FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
K812867 |
10/13/1981 |
STERI-VAC #400C GAS STERILIZER |
3M COMPANY |
|
K812925 |
10/19/1981 |
ABBOTT PAP-EIA |
ABBOTT LABORATORIES |
|
K812926 |
10/19/1981 |
ALT-QUANTICHROM |
ABBOTT LABORATORIES |
|
K813031 |
10/28/1981 |
MS-2 BACTERIAL IDENTIFICATION SYS |
ABBOTT LABORATORIES |
|
K812874 |
10/14/1981 |
PEDIATRIC MICROAGGREGATE BLOOD FILTER |
ABBOTT LABORATORIES |
|
K812865 |
10/13/1981 |
QUANTUMATIC DUAL-WAVELENGTH SPECTRO |
ABBOTT LABORATORIES |
|
K812932 |
10/20/1981 |
ANERIOD GAUZE |
ABCO DEALERS, INC. |
|
K812887 |
10/14/1981 |
ROBINSON CATHETERS NON-STERILE |
ABCO DEALERS, INC. |
|
K812809 |
10/06/1981 |
STERILE ADHERENT DRAPES |
ABCO DEALERS, INC. |
|
K812845 |
10/09/1981 |
SURGICAL SUCTION INSTRUMENTS-DISPOS. |
ABCO DEALERS, INC. |
|
K812848 |
10/09/1981 |
ACCRA LAB HEMOTOLOGY |
ACCRA LABORATORIES, INC. |
|
K812977 |
10/23/1981 |
RESPIRATORY CARE MONITOR |
ADVANCED MEDICAL EQUIPMENT, INC. |
|
K813037 |
10/28/1981 |
FLOWGUARD CATHETERS & CANNALAE |
ADVOCACY INTERNATIONAL, LTD. |
|
K813034 |
10/28/1981 |
POLYSTAN HEART LUNG MACHINE SYS |
ADVOCACY INTERNATIONAL, LTD. |
|
K813035 |
10/28/1981 |
POLYSTAN VERTICLUDE BLOOD PUMP |
ADVOCACY INTERNATIONAL, LTD. |
|
K812880 |
10/14/1981 |
OHIO NON-REUSABLE TRACHEAL TUBE MAJILL |
AIRCO/OHIO MEDICAL PRODUCTS |
|
K812879 |
10/14/1981 |
OHIO NON-REUSABLE TRACHEAL TUBE MURPHY |
AIRCO/OHIO MEDICAL PRODUCTS |
|
K812904 |
10/19/1981 |
STERILE ORTHOPEDIC STOCKINETTE |
ALBA HEALTH CARE |
|
K812969 |
10/22/1981 |
S/P CAPILLARY TUBES, HEPARINIZED (2A) |
AMERICAN DADE |
|
K812970 |
10/22/1981 |
S/P CAPILLARY TUBES, HEPARINIZED (3A) |
AMERICAN DADE |
|
K812892 |
10/15/1981 |
S/P SERUM DROPPER PIPETS |
AMERICAN DADE |
|
K812921 |
10/19/1981 |
S/P SURE-CAP |
AMERICAN DADE |
|
K812922 |
10/19/1981 |
S/P SURE-CAP C |
AMERICAN DADE |
|
K812923 |
10/19/1981 |
S/P SURE-CAP N |
AMERICAN DADE |
|
K812935 |
10/20/1981 |
FOGARTY FLEXIBLE PROBE |
AMERICAN EDWARDS LABORATORIES |
|
K813069 |
10/30/1981 |
PERITONEAL DIALYSIS CYCLER SET |
AMERICAN MEDICAL PRODUCTS, INC. |
|
K812965 |
10/22/1981 |
MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE |
AMERICAN OPTICAL CORP. |
|
K812830 |
10/08/1981 |
APC IMPLANTABLE PACING LEAD |
AMERICAN PACEMAKER CORP. |
|
K812807 |
10/06/1981 |
APC IMPLANTABLE PACING LEADS |
AMERICAN PACEMAKER CORP. |
|
K812927 |
10/19/1981 |
ARTERIOGRAM TRAY |
AMERICAN PHARMASEAL DIV. AHSC |
|
K812928 |
10/19/1981 |
VACU-FIL TRANSFER SET |
AMERICAN PHARMASEAL DIV. AHSC |
|
K812895 |
10/15/1981 |
YARMO NASAL CARTILAGE SOFTENER |
AMERICAN V. MUELLER |
|
K812979 |
10/23/1981 |
VITAMIN B12/FOLATE DUAL RADIOASSAY KITS |
AMERSHAM CORP. |
|
K812936 |
10/20/1981 |
BLOOD PRESSURE MONITOR |
AMERTEK |
|
K812945 |
10/20/1981 |
LIQUILYME BUN REAGENT |
AMRESCO, INC. |
|
K812862 |
10/13/1981 |
API GERM TUBE |
ANALYTAB PRODUCTS, INC. |
|
K812877 |
10/14/1981 |
PENASE |
ANALYTAB PRODUCTS, INC. |
|
K812837 |
10/09/1981 |
ALKALINE PHOSPHATASE REAGENT SET |
ANCO MEDICAL REAGENTS & ASSOC. |
|
K812834 |
10/09/1981 |
CREATININE REAGENT SET |
ANCO MEDICAL REAGENTS & ASSOC. |
|
K812839 |
10/09/1981 |
HDL CHOLESTEROL REAGENT SET |
ANCO MEDICAL REAGENTS & ASSOC. |
|
K812836 |
10/09/1981 |
LDH REAGENT SET |
ANCO MEDICAL REAGENTS & ASSOC. |
|
K812840 |
10/09/1981 |
SERUM IRON REAGENT SET |
ANCO MEDICAL REAGENTS & ASSOC. |
|
K812841 |
10/09/1981 |
TOTAL & DIRECT BILIRUBIN REAGENT SET |
ANCO MEDICAL REAGENTS & ASSOC. |
|
K812835 |
10/09/1981 |
TOTAL CALCIUM REAGENT SET |
ANCO MEDICAL REAGENTS & ASSOC. |
|
K812833 |
10/09/1981 |
TOTAL PROTEIN REAGENT SET |
ANCO MEDICAL REAGENTS & ASSOC. |
|
K812838 |
10/09/1981 |
TRIGLYCERIDE REAGENT SET |
ANCO MEDICAL REAGENTS & ASSOC. |
|
K812878 |
10/14/1981 |
THE NEW 1600 ELECTRODE |
ANDOVER MEDICAL, INC. |
|
K812924 |
10/19/1981 |
ANSWER (R) |
ARMKEL, LLC. |
|
K812881 |
10/14/1981 |
IMMUNEX CRP |
ARMKEL, LLC. |
|
K812882 |
10/14/1981 |
RHEUMATEX |
ARMKEL, LLC. |
|
K813013 |
10/27/1981 |
GEL ELECTRODE |
ARNDT AUTOMATION & ASSOC. |
|
K812903 |
10/16/1981 |
HUTT SWIVEL WALKER & HUTT STANDING FRAME |
BARNETT MEDICAL |
|
K813025 |
10/28/1981 |
STANDING FRAME |
BARNETT MEDICAL |
|
K812896 |
10/15/1981 |
I.V.E. REFRACTION SYSTEM |
BAUSCH & LOMB, INC. |
|
K812808 |
10/06/1981 |
BBL DIRECTIGEN TEST KIT |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K813033 |
10/28/1981 |
CLAY ADAMS QBC CENTRIFUGAL HEMOTOLOGY |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K812844 |
10/09/1981 |
MOXALACTAM 30MCG. SENSI-DISC |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K812784 |
10/05/1981 |
BECKMAN ASTRA SYS. TOTAL BILIRUBIN MOD |
BECKMAN INSTRUMENTS, INC. |
|
K813053 |
10/29/1981 |
DISPOSABLE BLOOD PRESSURE TRANSDUCER DOM |
BENTLEY LABORATORIES, INC. |
|
K812980 |
10/23/1981 |
MA-2 VENTILATOR |
BIO-MEDICAL REPAIR, INC. |
|
K812901 |
10/16/1981 |
125I FERRITIN RADIOIMMUNOASSAY KIT |
BIO-RIA |
|
K812946 |
10/20/1981 |
TRONZO HIP |
BIOMET, INC. |
|
K812825 |
10/08/1981 |
FLO-COR I |
BIOTRINE CORP. |
|
K812982 |
10/23/1981 |
BLOM-SINGER VOICE PROSTHESIS |
BIVONA MEDICAL TECHNOLOGIES |
|
K812978 |
10/23/1981 |
URIC ACID SYSTEM PACK TEST |
BOEHRINGER MANNHEIM CORP. |
|
K813020 |
10/27/1981 |
BOMED-NCCOM |
BOMED MEDICAL MFR., LTD. |
|
K813023 |
10/27/1981 |
FUKUDA DENSHI CARDIMAX FK-11 |
BRENTWOOD INSTRUMENTS, INC. |
|
K813022 |
10/27/1981 |
FUKUDA DENSHI CARDIMAX FK-12 |
BRENTWOOD INSTRUMENTS, INC. |
|
K813021 |
10/27/1981 |
FUKUDA DENSHI...ELECTROCARDIOGRAPH FD-36 |
BRENTWOOD INSTRUMENTS, INC. |
|
K812788 |
10/05/1981 |
A-1 TEST |
C.F. MEDICAL, INC. |
|
K812789 |
10/05/1981 |
ACU-SLIDE TEST |
C.F. MEDICAL, INC. |
|
K812957 |
10/21/1981 |
EAST AUTOCLAVE HUMIDIFIER |
CAIRCO LTD. |
|
K812960 |
10/21/1981 |
EAST VENTILARM PRESSURE MONITOR ALARM S. |
CAIRCO LTD. |
|
K812955 |
10/21/1981 |
EAST WATER UNIT MARK 3 |
CAIRCO LTD. |
|
K812958 |
10/21/1981 |
EAST-FREEMAN VENTILATOR MARK 2 |
CAIRCO LTD. |
|
K812953 |
10/21/1981 |
RADCLIFFE VENTILATOR MARK 5 |
CAIRCO LTD. |
|
K812961 |
10/21/1981 |
SHEFFIELD INFANT VENTILATOR MARK 4 |
CAIRCO LTD. |
|
K812959 |
10/21/1981 |
SPIROX "A" |
CAIRCO LTD. |
|
K812956 |
10/21/1981 |
SPIROX "H" |
CAIRCO LTD. |
|
K812917 |
10/19/1981 |
PORTABLE LIDOCAINE INFUSION PUMP |
CARDIAC PACEMAKERS, INC. |
|
K813051 |
10/29/1981 |
COMPTAR III |
CGR MEDICAL CORP. |
|
K812963 |
10/22/1981 |
IBIS II |
CGR MEDICAL CORP. |
|
K812908 |
10/19/1981 |
ELECTRO-GONIOMETER |
CHATTANOOGA GROUP, INC. |
|
K812899 |
10/16/1981 |
MED-EX |
CHATTANOOGA GROUP, INC. |
|
K813000 |
10/26/1981 |
DISPOSABLE ARTHROSCOPY CANNULA SET |
CLINICAL TECHNOLOGY CORP. |
|
K812832 |
10/09/1981 |
MODEL 325C UNIPOLAR CARDIAC PULSE GEN. |
COOK PACEMAKER CORP. |
|
K813049 |
10/28/1981 |
AQUANOMICS, #HHU100 |
COOPER-HEWITT ELECTRIC CO. |
|
K813046 |
10/28/1981 |
AQUANOMICS, #HHU60 |
COOPER-HEWITT ELECTRIC CO. |
|
K813048 |
10/28/1981 |
AQUANOMICS, #MP2SF |
COOPER-HEWITT ELECTRIC CO. |
|
K813050 |
10/28/1981 |
AQUANOMICS, #MP4SF |
COOPER-HEWITT ELECTRIC CO. |
|
K813045 |
10/28/1981 |
AQUANOMICS, #SP36SF |
COOPER-HEWITT ELECTRIC CO. |
|
K813047 |
10/28/1981 |
AQUANOMICS, MINI 60L |
COOPER-HEWITT ELECTRIC CO. |
|
K812781 |
10/05/1981 |
TEMPORARY PERVENOUS J-ATRIAL LEAD |
CORDIS CORP. |
|
K812786 |
10/05/1981 |
FERRITIN(125I) RADIOIMMUNOASSAY TEST SYS |
CORNING MEDICAL & SCIENTIFIC |
|
K812937 |
10/20/1981 |
BEHIND-THE-EAR MODEL 115 |
DANAVOX, INC. |
|
K812939 |
10/20/1981 |
IN-THE-EAR MODEL 101M |
DANAVOX, INC. |
|
K812938 |
10/20/1981 |
IN-THE-EAR MODEL 821 |
DANAVOX, INC. |
|
K812828 |
10/08/1981 |
MODEL 2000 MONITOR |
DATASCOPE CORP. |
|
K812858 |
10/13/1981 |
CHEMFIL |
DENTSPLY INTL. |
|
K812905 |
10/19/1981 |
PERMANENT ENDOCARD. UNIPOLAR TINED LEAD |
DIAG CORP. |
|
K812768 |
10/05/1981 |
COAT-A-COUNT FREE & TOTAL ESTRIOL KIT |
DIAGNOSTIC PRODUCTS CORP. |
|
K812973 |
10/23/1981 |
PERCUTANEOUS INTRODUCER COURNAND STYLE |
DIP, INC. |
|
K813019 |
10/27/1981 |
PERCUTANEOUS INTRODUCER: SELDINGER STYLE |
DIP, INC. |
|
K812852 |
10/13/1981 |
SET FOR ASEPTIC DECANTING OF A FLEX I.V |
DIP, INC. |
|
K812799 |
10/06/1981 |
"DCATS" |
DOREX, INC. |
|
K812864 |
10/13/1981 |
SILASTIC VOICE PROSTHESIS |
DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS |
|
K812772 |
10/05/1981 |
PERITONEAL DIALYSIS CYCLER SET (8UNIT) |
DRAVON MEDICAL, INC. |
|
K812771 |
10/05/1981 |
PERITONEAL DIALYSIS DRAINAGE |
DRAVON MEDICAL, INC. |
|
K812885 |
10/14/1981 |
DULBECCO MINIMUM ESSENTIAL MED NO GLUTAM |
DUTCHLAND LABORATORIES, INC. |
|
K813005 |
10/27/1981 |
KODAK CINEFLUOROGRAPHIC FILM SO-274 |
EASTMAN KODAK COMPANY |
|
K812776 |
10/05/1981 |
TRANSDUCER ANTISEPTIC TOWELETTE |
ECHO LABORATORIES, INC. |
|
K812898 |
10/16/1981 |
PE-01 ELECTRONIC INFUSION PUMP |
EGNELL, INC. |
|
K812902 |
10/16/1981 |
"ACUPRESS" VIBRATOR |
EICONA CORP. |
|
K812996 |
10/26/1981 |
FILTER FLOW MASK CAT. #300 |
ELDREDGE MFG. CO. |
|
K812997 |
10/26/1981 |
FILTER FLOW MASK CAT. #350 |
ELDREDGE MFG. CO. |
|
K812758 |
10/01/1981 |
PHYSIOLOGICAL PRESSURE TRANSDUCER |
ELECTROMEDICS, INC. |
|
K813018 |
10/27/1981 |
OXYTRON OXYGEN GENERATOR |
ELMORE TECHNOLOGY CORP. |
|
K812984 |
10/26/1981 |
SLIMTRONICS 2000 |
EMS DIST. |
|
K813007 |
10/27/1981 |
EPCOM EMS-180 ANTEPARTUM FETAL MONITOR |
EPCOM MEDICAL SYSTEMS, INC. |
|
K812811 |
10/06/1981 |
MICROCOIL 80 DIALYZER |
ERIKA, INC. |
|
K812819 |
10/07/1981 |
ETHICON* SURGICAL SUTURES W/COMPRESS BOL |
ETHICON, INC. |
|
K812909 |
10/19/1981 |
HYGIENTIST; CYCLOSON I & II; RETROFIT |
FIBRA SONICS, INC. |
|
K812947 |
10/20/1981 |
MONO-POLY RESOLVING MEDIUM |
FLOW LABORATORIES, INC. |
|
K812818 |
10/07/1981 |
TITERTEK AUTODROP |
FLOW LABORATORIES, INC. |
|
K812831 |
10/09/1981 |
SURGICAL DRESSINGS |
FOREIGN TRADE ZONE OF WISCONSIN |
|
K812826 |
10/08/1981 |
FORMA CH/P GAS PROCESSOR |
FORMA SCIENTIFIC, INC. |
|
K812888 |
10/15/1981 |
SYRINGE, PISTON |
FRISCO PRODUCTS, INC. |
|
K812916 |
10/19/1981 |
MEZLOCILLIN 75MCG ANTIMICROB. SUSCEPT. D |
GENERAL DIAGNOSTICS |
|
K812994 |
10/26/1981 |
MINOCYCLINE 30MCG ANTIMICROBIAL SUS. DSK |
GENERAL DIAGNOSTICS |
|
K812993 |
10/26/1981 |
MOXALACTOM 30MCG ANTIMICROBIAL SUS. DISK |
GENERAL DIAGNOSTICS |
|
K812783 |
10/05/1981 |
TRIMETHOPRIM 5MCG. ANTIMICROBIAL DISK |
GENERAL DIAGNOSTICS |
|
K812929 |
10/19/1981 |
3.5 MHZ BIOPSY TRANSDUCER |
GENERAL ELECTRIC CO. |
|
K812966 |
10/22/1981 |
400T ECT SOFTWARE |
GENERAL ELECTRIC CO. |
|
K813065 |
10/30/1981 |
B.D.A.S. |
GENERAL ELECTRIC CO. |
|
K812775 |
10/05/1981 |
FLUORICON L300 IMAGE INTENSIFIER |
GENERAL ELECTRIC CO. |
|
K812914 |
10/19/1981 |
MICRO-PREPROCESSOR UNIT |
GENERAL ELECTRIC CO. |
|
K812915 |
10/19/1981 |
MX 125 |
GENERAL ELECTRIC CO. |
|
K812913 |
10/19/1981 |
OMEGA II ANGIOGRAPHIC TABLE |
GENERAL ELECTRIC CO. |
|
K812911 |
10/19/1981 |
BCYE MEDIUM |
GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. |
|
K812787 |
10/05/1981 |
EIA RUBELLA |
GILFORD |
|
K812861 |
10/13/1981 |
CHOLESTEROL CALIBRATORS |
GILFORD DIAGNOSTICS |
|
K812912 |
10/19/1981 |
GILCHEM ALP REAGENT |
GILFORD DIAGNOSTICS |
|
K812820 |
10/07/1981 |
CHANG MEDIUM |
HANA BIOLOGICS, INC. |
|
K813044 |
10/28/1981 |
ULTRACHEM ALB, ITEM #64970 |
HARLECO |
|
K813040 |
10/28/1981 |
ULTRACHEM CA, ITEM #64975 |
HARLECO |
|
K813043 |
10/28/1981 |
ULTRACHEM CREA ITEM #64972 |
HARLECO |
|
K813039 |
10/28/1981 |
ULTRACHEM E-CHOL, ITEM #65025 |
HARLECO |
|
K813042 |
10/28/1981 |
ULTRACHEM GLUC-DH SET, ITEM #65048 |
HARLECO |
|
K813038 |
10/28/1981 |
ULTRACHEM TP, ITEM #64974 |
HARLECO |
|
K813041 |
10/28/1981 |
ULTRAZYME-GT, ITEM #64959 & 65032 |
HARLECO |
|
K812986 |
10/26/1981 |
AGGLUTEX AMPHETAMINE TEST KIT |
HOFFMANN-LA ROCHE, INC. |
|
K812988 |
10/26/1981 |
AGGLUTEX BARBITURATES TEST KIT |
HOFFMANN-LA ROCHE, INC. |
|
K812987 |
10/26/1981 |
AGGLUTEX METHAQUALONE TEST KIT |
HOFFMANN-LA ROCHE, INC. |
|
K812985 |
10/26/1981 |
AGGLUTEX MORPHINE TEST KIT |
HOFFMANN-LA ROCHE, INC. |
|
K813064 |
10/30/1981 |
TELEMETRY TRANSMITTER & RECEIVER |
HONEYWELL, INC. |
|
K812763 |
10/02/1981 |
ECG MEDATAPE-601 |
HOSPITAL EQUIPMENT SERVICE |
|
K812793 |
10/06/1981 |
P.E.T. |
HOSPITAL EQUIPMENT SERVICE |
|
K812803 |
10/06/1981 |
INFANT PERCUSSOR #5534 |
HUDSON OXYGEN THERAPY SALES CO. |
|
K812774 |
10/05/1981 |
VENTILATOR CIRCUIT |
HUDSON OXYGEN THERAPY SALES CO. |
|
K812773 |
10/05/1981 |
BENNETT VOLUME VENTILATOR CIRCUIT |
IDEAL MEDICAL, INC. |
|
K812823 |
10/08/1981 |
IMED MODEL 970 & 975 VOL. INFUSION PUMP |
IMED CORP. |
|
K812824 |
10/08/1981 |
PRESSURE DISC COMPONENT FOR ACCUSET |
IMED CORP. |
|
K813029 |
10/28/1981 |
VALVED SURGICAL ASPIRATORS |
IMEDIX |
|
K812821 |
10/07/1981 |
H-103 IGG, H-104 IGA, H-105 IGM |
IMMULOK, INC. |
|
K813026 |
10/28/1981 |
GUIDE WIRE |
INMED CORP. |
|
K812859 |
10/13/1981 |
IDS PORPHYRIN REAGENT |
INNOVATIVE DIAGNOSTIC SYSTEMS, INC. |
|
K812762 |
10/01/1981 |
IL 501, NA/K ANALYZER |
INSTRUMENTATION LABORATORY CO. |
|
K812872 |
10/14/1981 |
OPTIONAL TOTAL CA-MODULE FOR IL 504/508 |
INSTRUMENTATION LABORATORY CO. |
|
K812920 |
10/19/1981 |
EVENT MASTER |
INSTRUMENTS FOR CARDIAC RESEARCH |
|
K812812 |
10/06/1981 |
INTERMEDICS ADAPTAID STEP-DOWN ADAPTER |
INTERMEDICS, INC. |
|
K812990 |
10/26/1981 |
INTERMEDICS POLYFLEX-MODEL 483-03 LEAD |
INTERMEDICS, INC. |
|
K812991 |
10/26/1981 |
INTERMEDICS POLYFLEX-MODEL 483-04 LEAD |
INTERMEDICS, INC. |
|
K812989 |
10/26/1981 |
INTERMEDICS POLYFLEX-MODEL 493-03 LEAD |
INTERMEDICS, INC. |
|
K812813 |
10/06/1981 |
INTERMEDICS PROGRAMMER, MODEL 522-03 |
INTERMEDICS, INC. |
|
K813028 |
10/28/1981 |
POLY-FLEX PACING LEADS |
INTERMEDICS, INC. |
|
K812968 |
10/22/1981 |
FIAX RHEUMATOID FACTOR TEST KIT |
INTL. DIAGNOSTIC TECHNOLOGY |
|
K812795 |
10/06/1981 |
ANAEROBIC BLOOD AGAR |
ISLE MEDIA AND STERILE PRODUCTS, INC. |
|
K812796 |
10/06/1981 |
ANAEROBIC CNA BLOOD AGAR |
ISLE MEDIA AND STERILE PRODUCTS, INC. |
|
K812798 |
10/06/1981 |
MOTILITY GI MEDIUM |
ISLE MEDIA AND STERILE PRODUCTS, INC. |
|
K812797 |
10/06/1981 |
SCHAEDLER AGARS |
ISLE MEDIA AND STERILE PRODUCTS, INC. |
|
K812827 |
10/08/1981 |
ORBIC* SPHERICAL ALLOY |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
|
K812829 |
10/08/1981 |
COATEST ANTITHROMBIN |
KABIVITRUM, INC. |
|
K812760 |
10/01/1981 |
HI-TEMP CARDIOVASCULAR CAUTERY |
KEY MEDICAL, INC. |
|
K812764 |
10/02/1981 |
KOI BLUE FIELD ENTOPTOSCOPE |
KOI, INC. |
|
K812863 |
10/13/1981 |
FETASONDE 5, #30, CENTRAL NURSING STAT |
KONTRON INSTRUMENTS, INC. |
|
K813032 |
10/28/1981 |
ZIKON 100 DIGITAL X-RAY SYSTEM |
KONTRON INSTRUMENTS, INC. |
|
K812889 |
10/15/1981 |
ESTILUX POSTERIOR |
KULZER, INC. |
|
K813056 |
10/29/1981 |
AUTOMATED URINALYSIS SYSTEM |
KYOTO DAIICHI KAGAKU CO., LTD. |
|
K813059 |
10/30/1981 |
LEECO TESTO-QUANT DIAG. KIT |
LEECO DIAGNOSTICS, INC. |
|
K813017 |
10/27/1981 |
NECKTRAC |
LOSSING ORTHOPEDIC, INC. |
|
K812875 |
10/14/1981 |
SURGICAL LOOPS |
M-W LABORATORIES, INC. |
|
K812876 |
10/14/1981 |
SURGICAL PAWS |
M-W LABORATORIES, INC. |
|
K812919 |
10/19/1981 |
MULTI-GRAM DEVELOPING TANK R-12 & R-3 |
MARION LABORATORIES, INC. |
|
K812792 |
10/06/1981 |
PFT SCREENER (SYSTEM 1100) |
MEDICAL GRAPHICS CORP. |
|
K812873 |
10/14/1981 |
MEDICON #8200 AMS |
MEDICON, INC. |
|
K812910 |
10/19/1981 |
MEDISYSTEMS NEEDLES & SYRINGES |
MEDISYSTEMS CORP. |
|
K812806 |
10/06/1981 |
KT-1000 DEVICE |
MEDMETRIC CORP. |
|
K813012 |
10/27/1981 |
STERILE BASIN SETS |
MEDSPEC CORP. |
|
K813008 |
10/27/1981 |
RESPOND II...NEUROMUSCULAR STIMULATOR |
MEDTRONIC VASCULAR |
|
K812817 |
10/07/1981 |
NEUTRAL DUFFERED FORMA-SCENT |
MERIDIAN DIAGNOSTICS, INC. |
|
K812893 |
10/15/1981 |
SUPERFLAB |
MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
|
K812857 |
10/13/1981 |
CHARLES MICRO PROBE |
MID LABORATORIES, INC. |
|
K812944 |
10/20/1981 |
MILLAR MIKRO-TIP CATHETER PRESSURE TRAN. |
MILLAR INSTRUMENTS, INC. |
|
K812804 |
10/06/1981 |
MODERN MATERIALS' INLAY CSTG. WAXES,A-C |
MODERN MATERIALS |
|
K812805 |
10/06/1981 |
STEELE'S ECON. PINK BASEPL. WAXES, I-III |
MODERN MATERIALS |
|
K812884 |
10/14/1981 |
NARCO TELECARE PRESSURE TRANSDUCER DOME |
NARCO SCIENTIFIC |
|
K812918 |
10/19/1981 |
PILLING "K" KNIFE |
NARCO SCIENTIFIC |
|
K812883 |
10/14/1981 |
TELECARE ISOTEC PRESSURE TRANSDUCER DOME |
NARCO SCIENTIFIC |
|
K812866 |
10/13/1981 |
ASTRA REAGENT CONCENTRATE SYSTEM |
NOBEL SCIENTIFIC INDUSTRIES, INC. |
|
K812761 |
10/01/1981 |
FLOW-DIRECTED BALLOON THERMODILUTION |
NOVA MEDICAL SPECIALTIES |
|
K812759 |
10/01/1981 |
NML CK-MB RIA |
NUCLEAR MEDICAL LABORATORIES, INC. |
|
K812971 |
10/22/1981 |
CARDIOINTEGRAM |
OCG TECHNOLOGY, INC. |
|
K812869 |
10/14/1981 |
D-3260 SORBENT CARTRIDGE |
ORGANON TEKNIKA CORP. |
|
K812967 |
10/22/1981 |
ACCURATE BETA |
ORGANON, INC. |
|
K812853 |
10/13/1981 |
OSRAM UVA LAMP |
OSRAM GMBH |
|
K812801 |
10/06/1981 |
HIP STEM SYSTEM TITANIUM ALLOY |
OSTEONICS CORP. |
|
K812972 |
10/23/1981 |
RA LATEX TEST |
OXOID U.S.A., INC. |
|
K812894 |
10/15/1981 |
VDRL CARBON ANTIGEN |
OXOID U.S.A., INC. |
|
K812815 |
10/07/1981 |
MODEL 833 ENDOCARDIAL TINED LEAD |
PACESETTER SYSTEMS |
|
K812816 |
10/07/1981 |
MODEL 841 ENDOCARDIAL TINED LEAD |
PACESETTER SYSTEMS |
|
K812810 |
10/06/1981 |
PENTAX FLEXIBLE DRIODENOFIBERSCOPE |
PENTAX PRECISION INSTRUMENT CORP. |
|
K812782 |
10/05/1981 |
DISPENSER ASPIRATOR DA 300 |
PHARMACIA, INC. |
|
K813010 |
10/27/1981 |
EEG TELEPHONE TRANSMITTER, MODEL #T-7 |
PHARMAQUEST CORP. |
|
K812850 |
10/09/1981 |
PTT-200 PULMONARY RECEIVER/MICROPROCES |
PHARMAQUEST CORP. |
|
K812849 |
10/09/1981 |
PTT-200 TELEPHONIC PULMONARY TRANSMITT |
PHARMAQUEST CORP. |
|
K813002 |
10/26/1981 |
MAVIS C |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
|
K812870 |
10/14/1981 |
IMPROVED PLAYTEX TAMPON |
PLAYTEX, INC. |
|
K812983 |
10/26/1981 |
DSD |
PM AMERICA, INC. |
|
K812794 |
10/06/1981 |
LIPASE |
POINTE SCIENTIFIC, INC. |
|
K812943 |
10/20/1981 |
SLICK ENDOTRACHEAL TUBE |
POLAMEDCO, INC. |
|
K813003 |
10/26/1981 |
P.P.P. TREATMENT CABINET |
PRECISION PROFESSIONAL PRODUCTS |
|
K812907 |
10/19/1981 |
FEMEX |
PROMAC |
|
K812949 |
10/21/1981 |
RMI TRANSILLUMINATOR, MODEL 292 |
RADIATION MEASUREMENTS, INC. |
|
K812890 |
10/15/1981 |
HEMASITE GRAFTLESS VASCULAR ACESS |
RENAL SYSTEMS, INC. |
|
K813058 |
10/30/1981 |
PORTABLE OXYGEN GENERATOR |
RESPIRATORY MARKETING, INC. |
|
K812791 |
10/06/1981 |
PORTABLE MEDICAL TABLE |
RICHARD D. SPRADLIN |
|
K812846 |
10/09/1981 |
CLEAR-RITE II |
RICHARD-ALLAN MEDICAL IND., INC. |
|
K812847 |
10/09/1981 |
XYLENE |
RICHARD-ALLAN MEDICAL IND., INC. |
|
K812822 |
10/08/1981 |
RIND AIRWAY |
RIND MEDICAL DEVELOPMENT |
|
K812951 |
10/21/1981 |
RION AUDIOMETER AA-67 |
RION ACOUSTIC INSTRUMENTS, INC. |
|
K812952 |
10/21/1981 |
RION AUDIOMETER AA-68 |
RION ACOUSTIC INSTRUMENTS, INC. |
|
K812976 |
10/23/1981 |
ARGYLE ACC-U-THERM W/TEMPERATURE PROBE |
SHERWOOD MEDICAL CO. |
|
K813066 |
10/30/1981 |
ARGYLE YANKAUER SUCTION TUBE |
SHERWOOD MEDICAL CO. |
|
K812974 |
10/23/1981 |
LANCER COAGENT HUMAN FACTOR 1X PLASMA |
SHERWOOD MEDICAL CO. |
|
K812975 |
10/23/1981 |
LANCER COAGENT HUMAN VACTOR VIII PLASMA |
SHERWOOD MEDICAL CO. |
|
K812933 |
10/20/1981 |
LANCER SPECIMEN CONTAINER |
SHERWOOD MEDICAL CO. |
|
K812934 |
10/20/1981 |
MONOJECT PREFILLED SYRINGES |
SHERWOOD MEDICAL CO. |
|
K813063 |
10/30/1981 |
FLAT DRAIN |
SIL-MED CORP. |
|
K813062 |
10/30/1981 |
VASCULAR PAWS |
SIL-MED CORP. |
|
K812860 |
10/13/1981 |
IMMUNOASSAY PLATE |
SKATRON, INC. |
|
K813057 |
10/29/1981 |
VIBRO-COM COMMUNICATOR #8827 |
SONIC SYSTEMS, INC. |
|
K812800 |
10/06/1981 |
FLOW-DIRECTED THERMODILUTION CATHETER |
SORENSEN RESEARCH |
|
K812868 |
10/14/1981 |
FETAL PULSE DETECTORS, F50/F60 |
SOUTH CAROLINA MEDICAL, INC. |
|
K812992 |
10/26/1981 |
SURGICAL MASK |
SOUTH MOUNTAIN MEDICAL |
|
K812851 |
10/13/1981 |
SBP-16 CLINIC MUSCLE STIMULATOR |
SOUTHWESTERN BIO-PHYSICAL CORP. |
|
K812856 |
10/13/1981 |
CHEMICAL INDICATORS |
STERILIZATION TECHNICAL SERVICES, INC. |
|
K813011 |
10/27/1981 |
HEPAQUANT |
STRECK LABORATORIES, INC. |
|
K812940 |
10/20/1981 |
10% NEUTRAL BUFFERED FORMALIN CONCENT |
SURGIPATH |
|
K813009 |
10/27/1981 |
TECA VISUAL/AUDIO STIMULATOR MODEL CS-2 |
TECA, INC. |
|
K813006 |
10/27/1981 |
MODEL TDS-2450-2 MICROWAVE DIATHERMY SYS |
TECHNOLOGY APPLICATIONS GROUP |
|
K813030 |
10/28/1981 |
O.R. ARMBOARD COVER |
TECNOL NEW JERSEY WOUND CARE, INC. |
|
K812790 |
10/05/1981 |
IMPLANTABLE VENTRICULAR-INHIBITED CARDI |
TELECTRONICS, INC. |
|
K812962 |
10/22/1981 |
BOUNDARY SURGICAL DRAPE |
THE BUCKEYE CELLULOSE CORP. |
|
K812777 |
10/05/1981 |
DIRECT IRON REAGENT SET |
THE DOW CHEMICAL CO. |
|
K812950 |
10/21/1981 |
QAC CONTROL |
THE QUALITY ASSURANCE SERVICE CORP. |
|
K812779 |
10/05/1981 |
EXTENSIONS-LUSATZTISCH |
THE TELOS CO. |
|
K812778 |
10/05/1981 |
THE TELOS EQUIPMENT |
THE TELOS CO. |
|
K812765 |
10/05/1981 |
DATASCRIBE #DS-40 |
TIMETER INSTRUMENT CORP. |
|
K812766 |
10/05/1981 |
PCS-5 ACCESSORIES |
TIMETER INSTRUMENT CORP. |
|
K812767 |
10/05/1981 |
SNIFF AIR COMPRESSOR #SF-6 |
TIMETER INSTRUMENT CORP. |
|
K812802 |
10/06/1981 |
CAPD U.V. GERMICIDAL CONNECTION SYSTEM |
TRAVENOL LABORATORIES, S.A. |
|
K813001 |
10/26/1981 |
FIBRI-FILTER 20 |
TRI-MED, INC. |
|
K813014 |
10/27/1981 |
PROTECT-O-SEAL |
TRI-MED, INC. |
|
K812964 |
10/22/1981 |
INTRODUCER, PERCUTANEOUS SELDINGER |
TRIAD MEDICAL DIVISION |
|
K812769 |
10/05/1981 |
TRIDENT #2001 |
TRIDENT SURGICAL CORP. |
|
K813067 |
10/30/1981 |
SPINAL WRENCH |
TWIN CITY SURGICAL, INC. |
|
K812886 |
10/14/1981 |
ENDODONTIC PAPER POINTS |
UNITED DENTAL MFG., INC. |
|
K812999 |
10/26/1981 |
PET POLYETHYLENE TORQUE CATHETER |
UNIVERSAL MEDICAL INSTRUMENT CORP. |
|
K812785 |
10/05/1981 |
VANCE-AMBROSE RESECTOSCOPE FORCEPS |
VANCE PRODUCTS, INC. |
|
K812995 |
10/26/1981 |
VANCE-JACOBELLIS MICROHEMATURIA CATHETER |
VANCE PRODUCTS, INC. |
|
K812854 |
10/13/1981 |
VENTRONICS #5590 ECII OXYGEN MONITOR |
VENTRONICS, DIV OF HUDSON OXYGEN THERAPY SALES CO. |
|
K812855 |
10/13/1981 |
VENTRONICS #5595 ECII OXYGEN ANALYZER |
VENTRONICS, DIV OF HUDSON OXYGEN THERAPY SALES CO. |
|
K812981 |
10/23/1981 |
FLUVEN SETS (EXT-1, EXT-2, EXT-3, EXT-4) |
VENUSA LTD. |
|
K813015 |
10/27/1981 |
HELIOSEAL |
VIVADENT (USA), INC. |
|
K812906 |
10/19/1981 |
ELVI BICLOT 816 |
VOLU SOL MEDICAL INDUSTRIES |
|
K813024 |
10/28/1981 |
WA1000 |
WALLACH SURGICAL DEVICES, INC. |
|
K813027 |
10/28/1981 |
STERILE IRRIGATING SYRINGES, KITS,TRAY |
WELCON, INC. |
|
K812814 |
10/06/1981 |
ZEE SURGICAL INSTRUMENTS |
ZEE MEDICAL PRODUCTS CO., INC. |
|
K813016 |
10/27/1981 |
ZEE TRACTION SPLINT |
ZEE MEDICAL PRODUCTS CO., INC. |
|
K813052 |
10/29/1981 |
ULTRACAST WATERLESS SYNTHETIC RESIN CAST |
ZIMMER, INC. |
|