FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K791057 |
06/20/1979 |
CAST BRACE COMPONENTS |
3M COMPANY |
|
K790905 |
06/15/1979 |
NUCLEAR SAMPLE READER |
ABBOTT LABORATORIES |
|
K782113 |
06/01/1979 |
CAP, TAMPER PROOF PLASTIC |
ACACIA, INC. |
|
K790901 |
06/27/1979 |
I.V. TUBING ORGANIZER |
ACUMED INSTRUMENTS CORP. |
|
K790608 |
06/15/1979 |
BL BILIRUBINOMETER |
ADVANCED INSTRUMENTS, INC. |
|
K790611 |
06/15/1979 |
OSMOMETER MODEL 3W11 |
ADVANCED INSTRUMENTS, INC. |
|
K791042 |
06/13/1979 |
I.P.P.B. MANIFOLD & NEBULIZER, UNIVERSAL |
AIRLIFE, INC. |
|
K790887 |
06/05/1979 |
TEE ADAPTER |
AIRLIFE, INC. |
|
K790890 |
06/27/1979 |
TEMPO2-I DISPOSABLE THERMOMETERS |
AIRLIFE, INC. |
|
K790891 |
06/27/1979 |
TEMPO2-II DISPOSABLE THERMOMETERS |
AIRLIFE, INC. |
|
K790888 |
06/27/1979 |
TRACH "T" WITH ONE-WAY VALVES |
AIRLIFE, INC. |
|
K791016 |
06/27/1979 |
ULTICARE 2500 TREATMENT CHAIR |
AMERICAN HEALTH CARE INDUSTRIES, INC. |
|
K790753 |
06/28/1979 |
DIMENSIONALL ROTATOR |
AMERICAN HOSPITAL SUPPLY CORP. |
|
K790840 |
06/28/1979 |
THYROID CONTROL SERA CODE QAS.101 |
AMERSHAM CORP. |
|
K790999 |
06/22/1979 |
APOLLO HEART RATE INDICATOR |
APOLLO PRODUCTS, INC. |
|
K790835 |
06/22/1979 |
DYNAJECT |
ATOMIC PRODUCTS CORP. |
|
K790553 |
06/15/1979 |
CHOLESTEROL KIT, HDL-DS |
BECKMAN INSTRUMENTS, INC. |
|
K791030 |
06/22/1979 |
HEMOGLOBIN AF/SC ELECTROPHORESIS CONTROL |
BECKMAN INSTRUMENTS, INC. |
|
K790862 |
06/28/1979 |
BIOVATION DIGITAL URINOMETER |
BIOVATION, INC. |
|
K790772 |
06/15/1979 |
CHEMTAB |
BOEHRINGER MANNHEIM CORP. |
|
K790953 |
06/27/1979 |
"BORDISPO" BRAND HYPODERMIC NEEDLE |
BORDA PRODUCTS, INC. |
|
K790754 |
06/01/1979 |
BROWNE MODEL CF-1 AND CF-1G |
BROWNE CORP. |
|
K790478 |
06/01/1979 |
BROWNE MODEL UD-4DE |
BROWNE CORP. |
|
K791020 |
06/27/1979 |
FLUID ADMINISTRATION SET FA-3160 |
BURRON MEDICAL PRODUCTS, INC. |
|
K790854 |
06/05/1979 |
FORCEPS #101 AND #102 |
C. INTL. |
|
K790982 |
06/27/1979 |
INSPIRON NEBULO TM 28 NEBULIZER KIT |
C.R. BARD, INC. |
|
K791047 |
06/13/1979 |
NERVE STIMULATOR, DIGITAL PERIPHERAL |
C.R. BARD, INC. |
|
K790773 |
06/15/1979 |
ENZYMATIC TRIGLYCERIDES-S.V.R. |
CALBIOCHEM-BEHRING CORP. |
|
K790911 |
06/27/1979 |
RIA OF PROGESTERONE |
CALBIOCHEM-BEHRING CORP. |
|
K790535 |
06/07/1979 |
CLAYTON COLON CLEANSING KIT |
CLAYTON MEDICAL PRODUCTS, INC. |
|
K791001 |
06/22/1979 |
PENLIGHT/SWAB HOLDER |
CONCEPT, INC. |
|
K772011 |
06/15/1979 |
WHOLEY OCCLUSION BALLOON CATHETER |
COOK, INC. |
|
K790944 |
06/28/1979 |
CITRATE AGAR GEL AND BUFFER SET |
CORNING MEDICAL & SCIENTIFIC |
|
K790943 |
06/22/1979 |
TRISEDTA-BORATE ELECTROPHORESIS FILM AGA |
CORNING MEDICAL & SCIENTIFIC |
|
K790812 |
06/28/1979 |
COULTER ACCU-ZYME IIY-GT REAGENT KIT |
COULTER ELECTRONICS, INC. |
|
K790824 |
06/27/1979 |
REPGREEN ULTRAFILTRATION MONITOR |
CYBEREX CORP. |
|
K790756 |
06/11/1979 |
HEAT EXCHANGER COIL |
DELTA MEDICAL INDUSTRIES |
|
K790996 |
06/27/1979 |
C.C.F. FEMORAL DEBRIDEMENT PROBE |
DEPUY, INC. |
|
K791009 |
06/11/1979 |
SANTA CASA DISTRACTOR |
DEPUY, INC. |
|
K791015 |
06/13/1979 |
"VOLUREX TM" |
DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. |
|
K790728 |
06/01/1979 |
"TOUCHLESS TM" FOLEY CATHETER KIT |
DIAMED DIVISION ILL. TOOL WORKS, INC. |
|
K790565 |
06/11/1979 |
AORTIC ROOT CANNULA |
DLP, INC. |
|
K790504 |
06/11/1979 |
"SANDEE" SANDING BLOCK |
DR. BERTRAM L. STEEL |
|
K790958 |
06/28/1979 |
120 WELL HISTO-PLATE |
DYNATECH LABORATORIES, INC. |
|
K790957 |
06/15/1979 |
HISTO-DISPENSER |
DYNATECH LABORATORIES, INC. |
|
K790956 |
06/15/1979 |
HISTO-OILER |
DYNATECH LABORATORIES, INC. |
|
K790974 |
06/20/1979 |
MIC-2000 INOCULATOR TEMPLATE |
DYNATECH LABORATORIES, INC. |
|
K790971 |
06/20/1979 |
MIC-2000 QUAD INOCULUM TRAY |
DYNATECH LABORATORIES, INC. |
|
K791049 |
06/28/1979 |
SYNALON ROLLER BOTTLE |
DYNATECH LABORATORIES, INC. |
|
K791157 |
06/27/1979 |
360 HEMOCLIP APPLIERS |
EDWARD WECK, INC. |
|
K790990 |
06/05/1979 |
REYNOLDS DOUBLE HEMOCLIP APPLIERS |
EDWARD WECK, INC. |
|
K790444 |
06/11/1979 |
ELECATH MULTI-PURPOSE ARTERIAL SURGER |
ELECTRO-CATHETER CORP. |
|
K791006 |
06/11/1979 |
SMART BILECTRODES |
ELECTRONICS FOR MEDICINE, INC. |
|
K790670 |
06/27/1979 |
PULSE GENERATOR MODEL 629 |
ELEMA-SCHONANDER, INC. |
|
K790545 |
06/06/1979 |
STRESS TESTING SYSTEM, LATERAL TILTING |
ENGINEERING DYNAMICS CORP. |
|
K790544 |
06/05/1979 |
STRESS TESTING SYSTEM, MULTI-POSITION |
ENGINEERING DYNAMICS CORP. |
|
K791092 |
06/12/1979 |
ESTERASE-CHLOROESTERASE, STAINING KIT |
EUREKA LABORATORIES, INC. |
|
K791046 |
06/13/1979 |
ENDOTRACHEAL TUBES, LONG & SHORT TERM |
EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
|
K790902 |
06/27/1979 |
INTEGRATED PATIENT STATIONS |
EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
|
K791045 |
06/13/1979 |
MODEL GV-10 LANZ PRESSURE-VALVE |
EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
|
K791044 |
06/13/1979 |
TRACHEOSTOMY TUBES, SHORT AND LONG TERM |
EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
|
K790955 |
06/20/1979 |
COVER GARD |
FEM-GARD, INC. |
|
K790954 |
06/20/1979 |
HEEL GARD |
FEM-GARD, INC. |
|
K790995 |
06/11/1979 |
CONTEX |
FOAM TEK, INC. |
|
K790973 |
06/15/1979 |
"LO-ION" |
GAMMA BIOLOGICALS, INC. |
|
K790791 |
06/15/1979 |
ELECTROPHORESIS REAGENT SET, HDL |
GELMAN SCIENCES, INC. |
|
K790942 |
06/27/1979 |
RADVIEW IMAGER SYSTEM |
GENERAL ELECTRIC CO. |
|
K790786 |
06/15/1979 |
GLUCOSE (HK) REAGENT |
GILFORD DIAGNOSTICS |
|
K790818 |
06/05/1979 |
MEDI-TRACE EEG CREME |
GRAPHIC CONTROLS CORP. |
|
K790966 |
06/11/1979 |
ULTRASONIC HUMIDIFIER |
HANKSCRAFT DIV. OF GERBER PRODUCTS CO. |
|
K790798 |
06/05/1979 |
FETAL MATURITY TEST PROCEDURE |
HELENA LABORATORIES |
|
K791135 |
06/28/1979 |
LYOPHILIZED G-HB QUIK COLUMN CONTROL |
HELENA LABORATORIES |
|
K790939 |
06/11/1979 |
MODEL 78501A PATIENT MONITORING SYSTEM |
HEWLETT-PACKARD CO. |
|
K790655 |
06/15/1979 |
ABUSCREEN RIA FOR PHENCYCLIDINE |
HOFFMANN-LA ROCHE, INC. |
|
K790793 |
06/22/1979 |
AMC "R" METACARPAL COMPONENT |
HOWMEDICA CORP. |
|
K791113 |
06/28/1979 |
LOW IONIC STRENGTH SOLUTION (LISS) |
HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES |
|
K790831 |
06/15/1979 |
ANTISTREPTOLYSIN (ASO) LATEX SLIDE TEST |
ICL SCIENTIFIC |
|
K790548 |
06/01/1979 |
ENDOCARDIAL PACING LEAD, MODEL 476-01 |
INTERMEDICS, INC. |
|
K790464 |
06/13/1979 |
FIAX TEST KIT FOR ANTI-TOXOPLASMA ANTIBO |
INTL. DIAGNOSTIC TECHNOLOGY |
|
K790650 |
06/27/1979 |
WEISS EMERGENCY AIRWAY SYSTEM |
INTL. MEDICAL DEVICES LTD. |
|
K790476 |
06/01/1979 |
QUICKSCAN HOLTER II |
INTL. MEDICAL, INC. |
|
K790882 |
06/11/1979 |
LEAD INTRODUCER SET |
INTROSTAT |
|
K790738 |
06/20/1979 |
HABITSABATER |
JACKSON ENT. |
|
K790968 |
06/11/1979 |
CATHETER METAL HUB/NONRADIOPAQUE |
JELCO LABORATORIES |
|
K790967 |
06/27/1979 |
CATHETER METAL HUB/RADIOPAQUE |
JELCO LABORATORIES |
|
K790972 |
06/05/1979 |
KIMLON IMPERVIOUS STOCKINETTES |
KIMBERLY-CLARK CORP. |
|
K791103 |
06/28/1979 |
LEECO GLYCO-HEMOGLOBIN DIAGNOSTIC KIT |
LEECO DIAGNOSTICS, INC. |
|
K791112 |
06/15/1979 |
LIBCO 1,2,3, EYEGLASS FRAMES |
LIBCO EYEWEAR, INC. |
|
K782154 |
06/21/1979 |
COLOSTOMY DEVICE, MACLET MAGNETIC |
MACLET MEDICAL DEVICES, INC. |
|
K790947 |
06/28/1979 |
AUTO ENZYMATIC CHOLESTEROL |
MACOMB CHEMICAL CO. |
|
K790559 |
06/01/1979 |
ALARM |
MADDAK, INC. |
|
K791170 |
06/25/1979 |
MIS AURAL ACOUSTIC SCREENER |
MAICO HEARING INSTRUMENTS, INC. |
|
K790411 |
06/01/1979 |
AUTO TRAUMA KIT |
MARSHALL ELECTRONICS, INC. |
|
K791098 |
06/22/1979 |
SINGLE-USE MINI-BULLDOG |
MED GENERAL |
|
K790952 |
06/05/1979 |
CLAMP COVERS |
MEDI-SPEC |
|
K790803 |
06/28/1979 |
SYRINGE TONOMETER |
MEDICOR USA LTD. |
|
K791070 |
06/20/1979 |
ACCU-SORB STERILE STOCKINETTES |
MEDLINE INDUSTRIES, INC. |
|
K790988 |
06/11/1979 |
MODEL 6971 W/ DBS WIRE |
MEDTRONIC VASCULAR |
|
K791093 |
06/20/1979 |
MODELS 2411/2418 VENTRICULAR-INHIBITED |
MEDTRONIC VASCULAR |
|
K790930 |
06/22/1979 |
TRACHE FITTING M-307 |
MEM MEDICAL, INC. |
|
K790992 |
06/22/1979 |
PSEUDO-PALETTE TM |
MICRO-PALETTES, INC. |
|
K790991 |
06/22/1979 |
YEAST-PALETTE TM |
MICRO-PALETTES, INC. |
|
K790906 |
06/27/1979 |
AUTOPAK CORTISOL TEST DELIVERY SYSTEM |
MICROMEDIC SYSTEMS |
|
K790907 |
06/27/1979 |
AUTOPAK TEST DELIVERY SYSTEM |
MICROMEDIC SYSTEMS |
|
K790584 |
06/15/1979 |
AMES TDA/GENTGMICIN |
MILES LABORATORIES, INC. |
|
K790965 |
06/28/1979 |
REAGENT STRIPS FOR URINALYSIS |
MILES LABORATORIES, INC. |
|
K790445 |
06/28/1979 |
ULTRA-FREE |
MILLIPORE CORP. |
|
K791107 |
06/22/1979 |
STOPCOCK, THREE WAY |
NORTON PERFORMANCE PLASTICS CORP. |
|
K790653 |
06/15/1979 |
NOVA 3 CHLORIDE/TOTAL DIOXIDE ANALYZER |
NOVA CORP. |
|
K790961 |
06/28/1979 |
LIQUID SCINTILLATION COUNTER |
NUCLEAR ENT. LTD. |
|
K790734 |
06/15/1979 |
PREGNOSTICON PREGNANCY TEST KIT |
ORGANON, INC. |
|
K790813 |
06/28/1979 |
MULTECON BLOOD GAS CONTROL |
ORTHO DIAGNOSTICS, INC. |
|
K782018 |
06/04/1979 |
LEADS, IMPLANTABLE CARDIAC PACEMAKERS |
OSCOR INC. |
|
K791023 |
06/28/1979 |
PROTHROMBIN FREE BEEF PLASMA (PFB) |
PACIFIC HEMOSTASIS |
|
K790879 |
06/01/1979 |
ULTIPOR SOLUTION CONTAINER FILTER |
PALL BIOMEDICAL PRODUCTS CO. |
|
K790896 |
06/05/1979 |
TWO-WAY ANESTHESIA FILTER |
PHARMASEAL DIV., BAXTER HEALTHCARE CORP. |
|
K791002 |
06/01/1979 |
ECG ELECTRODES, PEDIATRIC-FOAM TAPE |
PHYSIO-CONTROL CORP. |
|
K791003 |
06/01/1979 |
ECG ELECTRODES, PEDIATRIC-MICROPOROUS TA |
PHYSIO-CONTROL CORP. |
|
K790757 |
06/01/1979 |
LIFEPAK 5 MONITOR, CASSETTE, #800923-01 |
PHYSIO-CONTROL CORP. |
|
K791062 |
06/20/1979 |
BOUNDARY SPECIALTY GOWN |
PROCTER & GAMBLE MFG. CO. |
|
K790696 |
06/20/1979 |
RDI-1 HOLLOW FIBER DIALYZER |
RENAL DEVICES, INC. |
|
K791125 |
06/27/1979 |
PLUG-LOK CEMENT RESTIRCTOR |
RICHARD'S MEDICAL EQUIP., INC. |
|
K790761 |
06/01/1979 |
FETASONDE MODEL 2108 |
ROCHE MEDICAL ELECTRONICS, INC. |
|
K790969 |
06/27/1979 |
ARGYLE URINE METER |
SHERWOOD MEDICAL CO. |
|
K790865 |
06/28/1979 |
LANCER HDL SEPARATION KIT |
SHERWOOD MEDICAL CO. |
|
K791060 |
06/15/1979 |
RAIN-X |
SHERWOOD MEDICAL CO. |
|
K790838 |
06/11/1979 |
ARTERIAL EMBOLECTOMY CATHETER (MODIFIED) |
SHILEY, INC. |
|
K790938 |
06/13/1979 |
SAPHENOUS VEIN IRRIGATION, PRESSURIZATIO |
SHILEY, INC. |
|
K790923 |
06/22/1979 |
MI-MARK ENDOCERVICAL SAMPLING SET |
SIMPSON/BASYE, INC. |
|
K790916 |
06/22/1979 |
CK-NUC REAGENT |
SMITH KLINE DIAGNOSTICS, INC. |
|
K790918 |
06/22/1979 |
ESKLAB REAGENT TABLETS |
SMITH KLINE DIAGNOSTICS, INC. |
|
K790917 |
06/22/1979 |
SPIN CHEM CK-NAC REAGENT |
SMITH KLINE DIAGNOSTICS, INC. |
|
K790841 |
06/27/1979 |
TG 2, TRI-GARD PRESSURE MONITOR |
SORENSEN RESEARCH |
|
K790814 |
06/27/1979 |
DELTA PUMP |
SPIESS DESIGN, INC. |
|
K790897 |
06/15/1979 |
QUAD IV CUSTOM IMPRESSION TRAY |
STED, INC. |
|
K791032 |
06/15/1979 |
CARDIAC CATHETERIZATION SHEETS/PACKS |
SURGIKOS, INC. |
|
K790937 |
06/15/1979 |
EMIT AUTO DIGOXIN ASSAY |
SYVA CO. |
|
K790398 |
06/15/1979 |
EMIT-D.A.U. PHENCYCLIDINE URINE LOW |
SYVA CO. |
|
K790401 |
06/15/1979 |
PHENCYCLIDINE URINE ASSAY |
SYVA CO. |
|
K790399 |
06/15/1979 |
URINE MEDIUM CALIBRATOR |
SYVA CO. |
|
K790400 |
06/15/1979 |
URINE NEGATIVE CALIBRATOR |
SYVA CO. |
|
K790919 |
06/28/1979 |
HPL RIA KIT |
TECHNIA DIAGNOSTICS LTD. |
|
K790805 |
06/06/1979 |
DRUG ABUSE DIPSTICKS |
TECHNICAL RESOURCES, INC. |
|
K790699 |
06/01/1979 |
TECNOL BODY HOLDER |
TECNOL NEW JERSEY WOUND CARE, INC. |
|
K790834 |
06/28/1979 |
UV URIC ACID DETERMINATION |
THE DOW CHEMICAL CO. |
|
K791021 |
06/15/1979 |
MUSCLE TESTING GUN |
THE ORTHODYN CO. |
|
K791073 |
06/20/1979 |
WRENCH |
TRUTH, INC. |
|
K791043 |
06/13/1979 |
LINDE OXYGEN CONCENTRATOR MODEL LOC-HC |
UNION CARBIDE CORP. |
|
K791069 |
06/27/1979 |
LINDE OXYGEN THERAPY FLOWMETERS, L33-L34 |
UNION CARBIDE CORP. |
|
K791050 |
06/15/1979 |
CENTRIA T3 UPTAKE TEST SET |
VENTREX LABORATORIES, INC. |
|
K790800 |
06/15/1979 |
CENTRIA T4 RIA TEST SET |
VENTREX LABORATORIES, INC. |
|
K790908 |
06/27/1979 |
RIA, TEST SET CENTRIA T3 |
VENTREX LABORATORIES, INC. |
|
K790945 |
06/01/1979 |
MODEL 113 TREONIC IP3 DIGITAL SYRINGE PU |
VICKERS AMERICA MEDICAL CORP. |
|
K791034 |
06/15/1979 |
PIGGYBACK BREATHING CIRCUIT |
VITAL SIGNS, INC. |
|
K790666 |
06/01/1979 |
VITALITH S 3000 SERIES |
VITATRON MEDICAL BV |
|
K790874 |
06/05/1979 |
"AMALCAP-NON-GAMMA-2" |
VIVADENT (USA), INC. |
|
K790595 |
06/15/1979 |
DENTAL ALGINATE IMPRESSION MATERIAL |
WALLACE A. ERICKSON & CO. |
|
K790593 |
06/15/1979 |
DENTAL CEMENT, ZINC PHOSPHATE |
WALLACE A. ERICKSON & CO. |
|
K790594 |
06/15/1979 |
DENTAL COMPOSITE RESTORATIVE MATERIAL |
WALLACE A. ERICKSON & CO. |
|
K790596 |
06/15/1979 |
ENAMEL BOND SYSTEM |
WALLACE A. ERICKSON & CO. |
|
K790592 |
06/15/1979 |
IMPRESSION MATERIAL, RUBBER |
WALLACE A. ERICKSON & CO. |
|
K790986 |
06/28/1979 |
RF CONTROLS |
WAMPOLE LABORATORIES |
|
K791026 |
06/22/1979 |
4F STERILE BALLOON-LESS, CATHETER 913-28 |
WATERS ASSOC., INC. |
|
K790946 |
06/05/1979 |
GORDON "IVS" INTRAVENOUS STABILIZER |
WHITMAN MEDICAL CORP. |
|
K790866 |
06/15/1979 |
"14 KARAT CASTING GOLD" |
WILLIAMS GOLD REFINING CO., INC. |
|
K791121 |
06/27/1979 |
ALLIGATOR FORECPTS, CUPPED FORCEPS |
XOMED, INC. |
|
K790915 |
06/27/1979 |
JUHN TYM-TAP |
XOMED, INC. |
|
K791124 |
06/27/1979 |
SURGICAL SCISSORS |
XOMED, INC. |
|
K790722 |
06/15/1979 |
PROPHYLAXIS ANGLE |
YOUNG DENTAL MANUFACTURING CO 1, LLC. |
|
K790723 |
06/15/1979 |
PROPHYLAXIS CUPS AND POLISHERS |
YOUNG DENTAL MANUFACTURING CO 1, LLC. |
|
K790987 |
06/22/1979 |
ZIMMER R TOTAL SHOULDER II |
ZIMMER, INC. |
|