FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
K760104 |
06/23/1976 |
RESPIRATION MONITOR |
AIR-SHIELDS, INC. |
|
K760124 |
06/28/1976 |
AUTO CELL DILUENT |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K760123 |
06/28/1976 |
AUTOZYME |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K760042 |
06/15/1976 |
BLOOD TUBING SETS |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K760054 |
06/16/1976 |
CULTURE TUBE, (VACUTAINER) |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K760041 |
06/15/1976 |
FILTER, RESPIRATORY (U-MID) |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K760045 |
06/15/1976 |
KIT, RADIOASSAY, SERUM IRON |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K760044 |
06/15/1976 |
KIT, RIA, HUMAN THYROID HORMONE |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K760063 |
06/16/1976 |
SPECIMEN COLLECTOR, ANAEROBIC |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K760040 |
06/15/1976 |
TEST, MONO., CARD (MACRO-VUE) |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K760043 |
06/15/1976 |
TEST, RHEUM. ARTH., CARD (MACRO-VUE) |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K760039 |
06/15/1976 |
VALVE, I.M.V. (U-MID ONE WAY) |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K760073 |
06/18/1976 |
BASIN, WASH, 6-QT RECTANGULAR |
BEMIS HEALTH CARE |
|
K760072 |
06/18/1976 |
CARAFE, PERSONAL, 1-QT SEMI-RECTANGULAR |
BEMIS HEALTH CARE |
|
K760071 |
06/18/1976 |
TRAY, PERSONAL, RECTANG. 8 1/2 X 5 1/4 |
BEMIS HEALTH CARE |
|
K760070 |
06/18/1976 |
TUMBLER, PERSONAL, ROUND, 9 OUNCE |
BEMIS HEALTH CARE |
|
K760134 |
06/28/1976 |
PROCEDURE, RA, THYROXINE BINDING PROTEIN |
BIO-RAD |
|
K760133 |
06/28/1976 |
PROCEDURE, RED CELL FOLATE ASSAY |
BIO-RAD |
|
K760135 |
06/28/1976 |
TEST, RA, QUANTA-COUNT T-4 |
BIO-RAD |
|
K760132 |
06/28/1976 |
TEST, RIA, TSH QUANTIMUNE |
BIO-RAD |
|
K760093 |
06/21/1976 |
CATHETER, SILICONE FOLEY (BARDEX) |
C.R. BARD, INC. |
|
K760095 |
06/21/1976 |
RESPIRIZOR |
CAMPILLARY SYSTEMS |
|
K760616 |
06/14/1976 |
PROPIOCEPTOR MASSAGER |
CELLERS RESEARCH, INC. |
|
K760138 |
06/29/1976 |
BANDAGE, CEB COTTON ELASTIC |
CONCO MEDICAL CO. |
|
K760141 |
06/29/1976 |
BANDAGE, CONFO-LASTIC ALL COTTON ELASTIC |
CONCO MEDICAL CO. |
|
K760139 |
06/29/1976 |
BANDAGE, E-COTTON ELASTIC |
CONCO MEDICAL CO. |
|
K760142 |
06/29/1976 |
BANDAGE, RAPIDO-LASTIC COTTON/NYLON |
CONCO MEDICAL CO. |
|
K760140 |
06/29/1976 |
BANDAGE, WRINKY-LASTIC ELASTIC GAUZE |
CONCO MEDICAL CO. |
|
K760105 |
06/24/1976 |
BAG, URINE COLLECTION, CLOSED SYSTEM |
CONCORD LABORATORIES, INC. |
|
K760085 |
06/21/1976 |
BASIN, STERILE (#3200) |
CONCORD LABORATORIES, INC. |
|
K760086 |
06/21/1976 |
TRAY, BLOOD SAMPLING (PULSATOR II) |
CONCORD LABORATORIES, INC. |
|
K760128 |
06/28/1976 |
TRAY, CATHETERIZATION W/ CATHETER |
CONCORD LABORATORIES, INC. |
|
K760127 |
06/28/1976 |
TRAY, CATHETERIZATION W/O CATHETER |
CONCORD LABORATORIES, INC. |
|
K760013 |
06/10/1976 |
PACER SYSTEMS ANALYZER (CORDIS) |
CORDIS CORP. |
|
K760076 |
06/18/1976 |
ABSORBER, ANESTHESIA CIRCLE SYS, CO2 |
FRASER SWEATMAN, INC. |
|
K760097 |
06/14/1976 |
FEBRILE ANTIGENS & CONTROL SERUMS |
GAMMA BIOLOGICALS, INC. |
|
K760096 |
06/14/1976 |
REAGENT, LYOPHILIZED ANTI-STREPTOLYSIN O |
GAMMA BIOLOGICALS, INC. |
|
K760098 |
06/14/1976 |
REAGENT, VDRL |
GAMMA BIOLOGICALS, INC. |
|
K760033 |
06/14/1976 |
TEST, ANTIBODIES FOR GRP A, LATEX SLIDE |
GAMMA BIOLOGICALS, INC. |
|
K760035 |
06/14/1976 |
TEST, C-REATIVE PROTEIN, LATEX SLIDE |
GAMMA BIOLOGICALS, INC. |
|
K760036 |
06/14/1976 |
TEST, LATEX SLIDE, RHEUMATOID FACTOR |
GAMMA BIOLOGICALS, INC. |
|
K760032 |
06/14/1976 |
TEST, MONO., DIFFERENTIAL SLIDE |
GAMMA BIOLOGICALS, INC. |
|
K760034 |
06/14/1976 |
TEST, STREP, LATEX SLIDE |
GAMMA BIOLOGICALS, INC. |
|
K760007 |
06/08/1976 |
BLOOD-SMEARING INSTRUMENT (MINIPREP TM) |
GEOMETRIC DATA, DIV. SMITHKLINE CORP. |
|
K760030 |
06/14/1976 |
CLINICARD PHOSPHORUS |
HARLECO |
|
K760028 |
06/14/1976 |
CPK - ISOENZYMES |
HARLECO |
|
K760027 |
06/14/1976 |
DSP - STAIN PACK |
HARLECO |
|
K760029 |
06/14/1976 |
ENZYMATIC TRIGLYCERIDE |
HARLECO |
|
K760031 |
06/14/1976 |
HISTOCHEMICAL PAS REACTION SET |
HARLECO |
|
K760129 |
06/28/1976 |
SALINE, ISOTONIC BUFFERED, AZIDE-FREE |
HARLECO |
|
K760024 |
06/14/1976 |
ULTRAZYME ALKALINE PHOSPHATASE |
HARLECO |
|
K760026 |
06/14/1976 |
ULTRAZYME AMYLASE |
HARLECO |
|
K760025 |
06/14/1976 |
ULTRAZYME GT |
HARLECO |
|
K760023 |
06/14/1976 |
ULTRAZYME HBD |
HARLECO |
|
K760089 |
06/21/1976 |
TEST, IN-VITRO DIAGNOSTIC |
HOFFMANN-LA ROCHE, INC. |
|
K760082 |
06/21/1976 |
BOTTLE, CONDENSATE (#1628) |
INSPIRON CORP. |
|
K760080 |
06/21/1976 |
CANNULA, NASAL, FOR OXYGEN |
INSPIRON CORP. |
|
K760081 |
06/21/1976 |
FILTER, BACTERIA (#2290) |
INSPIRON CORP. |
|
K760037 |
06/15/1976 |
HEATER, IMMERSION W/ HUMIDIFIER & NEBUL. |
INSPIRON CORP. |
|
K760064 |
06/16/1976 |
CATHETER, THERMAL DILUTION, ANIMAL & PED |
INSTRUMENTATION LABORATORY CO. |
|
K760067 |
06/16/1976 |
CATHETER, THERMAL DILUTION, OPEN CHEST |
INSTRUMENTATION LABORATORY CO. |
|
K760065 |
06/16/1976 |
CATHETER, THERMAL DILUTION, PEDIATRIC |
INSTRUMENTATION LABORATORY CO. |
|
K760119 |
06/25/1976 |
SAMPLER, FLAMELESS (IL MODEL 555) |
INSTRUMENTATION LABORATORY CO. |
|
K760066 |
06/16/1976 |
TRAY, ICED INJECTABLE (26420) |
INSTRUMENTATION LABORATORY CO. |
|
K760075 |
06/18/1976 |
KIT, METHADONE (TOXI-PAK IMMUNO HI) |
J.T. BAKER CHEMICAL CO. |
|
K760074 |
06/18/1976 |
KIT, MORPHINE (TOXI-PAK IMMUNO HI) |
J.T. BAKER CHEMICAL CO. |
|
K760103 |
06/23/1976 |
CAP, INJECTION (#4600) |
JELCO LABORATORIES |
|
K760110 |
06/24/1976 |
FILTER, I.V. (#4700) |
JELCO LABORATORIES |
|
K760111 |
06/24/1976 |
FILTER, I.V., WITH FLASH BULB (#4701) |
JELCO LABORATORIES |
|
K760022 |
06/14/1976 |
NEEDLE, FILTER |
JELCO LABORATORIES |
|
K760019 |
06/11/1976 |
VACUUM TUBES, PEDIATRIC SIZES (J-VAC) |
JELCO LABORATORIES |
|
K760018 |
06/11/1976 |
VACUUM TUBES, STERILE (J-VAC) |
JELCO LABORATORIES |
|
K760118 |
06/25/1976 |
THERMOMETER, DIGITAL FEVER (MEDITEMP) |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
|
K760094 |
06/21/1976 |
SPONGE, CURITY WASHED GAUZE |
KENDALL RESEARCH CENTER |
|
K760008 |
06/08/1976 |
DENTAL MATERIAL, IMPLANT, HIGH-PURITY AL |
KYOCERA INTERNATIONAL, INC. |
|
K760121 |
06/28/1976 |
IMPULSE HEAT SEALER |
LORVIC CORP. |
|
K760052 |
06/15/1976 |
KIT, PREP SHAVE |
M-C IND., INC. |
|
K760047 |
06/15/1976 |
TRAY, BLADDER IRRIGATION |
M-C IND., INC. |
|
K760051 |
06/15/1976 |
TRAY, SUTURE REMOVAL |
M-C IND., INC. |
|
K760048 |
06/15/1976 |
TRAY, URETHRAL CATHETERIZATION |
M-C IND., INC. |
|
K760017 |
06/11/1976 |
CONSIOUS SEDATION (ANALOR P-76) |
MCKESSON CORP. |
|
K760090 |
06/21/1976 |
GRAFT, COOLEY GUIDELINE, STERILE |
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. |
|
K760092 |
06/21/1976 |
GRAFT, COOLEY WOVEN VASCULAR, STERILE |
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. |
|
K760091 |
06/21/1976 |
GRAFT, MICROVEL GUIDELINE, STERILE |
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. |
|
K760087 |
06/21/1976 |
TAPE, VASCULAR, 1/4" DACRON |
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. |
|
K760006 |
06/07/1976 |
RADIOASSAY, CONCEPT 4 |
MICROMEDIC SYSTEMS |
|
K760084 |
06/21/1976 |
MONITOR, GSR (NB-401) |
NARCO BIO-SYSTEMS |
|
K760083 |
06/21/1976 |
PHYSIOSCOPE |
NARCO BIO-SYSTEMS |
|
K760068 |
06/16/1976 |
KIT, RIA, GENTAMICIN SULF. |
NEW ENGLAND NUCLEAR |
|
K760088 |
06/21/1976 |
ANALYZER, SENTORR BLOOD GAS |
OHIO MEDICAL PRODUCTS |
|
K760102 |
06/23/1976 |
FLOWMETER, P.C., REDESIGNED VERSION |
OHIO MEDICAL PRODUCTS |
|
K760101 |
06/23/1976 |
OXYGEN & RESUSCITATION (HOPE II MODEL) |
OHIO MEDICAL PRODUCTS |
|
K760149 |
06/30/1976 |
CONDUCTIVE ANESTHSIA BREATH. CIRCUIT |
OMNICON MEDICAL CORP. |
|
K760106 |
06/24/1976 |
PROSTHESIS, TOTAL HIP-FEMORAL |
ORTHOPEDIC EQUIPMENT CO., INC. |
|
K760109 |
06/24/1976 |
PROSTHESIS, TOTAL HIP-RASP |
ORTHOPEDIC EQUIPMENT CO., INC. |
|
K760108 |
06/24/1976 |
PROSTHESIS, TOTAL HIP-TEST CUP |
ORTHOPEDIC EQUIPMENT CO., INC. |
|
K760107 |
06/24/1976 |
PROSTHESIS, TOTAL HIP-TEST FEMORAL |
ORTHOPEDIC EQUIPMENT CO., INC. |
|
K760078 |
06/18/1976 |
REAGENT, RIA TRIIODOTHYRONINE T3 (#200) |
OXFORD LABORATORIES, INC. |
|
K760079 |
06/18/1976 |
REAGENT, THYROXINE T4 (#210) |
OXFORD LABORATORIES, INC. |
|
K760143 |
06/29/1976 |
SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN |
OXFORD LABORATORIES, INC. |
|
K760148 |
06/29/1976 |
SERUM, B1A GLOBULIN C3C GOAT ANTI-HUMAN |
OXFORD LABORATORIES, INC. |
|
K760144 |
06/29/1976 |
SERUM, HAPTOGLOBIN GOAT ANTI-HUMAN ACID |
OXFORD LABORATORIES, INC. |
|
K760146 |
06/29/1976 |
SERUM, IGA GOAT ANTI-HUMAN ACID |
OXFORD LABORATORIES, INC. |
|
K760145 |
06/29/1976 |
SERUM, IGG GOAT ANTI-HUMAN ACID |
OXFORD LABORATORIES, INC. |
|
K760147 |
06/29/1976 |
SERUM, IGM ANTI-HUMAN ACID |
OXFORD LABORATORIES, INC. |
|
K760113 |
06/24/1976 |
SPONGE, LAPAROTOMY GAUZE |
PARKE-DAVIS CO. |
|
K760016 |
06/11/1976 |
SURGICAL BLADES (BEAVER) |
PARKE-DAVIS CO. |
|
K760069 |
06/16/1976 |
BAG, LEG, URINE COLLECTING DEVICE |
PHARMASEAL DIV., BAXTER HEALTHCARE CORP. |
|
K760125 |
06/28/1976 |
AIRWAY, ARGYLE NASOPHARYNGEAL |
SHERWOOD MEDICAL INDUSTRIES |
|
K760163 |
06/30/1976 |
CATHETER, INTRAVASCULAR (MEDICUT T) |
SHERWOOD MEDICAL INDUSTRIES |
|
K760136 |
06/28/1976 |
CATHETER, THORACIC DRAIN |
SHERWOOD MEDICAL INDUSTRIES |
|
K760137 |
06/28/1976 |
TUBE, FEEDING, ARGYLE |
SHERWOOD MEDICAL INDUSTRIES |
|
K760131 |
06/28/1976 |
AGARO-GEL, PRODUCT # A1266 |
SIGMA CHEMICAL CO. |
|
K760055 |
06/16/1976 |
REAGENT, GLUCOSE, FLOW-THROUGH ANALYZER |
SMITH KLINE DIAGNOSTICS, INC. |
|
K760077 |
06/18/1976 |
TEST, RIA, SERUM DIGOXIN |
SMITH KLINE DIAGNOSTICS, INC. |
|
K760057 |
06/16/1976 |
TEST, RIA, TRIODOTHYRONINE |
SMITH KLINE DIAGNOSTICS, INC. |
|
K760120 |
06/28/1976 |
PULSE CARDULE (MODEL 1859/1860 ECG) |
SPACELABS, INC. |
|
K760004 |
06/07/1976 |
SYRINGE, DISPOSABLE, ALL PLASTIC |
STEWART-NAUMANN LABORATORIES |
|
K760005 |
06/07/1976 |
SYRINGE, DISPOSABLE, GLASS & PLASTIC |
STEWART-NAUMANN LABORATORIES |
|
K760009 |
06/10/1976 |
COLORIMETRIC DETERMINATION (LDH) |
THE DOW CHEMICAL CO. |
|
K760010 |
06/10/1976 |
COLORIMETRIC DETERMINATION (SGOT/SGPT) |
THE DOW CHEMICAL CO. |
|
K760011 |
06/10/1976 |
REAGENT, TRIGLYCERIDES |
THE DOW CHEMICAL CO. |
|
K760112 |
06/24/1976 |
SPECTROPHOTOMETER (JUNIOR III) |
THE PERKIN-ELMER CORP. |
|
K760046 |
06/15/1976 |
CASE, CONTACT LENS, PLASTIC |
TOMLIN B. HORSLEY, JR. |
|
K760012 |
06/10/1976 |
BLOOD WARMER (CODE 4R4305) |
TRAVENOL LABORATORIES, S.A. |
|
K760126 |
06/28/1976 |
LENS, HARD CONTACT |
TRU-FORM OPTICS, INC. |
|
K760130 |
06/28/1976 |
PROSTHESIS, VASCULAR BIFURCATED |
USCI, DIV. C.R. BARD, INC. |
|
K760122 |
06/28/1976 |
WILL-CERAM Y-2 |
WILLIAMS GOLD REFINING CO., INC. |
|