FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K790850 |
05/31/1979 |
T.E.N.S.* SINGLE-USE ELECTRODE |
3M COMPANY |
|
K782008 |
05/14/1979 |
DRESSING, ENVIRON WOUND |
ABBOTT LABORATORIES |
|
K790731 |
05/08/1979 |
OXYGEN HUMIDIFIER KIT |
ABBOTT LABORATORIES |
|
K790543 |
05/03/1979 |
THE ABBOTT EXECUTIVE |
ABBOTT LABORATORIES |
|
K790633 |
05/17/1979 |
"ACCOR" MATRIX |
ACCOR, INC. |
|
K790809 |
05/04/1979 |
VS, ANESTHESIA VENTILATOR |
AIRCO/OHIO MEDICAL PRODUCTS |
|
K790889 |
05/17/1979 |
CIRCUIT, BREATHING (W CONNEC, Y PIECE) |
AIRLIFE, INC. |
|
K790886 |
05/17/1979 |
CORRUGATED FLEXIBLE POLYETHYLENE |
AIRLIFE, INC. |
|
K790884 |
05/17/1979 |
FACE TENT-VINYL |
AIRLIFE, INC. |
|
K790885 |
05/17/1979 |
NASAL, OXYGEN, CANNULA |
AIRLIFE, INC. |
|
K790847 |
05/25/1979 |
EGS MODEL 300 |
ALFRED V. GRECO |
|
K790519 |
05/14/1979 |
ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2 |
AMERICAN MEDICAL SYSTEMS, INC. |
|
K790461 |
05/03/1979 |
T-3 UPTAKE (MAA) KIT |
AMERSHAM CORP. |
|
K790627 |
05/01/1979 |
LOMBARD-DOWELL DEOXYRILBONUCLERIC ACID |
ANAEROBE SYSTEMS |
|
K790625 |
05/01/1979 |
PEPTONE-YEAST EXTRACT BROTH |
ANAEROBE SYSTEMS |
|
K790799 |
05/31/1979 |
PULPTESTER MODEL 2001 |
ANALYTIC TECHNOLOGY |
|
K790322 |
05/14/1979 |
OPTIONAL ACCESSORY FOOT SWITCH MODEL 100 |
APPLIED MEDICAL RESEARCH |
|
K790436 |
05/14/1979 |
IMPLANTABLE HEART LEAD TERMINAL ADAPTER |
ARCO MEDICAL PRODUCTS CO. |
|
K790549 |
05/03/1979 |
HEATING BLOCK, WAMPOLE 37 C |
ARMKEL, LLC. |
|
K790770 |
05/18/1979 |
SAFETY HOLSTER, SINGLE-USE |
ASPEN LABORATORIES, INC. |
|
K790899 |
05/23/1979 |
BACTEC |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K790513 |
05/31/1979 |
HLA-2000 |
BDT ENT. |
|
K790308 |
05/01/1979 |
DISPOSABLE DIALYZERS, SD-ID, SD-2D |
BENTLEY LABORATORIES, INC. |
|
K790360 |
05/22/1979 |
QUANTAZYME TOXOPLASMA |
BIO-RAD |
|
K790769 |
05/03/1979 |
BETA/PAK |
BIO/DATA CORP. |
|
K790762 |
05/14/1979 |
PLATFORM TCCK TOTAL KNEE |
BIOMET, INC. |
|
K790872 |
05/23/1979 |
ENTERIC TUBE GUIDE |
BIOSEARCH MEDICAL PRODUCTS, INC. |
|
K790612 |
05/11/1979 |
NUTRIFLOW NASOGASTRIC FEEDING TUBE |
BIOSEARCH MEDICAL PRODUCTS, INC. |
|
K790120 |
05/07/1979 |
SLENDERTONE |
BLOOMEX INTERNATIONAL, INC. |
|
K790856 |
05/29/1979 |
PROCTOSCOPE #501 |
C. INTL. |
|
K790556 |
05/07/1979 |
CHOLESTEROL REAGENT, AUTOMATED ENZYMATIC |
CALBIOCHEM-BEHRING CORP. |
|
K790460 |
05/25/1979 |
TXOCELL-IHA REAGENT SYSTEM |
CALBIOCHEM-BEHRING CORP. |
|
K790503 |
05/17/1979 |
CARDIOTEST 2200 |
CARDIAC PACEMAKERS, INC. |
|
K790677 |
05/07/1979 |
EO EVACUATING SYSTEM I |
CASTLE CO. |
|
K790801 |
05/03/1979 |
STERILE DEFIBRINATED SHEEP BLOOD |
CENTRAL BIOLOGICAL CO. |
|
K790546 |
05/11/1979 |
FLOWMETER, OPTIFLO GAS |
COBE LABORATORIES, INC. |
|
K790690 |
05/16/1979 |
OMNI-STANICOR-(THETA) MODEL 217 |
CORDIS CORP. |
|
K790483 |
05/03/1979 |
"COULTER ACCU-ZYME II GOT REAGENT" |
COULTER ELECTRONICS, INC. |
|
K790522 |
05/01/1979 |
COULTER ACCU-ZYME II GPT REAGENT |
COULTER ELECTRONICS, INC. |
|
K790869 |
05/17/1979 |
"CARDIO-SLIDECOMP" |
CREATIVE INSTRUMENTS |
|
K790810 |
05/25/1979 |
DISPOSA-CUF |
CREST MEDICAL EQUIPMENT |
|
K790776 |
05/23/1979 |
DADE LOW IONIC STRENGTH SOLUITION (LISS) |
DADE, BAXTER TRAVENOL DIAGNOSTICS, INC. |
|
K790767 |
05/23/1979 |
IMMU-TEK AUTOMATIC CENTRIFUGE |
DADE, BAXTER TRAVENOL DIAGNOSTICS, INC. |
|
K790524 |
05/23/1979 |
DATA-ZYME ACIA PHOSPHATASE PROCEDURE |
DATA MEDICAL ASSOCIATES, INC. |
|
K790343 |
05/01/1979 |
DATA-ZYME CK CALORIMETRIC/UV PROCEDURE |
DATA MEDICAL ASSOCIATES, INC. |
|
K790668 |
05/23/1979 |
VENOUS PRESSURE MONITOR, MF 35 LF |
DECO MEDICAL, INC. |
|
K790941 |
05/23/1979 |
D.T.T. LOCK SCREW INSERTER |
DEPUY, INC. |
|
K790641 |
05/01/1979 |
GDC-685 |
DERINGER-NEY INC. |
|
K790820 |
05/04/1979 |
NON-REBREATHING "T" PIECE |
DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. |
|
K790514 |
05/03/1979 |
I NETILMICIN RIA KIT |
DIAGNOSTIC PRODUCTS CORP. |
|
K790672 |
05/31/1979 |
ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU |
DIAGNOSTICA, INC. |
|
K790671 |
05/31/1979 |
DERMATOPHYTIN "O" |
DIAGNOSTICA, INC. |
|
K790640 |
05/01/1979 |
HOWMEDICA BRASS CENTER DISC |
E.C. MOORE CO. |
|
K790452 |
05/08/1979 |
28 UNIPOLAR AND BIPOLAR PULSE GENERATORS |
EDWARDS PACEMAKER SYSTEMS |
|
K790562 |
05/08/1979 |
PULSE GENERATOR MODEL 61 AND 128 |
ELA MEDICAL, INC. |
|
K790794 |
05/31/1979 |
SIEMENS CARDIOSTAT 701 |
ELMED, INC. |
|
K790382 |
05/02/1979 |
COIL DIALYSIS, MODELS DM-360 AND DM-360- |
ESTRACORPOREAL, INC. |
|
K790578 |
05/15/1979 |
GAMMA SMAC REAGENTS |
GAMMA ENTERPRISES, INC. |
|
K790372 |
05/03/1979 |
H-D-EL |
GENERAL DIAGNOSTICS |
|
K790687 |
05/03/1979 |
BRUCELLA BROTH W/SPS, 6% SORBITOL & CO2 |
GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. |
|
K790771 |
05/15/1979 |
LD-P REAGENT (LDH P-L REAGENT) |
GILFORD DIAGNOSTICS |
|
K790846 |
05/17/1979 |
MIDDLE EAR ANALYZER (IMPED. AUDIOMTR) |
GRASON-STADLER, INC. |
|
K790871 |
05/14/1979 |
ENCLOSED CASE CART |
HAMILTON INDUSTRIES, INC. |
|
K790537 |
05/08/1979 |
AUTOMATIC ELECTRONIC SPHYMOMONOMETER |
HEALTHCARE ENTERPRISES, INC. |
|
K790737 |
05/16/1979 |
HSI MODEL C. CUSTOM IN-THE-EAR HEAR/AID |
HEARING SERVICES, INC. |
|
K790826 |
05/31/1979 |
COAGULATION ARP |
HELENA LABORATORIES |
|
K790646 |
05/23/1979 |
HELENA "QUIPLATE" SYSTEM |
HELENA LABORATORIES |
|
K790365 |
05/11/1979 |
FLUID MEASUREMENT STAND |
HEWLETT-PACKARD CO. |
|
K790485 |
05/03/1979 |
AMYLOCHROME STAT SEPARATOR, TEST |
HOFFMANN-LA ROCHE, INC. |
|
K790849 |
05/11/1979 |
H-H FIXATION AND JOINING CONNECTORS |
HOLTER-HAUSNER INTL. |
|
K790825 |
05/31/1979 |
LS-8 VISICORDER |
HONEYWELL, INC. |
|
K790600 |
05/21/1979 |
HOWMEDICA STRIP CROWN |
HOWMEDICA CORP. |
|
K790598 |
05/21/1979 |
RUWA FINISHING STRIPS |
HOWMEDICA CORP. |
|
K790599 |
05/21/1979 |
RUWA MATRIX STRIPS |
HOWMEDICA CORP. |
|
K790249 |
05/16/1979 |
TEST CELLS |
HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES |
|
K790669 |
05/14/1979 |
DROP CONTROLLER |
IMED CORP. |
|
K790674 |
05/14/1979 |
"THE SURGICAL ASSISTANT" |
INSTRUMENT MAKAR, INC. |
|
K790320 |
05/18/1979 |
DELTA-LITE |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
|
K790085 |
05/29/1979 |
KAGER TRAPDUST |
KAGER INTL. |
|
K790588 |
05/15/1979 |
ASSAY REAGENTS, LSA 290 |
KALLESTAD LABORATORIES, INC. |
|
K790636 |
05/08/1979 |
KIMLON UNIVERSAL DRAPE |
KIMBERLY-CLARK CORP. |
|
K790586 |
05/16/1979 |
CHEMBOND |
L.D. CAULK CO. |
|
K790585 |
05/16/1979 |
FINESSE |
L.D. CAULK CO. |
|
K790397 |
05/23/1979 |
CONCEP-7-B-HCG |
LEECO DIAGNOSTICS, INC. |
|
K790532 |
05/29/1979 |
FEVER TESTER |
MADDAK, INC. |
|
K790726 |
05/01/1979 |
BEHIND-THE-EAR HEARING INSTRUMENT, H54 |
MARCON HEARING INSTRUMENTS, INC. |
|
K790700 |
05/01/1979 |
BEHIND-THE-EAR HEARING INSTRUMENT, H56 |
MARCON HEARING INSTRUMENTS, INC. |
|
K790727 |
05/01/1979 |
BEHIND-THE-EAR, MODEL H37D |
MARCON HEARING INSTRUMENTS, INC. |
|
K790779 |
05/16/1979 |
MODEL H39C-BEHING-THE-EAR HEARING INSTRU |
MARCON HEARING INSTRUMENTS, INC. |
|
K790697 |
05/01/1979 |
MODEL H58-BEHIND-THE-EAR HEARING INSTR. |
MARCON HEARING INSTRUMENTS, INC. |
|
K790815 |
05/15/1979 |
CULTURETTE BRAND PVA |
MARION LABORATORIES, INC. |
|
K790407 |
05/16/1979 |
MICROTEC BACTERIAL FILTER |
MEDEX, INC. |
|
K790295 |
05/25/1979 |
TEST KIT, IIF-AMA |
MEDICA CORP. |
|
K790758 |
05/08/1979 |
HEMOCLEAR U-NEPHROS 1.0 DIALYZER |
MEDICAL, INC. |
|
K790766 |
05/25/1979 |
MEDTRONIC MODELS 6907/6901 |
MEDTRONIC VASCULAR |
|
K790790 |
05/25/1979 |
PISCES-SELECTOR X |
MEDTRONIC VASCULAR |
|
K790928 |
05/21/1979 |
3-WAY "T" 22MM MALE |
MEM MEDICAL, INC. |
|
K790932 |
05/21/1979 |
AEROSOL MOUTHPIECE NO. M-091 |
MEM MEDICAL, INC. |
|
K790931 |
05/21/1979 |
CORRUGATED TUBE WITH MOUTHPIECE |
MEM MEDICAL, INC. |
|
K790929 |
05/21/1979 |
DRAINAGE BAG |
MEM MEDICAL, INC. |
|
K790933 |
05/21/1979 |
MOUTHPIECE M-187 |
MEM MEDICAL, INC. |
|
K790924 |
05/21/1979 |
NEBULIZER NO. M-175 |
MEM MEDICAL, INC. |
|
K790925 |
05/21/1979 |
NEBULIZER WITH 4-WAY T NO M-174 |
MEM MEDICAL, INC. |
|
K790926 |
05/21/1979 |
NEBULIZER WITH MOUTHPIECE AND TEE |
MEM MEDICAL, INC. |
|
K790934 |
05/21/1979 |
OXYGEN BARB M-552 |
MEM MEDICAL, INC. |
|
K790927 |
05/21/1979 |
OXYGENERATOR NO. M-049 |
MEM MEDICAL, INC. |
|
K790642 |
05/08/1979 |
LEY ELECTRO-SURGICAL UNITS |
MERCED MEDICAL, INC. |
|
K790665 |
05/15/1979 |
NEONATAL TY AUTOPAK TEST DELIVERY SYSTEM |
MICROMEDIC SYSTEMS |
|
K790581 |
05/15/1979 |
CHROMATOGRAPHY TUBES |
MILES LABORATORIES, INC. |
|
K790580 |
05/25/1979 |
RIA KIT, PROSTATIC ACID |
MONITOR SCIENCE CORP. |
|
K790552 |
05/01/1979 |
AS7 & AS8 MONITORS |
NARCO AIR-SHIELDS |
|
K790817 |
05/07/1979 |
RIA KIT, QUANTITATION OF PROSTATIC ACID |
NEW ENGLAND NUCLEAR |
|
K790570 |
05/23/1979 |
STIMULATOR, NIC-106 VISUAL |
NICOLET BIOMEDICAL INSTRUMENTS |
|
K790282 |
05/04/1979 |
ELDONCARD |
NORDISK INFUSER SYSTEM |
|
K790843 |
05/31/1979 |
SNAP-WAY |
NORTHWEST ORTHODONTICS, INC. |
|
K790604 |
05/04/1979 |
CUSTOM TUBING SETS |
NORTON PERFORMANCE PLASTICS CORP. |
|
K790673 |
05/04/1979 |
OMNIMEDICAL AUTOMATIC 1001 |
OMNIMEDICAL |
|
K790729 |
05/01/1979 |
OCTAGONAL ALUMINUM FRAMING SYSTEM |
ORTHOPEDIC SYSTEMS, INC. |
|
K790861 |
05/07/1979 |
MOIRE CONTOURGRAPH, MODELS MS-1, SS-1 |
OTAL PRECISION CO. LTD. |
|
K790638 |
05/25/1979 |
ACCUTRON POLLUTION REDUCER |
PARKER LABORATORIES, INC. |
|
K790959 |
05/31/1979 |
LIFEPATCH ECG ELECTRODES |
PHYSIO-CONTROL CORP. |
|
K790860 |
05/29/1979 |
RT-HOOD |
PLASTICS SUPPLIES & PRODUCTS |
|
K790421 |
05/15/1979 |
ROCHE LACTATE ANALYZER 640 |
ROCHE MEDICAL ELECTRONICS, INC. |
|
K790858 |
05/15/1979 |
PERMOBIL EXTERIOR |
SAAB-SCANIA OF AMERICA, INC. |
|
K790859 |
05/15/1979 |
PERMOBIL SUPERIOR |
SAAB-SCANIA OF AMERICA, INC. |
|
K790684 |
05/18/1979 |
COLOR CODING OF SURGICAL INSTRUMENTS |
SARA DAN, INC. |
|
K790492 |
05/01/1979 |
SERO-STAT STREPTOCOCCUS TEST |
SCOTT LABORATORIES, INC. |
|
K790746 |
05/14/1979 |
THE "BIONIC EXERCISER" |
SCUDDER MOLNER INSTRUMENTS |
|
K790679 |
05/23/1979 |
ESTRADIOL RIA KIT |
SERONO LABORATORIES, INC. |
|
K790440 |
05/03/1979 |
PROGESTERONE |
SERONO LABORATORIES, INC. |
|
K790783 |
05/07/1979 |
KOORDINAT 3D |
SIEMENS CORP. |
|
K790747 |
05/04/1979 |
MEVATRON 74 |
SIEMENS MEDICAL LABORATORIES, INC. |
|
K790724 |
05/23/1979 |
ENZYMATIC DETERMINATION |
SIGMA CHEMICAL CO. |
|
K790760 |
05/23/1979 |
REAGENT SYSTEM #350HDL, SIGMA PROCEDURE |
SIGMA CHEMICAL CO. |
|
K790507 |
05/18/1979 |
800 ECG ELECTRODE |
SIMONSEN & WEELS EFTF. |
|
K790607 |
05/11/1979 |
GREENLINE IRRIGATION TRAYS |
SNYDER LABORATORIES, INC. |
|
K790678 |
05/11/1979 |
INTRAUTERINE CATHETER TIP |
SONICAID, INC. |
|
K790837 |
05/16/1979 |
ARRHYTHMIA II CARDULE |
SPACELABS, INC. |
|
K790877 |
05/23/1979 |
BIOVAC: LFA LASER FUME (SMOKE) EVACUATIO |
STACKHOUSE ASSOC. |
|
K790542 |
05/23/1979 |
ELECTRODES, STAODERM STERILE |
STAODYNAMICS, INC. |
|
K790904 |
05/18/1979 |
STAO-HOTPACK |
STAODYNAMICS, INC. |
|
K790745 |
05/01/1979 |
_MODEL WC-1 BEHIND-THE-EAR HEARING AID |
STARKEY LABORATORIES, INC. |
|
K790802 |
05/01/1979 |
ESSAR TOURNIQUET FOR VENIPUNCTURE |
STEWART RESEARCH, INC. |
|
K790725 |
05/11/1979 |
BARRIER SURGICAL DRAPES W/ DRISITE* W/MICROCIDE* |
SURGIKOS, INC. |
|
K790804 |
05/25/1979 |
PURGE LINE UNIT |
SURGIKOS, INC. |
|
K790431 |
05/04/1979 |
TREATED BARRIER INCISE DRAPE |
SURGIKOS, INC. |
|
K790686 |
05/25/1979 |
EMIT CFA THYROXINE ASSAY |
SYVA CO. |
|
K790829 |
05/15/1979 |
EMIT GENTAMICIN ASSAY |
SYVA CO. |
|
K790830 |
05/15/1979 |
EMIT GENTAMICIN CONTROL |
SYVA CO. |
|
K790735 |
05/03/1979 |
EMIT-TOX SERUM CALIBRATORS |
SYVA CO. |
|
K790495 |
05/03/1979 |
THYROXINE RIA KIT |
TECHNIA DIAGNOSTICS LTD. |
|
K790867 |
05/31/1979 |
CARDIAC PULSE GENERATOR, 16 SERIES |
TELECTRONICS, INC. |
|
K790868 |
05/25/1979 |
GENERATOR, 16 SERIES, MODIFIED TOP CAP |
TELECTRONICS, INC. |
|
K790105 |
05/24/1979 |
TERUMO IMUGARD |
TERUMO AMERICA, INC. |
|
K790912 |
05/21/1979 |
ARIDYNE 3500 |
TIMETER INSTRUMENT CORP. |
|
K790903 |
05/31/1979 |
TRACOR MODEL RA-411 MICROPROCESSOR |
TRACOR INSTRUMENTS, INC. |
|
K790315 |
05/15/1979 |
BLOOD CELL SEPARATOR SYSTEM CS3000 |
TRAVENOL LABORATORIES, S.A. |
|
K790533 |
05/02/1979 |
HD CAPILLARY FILM DIALYZER, MODEL 1001 |
TRAVENOL LABORATORIES, S.A. |
|
K790591 |
05/02/1979 |
HEMODIALYSIS BLOOD CIRCUIT |
TRAVENOL LABORATORIES, S.A. |
|
K790550 |
05/07/1979 |
CENTRIA SYSTEM |
UNION CARBIDE CORP. |
|
K790643 |
05/23/1979 |
CENTRIFICHEM FILTER CALIBRATION SET |
UNION CARBIDE CORP. |
|
K790662 |
05/15/1979 |
CENTRIFICHEM INORGANIC PHOSPHORUS |
UNION CARBIDE CORP. |
|
K790750 |
05/14/1979 |
COLOSTOMY DEVICE W/ PRESSURE LID |
VABAR CORP. |
|
K790749 |
05/16/1979 |
COLOSTOMY ENEMA DEVICE |
VABAR CORP. |
|
K790780 |
05/03/1979 |
ATOMIC ABSORPTION SPECTROPHOTOMETER, |
VARIAN ASSOC., INC. |
|
K790781 |
05/03/1979 |
SPECTROPHOTOMETER SYSTEM, MODEL AA-475 |
VARIAN ASSOC., INC. |
|
K790601 |
05/31/1979 |
DENTAL HANDPIECE |
VENTURE TECHNOLOGY, INC. |
|
K790689 |
05/29/1979 |
REVISED BATTERY CHARGER |
VICKERS AMERICA MEDICAL CORP. |
|
K790768 |
05/23/1979 |
WAKO CHOLESTEROL TEST |
WAKO INTL., INC. |
|
K790496 |
05/03/1979 |
BIOBRANE BRAND TEMPORARY WOUND DRESSING |
WOODROOF LABORATORIES, INC. |
|
K790474 |
05/01/1979 |
SZAMYL 6.5 |
WORTHINGTON DIAGNOSTIC SYSTEMS |
|
K790582 |
05/29/1979 |
INTRAVASCULAR ADMINISTRATION SET |
Y |
|
K790317 |
05/07/1979 |
PAP RIA KIT |
YANG LABORATORIES, INC. |
|
K790104 |
05/14/1979 |
PISTORMATIC |
ZELBY, BURSTEIN, HARTMAN & BURSTEIN |
|
K790219 |
05/08/1979 |
PROTHESIS, RETAINED GEOMETRIC KNEE |
ZIMMER, INC. |
|