1981 |
CYBERLITH PROGRAMMER |
INTERMEDICS, INC. |
|
K812990 |
11/16/1981 |
INTERMEDICS POLYFLEX-MODEL 483-03 LEAD |
INTERMEDICS, INC. |
|
K812991 |
11/16/1981 |
INTERMEDICS POLYFLEX-MODEL 483-04 LEAD |
INTERMEDICS, INC. |
|
K812989 |
11/16/1981 |
INTERMEDICS POLYFLEX-MODEL 493-03 LEAD |
INTERMEDICS, INC. |
|
K812755 |
11/16/1981 |
MODEL 535-03 TRACE A PACE |
INTERMEDICS, INC. |
|
K812968 |
11/06/1981 |
FIAX RHEUMATOID FACTOR TEST KIT |
INTL. DIAGNOSTIC TECHNOLOGY |
|
K803307 |
01/13/1981 |
MATTRESS, AIR FLOATATION, ALTERN. PRESS. |
INTL. MEDICAL EQUIPMENT CORP. |
|
K813104 |
11/20/1981 |
POWER DRIVE WHEELCR |
INTL. MEDICAL EQUIPMENT CORP. |
|
K802856 |
01/28/1981 |
MINIATURE ION SELECTIVE ELECTRODES |
IONETICS, INC. |
|
K801771 |
01/16/1981 |
ALPHA-THAL SCREEN 20 TEST KIT & 100 KIT |
ISOLAB, INC. |
|
K812017 |
11/20/1981 |
X-RAY DETECTABLE BAND |
ISRAMED, INC. |
|
K812018 |
11/20/1981 |
X-RAY DETECTABLE THREAD |
ISRAMED, INC. |
|
K812745 |
11/02/1981 |
WARMING LISTHTS #96H & 96HT |
J. H. EMERSON CO. |
|
K802458 |
01/12/1981 |
KEVORKIAN-YOUNGE BIOPSY CURETTE #90-6611 |
J. SKLAR MFG. CO., INC. |
|
K802457 |
01/12/1981 |
KEVORKIAN-YOUNGE BIOPSY PUNCH, #90-6610 |
J. SKLAR MFG. CO., INC. |
|
K812362 |
11/20/1981 |
DISP. TOOTHBRUSH W/3 G. TUBE OF TOOTHPST |
JDM COMMODITIES |
|
K812363 |
11/20/1981 |
DISP. TOOTHBRUSH W/TOOTHPASTE ATTACHED |
JDM COMMODITIES |
|
K812364 |
11/20/1981 |
PORT. TOOTHBRUSH KIT W/4 G. TOOTHPASTE |
JDM COMMODITIES |
|
K812361 |
11/20/1981 |
PORTABLE TOOTHBRUSH KIT (NO SAMPLE) |
JDM COMMODITIES |
|
K803291 |
01/28/1981 |
ARTUS DRILL #2000 |
JEDMED INSTRUMENT CO. |
|
K803290 |
01/28/1981 |
ARTUS DRILL #3000 |
JEDMED INSTRUMENT CO. |
|
K803289 |
01/28/1981 |
ARTUS DRILL #4000 |
JEDMED INSTRUMENT CO. |
|
K803288 |
01/28/1981 |
ARTUS DRILL #6000 |
JEDMED INSTRUMENT CO. |
|
K803176 |
01/09/1981 |
INTEROOM(POWERED OPHTHALMIC TABLE) |
JOCEVEST INTEROOM, INC. |
|
K803310 |
01/14/1981 |
CERAMCO PORCELAIN |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
|
K802522 |
01/08/1981 |
DELTA-LITE CASTING TAPE & SPLINTS |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
|
K810053 |
01/28/1981 |
JOHNSON & JOHNSON ADHESIVE FILM DRESSING |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
|
K812827 |
11/16/1981 |
ORBIC* SPHERICAL ALLOY |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
|
K812411 |
11/10/1981 |
IMMUNO-CELL IMMUNO-SEP KIT |
KALLESTAD LABORATORIES, INC. |
|
K812726 |
11/05/1981 |
KERMATH THERAPY SIMULATOR |
KERMATH MFG. CORP. |
|
K813133 |
11/20/1981 |
KEYMED KEY LIGHT |
KEYMED, INC. |
|
K803293 |
01/28/1981 |
GUARDIAN PEEL POUCHES |
KIMBERLY-CLARK CORP. |
|
K802952 |
01/07/1981 |
MODEL HEC-7 HEART EVALUATION COMPUTER |
KLUWE CORP. |
|
K812863 |
11/06/1981 |
FETASONDE 5, #30, CENTRAL NURSING STAT |
KONTRON INSTRUMENTS, INC. |
|
K813032 |
11/24/1981 |
ZIKON 100 DIGITAL X-RAY SYSTEM |
KONTRON INSTRUMENTS, INC. |
|
K812889 |
11/17/1981 |
ESTILUX POSTERIOR |
KULZER, INC. |
|
K803013 |
01/02/1981 |
CHLORIDE/TCO2 ANALYZER REAGENTS |
LABORATORY PRODUCTS, INC. |
|
K803051 |
01/09/1981 |
FLAME PHOTOMETRY REAGENTS |
LABORATORY PRODUCTS, INC. |
|
K810021 |
01/23/1981 |
FLO-TEMP |
LAMINAR FLOW INDUSTRIES |
|
K813059 |
11/16/1981 |
LEECO TESTO-QUANT DIAG. KIT |
LEECO DIAGNOSTICS, INC. |
|
K803001 |
01/02/1981 |
LEECO TESTO-QUANT DIAGNOSTIC KIT |
LEECO DIAGNOSTICS, INC. |
|
K802614 |
01/07/1981 |
ENGSTROM EMMA ANESTHETIC GAS MONITOR |
LKB INSTRUMENTS, INC. |
|
K812642 |
11/05/1981 |
ENGSTROM ERICA |
LKB INSTRUMENTS, INC. |
|
K803131 |
01/15/1981 |
LKB-WALLACE 1250 LUMINOMETER |
LKB INSTRUMENTS, INC. |
|
K812090 |
11/10/1981 |
LORENZ BLOOD GAS ANALYZER |
LORENZ INSTRUMENTS |
|
K813017 |
11/25/1981 |
NECKTRAC |
LOSSING ORTHOPEDIC, INC. |
|
K812219 |
11/16/1981 |
MODEL 900S INTRAOCULAR PROBE |
LUMENIS, INC. |
|
K812875 |
11/20/1981 |
SURGICAL LOOPS |
M-W LABORATORIES, INC. |
|
K812876 |
11/20/1981 |
SURGICAL PAWS |
M-W LABORATORIES, INC. |
|
K802888 |
01/09/1981 |
RAYTHEON MEDICAL IMAGING |
MACHLETT LABORATORIES, INC. |
|
K803088 |
01/02/1981 |
MAGNESIUM TEST KIT |
MALLINCKRODT CRITICAL CARE |
|
K803298 |
01/12/1981 |
MINI-TIP CULTURETTE |
MARION LABORATORIES, INC. |
|
K812919 |
11/02/1981 |
MULTI-GRAM DEVELOPING TANK R-12 & R-3 |
MARION LABORATORIES, INC. |
|
K812603 |
11/20/1981 |
TANARAMA |
MARKETING CONSULTANTS OF AMERICA |
|
K810008 |
01/16/1981 |
ALP-KII |
MARTIN'S MAINE EXCHANGE |
|
K812248 |
11/24/1981 |
COOLEY 2 VASCULAR PROSTHESIS STRAIGHT |
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. |
|
K802361 |
01/16/1981 |
DIALYIS START CARE KIT |
MED-PAK CORP. |
|
K813100 |
11/27/1981 |
BIO-STIMULATOR, MODEL 400 |
MED-WESTERN ELECTRONICS, INC. |
|
K812555 |
11/16/1981 |
DISPOSABLE SUTURE REMOVAL SCISSORS |
MEDCARE PRODUCTS |
|
K803259 |
01/09/1981 |
CLOSED SYSTEM URETHRAL CATHETERIZ. SET |
MEDICAL DEVICES, INC. |
|
K803156 |
01/15/1981 |
SURGITEK MEDI-LOOPS |
MEDICAL ENGINEERING CORP. |
|
K812792 |
11/27/1981 |
PFT SCREENER (SYSTEM 1100) |
MEDICAL GRAPHICS CORP. |
|
K810017 |
01/05/1981 |
MICROSURG CAUTERY |
MEDICAL PRODUCTS DEVELOPMENT, INC. |
|
K810019 |
01/23/1981 |
SURG-FLEX 15" SURGICAL LIGHT |
MEDICAL PRODUCTS DEVELOPMENT, INC. |
|
K810018 |
01/23/1981 |
SURG-FLEX 5" SURGICAL LIGHT |
MEDICAL PRODUCTS DEVELOPMENT, INC. |
|
K812735 |
11/06/1981 |
CLOTH SURGICAL GLOVES |
MEDICAL SYNERGY |
|
K801799 |
01/02/1981 |
ATRIAL/VENTRICULAR SEQENTIAL #080-20000 |
MEDICAL TESTING SYSTEM, INC. |
|
K801802 |
01/02/1981 |
ELECTROMAGNETIC BLOOD & ARTERIAL GAUGE |
MEDICAL TESTING SYSTEM, INC. |
|
K813131 |
11/27/1981 |
INTERFACE ARTERIAL BLOOD FILTER |
MEDICAL, INC. |
|
K812873 |
11/16/1981 |
MEDICON #8200 AMS |
MEDICON, INC. |
|
K812910 |
11/06/1981 |
MEDISYSTEMS NEEDLES & SYRINGES |
MEDISYSTEMS CORP. |
|
K812713 |
11/05/1981 |
DRAWER TEST |
MEDMETRIC CORP. |
|
K812806 |
11/10/1981 |
KT-1000 DEVICE |
MEDMETRIC CORP. |
|
K813012 |
11/06/1981 |
STERILE BASIN SETS |
MEDSPEC CORP. |
|
K812707 |
11/02/1981 |
STERILE DISSECTOR SPONGES-X-RAY DETECT |
MEDSPEC CORP. |
|
K812711 |
11/02/1981 |
STERILE GAUZE PADS 12PLY |
MEDSPEC CORP. |
|
K812710 |
11/02/1981 |
STERILE LAPAROTOMY SPONGES-X-RAY DETECT |
MEDSPEC CORP. |
|
K812725 |
11/16/1981 |
MODEL 5867-12 BIPOLAR LOW-PROFILE LEAD |
MEDTRONIC VASCULAR |
|
K803062 |
01/07/1981 |
CATH-SECURE |
MELISSA C. JOHNSON |
|
K812817 |
11/10/1981 |
NEUTRAL DUFFERED FORMA-SCENT |
MERIDIAN DIAGNOSTICS, INC. |
|
K802754 |
01/21/1981 |
IMMUNOREACTIVE ESTRIOL RIA KIT |
MICROANALYTIC RESEARCH, INC. |
|
K803132 |
01/28/1981 |
HERPES SIMPLEX VIRUS SEROLOGICAL REAGENT |
MICROBIOLOGICAL RESEARCH CORP. |
|
K803133 |
01/29/1981 |
RUBELLA VIRUS SEROLOGICAL REAGENT RUBEL |
MICROBIOLOGICAL RESEARCH CORP. |
|
K803175 |
01/29/1981 |
RUBELLA VIRUS SEROLOGICAL REAGENTS |
MICROBIOLOGICAL RESEARCH CORP. |
|
K803134 |
01/29/1981 |
TOXOPLASMA GONDII SEROLOGICAL REAGENTS |
MICROBIOLOGICAL RESEARCH CORP. |
|
K803252 |
01/12/1981 |
MICROMEDIC REAGENT DISPENSER |
MICROMEDIC SYSTEMS |
|
K803237 |
01/09/1981 |
AMES SERA-PAK ALBUMIN REAGENT KIT |
MILES LABORATORIES, INC. |
|
K803248 |
01/26/1981 |
AMES SERA-PAK HEMOGLOBIN REAGENT |
MILES LABORATORIES, INC. |
|
K803241 |
01/28/1981 |
HISTOLOGICAL EMBEDDING MEDIA |
MILES LABORATORIES, INC. |
|
K812944 |
11/16/1981 |
MILLAR MIKRO-TIP CATHETER PRESSURE TRAN. |
MILLAR INSTRUMENTS, INC. |
|
K812706 |
11/16/1981 |
MILLER/NADLER GLARE TESTER |
MOSEBACH ELECTRIC & SUPPLY |
|
K803061 |
01/13/1981 |
SUN TANNING DEVICES |
MUTZHAS CORP. |
|
K812884 |
11/02/1981 |
NARCO TELECARE PRESSURE TRANSDUCER DOME |
NARCO SCIENTIFIC |
|
K803096 |
01/13/1981 |
NARCO TELECARE TRANSDUCER DOME #700-4000 |
NARCO SCIENTIFIC |
|
K812918 |
11/06/1981 |
PILLING "K" KNIFE |
NARCO SCIENTIFIC |
|
K812883 |
11/02/1981 |
TELECARE ISOTEC PRESSURE TRANSDUCER DOME |
NARCO SCIENTIFIC |
|
K812331 |
11/16/1981 |
VTS-1000 VISUAL TESTING SYSTEM |
NICOLET BIOMEDICAL INSTRUMENTS |
|
K813228 |
11/27/1981 |
CONNECTING TUBE |
NORTHERN MEDICAL INDUSTRIES |
|
K812396 |
11/20/1981 |
ARTHRO-PREP REST |
NORTHWEST SURGICAL CONCEPTS, INC. |
|
K812395 |
11/20/1981 |
ARTHRO-PREP REST W/STAND |
NORTHWEST SURGICAL CONCEPTS, INC. |
|
K812761 |
11/02/1981 |
FLOW-DIRECTED BALLOON THERMODILUTION |
NOVA MEDICAL SPECIALTIES |
|
K802886 |
01/28/1981 |
NUCLI-PAP TM-(I125)-PAP RADIOIMMUNOAS- |
NUCLEAR DIAGNOSTICS, INC. |
|
K810033 |
01/21/1981 |
CORTI-SHURE |
NUCLEAR MEDICAL LABORATORIES, INC. |
|
K802690 |
01/08/1981 |
ULTRAPAK CAT. #100-0251 |
OCCUMEDICS, INC. |
|
K803316 |
01/14/1981 |
ORTHODONTIC BRACKET |
OREC CORP. |
|
K810010 |
01/28/1981 |
ORTHODONTIC ELASTICS |
OREC CORP. |
|
K812967 |
11/06/1981 |
ACCURATE BETA |
ORGANON, INC. |
|
K802930 |
01/09/1981 |
CYTOMEGALO VIRUS & CONTROLS |
ORION DIAGNOSTICA, INC. |
|
K802931 |
01/12/1981 |
INFLUENZA A & B S-ANTIGEN & CONTROLS |
ORION DIAGNOSTICA, INC. |
|
K813167 |
11/24/1981 |
ORTHO UNASSAYED CONTROL SERUM LEVEL II |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
|
K812566 |
11/10/1981 |
UNIVERSAL SUTURE PASSER |
ORTHO PARED INSTRUMENTS, INC. |
|
K803192 |
01/23/1981 |
HCL ACETABULAR COMPONENTS |
OSTEONICS CORP. |
|
K803191 |
01/23/1981 |
PROSTHESIS, HIP FEMORAL COMPONENT METAL |
OSTEONICS CORP. |
|
K812972 |
11/06/1981 |
RA LATEX TEST |
OXOID U.S.A., INC. |
|
K812894 |
11/06/1981 |
VDRL CARBON ANTIGEN |
OXOID U.S.A., INC. |
|
K810139 |
11/27/1981 |
ELECTRODE, PACEMAKER, PERMANENT |
PACESETTER SYSTEMS |
|
K810286 |
11/27/1981 |
PACEPATH IMPLANT. ENDOCARD. PACING LEAD |
PACESETTER SYSTEMS |
|
K810850 |
11/06/1981 |
PERSONAL MEDICATION INFUSER |
PACESETTER SYSTEMS |
|
K803180 |
01/09/1981 |
1-125 LABELED TRIIODOTHYRONINE(T3) |
PCL-RIA, INC. |
|
K801253 |
01/02/1981 |
CREST ELECTRONIC WARMING BLANKET |
PENLON, INC. |
|
K803052 |
01/07/1981 |
NUFFIELD ANESTHESIA VENTILATOR SER. 400 |
PENLON, INC. |
|
K812810 |
11/17/1981 |
PENTAX FLEXIBLE DRIODENOFIBERSCOPE |
PENTAX PRECISION INSTRUMENT CORP. |
|
K810007 |
01/15/1981 |
PENTAX UPPER G.I. FIBERSCOPE, #FG-34 |
PENTAX PRECISION INSTRUMENT CORP. |
|
K803032 |
01/22/1981 |
PFIZER PZ-SLM RAD. THERAPY TRTMT. SIMUL. |
PFIZER MEDICAL SYSTEMS, INC. |
|
K813010 |
11/16/1981 |
EEG TELEPHONE TRANSMITTER, MODEL #T-7 |
PHARMAQUEST CORP. |
|
K802996 |
01/09/1981 |
VECTOR-100 X-RAY GENERATOR |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
|
K812983 |
11/10/1981 |
DSD |
PM AMERICA, INC. |
|
K813102 |
11/24/1981 |
POLI-MAK II |
PM AMERICA, INC. |
|
K812943 |
11/06/1981 |
SLICK ENDOTRACHEAL TUBE |
POLAMEDCO, INC. |
|
K813106 |
11/24/1981 |
PORT-OP |
PORTEC, INC. |
|
K813003 |
11/06/1981 |
P.P.P. TREATMENT CABINET |
PRECISION PROFESSIONAL PRODUCTS |
|
K812907 |
11/02/1981 |
FEMEX |
PROMAC |
|
K803257 |
01/22/1981 |
CSG-FLOW CONTROL VALVE |
PUDENZ-SCHULTE MEDICAL RESEARCH CORP. |
|
K803120 |
01/22/1981 |
TILTING IMAGING TABLE #846T |
QUINTON, INC. |
|
K803287 |
01/16/1981 |
CHOLESTEROL REAGENT ENZYMATIC |
RAI, INC. |
|
K803091 |
01/09/1981 |
TRIGLYCERIDES (UV)-2 REAGENTS |
REAGENTS APPLICATIONS, INC. |
|
K802757 |
01/08/1981 |
BUFFERED CHARCOAL YEAST EXTRACT AGAR |
REMEL CO. |
|
K812890 |
11/16/1981 |
HEMASITE GRAFTLESS VASCULAR ACESS |
RENAL SYSTEMS, INC. |
|
K813237 |
11/30/1981 |
HEMASITE VASCULAR ACCESS SHUNT HM-1000 |
RENAL SYSTEMS, INC. |
|
K812230 |
11/06/1981 |
MODEL RS 8300 |
RENAL SYSTEMS, INC. |
|
K802969 |
01/02/1981 |
CORTISOL 125-I RADIOIMMUNOASSAY KIT |
RIA PRODUCTS, INC. |
|
K812791 |
11/24/1981 |
PORTABLE MEDICAL TABLE |
RICHARD D. SPRADLIN |
|
K813094 |
11/20/1981 |
ACETABULAR CEMENT COMPRESSOR |
RICHARD'S MEDICAL EQUIP., INC. |
|
K803284 |
01/09/1981 |
OSTEO OSCILAIR |
RICHARD'S MEDICAL EQUIP., INC. |
|
K813093 |
11/20/1981 |
RICHARDS ACETABULAR BRUSH |
RICHARD'S MEDICAL EQUIP., INC. |
|
K812822 |
11/16/1981 |
RIND AIRWAY |
RIND MEDICAL DEVELOPMENT |
|
K812951 |
11/06/1981 |
RION AUDIOMETER AA-67 |
RION ACOUSTIC INSTRUMENTS, INC. |
|
K812952 |
11/06/1981 |
RION AUDIOMETER AA-68 |
RION ACOUSTIC INSTRUMENTS, INC. |
|
K810054 |
01/28/1981 |
RICA (DIAGNOSTIC INSTRUMENTS) |
ROBERT I. CHIEN & ASSOC., INC. |
|
K802832 |
01/16/1981 |
SANDARE GLYCOHEMOGLOBIN PROCEDURE |
SANDARE CHEMICAL CO., INC. |
|
K802829 |
01/15/1981 |
SCANLAN VASCU-STATT |
SCANLAN INTL., INC. |
|
K813090 |
11/24/1981 |
COMPOSITE DENTAL RESTORATIVE MATERIAL |
SCI-PHARM, INC. |
|
K813091 |
11/24/1981 |
FISSURE SEALER & BONDING AGENT |
SCI-PHARM, INC. |
|
K810110 |
01/26/1981 |
COBBLER'S CHIP SPLINTS |
SECOL CO. |
|
K810109 |
01/26/1981 |
METAL SPLINTS |
SECOL CO. |
|
K803187 |
01/09/1981 |
ARGYLE UNIVERSAL POOLE SUCTION TUBE |
SHERWOOD MEDICAL CO. |
|
K813066 |
11/16/1981 |
ARGYLE YANKAUER SUCTION TUBE |
SHERWOOD MEDICAL CO. |
|
K812974 |
11/16/1981 |
LANCER COAGENT HUMAN FACTOR 1X PLASMA |
SHERWOOD MEDICAL CO. |
|
K812975 |
11/16/1981 |
LANCER COAGENT HUMAN VACTOR VIII PLASMA |
SHERWOOD MEDICAL CO. |
|
K803087 |
01/02/1981 |
LANCER CREATININE MICROSAMPLE STAT ANA |
SHERWOOD MEDICAL CO. |
|
K812933 |
11/06/1981 |
LANCER SPECIMEN CONTAINER |
SHERWOOD MEDICAL CO. |
|
K812934 |
11/06/1981 |
MONOJECT PREFILLED SYRINGES |
SHERWOOD MEDICAL CO. |
|
K812742 |
11/02/1981 |
SHILEY ARTERIAL FILTER W/40 MICRON SCREE |
SHILEY, INC. |
|
K812721 |
11/04/1981 |
DIGITRON |
SIEMENS CORP. |
|
K803130 |
01/28/1981 |
MULTIX U. BUCKY TABLE X-RAY UNIT |
SIEMENS CORP. |
|
K803124 |
01/22/1981 |
SIDOS U. |
SIEMENS CORP. |
|
K802816 |
01/16/1981 |
ENDOCARDIAL LEADS 414S & 515S |
SIEMENS ELEMA AB |
|
K810036 |
01/29/1981 |
SIEMENS-ELEMA MYOCARDIAL LEAD |
SIEMENS ELEMA AB |
|
K811842 |
11/20/1981 |
IMAGER 2000 REAL TIME SYSTEM |
SIEMENS GAMMASONICS, INC. |
|
K802759 |
01/07/1981 |
SIEMENS PHO/SONIC ALPHA 1000 |
SIEMENS GAMMASONICS, INC. |
|
K812646 |
11/16/1981 |
SKI 5000 |
SMITH KLINE DIAGNOSTICS, INC. |
|
K802024 |
01/07/1981 |
GRAVIDAPHONE |
SOLAR ELECTRONICS |
|
K812409 |
11/02/1981 |
SPHYGMOMANOMETER |
SOMATRONIX RESEARCH CORP. |
|
K803246 |
01/28/1981 |
ULTRASONIC STETHOSCOPE |
SONICAID, INC. |
|
K812720 |
11/05/1981 |
BODAI PATIENT COMMUNICATOR |
SONTEK INDUSTRIES, INC. |
|
K812757 |
11/02/1981 |
SORENSON THERMODILUTION CARDIAC COMPUT |
SORENSEN RESEARCH |
|
K812868 |
11/25/1981 |
FETAL PULSE DETECTORS, F50/F60 |
SOUTH CAROLINA MEDICAL, INC. |
|
K813098 |
11/20/1981 |
TENS DEVICE |
STAODYNAMICS, INC. |
|
K812856 |
11/06/1981 |
CHEMICAL INDICATORS |
STERILIZATION TECHNICAL SERVICES, INC. |
|
K813070 |
11/20/1981 |
PERIOGRAF |
STERLING DRUG, INC. |
|
K803090 |
01/22/1981 |
"SUNMAKER" (SUN TANNING BED) |
SUNMAKER, INC. |
|
K803189 |
01/28/1981 |
SUNSCENE TANNING STUDIO |
SUNSCENE TANNING STUDIO |
|
K812312 |
11/13/1981 |
STERILE WATER 4OZ. |
SUPERIOR PLASTIC PRODUCTS CORP. |
|
K810035 |
01/23/1981 |
PRENATAL SUPPORT PILLOW |
SUPPORTECH, INC. |
|
K813101 |
11/27/1981 |
CARDIOBEEPER MEMORY MONITOR |
SURVIVAL TECHNOLOGY, INC. |
|
K812691 |
11/16/1981 |
SILICONE IMPLANTS |
SUTTER BIOMEDICAL, INC. |
|
K812263 |
11/02/1981 |
KENZ-GELECT |
SUZUKEN CO., LTD. |
|
K802451 |
01/09/1981 |
BLF EIKEN KIT DETER. OF B-LIPOPR. FRAC. |
SYN-KIT, INC. |
|
K813192 |
11/27/1981 |
HDL-C EIKEN |
SYN-KIT, INC. |
|
K802448 |
01/05/1981 |
RA 80 EIKEN KIT DETERM. OF RHEUMATIC F. |
SYN-KIT, INC. |
|
K812464 |
11/16/1981 |
SYNTHEMED PULSE GENERATOR VVI MODEL 1000 |
SYNTHEMED CORP. |
|
K813146 |
11/27/1981 |
SYVA ADVANCE TM FLUOROMETER |
SYVA CO. |
|
K802760 |
01/12/1981 |
PETAL SOFT PLASTIC APPLICATOR TAMPAX |
TAMPAX, INC. |
|
K810160 |
01/28/1981 |
TAMPAX MAXITHINS PADS |
TAMPAX, INC. |
|
K802756 |
01/22/1981 |
SEMI-OVAL MODULAR SUNTANNING BOOTH |
TANNHUT |
|
K812743 |
11/16/1981 |
FETAL VITABILITY TM MODE |
TECHNICARE CORP. |
|
K813077 |
11/16/1981 |
TECHNICON RA 1000 SYSTEM |
TECHNICON CORP. |
|
K802850 |
01/13/1981 |
TECNOL O.R. TOURNIQUET COVER |
TECNOL NEW JERSEY WOUND CARE, INC. |
|
K803103 |
01/22/1981 |
TECHNY REX 3000 MOBILE X-RAY UNIT |
TECNOMED, INC. |
|
K803197 |
01/22/1981 |
IMPL. PROGRAMMABLE BIPOLAR CARD.GEN.#274 |
TELECTRONICS, INC. |
|
K802413 |
01/02/1981 |
IMPLANT. ENDOCARDIAL DISH TIP ELECT. LDS |
TELECTRONICS, INC. |
|
K803155 |
01/08/1981 |
PROPHYLAXIS CUP. |
TELEDYNE DENSCO |
|
K802970 |
01/22/1981 |
TERUMO HOLLOW FIBER OXYGENATOR |
TERUMO AMERICA, INC. |
|
K802545 |
01/16/1981 |
CARDIOPLEGIC SETS |
TEXAS MEDICAL PRODUCTS, INC. |
|
K802542 |
01/16/1981 |
DISPOSABLE CONNECTORS |
TEXAS MEDICAL PRODUCTS, INC. |
|
K802539 |
01/16/1981 |
DISPOSABLE GAS LINE FILTER |
TEXAS MEDICAL PRODUCTS, INC. |
|
K802541 |
01/16/1981 |
DISPOSABLE PARALLEL "Y" CONNECTORS |
TEXAS MEDICAL PRODUCTS, INC. |
|
K802544 |
01/16/1981 |
DISPOSABLE QUICK RELEASE PERFUSION ADAP |
TEXAS MEDICAL PRODUCTS, INC. |
|
K802543 |
01/16/1981 |
RIDGID VENA CAVA CANNULAE |
TEXAS MEDICAL PRODUCTS, INC. |
|
K812738 |
11/16/1981 |
BOUNDARY PROCESS CHANGE |
THE BUCKEYE CELLULOSE CORP. |
|
K812962 |
11/20/1981 |
BOUNDARY SURGICAL DRAPE |
THE BUCKEYE CELLULOSE CORP. |
|
K803158 |
01/15/1981 |
IRRADIATED BOUNDARY DEVICES |
THE BUCKEYE CELLULOSE CORP. |
|
K813263 |
11/27/1981 |
PATIENT UNDERPAD |
THE BUCKEYE CELLULOSE CORP. |
|
K812736 |
11/06/1981 |
SOFTCARE BARRIER WET DRESSING |
THE KENDAL CO. |
|
K803182 |
01/16/1981 |
SYRINGE FOR BLOOD SAMPLING |
THE UNIVERSITY OF CHICAGO |
|
K812765 |
11/16/1981 |
DATASCRIBE #DS-40 |
TIMETER INSTRUMENT CORP. |
|
K803207 |
01/15/1981 |
REGULATOR, OXYGEN MECHANICAL |
TIMETER INSTRUMENT CORP. |
|
K812767 |
11/27/1981 |
SNIFF AIR COMPRESSOR #SF-6 |
TIMETER INSTRUMENT CORP. |
|
K803240 |
01/09/1981 |
CORNING 760 FLUOROMETER/DENSITOMETER |
TRANSIDYNE GENERAL CORP. |
|
K810028 |
01/16/1981 |
FETAL BLOOD SAMPLING KIT MODEL 1560 |
TRANSIDYNE GENERAL CORP. |
|
K811924 |
11/10/1981 |
PRE-FILLED SYRINGE & CYSTOFLO URINARY BG |
TRAVENOL LABORATORIES, S.A. |
|
K803231 |
01/16/1981 |
THB 6000 HARDSHELL BUBBLE OXYGENATOR |
TRAVENOL LABORATORIES, S.A. |
|
K813001 |
11/06/1981 |
FIBRI-FILTER 20 |
TRI-MED, INC. |
|
K813014 |
11/10/1981 |
PROTECT-O-SEAL |
TRI-MED, INC. |
|
K812964 |
11/16/1981 |
INTRODUCER, PERCUTANEOUS SELDINGER |
TRIAD MEDICAL DIVISION |
|
K812769 |
11/06/1981 |
TRIDENT #2001 |
TRIDENT SURGICAL CORP. |
|
K803285 |
01/16/1981 |
PHOTOMETER |
TURNER DESIGNS, INC. |
|
K813067 |
11/24/1981 |
SPINAL WRENCH |
TWIN CITY SURGICAL, INC. |
|
K812209 |
11/16/1981 |
ULTRA COM |
ULTRANAMICS, INC. |
|
K803216 |
01/09/1981 |
CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT |
UNION CARBIDE CORP. |
|
K812886 |
11/16/1981 |
ENDODONTIC PAPER POINTS |
UNITED DENTAL MFG., INC. |
|
K812999 |
11/16/1981 |
PET POLYETHYLENE TORQUE CATHETER |
UNIVERSAL MEDICAL INSTRUMENT CORP. |
|
K812213 |
11/05/1981 |
AUTOMATED ELECTROCAUTERY SYSTEM |
UNIVERSITY OF WASHINGTON |
|
K803292 |
01/29/1981 |
FIELD SUCTION DISSECTOR |
V. MUELLER O.V. BAXTER HEALTHCARE CORP. |
|
K813072 |
11/10/1981 |
E2502 & E2502B LECTROSWITCH |
VALLEYLAB, INC. |
|
K813071 |
11/10/1981 |
E2508 DISPOSABLE HANDSWITCHING PENCIL |
VALLEYLAB, INC. |
|
K802647 |
01/08/1981 |
ECA GEL PROUDUCT REFORMULATION |
VANARAY LABORATORIES, INC. |
|
K812785 |
11/16/1981 |
VANCE-AMBROSE RESECTOSCOPE FORCEPS |
VANCE PRODUCTS, INC. |
|
K802808 |
01/07/1981 |
6MV PORT FILM CAPABILITY OPTION |
VARIAN ASSOC., INC. |
|
K802809 |
01/07/1981 |
ELECTRON ARC THERAPY |
VARIAN ASSOC., INC. |
|
K812854 |
11/06/1981 |
VENTRONICS #5590 ECII OXYGEN MONITOR |
VENTRONICS, DIV OF HUDSON OXYGEN THERAPY SALES CO. |
|
K812855 |
11/06/1981 |
VENTRONICS #5595 ECII OXYGEN ANALYZER |
VENTRONICS, DIV OF HUDSON OXYGEN THERAPY SALES CO. |
|
K812981 |
11/06/1981 |
FLUVEN SETS (EXT-1, EXT-2, EXT-3, EXT-4) |
VENUSA LTD. |
|
K812121 |
11/16/1981 |
DIGICLOT 2-#820 |
VOLU SOL MEDICAL INDUSTRIES |
|
K812122 |
11/10/1981 |
MULTI CLOT-#819 |
VOLU SOL MEDICAL INDUSTRIES |
|
K803299 |
01/15/1981 |
COLD/HOT PACK |
W.G. WHITNEY CORP. |
|
K803204 |
01/21/1981 |
IRRIGATION PISTON |
WALPAK CO. |
|
K803200 |
01/21/1981 |
IRRIGATION SET W/BULB SYRINGE |
WALPAK CO. |
|
K803198 |
01/15/1981 |
IRRIGATION SET W/PISTON SYRINGE |
WALPAK CO. |
|
K803199 |
01/15/1981 |
SUTURE REMOVAL KIT |
WALPAK CO. |
|
K813027 |
11/20/1981 |
STERILE IRRIGATING SYRINGES, KITS,TRAY |
WELCON, INC. |
|
K812432 |
11/06/1981 |
HEALTH-UP |
WFX INDUSTRIES, INC. |
|
K810065 |
01/28/1981 |
SCOTT CM42 PASTEURIZER |
WILLIAM HARVEY LIFE PRODUCTS CORP. |
|
K812390 |
11/24/1981 |
NEUROSPONGE PADDIE |
WINN HIRSCH & ASSOC. |
|
K812391 |
11/24/1981 |
NEUROSPONGES |
WINN HIRSCH & ASSOC. |
|
K810026 |
01/28/1981 |
DENTAL ENDODONTIC CEMENT |
WITECH LABORATORY |
|
K803172 |
01/15/1981 |
GAUZE SPONGES |
WORLDWIDE SURGICAL GAUZE |
|
K812572 |
11/02/1981 |
GAUZE SPONGES |
WORLDWIDE SURGICAL GAUZE |
|
K812814 |
11/06/1981 |
ZEE SURGICAL INSTRUMENTS |
ZEE MEDICAL PRODUCTS CO., INC. |
|
K813016 |
11/24/1981 |
ZEE TRACTION SPLINT |
ZEE MEDICAL PRODUCTS CO., INC. |
|