FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
K771908 |
10/11/1977 |
ISO-SHIELD SALIVA ABSORBERS |
3M COMPANY |
|
K772001 |
10/21/1977 |
SARNES HELP |
3M HEALTH CARE, SARNS |
|
K771972 |
10/17/1977 |
5UM FILTERSET WITH Y-INJECTION SITE |
ABBOTT LABORATORIES |
|
K771991 |
10/19/1977 |
CARDIAC OUTPUT THERMODILUTION MODULE |
ABBOTT LABORATORIES |
|
K771909 |
10/11/1977 |
DUAL WAVELENGTH PHOTOMETER, 1177 |
ABBOTT LABORATORIES |
|
K772036 |
10/27/1977 |
IN-LINE BURETTE SET |
ABBOTT LABORATORIES |
|
K771869 |
10/03/1977 |
DIAG. ULTRASOUND B-SCANNER |
ACCUSONICS, INC. |
|
K771942 |
10/17/1977 |
TILT 10, CATALOG #S-2600 |
AFFILIATED HOSPITAL PRODUCTS, INC. |
|
K771913 |
10/11/1977 |
HEEL/ELBOW PROTECTOR |
ALBA-WALDENSIAN, INC. |
|
K772046 |
10/28/1977 |
INTUBATION PROCEDURE KIT |
AMERICAN HOSPITAL SUPPLY CORP. |
|
K772047 |
10/28/1977 |
RESPIRATORY KIT |
AMERICAN HOSPITAL SUPPLY CORP. |
|
K771914 |
10/12/1977 |
SUBJECTIVE REFRACTOR, MOSEL SR-111 |
AMERICAN OPTICAL CORP. |
|
K771915 |
10/12/1977 |
MICRO OSCILLATING SAW |
AMERICAN STERILIZER CO. |
|
K771980 |
10/17/1977 |
FEVER TESTER |
AMERICAN THERMOMETER COMPANY, INC. |
|
K771877 |
10/04/1977 |
DIGOXIN RIA KIT |
ANTIBODIES INC. |
|
K771895 |
10/06/1977 |
DINAMAP MADEL 845 |
APPLIED MEDICAL RESEARCH |
|
K771896 |
10/06/1977 |
DINAMAP MODEL 835 |
APPLIED MEDICAL RESEARCH |
|
K771897 |
10/06/1977 |
DINAMAP MODEL 837 |
APPLIED MEDICAL RESEARCH |
|
K771981 |
10/18/1977 |
MINIMAP MODEL 810 |
APPLIED MEDICAL RESEARCH |
|
K771931 |
10/14/1977 |
MONITOR, DINMAP, MODEL 850 |
APPLIED MEDICAL RESEARCH |
|
K771932 |
10/14/1977 |
RECORDER, DINMAP, MODEL 950 |
APPLIED MEDICAL RESEARCH |
|
K771988 |
10/19/1977 |
VERTETRAC |
BALLERT ORTHOPEDIC CORP. |
|
K771983 |
10/18/1977 |
SCALP VEIN SET |
BERMAN, PCP & CONSULTANTS, INC. |
|
K771894 |
10/06/1977 |
LDH ISOENZYME CONTROL |
BIO-REAGENTS & DIAGNOSTICS, INC. |
|
K771867 |
10/03/1977 |
MYCOPLASMA DETECTION KIT |
BIOASSAY SYSTEMS RESEARCH CORP. |
|
K771923 |
10/13/1977 |
FASTCHEM BUN |
BOEHRINGER MANNHEIM CORP. |
|
K771993 |
10/21/1977 |
AFT SYSTEM |
CALBIOCHEM |
|
K771933 |
10/14/1977 |
CILCO ANTERIOR CHAMBER LENS |
CALIFORNIA INTRAOCULAR LENS |
|
K772027 |
10/27/1977 |
CARDIOCASSETTE II |
CARDIODYNE, INC. |
|
K772015 |
10/25/1977 |
PATIENT HEATER SYSTEM, MODEL PH112 |
CAROLINA MEDICAL ELECTRONICS |
|
K771865 |
10/03/1977 |
DAYSTAR SURG. LIGHT 9100 & ORBITER 9110 |
CASTLE CO. |
|
K771890 |
10/06/1977 |
PERCEPTION SERIES DELIVERY SYS. |
CHAYES VIRGINIA, INC. |
|
K771873 |
10/04/1977 |
VISION SERIES DENTAL CHAIR |
CHAYES VIRGINIA, INC. |
|
K771878 |
10/04/1977 |
IRIDIUM 192 WIRES & PINS |
CIS RADIOPHARMACEUTICALS, INC. |
|
K771985 |
10/19/1977 |
FILTER SAMPLER BLOOD SERUM FILTER |
CLASROCK |
|
K772017 |
10/26/1977 |
IN VITRO THEOPHYLLINE RIA TEST |
CLINICAL ASSAYS, INC. |
|
K771929 |
10/14/1977 |
PEDIATRICS GOWN |
CONVERTORS |
|
K772011 |
10/25/1977 |
WHOLEY OCCLUSION BALLOON CATHETER |
COOK, INC. |
|
K771992 |
10/21/1977 |
L-501 CARDIAC PACEMAKER |
CORATOMIC, INC. |
|
K772053 |
10/31/1977 |
LINE CHARGER MODEL LC-100 |
DATASCOPE CORP. |
|
K772056 |
10/31/1977 |
PHYSIOLOGICAL MONITOR MODEL 871 |
DATASCOPE CORP. |
|
K772052 |
10/31/1977 |
PHYSIOLOGICAL RECORDER MODEL 721A |
DATASCOPE CORP. |
|
K772054 |
10/31/1977 |
PHYSIOLOGICAL RECORDER MODEL 740 |
DATASCOPE CORP. |
|
K771971 |
10/17/1977 |
HYDROMASSAGE EQUIP. MODEL 1000 |
DAZEY PRODUCTS CO. |
|
K771969 |
10/17/1977 |
TURBO-JET MODEL 76 |
DAZEY PRODUCTS CO. |
|
K771966 |
10/17/1977 |
VIBRO BATH MODEL FS-1 |
DAZEY PRODUCTS CO. |
|
K771967 |
10/17/1977 |
WHIRLPOOL BATH MODEL 2270 |
DAZEY PRODUCTS CO. |
|
K771968 |
10/17/1977 |
WHIRLPOOL BATH MODEL 2273 |
DAZEY PRODUCTS CO. |
|
K771970 |
10/17/1977 |
WHIRLPOOL BATH MODEL 50 |
DAZEY PRODUCTS CO. |
|
K771973 |
10/17/1977 |
GINGITRACT |
DEN-MAT CORP. |
|
K771974 |
10/17/1977 |
SOLVENEX I-0 |
DEN-MAT CORP. |
|
K771965 |
10/17/1977 |
WHIRLPOOL BATH MODEL 2274 |
DOZEY PRODUCTS CO. |
|
K771989 |
10/19/1977 |
CONTINUOUS FLOW ANESTHESIA MACHINE |
DRAEGER MEDICAL, INC. |
|
K771899 |
10/06/1977 |
VAPOR 19 |
DRAEGER MEDICAL, INC. |
|
K771924 |
10/13/1977 |
HEARTBEATER |
DUNN INSTRUMENTS, INC. |
|
K771898 |
10/06/1977 |
AUTOMATED SLIDE SPINNER |
DYNATECH CRYOMEDICAL CO. |
|
K771866 |
10/03/1977 |
TROUTMAN CORNEAL PUNCH |
EDWARD WECK, INC. |
|
K771987 |
10/19/1977 |
MICROPULSE 26U PULSE GENERATOR |
EDWARDS PACEMAKER SYSTEMS |
|
K772059 |
10/31/1977 |
CATHETER, PACING/MONITORING |
ELECTRO-CATHETER CORP. |
|
K771994 |
10/21/1977 |
ELECTROTHERM MODEL HT-1 |
ELECTROMEDICS, INC. |
|
K771999 |
10/21/1977 |
ELECTROTHERM MODELS F&C18,14,78, F84 |
ELECTROMEDICS, INC. |
|
K771995 |
10/21/1977 |
ELECTROTHERM MODELS TC-100 & M-99 |
ELECTROMEDICS, INC. |
|
K771996 |
10/21/1977 |
TELETHERMOMETER MODEL T T-100 |
ELECTROMEDICS, INC. |
|
K771997 |
10/21/1977 |
TELETHERMOMETER MODEL T T-400 |
ELECTROMEDICS, INC. |
|
K771998 |
10/21/1977 |
TEMP-A-LERT MODEL TA-986 |
ELECTROMEDICS, INC. |
|
K771978 |
10/17/1977 |
CTR 100L |
EMI MEDICAL, INC. |
|
K771930 |
10/14/1977 |
EMISONIC 4500 TM |
EMI MEDICAL, INC. |
|
K771902 |
10/06/1977 |
EMI FOUR |
EMI THERAPY SYSTEMS, INC. |
|
K771885 |
10/05/1977 |
IMPORTED PAIN CONTROL DEVICE |
EMPI |
|
K771901 |
10/07/1977 |
CAPMIX |
ESPE DENTAL PRODUCTS |
|
K771889 |
10/06/1977 |
UNIOLITE |
ESPE DENTAL PRODUCTS |
|
K771956 |
10/17/1977 |
HUMAN O BUFFER |
FLOW LABORATORIES, INC. |
|
K771957 |
10/17/1977 |
RUBELLA HEMAGGLUTINATION REAGENT KIT |
FLOW LABORATORIES, INC. |
|
K771955 |
10/17/1977 |
TRYPSIN 1% |
FLOW LABORATORIES, INC. |
|
K771976 |
10/17/1977 |
ECG AMPLIFIER/R WAVE TRIGGER |
G.D. SEARLE AND CO. |
|
K772004 |
10/21/1977 |
HUMAN C4 COMPLEMENT CONTROL SERUM |
G.D. SEARLE AND CO. |
|
K772003 |
10/21/1977 |
HUMAN REFERENCE SERUM C4 COMPLEMENT |
G.D. SEARLE AND CO. |
|
K771934 |
10/14/1977 |
LINEAR ARRAY B-MODE SCANNER |
G.D. SEARLE AND CO. |
|
K772002 |
10/21/1977 |
PLATES FOR HUMAN C4 COMPLEMENT |
G.D. SEARLE AND CO. |
|
K772024 |
10/26/1977 |
RX LENS SERIES |
GENTEX CORPORATION |
|
K771870 |
10/04/1977 |
MARTIN LEWIS AGAR (JEMBEC) |
GRANITE DIAGNOSTICS, INC. |
|
K771871 |
10/04/1977 |
MARTIN LEWIS AGAR (PLATE) |
GRANITE DIAGNOSTICS, INC. |
|
K771872 |
10/04/1977 |
MARTIN LEWIS TRANSGROW |
GRANITE DIAGNOSTICS, INC. |
|
K772049 |
10/31/1977 |
WALKING AID |
GUARDIAN PRODUCTS CO., INC. |
|
K771928 |
10/14/1977 |
CALCIUM SET, ITEM NO. 65004 |
HARLECO |
|
K772029 |
10/27/1977 |
GEMSAEC APPLI, FOR ULTRAZYME PLUS GOT |
HARLECO |
|
K772032 |
10/27/1977 |
GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP |
HARLECO |
|
K772033 |
10/27/1977 |
GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP* |
HARLECO |
|
K772034 |
10/27/1977 |
GEMSAEC APPLI. FOR ULTRAZYME PLUS CK-1 |
HARLECO |
|
K772030 |
10/27/1977 |
GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT |
HARLECO |
|
K772028 |
10/27/1977 |
GEMSAEC APPLI. FOR ULTRAZYME PLUS LDH |
HARLECO |
|
K772035 |
10/27/1977 |
GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-AMYL |
HARLECO |
|
K772031 |
10/27/1977 |
GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-GT |
HARLECO |
|
K771927 |
10/14/1977 |
IRON SET, ITEM NO. 65008 |
HARLECO |
|
K771925 |
10/14/1977 |
KRYSTALONR LIQ. MOUNTING MED.&COVERSLIP |
HARLECO |
|
K771926 |
10/14/1977 |
TOTAL PROTEIN SET, ITEM NO. 64010 |
HARLECO |
|
K772048 |
10/24/1977 |
SINGLE & DUAL CHANNEL RECORDER |
HEWLETT-PACKARD CO. |
|
K772012 |
10/25/1977 |
VIDEO ADAPTER FOR GRAPHIC RECORDERS |
HONEYWELL, INC. |
|
K771883 |
10/04/1977 |
REPLICA ACID-ETCH |
HOYT LABORATORIES |
|
K771881 |
10/04/1977 |
REPLICA BONDING AGENT |
HOYT LABORATORIES |
|
K771880 |
10/04/1977 |
REPLICA DENTAL COMPOSIT |
HOYT LABORATORIES |
|
K771882 |
10/04/1977 |
REPLICA DENTAL COMPOSITE-RADIOPAQUE |
HOYT LABORATORIES |
|
K771879 |
10/04/1977 |
GLYCOPROTEIN TEST, LAS-R HUMAN 1-ACID |
HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES |
|
K771912 |
10/11/1977 |
LAS-R BETA LIPOPROTEIN TEST |
HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES |
|
K771922 |
10/13/1977 |
MINICLINIC TM |
INSTROMEDIX, INC. |
|
K771977 |
10/17/1977 |
CARDIAC OUTPUT COMPUTER MODEL 701 |
INSTRUMENTATION LABORATORY CO. |
|
K771953 |
10/17/1977 |
GASTRIN RIA MODULE |
INTER SCIENCE INSTITUTE |
|
K771948 |
10/17/1977 |
GLUCAGON RIA MODULE |
INTER SCIENCE INSTITUTE |
|
K771947 |
10/17/1977 |
INSULIN RIA MODULE |
INTER SCIENCE INSTITUTE |
|
K772057 |
10/31/1977 |
BIPOLAR PACEMAKER MODEL 224 |
INTERMEDICS, INC. |
|
K771874 |
10/03/1977 |
J-VAC VACUUM TUBE |
JELCO LABORATORIES |
|
K772020 |
10/26/1977 |
CLOTH ADHESIVE TAPE |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
|
K771958 |
10/17/1977 |
12MM SELF-SEALING TROCAR & CANNULA |
KLI |
|
K771959 |
10/17/1977 |
8MM SELF-SEALING TROCAR & CANNULA |
KLI |
|
K771964 |
10/17/1977 |
8MM TROCAR & CANNUAL W/STOPCOCK |
KLI |
|
K771962 |
10/17/1977 |
CAMERA ADAPTER FOR ENDOSCOPES |
KLI |
|
K771961 |
10/17/1977 |
DUAL INCISION TUBAL OCCLUS. BAND APPLI. |
KLI |
|
K771963 |
10/17/1977 |
SINGLE INCISION TUBAL OCCLU. BAND APPL. |
KLI |
|
K771960 |
10/17/1977 |
TUBAL OCCLUSION INSERTER/LAPAROSCOPE |
KLI |
|
K771935 |
10/14/1977 |
DIGITAL THERMOMETER |
MEDICAL NETWORKS |
|
K771862 |
10/03/1977 |
TRANSFUSION BLOOD FILTER |
MEDICAL, INC. |
|
K771911 |
10/11/1977 |
PLASTIC STOPCOCK W/ EXTENSION TUBE |
MEDON CORP. |
|
K772058 |
10/31/1977 |
LEAD ADAPTOR KIT MODEL 5866-21 |
MEDTRONIC VASCULAR |
|
K772013 |
10/25/1977 |
PERCUPASS TUNNELING TOOL MODEL 3452 |
MEDTRONIC VASCULAR |
|
K772000 |
10/21/1977 |
ECG TELEMETRY SYSTEM |
MENNEN GREATBATCH ELECTONICS |
|
K772005 |
10/21/1977 |
MYOTONE EMG MONITOR |
MICROTRONICS CORP. |
|
K772014 |
10/25/1977 |
AMES T-4 STRIP TEST |
MILES LABORATORIES, INC. |
|
K772039 |
10/28/1977 |
BETA-HCG RIA |
MONITOR SCIENCE CORP. |
|
K772038 |
10/28/1977 |
KANAMYCIN RIA |
MONITOR SCIENCE CORP. |
|
K771921 |
10/12/1977 |
HYDRON ROOT CANAL FILLING SYSTEM |
NATIONAL PATENT DEVELOPMENT CORP. |
|
K772060 |
10/31/1977 |
PROTECT IV GARD |
OMNICON MEDICAL CORP. |
|
K771990 |
10/19/1977 |
OMNIMEDICAL 400L |
OMNIMEDICAL SERVICES, INC. |
|
K771941 |
10/17/1977 |
QUANTROLS IM |
ORGANON, INC. |
|
K771940 |
10/17/1977 |
QUANTROLS RF |
ORGANON, INC. |
|
K771888 |
10/05/1977 |
SYRINGE, DISPOSABLE |
ORTHOPEDIC EQUIPMENT CO., INC. |
|
K772051 |
10/31/1977 |
MDL-201 |
PACESETTER SYSTEMS |
|
K772050 |
10/31/1977 |
TDL-100 B |
PACESETTER SYSTEMS |
|
K772023 |
10/21/1977 |
OB/GYN LASER, MODEL 920 |
PHOTON SOURCES |
|
K772006 |
10/21/1977 |
ACUTE CARDIAC CARE SYSTEM |
PHYSIO-CONTROL CORP. |
|
K772055 |
10/31/1977 |
PENTAX F.O.-IT OBSERVER SCOPE |
PILLING CO. |
|
K771892 |
10/06/1977 |
VALVE ANESTHETIC |
PROMED CORP. |
|
K771918 |
10/12/1977 |
FIBEO OPTICS ILLUM. SYSTEM |
PROPPER MFG. CO., INC. |
|
K771920 |
10/12/1977 |
FIBER OPTICS PROCTOSCOPE |
PROPPER MFG. CO., INC. |
|
K771919 |
10/12/1977 |
FIBER OPTICS SIGMOIDOSCOPE |
PROPPER MFG. CO., INC. |
|
K771975 |
10/17/1977 |
ARTERIAL BLOOD SAMPLING TRAY |
RESPIRATORY CARE, INC. |
|
K772016 |
10/25/1977 |
RESPITRACE |
RESPITRACE CORP. |
|
K771936 |
10/17/1977 |
MICROBIOLOGICAL CULTURE MEDIUM |
SCOTT LABORATORIES, INC. |
|
K771876 |
10/04/1977 |
ARGYLE PEOCUSSOR SYSTEM |
SHERWOOD MEDICAL INDUSTRIES |
|
K771916 |
10/11/1977 |
PROCEDURE NO. 555 |
SIGMA CHEMICAL CO. |
|
K771904 |
10/07/1977 |
GLYCEROL KINASE |
SIMMLER & SON, INC. |
|
K771905 |
10/07/1977 |
GLYCEROL SUBSTRATE |
SIMMLER & SON, INC. |
|
K771903 |
10/07/1977 |
LIPASE |
SIMMLER & SON, INC. |
|
K771906 |
10/07/1977 |
PHOSPHATE |
SIMMLER & SON, INC. |
|
K772043 |
10/28/1977 |
ALPHA/CHOL |
STANDARD SCIENTIFIC, INC. |
|
K772008 |
10/20/1977 |
SCALP VEIN SETS |
SURU CHEMICALS & PHARMACEUTICALS, LTD. |
|
K771939 |
10/17/1977 |
STAC SYSTEM-ADDI. ANALYTES |
TECHNICON INSTRUMENTS CORP. |
|
K772044 |
10/28/1977 |
TECHSIGHT LENSES WITH ZUMA COATING |
TECHSIGHT CORP. |
|
K772026 |
10/27/1977 |
CARDIAC PULSE GENERATOR, MODEL 150L |
TELECTRONICS, INC. |
|
K772040 |
10/28/1977 |
TRANSDUCER PROTECTOR |
TERUMO AMERICA, INC. |
|
K771986 |
10/19/1977 |
CATHETER, MEDIASTINAL&PERICARDIAL |
THE MINNESOTA BACK BRACE CO. |
|
K771938 |
10/17/1977 |
ALGINATE IMPRESSION MATERIAL |
THE S. S. WHITE CO. |
|
K771861 |
10/03/1977 |
CATHETER, CEBTRAL VENOUS, 2N1501 |
TRAVENOL LABORATORIES, S.A. |
|
K771891 |
10/06/1977 |
CATHETER, UMBILICAL, VICRA |
TRAVENOL LABORATORIES, S.A. |
|
K771875 |
10/05/1977 |
ULTRAFILTRATION MONITOR 5M9034 |
TRAVENOL LABORATORIES, S.A. |
|
K771979 |
10/17/1977 |
CENTRIA INSULIN RIA |
UNION CARBIDE CORP. |
|
K771982 |
10/18/1977 |
888 ARTERIAL/VENOUS CATHETER INTRODUCER |
USCI, DIV. C.R. BARD, INC. |
|
K772021 |
10/26/1977 |
TRC STAINLESS STEEL SAFETY SPRING GUIDES |
USCI, DIV. C.R. BARD, INC. |
|
K772022 |
10/26/1977 |
SPECTROPHOTOMETER CARY 219 |
VARIAN ASSOC., INC. |
|
K772010 |
10/25/1977 |
CARDIAC PACEMAKER C2001 |
VITATRON MEDICAL BV |
|
K772009 |
10/25/1977 |
CARDIAC PACEMAKER S6001 |
VITATRON MEDICAL BV |
|
K771900 |
10/06/1977 |
71110 DESK CHARGER |
WELCH ALLYN, INC. |
|
K771864 |
10/03/1977 |
WALL TRANSFORMERS 74710 & 74910 |
WELCH ALLYN, INC. |
|
K771886 |
10/05/1977 |
ACCU-PAQUE |
WILLIAMS GOLD REFINING CO., INC. |
|
K771887 |
10/05/1977 |
ACCU-STAIN |
WILLIAMS GOLD REFINING CO., INC. |
|
K771863 |
10/02/1977 |
COLOR COTE |
WILLIAMS GOLD REFINING CO., INC. |
|
K772025 |
10/27/1977 |
URIC ACID STD. FOR QUANT. URIC ACID |
WORTHINGTON BIOCHEMICAL CORP. |
|