FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K801748 |
12/18/1980 |
3M I-125 SEEDS IN ABSORBABLE CARRIER |
3M COMPANY |
|
K803105 |
12/31/1980 |
SARNS INFANT ARTERIAL BUBBLE SENSOR |
3M HEALTH CARE, SARNS |
|
K802902 |
12/19/1980 |
CYBREX CARBAMAZEPINE |
ABBOTT LABORATORIES |
|
K803075 |
12/22/1980 |
DIGOXIN RIABEAD DIAGNOSTIC KIT |
ABBOTT LABORATORIES |
|
K802309 |
12/01/1980 |
MS-2 IDENTIFICATION SYSTEM |
ABBOTT LABORATORIES |
|
K802861 |
12/11/1980 |
COMBINATION PADS STERILE SINGLES |
ABCO DEALERS, INC. |
|
K803151 |
12/30/1980 |
ECG & ULTRASOUND GELS, CREAMS & LOTION |
ABCO DEALERS, INC. |
|
K802992 |
12/30/1980 |
ELASTIC GAUZE |
ABCO DEALERS, INC. |
|
K802862 |
12/11/1980 |
GAUZE PADS STERILE SINGLES |
ABCO DEALERS, INC. |
|
K802863 |
12/11/1980 |
GAUZE SPONGES |
ABCO DEALERS, INC. |
|
K802860 |
12/11/1980 |
POST OP. SPONGES STERILE |
ABCO DEALERS, INC. |
|
K802991 |
12/30/1980 |
ROLL STRETCH GAUZE |
ABCO DEALERS, INC. |
|
K802382 |
12/16/1980 |
SONIC EAR |
ACOUSTICON ELECTRONICS |
|
K802998 |
12/22/1980 |
PATIENT CARE DISPOSABLE INFANT SHIRTS |
AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL |
|
K803045 |
12/22/1980 |
IMMU-TRACE DIGOXIN (125I) RADIOIMMUN. |
AMERICAN DADE |
|
K802841 |
12/18/1980 |
DIGOXIN RADIOIMMUNOASSAY KIT |
AMERICAN DIAGNOSTIC CORP. |
|
K802586 |
12/18/1980 |
AMERICAN HEYER-SCHULTE LOW PROFILE VALVE |
AMERICAN HEYER SCHULTE |
|
K803080 |
12/22/1980 |
ALL PUPOSE URETHRAL CATHETER |
AMERICAN HOSPITAL SUPPLY CORP. |
|
K803079 |
12/22/1980 |
FOLEY CATHETER |
AMERICAN HOSPITAL SUPPLY CORP. |
|
K803117 |
12/23/1980 |
CUSTOM DRESSING TRAY WET TO DRY |
AMERICAN MEDICAL DISPOSABLE, INC. |
|
K803114 |
12/22/1980 |
HYPERALIMENTATION DRESSING CHANGE TRAY |
AMERICAN MEDICAL DISPOSABLE, INC. |
|
K803119 |
12/30/1980 |
LARGE WOUND DRESSING KIT |
AMERICAN MEDICAL DISPOSABLE, INC. |
|
K803118 |
12/22/1980 |
SIMPLE DRESSING TRAY #82028 |
AMERICAN MEDICAL DISPOSABLE, INC. |
|
K800746 |
12/16/1980 |
UNIFOCAL VP, MODELS 7501 AND 7502 |
AMERICAN PACEMAKER CORP. |
|
K803097 |
12/22/1980 |
DIGOXIN & PHENYTOIN CONTROL SERA |
AMERSHAM CORP. |
|
K802963 |
12/19/1980 |
101, 151, 161 PORTABLE AUDIOMETERS |
AMPLAID USA, INC. |
|
K802838 |
12/11/1980 |
STERNUM SAW BLADE |
AMSCO CO. |
|
K802980 |
12/19/1980 |
DISPOSABLE STERILE LAP SPONGE |
ANAGO, INC. |
|
K802641 |
12/11/1980 |
GAMMEX SURGICAL GLOVES |
ANSELL, INC. |
|
K802877 |
12/19/1980 |
AMIKACIN RIA KIT |
ANTIBODIES INC. |
|
K802999 |
12/22/1980 |
BETA-TEC QUALITATIVE |
ARMKEL, LLC. |
|
K802774 |
12/16/1980 |
FIBER OPTIC ADAPTER #60-0892 |
ASPEN LABORATORIES, INC. |
|
K802772 |
12/16/1980 |
FIBER OPTIC ADAPTER #60-0894 |
ASPEN LABORATORIES, INC. |
|
K802775 |
12/16/1980 |
FIBER OPTIC ADAPTER #60-0896 |
ASPEN LABORATORIES, INC. |
|
K802768 |
12/16/1980 |
FIBER OPTIC ADAPTER #60-0897 |
ASPEN LABORATORIES, INC. |
|
K802771 |
12/16/1980 |
FIBER OPTIC ADAPTER #60-895 |
ASPEN LABORATORIES, INC. |
|
K802766 |
12/16/1980 |
FIBER OPTIC ADAPTER CAT#60-0898 |
ASPEN LABORATORIES, INC. |
|
K802769 |
12/11/1980 |
FIBER OPTIC HEADLIGHT #60-0765 |
ASPEN LABORATORIES, INC. |
|
K802770 |
12/11/1980 |
FIBER OPTIC HEADLIGHT #60-0766766 |
ASPEN LABORATORIES, INC. |
|
K802773 |
12/16/1980 |
FIBER OPTIC LIGHT GUIDE #60-0767 |
ASPEN LABORATORIES, INC. |
|
K802767 |
12/16/1980 |
FIBER OPTIC LIGHT GUIDE CAT#60-0768 |
ASPEN LABORATORIES, INC. |
|
K802954 |
12/17/1980 |
DRESSING CHANGE TRAY-MEDIUM |
ASSOCIATED MEDICAL PRODUCTS CO. |
|
K802644 |
12/22/1980 |
EMERG. OXYGEN KIT #65350 & #65399 CASE |
B & F MEDICAL PRODUCTS, INC. |
|
K802869 |
12/11/1980 |
BACKTRAC 90-90 TRACTION |
BACKTRAC |
|
K803027 |
12/22/1980 |
CDC ANAEROBE BL AGAR W/PHENYLETHYL ETC. |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K803022 |
12/22/1980 |
CDC ANAEROBE BLD AGAR W/KANAMYCIN ETC. |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K803025 |
12/22/1980 |
CDC ANAEROBE BLOOD AGAR |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K803024 |
12/22/1980 |
CDC ANAEROBE LAKED BL AGAR W/PARAMOMY. |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K803023 |
12/22/1980 |
ENRICHED THIOGLYCOLLATE MEDIUM |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K803026 |
12/22/1980 |
PEPTONE YEAST EXTRACT GLUCOSE BROTH |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K802688 |
12/18/1980 |
RHEUMATOID FACTOR TEST SYSTEMS |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K802923 |
12/19/1980 |
BECKMAN ASTRA SYSTEMS CALCIUM CHEMISTRY |
BECKMAN INSTRUMENTS, INC. |
|
K802854 |
12/11/1980 |
BECKMAN ICS DRUG CONTROL SERA |
BECKMAN INSTRUMENTS, INC. |
|
K802339 |
12/18/1980 |
EIA RUBELLA-G |
BECKMAN INSTRUMENTS, INC. |
|
K802810 |
12/10/1980 |
HEXOKINASE, GLUCOSE |
BECKMAN INSTRUMENTS, INC. |
|
K802628 |
12/11/1980 |
PARAGON ELECTROPHORESIS LACTATE REAG.KIT |
BECKMAN INSTRUMENTS, INC. |
|
K802821 |
12/11/1980 |
PARAGON HEMOGLOBIN ELECTRO. REAG. KIT |
BECKMAN INSTRUMENTS, INC. |
|
K802822 |
12/11/1980 |
PARAGON LIPOPROTEIN ELECTRO. REAG. KIT |
BECKMAN INSTRUMENTS, INC. |
|
K801633 |
12/18/1980 |
THE BRAVO NEW PARALLEL FLOW DIALYZER |
BELLCO ARTIFIDIAL ORGAN SPEC., INC. |
|
K801634 |
12/17/1980 |
THE VITA 2 DISPOSABLE DIALYZER |
BELLCO ARTIFIDIAL ORGAN SPEC., INC. |
|
K802848 |
12/11/1980 |
CARDIOPLEGIA COOLING SYST. CCAS-2 |
BENTLEY LABORATORIES, INC. |
|
K802847 |
12/16/1980 |
OXYGEN SATURATION METER MODEL NO. SM-1 |
BENTLEY LABORATORIES, INC. |
|
K802719 |
12/16/1980 |
SPIRAFLO BLOOD OXYGENATORS MODEL BOS-10S |
BENTLEY LABORATORIES, INC. |
|
K802720 |
12/16/1980 |
SPIRAFLO BLOOD OXYGENATORS MODEL BOS-5S |
BENTLEY LABORATORIES, INC. |
|
K802740 |
12/10/1980 |
FLUFF UNDERPAD TYPE UP1001 |
BIO D CORP. |
|
K802730 |
12/10/1980 |
FLUFF UNDERPAD TYPE UP1002 |
BIO D CORP. |
|
K802738 |
12/18/1980 |
URINE COLLECTION BAG TYPE 1505V |
BIO D CORP. |
|
K802737 |
12/18/1980 |
URINE COLLECTION BAG TYPE 1590V |
BIO D CORP. |
|
K802729 |
12/18/1980 |
URINE COLLECTION BAG TYPE 2132V |
BIO D CORP. |
|
K802734 |
12/18/1980 |
URINE COLLECTION BAG TYPE 710 |
BIO D CORP. |
|
K802739 |
12/18/1980 |
URINE COLLECTION BAG TYPE 710AP |
BIO D CORP. |
|
K802735 |
12/18/1980 |
URINE COLLECTION BAG TYPE 740AP |
BIO D CORP. |
|
K802733 |
12/18/1980 |
URINE COLLECTION BAG TYPE AP2090V |
BIO D CORP. |
|
K802732 |
12/18/1980 |
URINE COLLECTION BAG TYPE AP2132V |
BIO D CORP. |
|
K802736 |
12/18/1980 |
URINE COOLECTION BAG TYPE 2090V |
BIO D CORP. |
|
K802092 |
12/18/1980 |
HF-100 DIALYZER |
BIO-MED CORP. |
|
K802944 |
12/22/1980 |
QUANTIMUNE E3 RIA |
BIO-RAD |
|
K803030 |
12/22/1980 |
THE BIO-TEK CHROMOSCAN |
BIO-TEK INSTRUMENTS, INC. |
|
K802356 |
12/01/1980 |
VON WILLEBRAND FACTOR ASSAY |
BIO/DATA CORP. |
|
K802752 |
12/10/1980 |
POROUS, BREATHING TAPE W/RELEASE LINER |
BIOADHESIVE SYSTEMS, INC. |
|
K803014 |
12/22/1980 |
SENSOMAT |
BIOCHEM INTERNATIONAL, INC. |
|
K802842 |
12/18/1980 |
SINGLE VIAL LIPASE TEST KIT |
BIODYNAMICS CORP. |
|
K802308 |
12/01/1980 |
T/K (ATA/AMA) UNIVERSAL BIOPAK |
BIOWARE PRODUCTS |
|
K802304 |
12/01/1980 |
SOLAR TONE |
BLOOMEX INTERNATIONAL, INC. |
|
K802916 |
12/19/1980 |
MONTG. TRACHEAL CANNULA |
BOSTON MEDICAL PRODUCTS, INC. |
|
K802915 |
12/19/1980 |
MONTG. TRACHEAL TREPHINE FENE STRATOR |
BOSTON MEDICAL PRODUCTS, INC. |
|
K802662 |
12/16/1980 |
POLYCARBONATE TEMPORARY CEMENT |
BUFFALO DENTAL MFG. CO., INC. |
|
K802906 |
12/16/1980 |
WILLIAM HARVEY OXYGENATING GAS FILTER |
C.R. BARD, INC. |
|
K802102 |
12/18/1980 |
RUBELLA ELISA REAGENTS RUBELLA IGG ANTI |
CALBIOCHEM-BEHRING CORP. |
|
K802352 |
12/22/1980 |
MICRO THIN-DII, #0521 |
CARDIAC PACEMAKERS, INC. |
|
K802353 |
12/22/1980 |
MICRO THIN-PII, #0523 |
CARDIAC PACEMAKERS, INC. |
|
K803035 |
12/22/1980 |
MICROTHIN-PII BIPOLAR PULSE GEN. #0621 |
CARDIAC PACEMAKERS, INC. |
|
K803034 |
12/22/1980 |
MICROTHIN-PII BIPOLAR PULSE GEN. #0623 |
CARDIAC PACEMAKERS, INC. |
|
K802230 |
12/22/1980 |
BELLCO SINGLE NEEDLE DOUBLE HEAD PUMP |
CARDIO MED SUPPLIES, INC. |
|
K803041 |
12/30/1980 |
SERUM FREE TISSUE CULTURE MEDIA |
CARTAYA ASSOC. |
|
K802928 |
12/17/1980 |
SPIROMETRIC COMPUTER #SC-10 |
CAVITRON CORP. |
|
K802704 |
12/11/1980 |
SIAM 80-INSTANTANEOUS SONOGRAPH W/STOR. |
CGR MEDICAL CORP. |
|
K802651 |
12/17/1980 |
POSTOPERATIVE UV GLASSES (PLANO/APHAKIC) |
CHIRON VISION CORP. |
|
K802814 |
12/10/1980 |
ORTHOFIX AXIALEXTERNAL FIXATION SYS. |
CINTOR ORTHOPAEDIC DIV. |
|
K802627 |
12/16/1980 |
ORTRON 90* HIP PROSTHESIS |
CINTOR ORTHOPAEDIC DIV. |
|
K802432 |
12/01/1980 |
GLYCO-TROL HUMAN GLYCOSYLATED HOM. CONT. |
CLINTECH DIAGNOSTICS CORP. |
|
K802895 |
12/22/1980 |
COBE CENTRY 2 VARIABLE CONCENTRATE-18- |
COBE LABORATORIES, INC. |
|
K802250 |
12/10/1980 |
DIALYSIS CONTROL UNIT-CENTRY 2000 |
COBE LABORATORIES, INC. |
|
K802845 |
12/17/1980 |
CONCEPT CANALICULUS INTUBATION SET |
CONCEPT, INC. |
|
K803174 |
12/30/1980 |
CONPHAR PERCUSSION HAMMER(BUCK TYPE) |
CONPHAR, INC. |
|
K802884 |
12/22/1980 |
CORNING NORMAL GLYCOSYLATED HEMOGLOBIN |
CORNING MEDICAL & SCIENTIFIC |
|
K803060 |
12/22/1980 |
FOLATE 125I RADIOIMMUNOASSAY |
CORNING MEDICAL & SCIENTIFIC |
|
K802661 |
12/10/1980 |
LIQUISOL TESTOSTERONE RADIOIMM. TEST KIT |
DAMON CORP. |
|
K802859 |
12/31/1980 |
BEHIND-THE-EAR HEARING AID |
DANAVOX, INC. |
|
K803102 |
12/22/1980 |
ARTERIAL BUBBLE TRAP K-20 |
DELTA MEDICAL INDUSTRIES |
|
K803101 |
12/22/1980 |
PREBYPASS FILTER CAT.#K-5 |
DELTA MEDICAL INDUSTRIES |
|
K803072 |
12/30/1980 |
HIGH FREQUENCY AUDIOMETER DELMAR #20-K |
DEMLAR MEDICAL, INC. |
|
K802853 |
12/18/1980 |
CLEANSER, ROOT CANAL |
DENTSPLY INTL. |
|
K802835 |
12/11/1980 |
COMPU-CHEM II CHEMISTRY ANALYZER |
DIAGNOSTIC AIDS, INC. |
|
K801175 |
12/18/1980 |
SILASTIC II MAMMARY IMPLANT |
DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS |
|
K802837 |
12/10/1980 |
DR. MICHAEL'S FOOT HELPER |
DR. MICHAEL'S FOOT-CARE PRODUCTS |
|
K802168 |
12/20/1980 |
DRAGER AV2 ANESTHESIA VENTILATOR |
DRAEGER MEDICAL, INC. |
|
K803177 |
12/31/1980 |
MOIST HEAT PACK |
DURO-MED IND., INC. |
|
K802857 |
12/11/1980 |
IMMULON REMOVAWELL STRIPS #011-010-6301 |
DYNATECH CORP. |
|
K802883 |
12/19/1980 |
T3-SQUIBB RIA KIT |
E. R. SQUIBB & SONS, INC. |
|
K803002 |
12/22/1980 |
ELECATH FLUID-DRAIN ASSEMBLY |
ELECTRO-CATHETER CORP. |
|
K802507 |
12/01/1980 |
TENSMATE EMPIMODEL 9980 |
EMPI |
|
K802881 |
12/19/1980 |
ABSELE* ABSORBABLE BONE SEALANT |
ETHICON, INC. |
|
K803038 |
12/30/1980 |
PROXIMATE*II DISPOSABLE SKIN STAPLER |
ETHICON, INC. |
|
K802880 |
12/17/1980 |
EXTRACORPOREAL'S #DM-952 DIALYSATE BYPAS |
EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
|
K803059 |
12/22/1980 |
INTERSEPT* VENOUS RESERVOIR BAG & HOLDER |
EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
|
K802381 |
12/17/1980 |
LEWICKY ANTERIOR CHAMBER MAINTEN. SYS. |
FIBRA SONICS, INC. |
|
K802956 |
12/22/1980 |
GAMBRO A-V FISTULA NEEDLE SET |
GAMBRO, INC. |
|
K802389 |
12/22/1980 |
GAMBRO LUNDIA PLATE DISP. DIALYZER |
GAMBRO, INC. |
|
K802831 |
12/18/1980 |
GAMBRO PERITONEAL DIALYSIS MONITOR |
GAMBRO, INC. |
|
K803039 |
12/22/1980 |
PROFILE ANTI-CONVUL. SET ASSAYED S. CTL. |
GENERAL DIAGNOSTICS |
|
K803036 |
12/22/1980 |
PROFILE CARDIAC SET ASSAYED SERUM CONTR. |
GENERAL DIAGNOSTICS |
|
K802548 |
12/02/1980 |
GENERATOR, HIGH VOLT, X-RAY, DIAG. MPX80 |
GENERAL ELECTRIC CO. |
|
K802549 |
12/02/1980 |
GENERATOR, HIGH VOLT, X-RAY, MPX 100 |
GENERAL ELECTRIC CO. |
|
K802550 |
12/02/1980 |
GENERATOR, HIGH VOLT, X-RAY, MPX 125 |
GENERAL ELECTRIC CO. |
|
K802551 |
12/02/1980 |
GENERATOR, HIGH VOLT, X-RAY, MPX100/125 |
GENERAL ELECTRIC CO. |
|
K802332 |
12/22/1980 |
INTRAJECT |
GENERAL MEDICAL ENGINEERING CORP. |
|
K802678 |
12/10/1980 |
TRANSCUTANEOUS ELECTRIC NERVE STIMULATOR |
GENERAL MEDICAL INDUSTRIES, INC. |
|
K803121 |
12/30/1980 |
MENTOR 150 TRANSCUTANEOUS NERVE STIMULA |
GEORGE H. FRISCH |
|
K803113 |
12/30/1980 |
MENTOR 402 TRANSCUTANEOUS ELEC. STIMULAT |
GEORGE H. FRISCH |
|
K802957 |
12/22/1980 |
MUELLER HINTON BROTH |
GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. |
|
K802632 |
12/11/1980 |
ALBUMIN/TOTAL PROTEIN STANDARDS |
GILFORD DIAGNOSTICS |
|
K802633 |
12/11/1980 |
BUN/GLUCOSE STANDARDS |
GILFORD DIAGNOSTICS |
|
K802631 |
12/11/1980 |
CREATININE STANDARDS |
GILFORD DIAGNOSTICS |
|
K802750 |
12/31/1980 |
NUVOX BEDSIDE TINNITUS MASKER |
HAL-HEN CO., INC. |
|
K802583 |
12/18/1980 |
INFANT VENTILATOR, (RESPIRATOR) PLAN B |
HEALTHDYNE, INC. |
|
K802912 |
12/22/1980 |
HELENA AT-III QUIPLATE PROCEDURE |
HELENA LABORATORIES |
|
K803016 |
12/30/1980 |
HELENA HEMESPEC II TOTAL HEMOGLOBIN MET. |
HELENA LABORATORIES |
|
K803015 |
12/30/1980 |
HEMESPEC II |
HELENA LABORATORIES |
|
K802608 |
12/11/1980 |
HEMATIC "BLOOD MIXER" |
HELMER LABS, INC. |
|
K801954 |
12/16/1980 |
HP MODEL 77020A ULTRASOUND SYSTEM |
HEWLETT-PACKARD CO. |
|
K802513 |
12/16/1980 |
DPA 207 PERSONAL |
HILL, FARRER & BORRILL |
TIM C BRUINSMA |
K802951 |
12/17/1980 |
I.M PROBES |
HOGAN & HARTSON |
|
K802783 |
12/16/1980 |
SURGEONS CHOICE STAPLE, REMOVE/IMPLANT |
HOSPITAL PRODUCTS INTL. |
|
K802872 |
12/11/1980 |
AUFRANC-TURNER ATS TOTAL HIP SYSTEM |
HOWMEDICA CORP. |
|
K802124 |
12/01/1980 |
GRISTINA GLENOID PROSTHESIS |
HOWMEDICA CORP. |
|
K802106 |
12/17/1980 |
LEWIS TRAPEZO METACARPAL PROSTHESIS |
HOWMEDICA CORP. |
|
K802922 |
12/17/1980 |
POROUS COATED ANATOMICAL-TOTAL KNEE |
HOWMEDICA CORP. |
|
K801970 |
12/31/1980 |
UCLA SHOULDER |
HOWMEDICA CORP. |
|
K802601 |
12/18/1980 |
ENDOTRACHEAL TUBE HOLDER |
HUDSON OXYGEN THERAPY SALES CO. |
|
K803063 |
12/22/1980 |
STRAP EASE 400 |
INDEPENDENT TRANSFER EQUIPMENT CO. |
|
K802973 |
12/19/1980 |
ISPVAC TM |
INNOVATIVE SURGICAL PRODUCTS INC. |
|
K802865 |
12/18/1980 |
SAFE T COUNT |
INSTRANETICS, INC. |
|
K801172 |
12/01/1980 |
INTERMEDICS' LIFELINE TLE ENDOCARDIAL |
INTERMEDICS, INC. |
|
K802976 |
12/19/1980 |
CARBONACRYL |
IPOS LUNEBURG |
|
K802977 |
12/19/1980 |
IPOCARBON STRETCH STOCKINETTE |
IPOS LUNEBURG |
|
K802997 |
12/22/1980 |
HDL-CHOLESTEROL CONTROL SERUM |
ISOLAB, INC. |
|
K803082 |
12/22/1980 |
ADHESIVE PERISTOMAL COVERING W/WO CONN. |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
|
K802967 |
12/30/1980 |
DISPERSALLOY-DISPERSED PHASE ALLOY SELF- |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
|
K802411 |
12/16/1980 |
BLOOD PRESSURE UNIT MODEL 310 |
JS & A GROUP |
|
K802412 |
12/16/1980 |
BLOOD PRESSURE UNIT MODEL 410 |
JS & A GROUP |
|
K802228 |
12/09/1980 |
BIOLOGICAL INDICATOR - KEMMED & BIOSURE |
KEM MEDICAL PRODUCTS CORP. |
|
K802229 |
12/09/1980 |
CHEMICAL INDICATOR - KEM MED & BIO SURE |
KEM MEDICAL PRODUCTS CORP. |
|
K802870 |
12/17/1980 |
RION ELECTRO-PALATOGRAPH MODEL DP-01 |
KINDEL & ANDERSON |
|
K803050 |
12/30/1980 |
SPRAY, SYNTHETIC SMEAR |
LABORATORY PRODUCTS, INC. |
|
K801535 |
12/16/1980 |
LARES HANDPIECE OIL |
LARES MANUFACTURING CO., INC. |
|
K802781 |
12/10/1980 |
BEDDING PADS "EGGCREATE" PADS |
LEEMART BEDDING MFG. CO. |
|
K802925 |
12/19/1980 |
6-415 FILTER, ELEMENT, 170-C |
LIFECARE SERVICES, INC. |
|
K802914 |
12/19/1980 |
6-435 FILTER PAD, 5/PKG. |
LIFECARE SERVICES, INC. |
|
K803004 |
12/22/1980 |
AMINO ACID ANALYSER SYSTEM |
LKB INSTRUMENTS, INC. |
|
K802983 |
12/30/1980 |
THE INQUINAL RESORVOIR INSERTER |
LONE STAR MEDICAL PRODUCTS, INC. |
|
K802181 |
12/31/1980 |
WISCONSIN BONE MINERAL ANALYZER |
LUNAR RADIATION CORP. |
|
K802180 |
12/31/1980 |
WISCONSIN DUAL-PHOTON BONE ANALYZER |
LUNAR RADIATION CORP. |
|
K802508 |
12/18/1980 |
RUBELISA IGM TEST KIT |
M.A. BIOPRODUCTS |
|
K802823 |
12/11/1980 |
CHOLESTEROL STANDARDS |
MALLINCKRODT CRITICAL CARE |
|
K802825 |
12/11/1980 |
COMBINED GLUCOSE AND BUN STANDARDS |
MALLINCKRODT CRITICAL CARE |
|
K802824 |
12/11/1980 |
COMBUNED CALCIUM AND PHOSPHORUS STD. |
MALLINCKRODT CRITICAL CARE |
|
K802836 |
12/11/1980 |
SERIES 1800 EXERCISE TREADMILL |
MARQUETTE ELECTRONICS, INC. |
|
K801672 |
12/18/1980 |
MEDCOMP SUBCLAVIAN CATHETER |
MEDICAL COMPONENTS, INC. |
|
K801284 |
12/01/1980 |
LOW PROFILE LEAD CONNECTOR MODIFICATION (4002) |
MEDTRONIC VASCULAR |
KEITH J PROCTOR |
K802355 |
12/17/1980 |
METRICON #120 FLUOROPHOTOMETER |
METRICON, LTD. |
|
K802743 |
12/10/1980 |
AMES SERA-PAK CHOLESTEROL REAGENT KIT |
MILES LABORATORIES, INC. |
|
K802724 |
12/10/1980 |
AMES SERA-PAK URIC ACID REAGENT KIT |
MILES LABORATORIES, INC. |
|
K803107 |
12/22/1980 |
AMES TDA AMIKACIN CONTROL SERUM |
MILES LABORATORIES, INC. |
|
K802742 |
12/11/1980 |
SERA-PAK TOTAL PROTEIN REAGENT |
MILES LABORATORIES, INC. |
|
K803019 |
12/22/1980 |
SERALYZER LDH REAGENT STRIPS, CALIBR |
MILES LABORATORIES, INC. |
|
K802830 |
12/10/1980 |
MILLAR MIKRO-TIP CATHETER PHONOTRANS |
MILLAR INSTRUMENTS, INC. |
|
K802351 |
12/17/1980 |
F110 PHOTO BINOCULAR OPHTHALMOSCOPE |
MINAMI, TOMINE & LEW |
|
K802962 |
12/22/1980 |
CHEM-ASSAY STANDARD-CONTROLS |
NATIONAL BIO-TECHNICAL LABORATORIES |
|
K802484 |
12/01/1980 |
SINVISION 2001 ULTRASOUND SCANNER |
NATIONAL ULTRASOUND CORP. |
|
K802887 |
12/16/1980 |
MODEL EEG 4221 |
NIHON KOHDEN AMERICA, INC. |
|
K802959 |
12/19/1980 |
NIKON URINE REFRACTOMER SG-1 |
NIPPON KOGAKU, INC. |
|
K802945 |
12/19/1980 |
PRESSURE MONITORING SET |
NORTON PERFORMANCE PLASTICS CORP. |
|
K802955 |
12/19/1980 |
MONITOR, AIRWAY PRESSURE |
NOVAMETRIX MEDICAL SYSTEMS, INC. |
|
K802702 |
12/10/1980 |
NEONATAL PHOTOTHERAPY UNIT |
OHIO MEDICAL PRODUCTS |
|
K802114 |
12/18/1980 |
NEPHROSS DIALYZER |
ORGANON TEKNIKA CORP. |
|
K802693 |
12/10/1980 |
OREIA-Q-TY, ENZYME IMMUNOASSAY |
ORGANON, INC. |
|
K802974 |
12/19/1980 |
RAPI-DOT |
ORGANON, INC. |
|
K802634 |
12/11/1980 |
STERIGAGE EO ETHYL. OXIDE STERIL. INDIC. |
ORGANON, INC. |
|
K802929 |
12/31/1980 |
ADENO VIRUS & CONTROLS |
ORION DIAGNOSTICA, INC. |
|
K802939 |
12/31/1980 |
HERPES SIMPLEX TYPE I |
ORION DIAGNOSTICA, INC. |
|
K802932 |
12/31/1980 |
MEASLES VIRUS & CONTROLS |
ORION DIAGNOSTICA, INC. |
|
K802933 |
12/31/1980 |
MUMPS S & V ANTIGENS & CONTROLS |
ORION DIAGNOSTICA, INC. |
|
K802946 |
12/22/1980 |
MYCOLOGY CULTURE SYSTEM |
ORION DIAGNOSTICA, INC. |
|
K802934 |
12/31/1980 |
MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL |
ORION DIAGNOSTICA, INC. |
|
K802947 |
12/22/1980 |
ORICULT DTM |
ORION DIAGNOSTICA, INC. |
|
K802935 |
12/31/1980 |
PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR |
ORION DIAGNOSTICA, INC. |
|
K802936 |
12/31/1980 |
RESPIRATORY SYNCYTIAL VIRUS ANTIGEN & |
ORION DIAGNOSTICA, INC. |
|
K802937 |
12/31/1980 |
RUBELLA VIRUS ANTIGENS & CONTROLS |
ORION DIAGNOSTICA, INC. |
|
K802938 |
12/31/1980 |
VARICELLA-ZOSTER ANTIGENS & CONTROLS |
ORION DIAGNOSTICA, INC. |
|
K803073 |
12/31/1980 |
ORTHO HEMATOLOGY CONTROL |
ORTHO INSTRUMENTS |
|
K803084 |
12/31/1980 |
ORTHO HEMATOLOGY CONTROL ABNORMAL LOW |
ORTHO INSTRUMENTS |
|
K803083 |
12/31/1980 |
ORTHO HEMOTOLOGY CONTROL-NORMAL |
ORTHO INSTRUMENTS |
|
K802911 |
12/17/1980 |
A/K SOCKET |
ORTHOMEDICS |
|
K803033 |
12/22/1980 |
CRUSADER HYPEREXTENSION BRACE |
ORTHOMEDICS |
|
K802909 |
12/17/1980 |
HUMERAL FRACTURE BRACE |
ORTHOMEDICS |
|
K802910 |
12/22/1980 |
PLASTIC FRACTURE CAST BRACE KNEE JOINT |
ORTHOMEDICS |
|
K802871 |
12/11/1980 |
TIBIAL FRACTURE BRACE |
ORTHOMEDICS |
|
K802908 |
12/17/1980 |
ULNAR FRACTURE BRACE |
ORTHOMEDICS |
|
K803029 |
12/22/1980 |
TLC SUPPORT PRODUCTS |
ORTHOPEDIC SYSTEMS, INC. |
|
K803021 |
12/12/1980 |
UPPER EXTREMITY TRACTION DEVICE |
ORTHOPEDIC SYSTEMS, INC. |
|
K802753 |
12/11/1980 |
CAMPYLOBACTER SELECTIVE SUPPLEMENT (BL.) |
OXOID U.S.A., INC. |
|
K802495 |
12/18/1980 |
CLOSTRIDIUM DIFFICILE AGAR BASE |
OXOID U.S.A., INC. |
|
K802593 |
12/22/1980 |
KERATOPLASTY SUTURING LENS |
PARIS CONTACT LENS LABORATORY |
|
K803092 |
12/22/1980 |
MIC-BIOPLATE INOCULATOR |
PASCO LABORATORIES, INC. |
|
K803047 |
12/22/1980 |
I-125 LABELED DIGOXIN |
PCL-RIA, INC. |
|
K802529 |
12/18/1980 |
PFIZONIC 100 ULTRASOUND SCANNER |
PFIZER MEDICAL SYSTEMS, INC. |
|
K802528 |
12/18/1980 |
PFIZONIC 150 ULTRASOUND SCANNER |
PFIZER MEDICAL SYSTEMS, INC. |
|
K802531 |
12/18/1980 |
PFIZONIC 200 ULTRASOUND SCANNER |
PFIZER MEDICAL SYSTEMS, INC. |
|
K802530 |
12/18/1980 |
PFIZONIC 250 ULTRASOUND SCANNER |
PFIZER MEDICAL SYSTEMS, INC. |
|
K802532 |
12/18/1980 |
PFIZONIC 300 ULTRASOUND SCANNER |
PFIZER MEDICAL SYSTEMS, INC. |
|
K802556 |
12/02/1980 |
PHADEBAS RAST TEST |
PHARMACIA, INC. |
|
K802897 |
12/16/1980 |
ELECTRONIC DIGITAL THERMOMETER |
PHILIP J. TEDERS |
|
K802578 |
12/18/1980 |
PACE-4-AUTOMATIC RIA GAMMA-COUTER |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
|
K802779 |
12/10/1980 |
LOAD SENTINEL II, TRANS. ELEC. NERVE |
POWERS MEDICAL SYSTMES |
|
K802400 |
12/16/1980 |
MS 16 SYRINGE DRIVER |
PRINCETON MEDICAL INSTRUMENTS, INC. |
|
K802813 |
12/17/1980 |
PMR-2 PURITAN MANUAL RESUSCITATOR |
PURITAN BENNETT CORP. |
|
K802268 |
12/31/1980 |
CRC(CYANMETHEMOGLOBIN REAGENT CONCENT |
R & D SYSTEMS, INC. |
|
K802892 |
12/11/1980 |
CULTURE MEDIA FOR IN VITRO DIAG. USE |
RADIATION TECHNOLOGY, INC. |
|
K802571 |
12/16/1980 |
CYE BIPHASIC BLOOD CULTURE MEDIUM |
REMEL CO. |
|
K803054 |
12/22/1980 |
SAF FIXATIVE |
REMEL CO. |
|
K802758 |
12/31/1980 |
SELECTIVE CHARCOAL YEAST EXTRACT AGAR |
REMEL CO. |
|
K802873 |
12/19/1980 |
SHEA LOCKING BAIL PROSTHESIS |
RICHARD'S MEDICAL EQUIP., INC. |
|
K802749 |
12/17/1980 |
BLENDED BIFOCAL |
ROBINSON-HOUCHIN, INC. |
|
K802658 |
12/30/1980 |
RODEL ELECTRODERM PADS |
RODEL PRODUCTS CORP. |
|
K802780 |
12/10/1980 |
JACKSON HYDRO SYSTEM |
S. JACKSON, INC. |
|
K802994 |
12/22/1980 |
TRYPTICASE SOY AGAR W/5% RABBIT BLD. CEL |
SACKS FARMS BIOLOGICAL PRODUCTS |
|
K802995 |
12/22/1980 |
TRYPTICASE SOY AGAR W/5% SHEEP BLD. CELL |
SACKS FARMS BIOLOGICAL PRODUCTS |
|
K802926 |
12/19/1980 |
SCI-PHARM UNIVERSAL CAVITY VARNISH |
SCIENTIFIC PHARMACEUTICALS, INC. |
|
K802792 |
12/10/1980 |
CELLONA |
SECOL CO. |
|
K802785 |
12/11/1980 |
ELASTIC BANDAGE |
SECOL CO. |
|
K802784 |
12/10/1980 |
ELASTIC OPEN WEAVE BANDAGE |
SECOL CO. |
|
K802799 |
12/17/1980 |
EYE PADS |
SECOL CO. |
|
K802793 |
12/18/1980 |
LOMATUELL OINTMENT DRESSING |
SECOL CO. |
|
K802787 |
12/17/1980 |
METALLINE DRESSINGS |
SECOL CO. |
|
K802797 |
12/17/1980 |
O.R. DRAPES |
SECOL CO. |
|
K802798 |
12/11/1980 |
OPRATEX ABDOMINAL PAD |
SECOL CO. |
|
K802795 |
12/10/1980 |
ORTHOPEDIC PADDING |
SECOL CO. |
|
K802786 |
12/17/1980 |
POROPLAST-EYE DRESSING |
SECOL CO. |
|
K802794 |
12/22/1980 |
PRO-OPHTA STICKS |
SECOL CO. |
|
K802789 |
12/10/1980 |
TUBULAR BANDAGE |
SECOL CO. |
|
K802791 |
12/17/1980 |
ZINC PASTE BANDAGE |
SECOL CO. |
|
K802667 |
12/16/1980 |
ARGYLE CLOSED URINARY DRAINAGE SET |
SHERWOOD MEDICAL CO. |
|
K802777 |
12/11/1980 |
ARGYLE CONNECT TUBE-CON & NON |
SHERWOOD MEDICAL CO. |
|
K802891 |
12/19/1980 |
ARGYLE DOUBLE SEAL CHEST DRAINAGE UNIT |
SHERWOOD MEDICAL CO. |
|
K802875 |
12/16/1980 |
ARGYLE HEMATURIA BALLOON CATHETER |
SHERWOOD MEDICAL CO. |
|
K802692 |
12/10/1980 |
LANCER URIC ACID AUTO/STAT KIT |
SHERWOOD MEDICAL CO. |
|
K802879 |
12/19/1980 |
BUCKBERG-SHILEY BLOOD CARDIOPLEGIC SPL. |
SHILEY, INC. |
|
K801879 |
12/16/1980 |
PUIG MASSANA-SHILEY ANNULOPLASTY RING |
SHILEY, INC. |
|
K803012 |
12/30/1980 |
SHUR-PATCH TAPE PATCH |
SHUR MEDICAL CORP. |
|
K803042 |
12/22/1980 |
SIEMENS-ELEMA ENDOCARDIAL LEAD 402S |
SIEMENS ELEMA AB |
|
K801324 |
12/01/1980 |
SIEMENS-ELEMA PULSE GENERATOR 668 |
SIEMENS ELEMA AB |
|
K802721 |
12/11/1980 |
GLYCOHEMOGLOBIN IN WHOLE BLOOD |
SIGMA CHEMICAL CO. |
|
K802341 |
12/10/1980 |
DIOSCAN |
SONOMETRICS SYSTEMS, INC. |
|
K803011 |
12/31/1980 |
DISPOSABLE DIAPHRAGM DONE |
SORENSEN RESEARCH |
|
K802961 |
12/31/1980 |
TRANSDUCER DOME, CAT.#SD-101 |
SORENSEN RESEARCH |
|
K802982 |
12/19/1980 |
GAUZE, ABSORBABLE X-RAY DETECT. LAP SPG. |
STANFORD LABORATORIES |
|
K802636 |
12/11/1980 |
PLATELET COUNTING KIT |
STRECK LABORATORIES, INC. |
|
K802868 |
12/19/1980 |
ACCU-COUNTER SURGICAL SPONGE COUNTING SY |
SURGICAL SYSTEMS, INC. |
|
K802987 |
12/30/1980 |
JOTA DIAMOND DENTAL BURS |
SWISS AMERICAN METAL CRAFT CORP. |
|
K802988 |
12/30/1980 |
JOTA TUNGSTEN CARBIDE & STEEL DENT. BURS |
SWISS AMERICAN METAL CRAFT CORP. |
|
K802984 |
12/30/1980 |
MEISINGER DIAMOND DENTAL BURS |
SWISS AMERICAN METAL CRAFT CORP. |
|
K802989 |
12/30/1980 |
MEISINGER TUNGSTEN CARBIDE & STEEL DT.B. |
SWISS AMERICAN METAL CRAFT CORP. |
|
K802827 |
12/11/1980 |
BOUIE ELECTROSURGICAL TIP CLEANER |
SYBRON CORP. |
|
K802452 |
12/18/1980 |
TOXOTEST-MT EIKEN KIT |
SYN-KIT, INC. |
|
K802462 |
12/16/1980 |
SYNTHES SPINAL IMPLANT SYSTEM |
SYNTHES (USA) |
|
K803077 |
12/05/1980 |
BIOLUMIN. SCREENING FOR BACT. BY ATP A. |
TECHNOLOGY, INC. |
|
K802849 |
12/16/1980 |
TECNOL TELEMETRY UNIT POUCH |
TECNOL NEW JERSEY WOUND CARE, INC. |
|
K802968 |
12/22/1980 |
UNIPOLAR ENDOCARDIAL LASER DRILLED ELEC |
TELECTRONICS, INC. |
|
K802441 |
12/18/1980 |
CLIRANS TH10 HOLLOW FIBER DIALYZER |
TERUMO AMERICA, INC. |
|
K802122 |
12/18/1980 |
CLIRANS TH13 HOLLOW FIBER DIALYZER |
TERUMO AMERICA, INC. |
|
K802833 |
12/10/1980 |
TETRA NATAL-MAT WATER FLOTATION MAT. |
TETRA GROUP U.S.A., INC. |
|
K802846 |
12/17/1980 |
TCM202 TCPO2 & TCM204 TCPO2/PO2 REC. SY. |
THE LONDON CO. |
|
K802820 |
12/10/1980 |
TRAVENOL 24 HR. INFUSOR (ELASTOMERIC PP) |
TRAVENOL LABORATORIES, S.A. |
|
K802901 |
12/17/1980 |
TRAVENOL INFUSION PUMP-2M8016 |
TRAVENOL LABORATORIES, S.A. |
|
K802054 |
12/01/1980 |
TRAVENOL ULTRASONIC NEBULIZER CUPS |
TRAVENOL LABORATORIES, S.A. |
|
K802474 |
12/15/1980 |
CMR 300, ROWATER TREATMENT UNIT |
U-MARC, INC. |
|
K802741 |
12/10/1980 |
CENTRIFICHEM COMB. SERUM-BASED CALIB. |
UNION CARBIDE CORP. |
|
K803048 |
12/22/1980 |
VANCE UROSTOMY APPLIANCE |
VANCE PRODUCTS, INC. |
|
K802725 |
12/11/1980 |
VISTA 54 LIQUID CHROMATOGRAPHY ANAL. SYS |
VARIAN ASSOC., INC. |
|
K802986 |
12/22/1980 |
POWERED WHEELCHAIR |
VESSA LTD. |
|
K802279 |
12/15/1980 |
VIDA 55 PULSE-ECHO ULTRASONIC DEVICE |
VIDA, INC. |
|
K802679 |
12/17/1980 |
SILANIT |
VIVADENT (USA), INC. |
|
K802535 |
12/18/1980 |
HYDROXYLATE DENTAL COMPOSITE RESTROATIVE |
WALLACE A. ERICKSON & CO. |
|
K803201 |
12/17/1980 |
LEMON GLYCERINE SWABS |
WALPAK CO. |
|
K803053 |
12/22/1980 |
APEXLINE OF PULMONARY FUNCT. INSTRUM. |
WARREN E. COLLINS, INC. |
|
K803069 |
12/22/1980 |
SHELL KRATON THERMO-PLASTIC RUBBER COMP. |
WARREN E. COLLINS, INC. |
|
K802728 |
12/11/1980 |
125I-TESTOSTERONE TEST SET |
WIEN LABORATORIES, INC. |
|
K803165 |
12/31/1980 |
ACETABULAR CEMENT COMPRESSOR |
ZIMMER, INC. |
|
K803064 |
12/31/1980 |
ZIMMER ELECTRICAL MUSCLE STIMULATOR |
ZIMMER, INC. |
|
K802899 |
12/19/1980 |
CERAMIBOND |
ZULAUF, INC. |
|