FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
K771764 |
09/19/1977 |
CORONARY PRESSURE PERFUSION PUMP |
3M HEALTH CARE, SARNS |
|
K771819 |
09/26/1977 |
CABG RINGS |
A&A ENT. |
|
K771858 |
09/29/1977 |
EXPAND. RETENTION ENDOSSEOUS IMPLANT |
A.L. MILLER, INC. |
|
K771669 |
09/01/1977 |
DIAG. KIT FOR TOTAL ANTITHROMBIN III |
ABBOTT LABORATORIES |
|
K771671 |
09/01/1977 |
AUDITORY TRAINER |
ACCUTONE, INC. |
|
K771668 |
09/01/1977 |
DISP. FLUID ISOLATOR & PRESS. RELIEF |
AILTECH |
|
K771699 |
09/06/1977 |
CARA-STAIN MODEL 3000 |
AMERICAN SAFETY EQUIPMENT CORP. |
|
K771772 |
09/19/1977 |
DINAMAP MODEL 825A |
APPLIED MEDICAL RESEARCH |
|
K771782 |
09/23/1977 |
DINIMAP MODEL 827A |
APPLIED MEDICAL RESEARCH |
|
K771678 |
09/02/1977 |
THROMBO-SCREEN PLATELET ADHESION |
BAY AREA HEMA. ONCO. CLINIC. & RES. L |
|
K771696 |
09/06/1977 |
EMODIALYSIS DEL. SYS. MODEL 7110 |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K771784 |
09/23/1977 |
IOPSY TRAY FOR SOFT TISSUE BIOPSY |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K771796 |
09/23/1977 |
RUBA-NOST TEST KITS |
BEHRING DIAGNOSTICS, INC. |
|
K771758 |
09/19/1977 |
ELASTOMULL GAUZE BANDAGE |
BEIERSDORF, INC. |
|
K771733 |
09/15/1977 |
8" EMESIS BASIN |
BEMIS HEALTH CARE |
|
K771738 |
09/15/1977 |
MALE URINAL |
BEMIS HEALTH CARE |
|
K771737 |
09/15/1977 |
SUCTION CANISTER |
BEMIS HEALTH CARE |
|
K771689 |
09/06/1977 |
DIAL X COLLIMATOR MODEL A&B |
BENNETT X-RAY CORP. |
|
K771711 |
09/12/1977 |
BIOTOME |
BERKELEY BIO-ENGINEERING |
|
K771722 |
09/13/1977 |
SENSOMAT |
BIOCHEM INTERNATIONAL, INC. |
|
K771825 |
09/27/1977 |
CARBA LINGUARDUC |
C.R. BARD, INC. |
|
K771775 |
09/19/1977 |
COLORPLAST TRANSVERSE SYSTEM |
C.R. BARD, INC. |
|
K771776 |
09/19/1977 |
ECG CLUSTER ELECTRODE |
C.R. BARD, INC. |
|
K771750 |
09/15/1977 |
RF CHOKE CABLE |
C.R. BARD, INC. |
|
K771792 |
09/22/1977 |
ENEMA SET |
CHASE MFG. CO. |
|
K771791 |
09/22/1977 |
NEEDLE COUNTING |
CHASE MFG. CO. |
|
K771813 |
09/27/1977 |
CENTRIFICHEM SYS 400 ANALYZER |
CLINICAL DIAGNOSTICS, INC. |
|
K771692 |
09/06/1977 |
TUBING SETS |
COBE LABORATORIES, INC. |
|
K771718 |
09/12/1977 |
CARDIOTHERM-500X |
COLUMBUS INSTRUMENTS INTL. CORP. |
|
K771785 |
09/23/1977 |
IRRIGATING NEEDLE, ILLUMINATED |
CONCEPT, INC. |
|
K771732 |
09/15/1977 |
THORNTON ANTERIOR CHAMBER IRRIGATOR |
CONCEPT, INC. |
|
K771673 |
09/02/1977 |
CATHETEO CARE TRAY #0242 |
CONCORD LABORATORIES, INC. |
|
K771855 |
09/28/1977 |
OMNICOR PROGRAMMER MODEL 222A |
CORDIS CORP. |
|
K771753 |
09/16/1977 |
HEMATOLOGY REFERENCE CONTROL |
COULTER ELECTRONICS, INC. |
|
K771740 |
09/15/1977 |
CARDIOZYME CK-CONTROL LEVEL 1 |
DADE, BAXTER TRAVENOL DIAGNOSTICS, INC. |
|
K771746 |
09/15/1977 |
FORCEPS |
DEPUY, INC. |
|
K771744 |
09/15/1977 |
OSTEOTOMES FOR CUTTING BONH |
DEPUY, INC. |
|
K771747 |
09/15/1977 |
PERIOSTEAL ELEVATOR |
DEPUY, INC. |
|
K771745 |
09/15/1977 |
RASPS FOR SCRAPING BONE |
DEPUY, INC. |
|
K771743 |
09/15/1977 |
SURG. SCISSORS FOR CUTTING TISSUE |
DEPUY, INC. |
|
K771708 |
09/12/1977 |
WORRELL PATELLA |
DEPUY, INC. |
|
K771710 |
09/12/1977 |
WORRELL PATELLA TEMPLATE |
DEPUY, INC. |
|
K771709 |
09/12/1977 |
WORRELL TRIAL PATELLA |
DEPUY, INC. |
|
K771815 |
09/27/1977 |
SIGMOSCOPE |
DYNATECH CRYOMEDICAL CO. |
|
K771799 |
09/23/1977 |
ACA ALCOHOL CALIBRATORS |
E.I. DUPONT DE NEMOURS & CO., INC. |
|
K771804 |
09/23/1977 |
ACA AMMONIA CALIBRATOR |
E.I. DUPONT DE NEMOURS & CO., INC. |
|
K771798 |
09/23/1977 |
ACA BILIRUBIN CALIBRATOR |
E.I. DUPONT DE NEMOURS & CO., INC. |
|
K771801 |
09/23/1977 |
ACA CARBON DIOXIDE CALIBRATOR |
E.I. DUPONT DE NEMOURS & CO., INC. |
|
K771800 |
09/23/1977 |
ACA GLUTAMYL TRANSFERASE |
E.I. DUPONT DE NEMOURS & CO., INC. |
|
K771802 |
09/23/1977 |
ACA IRON CALIBRATOR |
E.I. DUPONT DE NEMOURS & CO., INC. |
|
K771803 |
09/23/1977 |
ACA PHOSPHORUS CALIBRATOR |
E.I. DUPONT DE NEMOURS & CO., INC. |
|
K771805 |
09/23/1977 |
ACA SALICYLATE CALIBRATOR |
E.I. DUPONT DE NEMOURS & CO., INC. |
|
K771797 |
09/23/1977 |
ACA TRIGLYCERIDE CALIBRATOR |
E.I. DUPONT DE NEMOURS & CO., INC. |
|
K771857 |
09/29/1977 |
AUTOMIXER, KODAK |
EASTMAN KODAK COMPANY |
|
K771682 |
09/06/1977 |
MIN-R CASSETTE |
EASTMAN KODAK COMPANY |
|
K771681 |
09/06/1977 |
ORTHO H FILM |
EASTMAN KODAK COMPANY |
|
K771691 |
09/06/1977 |
ANGLED FORCEP APPLIER |
EDWARD WECK, INC. |
|
K771751 |
09/16/1977 |
DISP. ELECTROSURGERY PENCIL |
EDWARD WECK, INC. |
|
K771752 |
09/16/1977 |
FINGER TIP CONTROL PENCIL |
EDWARD WECK, INC. |
|
K771859 |
09/29/1977 |
NEEDLE HOLDER, MICROVASCULAR |
EDWARD WECK, INC. |
|
K771811 |
09/27/1977 |
EMI CTR 100 |
EMI MEDICAL, INC. |
|
K771817 |
09/26/1977 |
EMI THERAPY SIMULATOR |
EMI THERAPY SYSTEMS, INC. |
|
K771852 |
09/29/1977 |
NIMETIC POLISHING PASTE |
ESPE GMBH (US) |
|
K771853 |
09/29/1977 |
PERMAGUM ADHESIVE |
ESPE GMBH (US) |
|
K771679 |
09/06/1977 |
MICROFLATOR |
FISONS CORP. |
|
K771768 |
09/19/1977 |
GOAT LAMBDA-LIGHT CHAIN ANTI-HUMAN SERUM |
G.D. SEARLE AND CO. |
|
K771774 |
09/19/1977 |
NEW BASE FOR ORTHODONTIC APPLIANCES |
GAC INTL., INC. |
MARK MANNI |
K771828 |
09/29/1977 |
ALBUMIN |
GAMMA ENTERPRISES, INC. |
|
K771829 |
09/21/1977 |
ALKALINE PHOSPHATASE |
GAMMA ENTERPRISES, INC. |
|
K771830 |
09/21/1977 |
BLOOD UREA NITROGEN BUN |
GAMMA ENTERPRISES, INC. |
|
K771831 |
09/21/1977 |
CALCIUM |
GAMMA ENTERPRISES, INC. |
|
K771832 |
09/21/1977 |
CHLORIDE |
GAMMA ENTERPRISES, INC. |
|
K771833 |
09/21/1977 |
CHOLESTEROL |
GAMMA ENTERPRISES, INC. |
|
K771834 |
09/21/1977 |
CREATININE |
GAMMA ENTERPRISES, INC. |
|
K771835 |
09/21/1977 |
INORGANIC PHOSPHORUS |
GAMMA ENTERPRISES, INC. |
|
K771836 |
09/21/1977 |
LACTATE DEHYDROGENASE |
GAMMA ENTERPRISES, INC. |
|
K771837 |
09/21/1977 |
POTASSIUM |
GAMMA ENTERPRISES, INC. |
|
K771838 |
09/21/1977 |
SERUM IRON |
GAMMA ENTERPRISES, INC. |
|
K771839 |
09/21/1977 |
SODIUM |
GAMMA ENTERPRISES, INC. |
|
K771840 |
09/21/1977 |
TOTAL BILIRUBIN |
GAMMA ENTERPRISES, INC. |
|
K771841 |
09/21/1977 |
TOTAL PROTEIN |
GAMMA ENTERPRISES, INC. |
|
K771842 |
09/21/1977 |
URIC ACID |
GAMMA ENTERPRISES, INC. |
|
K771844 |
09/21/1977 |
WASH SOLUTIONS |
GAMMA ENTERPRISES, INC. |
|
K771843 |
09/21/1977 |
WETTING AGENTS |
GAMMA ENTERPRISES, INC. |
|
K771812 |
09/27/1977 |
LIPPOPROTEIN ELECTROPHORESIS REAGENT SET |
GELMAN INSTRUMENT CO. |
|
K771748 |
09/15/1977 |
INTRA ORAL X-RAY CONES |
GENERAL ELECTRIC CO. |
|
K771686 |
09/06/1977 |
UREAPLASMA DIFFERENTIAL BASAL AGAR MED. |
GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. |
|
K771742 |
09/15/1977 |
EVOKED RESPONSE SYS., MODEL 10 |
GRASS INSTRUMENT CO. |
|
K771773 |
09/19/1977 |
CLINICARD CREATININE CHEMISTRY |
HARLECO |
|
K771754 |
09/16/1977 |
GLUCOSE REAGENT FOR GLUC. ANALYZER |
HARLECO |
|
K771731 |
09/14/1977 |
CHOLAR PRODU&T #17010 |
HI CHEM, INC. |
|
K771683 |
09/06/1977 |
AMPLIFIER MODEL N3B-EEG |
HONEYWELL, INC. |
|
K771684 |
09/06/1977 |
AMPLIFIER MODEL N5A-ECG |
HONEYWELL, INC. |
|
K771685 |
09/06/1977 |
AMPLIFIER MODEL N5A-HIS |
HONEYWELL, INC. |
|
K771714 |
09/12/1977 |
SLIDE STAINERS GLS 360 & 360-1 |
HONEYWELL, INC. |
|
K771795 |
09/23/1977 |
LAS-R CERULOPLASMIN TEST |
HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES |
|
K771780 |
09/23/1977 |
LAS-R TM |
HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES |
|
K771700 |
09/07/1977 |
TMA BICARBONATE/GLYCEROL DILUENT |
HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES |
|
K771703 |
09/09/1977 |
ENTERIC 20 |
INOLEX CORP./DIV OF BIOMEDICAL |
|
K771806 |
09/23/1977 |
THOREK SCISSORS 7 1/4 & 10" |
J. SKLAR MFG. CO., INC. |
|
K771787 |
09/20/1977 |
AZIDE FREE BLOOD DILUTING REAGENT |
J.T. BAKER CHEMICAL CO. |
|
K771789 |
09/20/1977 |
BLANKING SOLUTION HGB |
J.T. BAKER CHEMICAL CO. |
|
K771788 |
09/20/1977 |
CYMET-AUTOMATED |
J.T. BAKER CHEMICAL CO. |
|
K771716 |
09/12/1977 |
CYMET-PLUS |
J.T. BAKER CHEMICAL CO. |
|
K771790 |
09/20/1977 |
DETECTOTERGE "AZIDE FREE" |
J.T. BAKER CHEMICAL CO. |
|
K771847 |
09/28/1977 |
TEMP-TESTER |
JABLECKI, CHARLES, DR. |
|
K771757 |
09/16/1977 |
EXAM GLOVES |
JAMAR HEALTH PRODUCTS |
|
K771826 |
09/19/1977 |
INTRAVENOUS FILTER W/AUTO AIR VENT |
JELCO LABORATORIES |
|
K771827 |
09/19/1977 |
INTRAVENOUS FILTER W/FLASH BULB |
JELCO LABORATORIES |
|
K771761 |
09/20/1977 |
SOLID OXYGEN SYSTEM |
JET RESEARCH CENTER, INC. |
|
K771719 |
09/12/1977 |
KARAYA ELECTRODES |
LECTEC CORP. |
|
K771820 |
09/23/1977 |
ENZYMATIC CHOLESTEROL |
MACOMB CHEMICAL CO. |
|
K771849 |
09/28/1977 |
CPK COLOR TEST KIT |
MALLINCKRODT CRITICAL CARE |
|
K771848 |
09/28/1977 |
PHOSPHORUS TEST KIT |
MALLINCKRODT CRITICAL CARE |
|
K771765 |
09/19/1977 |
MYO-CHECK |
MED GENERAL |
|
K771701 |
09/08/1977 |
VESSEL-CLUDE |
MED GENERAL |
|
K771702 |
09/08/1977 |
VESSEL-STABILIZER |
MED GENERAL |
|
K771779 |
09/21/1977 |
CATHETERIZATION SYS. URINARY DRAINAGE |
MEDICAL DEVICES, INC. |
|
K771676 |
09/02/1977 |
FOOT DROP BOOT |
MEDICAL RESTRAINTS, INC. |
|
K771715 |
09/12/1977 |
PELVIC WHEELCHAIR RESTRAINT |
MEDICAL RESTRAINTS, INC. |
|
K771824 |
09/27/1977 |
MEDPRO FLOTATION SYSTEM |
MEDPRO, INC. |
|
K771786 |
09/21/1977 |
CARDIAC PULSE GENERATORS 5982/5983 |
MEDTRONIC VASCULAR |
|
K771770 |
09/19/1977 |
XYREL-RA MODELS 5994/5995 |
MEDTRONIC VASCULAR |
|
K771755 |
09/16/1977 |
9-WAY URINE TEST WITH ASCORBIC |
MILES LABORATORIES, INC. |
|
K771672 |
09/01/1977 |
MICROCULT-ID |
MILES LABORATORIES, INC. |
|
K771767 |
09/19/1977 |
SERALUTE TSH (RIA) |
MILES LABORATORIES, INC. |
|
K771713 |
09/12/1977 |
TEK-CHEK-2 |
MILES LABORATORIES, INC. |
|
K771763 |
09/19/1977 |
HEMO-RO |
MILLIPORE CORP. |
|
K771749 |
09/15/1977 |
AMALGAM DISPENSER |
NEW DIMENSIONS IN MEDICINE, INC. |
|
K771756 |
09/16/1977 |
FOLLICLE-STIMULATING HORMONE |
NICHOLS INSTITUTE DIAGNOSTICS |
|
K771783 |
09/23/1977 |
PTH RIA |
NICHOLS INSTITUTE DIAGNOSTICS |
|
K771706 |
09/09/1977 |
SAIF-BOW |
NORTHWEST ORTHODONTICS, INC. |
|
K771854 |
09/28/1977 |
SPINSEP-T3 |
NUCLEAR DIAGNOSTICS, INC. |
|
K771814 |
09/27/1977 |
REAGENT CONFIDENCE SERA |
ORTHO DIAGNOSTICS, INC. |
|
K771760 |
09/19/1977 |
EXTEMP |
PHARMACO, INC. |
|
K771759 |
09/19/1977 |
EXTEMP-V |
PHARMACO, INC. |
|
K771810 |
09/27/1977 |
PRESSURE TUBING |
PHARMASEAL DIV., BAXTER HEALTHCARE CORP. |
|
K771723 |
09/13/1977 |
HILL TUBE |
PHYSIO-CONTROL CORP. |
|
K771739 |
09/15/1977 |
PENTAX LH-150F LIGHT SOURCE |
PILLING CO. |
|
K771860 |
09/30/1977 |
FOLHY CATHETER |
POLYSIL, INC. |
|
K771697 |
09/06/1977 |
CARDIO-EXERCISE TREADMILL 550 |
QUINTON, INC. |
|
K771704 |
09/06/1977 |
DERTRAN-COATED CHARCOAL TABLETS |
REFLEX INDUSTRIES, INC. |
|
K771705 |
09/09/1977 |
RS-7800 MINIPUMP |
RENAL SYSTEMS, INC. |
|
K771851 |
09/29/1977 |
ARTHROSCOPE OPERATIVE KNIFE SET |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
|
K771850 |
09/29/1977 |
UROFLOW-CYSTOMETER SYSTEM |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
|
K771816 |
09/27/1977 |
ROCHE AXISCAN 5 |
ROCHE MEDICAL ELECTRONICS, INC. |
|
K771695 |
09/06/1977 |
ALKALINE PHOSPHATASE TEST |
SCLAVO, INC. |
|
K771712 |
09/12/1977 |
CATHETER DRESSING CHANCE SET |
SHIELD LABORATORIES, INC. |
|
K771720 |
09/13/1977 |
AMIDO BLACK CONCENTRATE |
SIGMA CHEMICAL CO. |
|
K771721 |
09/13/1977 |
BARBITAL BUFFER |
SIGMA CHEMICAL CO. |
|
K771777 |
09/20/1977 |
PONCEAU S CONCENTRATE |
SIGMA CHEMICAL CO. |
|
K771856 |
09/29/1977 |
DIR. QUANT. COLOR. DETERM. SERUM CREAT. |
STANBIO LABORATORY |
|
K771771 |
09/19/1977 |
QUAN. COLOR. DETER. OF SERUM ALBUMIN |
STANBIO LABORATORY |
|
K771680 |
09/06/1977 |
ARMOR-KOT SURGICAL INSTRUMENTS |
STORZ INSTRUMENT CO. |
|
K771688 |
09/06/1977 |
ECHO-OCULOMETER |
STORZ INSTRUMENT CO. |
|
K771846 |
09/28/1977 |
SUOGIPEEL PACKAGING SYSTEM |
SURGICOT, INC. |
|
K771728 |
09/14/1977 |
AUTO. LEUCOCYTE DIFFER. ANALYZER D/90 |
TECHNICON INSTRUMENTS CORP. |
|
K771822 |
09/22/1977 |
BG II ANALYZER |
TECHNICON INSTRUMENTS CORP. |
|
K771821 |
09/23/1977 |
STAC SYSTEM |
TECHNICON INSTRUMENTS CORP. |
|
K771670 |
09/01/1977 |
IMPLANTED PACEMAKER PLUSE GENERATOR |
TELECTRONICS, INC. |
|
K771693 |
09/06/1977 |
CLIRANS BLOOD LINES SET |
TERUMO AMERICA, INC. |
|
K771694 |
09/06/1977 |
CLIRANS TH 15 HOLLOW FIBER DIALYZER |
TERUMO AMERICA, INC. |
|
K771707 |
09/09/1977 |
ADIDYNE 3000 |
TIMETER INSTRUMENT CORP. |
|
K771766 |
09/19/1977 |
T3U |
UNION CARBIDE CORP. |
|
K771823 |
09/23/1977 |
CATHETER, CARDIOVASCULAR |
USCI, DIV. C.R. BARD, INC. |
|
K771808 |
09/27/1977 |
CLINAC 4/100 |
VARIAN ASSOC., INC. |
|
K771809 |
09/27/1977 |
CLINAC 6/100 |
VARIAN ASSOC., INC. |
|
K771807 |
09/26/1977 |
SPECTROPHOTOMETER ANALYSIS SYS. |
VARIAN ASSOC., INC. |
|
K771762 |
09/19/1977 |
MODULAR HEARING DEVICE, MODEL S291 |
VICON INSTRUMENT CO. |
|
K771769 |
09/19/1977 |
TINNITUS MASKERS, MODELS S564&S574 |
VICON INSTRUMENT CO. |
|
K771729 |
09/14/1977 |
17-HYDROXYPROGESTERONE TEST SET |
WIEN LABORATORIES, INC. |
|
K771793 |
09/22/1977 |
DHEA TEST SET |
WIEN LABORATORIES, INC. |
|
K771725 |
09/13/1977 |
BIOSP. TOTAL OSSICULAR REPLACE. PROSTHE. |
XOMED, INC. |
|
K771727 |
09/13/1977 |
BIOSPONGE RECONSTRUCTION DISCS |
XOMED, INC. |
|
K771726 |
09/13/1977 |
BIOSPONGE STAPES PISTON |
XOMED, INC. |
|