FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
K800758 |
04/04/1980 |
TENZCARE DUAL-CHANNEL STIMULATOR |
3M COMPANY |
|
K800725 |
04/01/1980 |
A-GENT QUANTICHROM THROMBIGEN I |
ABBOTT LABORATORIES |
|
K800911 |
04/21/1980 |
A-GENT THYROZYME UPTAKE INHIBITOR ASSAY |
ABBOTT LABORATORIES |
|
K800993 |
04/25/1980 |
INPERSOL CAPD ADMIN. SET & CATHETER ADAP |
ABBOTT LABORATORIES |
|
K800990 |
04/24/1980 |
TRACH MIST UNIT W/OR WITHOUT ELBOW |
AIRLIFE, INC. |
|
K800817 |
04/11/1980 |
SHIELD DISP. REINFORCED DRAPE SHEETS |
AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL |
|
K800735 |
04/02/1980 |
U-STYLE ADAPTER |
AMERICAN MIDWEST |
|
K800746 |
04/03/1980 |
UNIFOCAL VP, MODELS 7501 AND 7502 |
AMERICAN PACEMAKER CORP. |
|
K801010 |
04/28/1980 |
KIRSCHNER WIRE |
AMERICAN SAFETY EQUIPMENT CORP. |
|
K800867 |
04/17/1980 |
DOSE CALIBRATION REF. SOURCES; BARIUM-13 |
AMERSHAM CORP. |
|
K800740 |
04/03/1980 |
PROLACTIN RIA KIT |
AMERSHAM CORP. |
|
K800939 |
04/22/1980 |
COMPUTRIM 900 |
AMF, INC. |
|
K800743 |
04/03/1980 |
TOBRAMYCIN RIA KIT |
ANTIBODIES INC. |
|
K800838 |
04/15/1980 |
ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN. |
ARCO MEDICAL PRODUCTS CO. |
|
K800837 |
04/15/1980 |
PROGRAMMABLE BIPOLAR CARDIAC GENERATOR |
ARCO MEDICAL PRODUCTS CO. |
|
K800940 |
04/22/1980 |
AUDIONICS PB MAX HEARING AID |
AUDIONICS CORP. |
|
K800796 |
04/09/1980 |
GAS PAK II DIS. GENERATOR ENVELOPES |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K800798 |
04/09/1980 |
HUMAN THYROID STIM. HORMONE/ARIA II |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K800797 |
04/09/1980 |
MACRO-VUE RUBELLA CARD TEST |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K800953 |
04/23/1980 |
FIXOMULL STERILE |
BEIERSDORF, INC. |
|
K800784 |
04/08/1980 |
MINUET MASKER; JUBILEE MASKER |
BELTONE ELECTRONICS CORP. |
|
K800782 |
04/08/1980 |
PACE-PULSE/COMPUTRAC |
BIB, INC. |
|
K801019 |
04/30/1980 |
125I-IGE RADIOIMMUNOASSAY KIT |
BIO-RIA |
|
K800781 |
04/08/1980 |
FETAL BOVINE SERUM |
BIOLABS, INC. |
|
K800831 |
04/14/1980 |
PY-CO-PROX TM DENTAL BRUSH |
BLOCK DRUG COMPANY, INC. |
|
K800755 |
04/04/1980 |
BOEHRINGER LABS AMBULATORY PEEP VALVE |
BOEHRINGER LABORATORIES |
|
K800779 |
04/08/1980 |
OMNITON MT80-A BODY HEARING AID |
BOSCH HEARING INSTRUMENTS, INC. |
|
K800845 |
04/15/1980 |
BRONZAGE TANNING SYSTEM |
BRONZAGE RAPIDE |
|
K801001 |
04/25/1980 |
AMBULATORY MONITOR AM-1 |
BURDICK CORP. |
|
K801008 |
04/28/1980 |
MULTI-AD FLUID DISPENSING PUMP MP-3000 |
BURRON MEDICAL PRODUCTS, INC. |
|
K800821 |
04/11/1980 |
AFT TM SYSTEM ANTIMITOCHONDRIAL ANTIBODY |
CALBIOCHEM-BEHRING CORP. |
|
K800820 |
04/11/1980 |
AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY |
CALBIOCHEM-BEHRING CORP. |
|
K800995 |
04/25/1980 |
IMMUNOGLOBULIN E TEST KIT |
CALBIOCHEM-BEHRING CORP. |
|
K800851 |
04/15/1980 |
SERIES 602 CKGTM RECORDER |
CARDIOKINETICS, INC. |
|
K800722 |
04/01/1980 |
AUTO-FIELD D AUTOMATED VISUAL DETECTOR |
CAVITRON CORP. |
|
K800869 |
04/17/1980 |
MODEL PM-20(N)(R)CO2 PATIENT MONITOR/ALA |
CAVITRON CORP. |
|
K801006 |
04/28/1980 |
CHARNLEY DESIGN HIP PROSTHESIS |
COLMED, LTD. |
|
K800762 |
04/07/1980 |
PS3 TITANIUM SCREW DENTAL IMPLANT |
COLMED, LTD. |
|
K800833 |
04/14/1980 |
VABRA ASPIRATOR |
COOPER MEDICAL DEVICES CORP. |
|
K800991 |
04/24/1980 |
CORDIA N |
CORDIS CORP. |
|
K800992 |
04/24/1980 |
CORDIA NP |
CORDIS CORP. |
|
K800742 |
04/03/1980 |
LIBERATOR/STROLLER II SYSTEM |
CRYOGENIC ASSOC. |
|
K800862 |
04/16/1980 |
1,3 & 4 WAY STERILE DIS. PLASTIC PKG. |
CUSTOM MEDICAL DEVICES INTL., INC. |
|
K800864 |
04/16/1980 |
STERILE DISPOS. PLASTIC STOPCOCKS W/TUBE |
CUSTOM MEDICAL DEVICES INTL., INC. |
|
K800863 |
04/16/1980 |
TANDEM ASSEMBED 3&4 WAY STERILE STOPCKS |
CUSTOM MEDICAL DEVICES INTL., INC. |
|
K801004 |
04/25/1980 |
FLOW MED 160 |
D.R.O. MEDICAL, INC. |
|
K800747 |
04/04/1980 |
BELTLESS MAXI, MINI & SUPER MAXI PADS |
DAFOE & DAFOE, INC. |
|
K800795 |
04/09/1980 |
PERMANENT & TEMP. PACEMAKER ELECTRODE |
DAIG CORP. |
|
K801009 |
04/28/1980 |
HOWMEDICA WHITE C&B ALLOY |
DENTAL LABORATORY PRODUCTS DIV. |
|
K800894 |
04/18/1980 |
DUPUY CEMENT RESTRICTOR TRIALS & INSTR. |
DEPUY, INC. |
|
K800813 |
04/11/1980 |
DIAGNOSTIC PRODUCTS CORP. RIA CONTROL |
DIAGNOSTIC PRODUCTS CORP. |
|
K800766 |
04/07/1980 |
ECHO-COMP |
DIGISONICS, INC. |
|
K800898 |
04/18/1980 |
SILASTIC BONE PLUG H.P.(CEMENT RESTRICT) |
DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS |
|
K800764 |
04/07/1980 |
DRAGER ORMC |
DRAEGER MEDICAL, INC. |
|
K800756 |
04/04/1980 |
DUNRICH TABLES |
DUNRICH, INC. |
|
K800989 |
04/24/1980 |
DYNAWASHER II |
DYNATECH LABORATORIES, INC. |
|
K801018 |
04/30/1980 |
IMMULON 1, #11-010-3350 & IMMULON 2 #-- |
DYNATECH LABORATORIES, INC. |
|
K800997 |
04/25/1980 |
DIGOXIN CLASP RIA KIT |
E. R. SQUIBB & SONS, INC. |
|
K800901 |
04/18/1980 |
KODAK EKTASPEED DENTAL X-RAY FILM |
EASTMAN KODAK COMPANY |
|
K800721 |
04/01/1980 |
GENERAL UTILITY SURG. SCISSORS #460180- |
EDWARD WECK, INC. |
|
K800787 |
04/08/1980 |
ANTIBODY TO VARICELLA-ZOSTER VIRUS |
ELECTRO-NUCLEONICS LABORATORIES, INC. |
|
K800915 |
04/21/1980 |
JOHNLOZ ENDOSCOPY HANDLE |
ENDOSCOPIC SURGICAL ACCESSORIES, INC. |
|
K800723 |
04/01/1980 |
MICRO-COIL 100 COIL DIALYZER |
ERIKA, INC. |
|
K800771 |
04/07/1980 |
MOD. DM-356 IPS INTERFACE MODULE |
EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
|
K800772 |
04/07/1980 |
MOD. DM-357 BICARBONATE RETROFIT KIT |
EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
|
K800726 |
04/01/1980 |
EYEWI ANKORS |
EYEVI & CO. |
|
K800809 |
04/10/1980 |
FLARE DIS. CONDUCTIVE&NON. SHOE COVERS |
FLARE PRODUCTS, INC. |
|
K800810 |
04/10/1980 |
FLARE DIS. NONWOVEN HEAD COVERS |
FLARE PRODUCTS, INC. |
|
K800815 |
04/11/1980 |
ENTERAL & NASOGASTRIC SOL. ADMIN. SET |
G.D. SEARLE AND CO. |
|
K800927 |
04/21/1980 |
WHITE KNIGHT DISP. STERILE BACK GOWN |
G.D. SEARLE AND CO. |
|
K800928 |
04/21/1980 |
WHITE KNIGHT SUPPLEMENTAL DRAPE |
G.D. SEARLE AND CO. |
|
K800929 |
04/21/1980 |
WHITE KNIGHT SURGICAL PACK |
G.D. SEARLE AND CO. |
|
K801016 |
04/29/1980 |
GAMBRO G SERIES BLOOD LINE SETS FOR HEM. |
GAMBRO, INC. |
|
K801011 |
04/25/1980 |
AVL #980 ELECTROLYTE ANALYZER |
GAUNTLET TECHNOLOGY CORP. |
|
K800812 |
04/11/1980 |
MEDI-THERM |
GAYMAR INDUSTRIES, INC. |
|
K800926 |
04/21/1980 |
THROMBOQUIK THROMBIN REAGENT PROD. #3551 |
GENERAL DIAGNOSTICS |
|
K800925 |
04/21/1980 |
VERIFY S PROD. #34141 |
GENERAL DIAGNOSTICS |
|
K800998 |
04/25/1980 |
ATLAS-S X-RAY SYSTEM W/KETROMAT GEN. |
GENERAL X-RAY, INC. |
|
K800849 |
04/15/1980 |
TMS 1000 TEMP. MONITOR & PROBES |
GICS PHARMACEUTICALS |
|
K800996 |
04/25/1980 |
HDL REAGENT |
GILFORD DIAGNOSTICS |
|
K801012 |
04/28/1980 |
TRIGLYCERIDE REAGENT (COLOR) |
GILFORD DIAGNOSTICS |
|
K800877 |
04/17/1980 |
ANESTHESIA EXTENSION TUBES |
HARVARD LABORATORIES |
|
K800879 |
04/17/1980 |
CLEAR PLASTIC CONNECTING TUBES |
HARVARD LABORATORIES |
|
K800881 |
04/17/1980 |
DISPOSABLE BERMAN AIRWAYS |
HARVARD LABORATORIES |
|
K800880 |
04/17/1980 |
PLASTIC TUBING ADAPTERS 5-IN-1- |
HARVARD LABORATORIES |
|
K800878 |
04/17/1980 |
SECONDARY I.V. TUBING SETS |
HARVARD LABORATORIES |
|
K800854 |
04/15/1980 |
A,A2 LYOPHILIZED HEMO CONTROL |
HELENA LABORATORIES |
|
K800856 |
04/15/1980 |
A,FDA2 LYOPHILIZED HEMO CONTROL |
HELENA LABORATORIES |
|
K800855 |
04/15/1980 |
A,FSC LYOPHILIZED HEMO CONTROL |
HELENA LABORATORIES |
|
K800853 |
04/15/1980 |
A,SA2 LYOPHILIZED HEMO CONTROL |
HELENA LABORATORIES |
|
K800857 |
04/15/1980 |
HELENA GLYCOSYLATED HEMOGLOBIN QUIK METH |
HELENA LABORATORIES |
|
K800852 |
04/15/1980 |
HEMESPEC CHECK SET |
HELENA LABORATORIES |
|
K801000 |
04/25/1980 |
LARGE SCREEN CRT DISPLAY #1311B |
HEWLETT-PACKARD CO. |
|
K800850 |
04/15/1980 |
HIGH STOY SMALL PARTS SCANNER #SP-100B |
HIGHSTOY |
|
K800994 |
04/25/1980 |
AUSTRY ALLOY(DENTAL BAKE-ON ALLOY) |
HOWMEDICA CORP. |
|
K800806 |
04/10/1980 |
I.C.S. MINI & SMALL FRAGMENT SET |
HOWMEDICA CORP. |
|
K800897 |
04/18/1980 |
RID SYSTEM-QUAD MULTITEST IGG, IGA,ETC. |
ICL SCIENTIFIC |
|
K800908 |
04/21/1980 |
CAPIK-CANDIDA ALBICANS IDENT. KIT. |
IMMUNO-MYCOLOGICS, INC. |
|
K800757 |
04/04/1980 |
IL MODEL 1303 PH/BLOOD GAS ANALYZER |
INSTRUMENTATION LABORATORY CO. |
|
K801007 |
04/28/1980 |
IL SYSTEM 502 NA/K ANALYZER |
INSTRUMENTATION LABORATORY CO. |
|
K800895 |
04/21/1980 |
MODEL 253-11 CYBERLITH PULSE GENERATOR |
INTERMEDICS, INC. |
|
K800749 |
04/04/1980 |
IPOCON 7 |
IPOS LUNEBURG |
|
K800818 |
04/11/1980 |
CHLAMYDOSPORE AGAR |
ISLE MEDIA AND STERILE PRODUCTS, INC. |
|
K800807 |
04/10/1980 |
CORN MEAL AGAR MEDIA |
ISLE MEDIA AND STERILE PRODUCTS, INC. |
|
K800794 |
04/09/1980 |
FAST HEMOGLOBIN CONTROL-LYOPHILIZED |
ISOLAB, INC. |
|
K801015 |
04/29/1980 |
PREZAPAK L ARTERIAL BLOOD SAMPLING KIT |
KIMBLE-TERUMO, INC. |
|
K800822 |
04/14/1980 |
CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE |
KLI |
|
K800913 |
04/21/1980 |
GYNECOLOGICAL CYSTO/URETHROSCOPE |
KLI |
|
K800836 |
04/15/1980 |
KMA FLOW DIRECTED THERMODILUTION CATHETE |
KMA, INC. |
|
K800835 |
04/14/1980 |
KANDI-NUCLEAR MED. DATA ACQU.&INFO. |
KRUPP INTERNATIONAL, INC. |
|
K800948 |
04/22/1980 |
DOODLE BRUSH |
LAWTON SURGICAL INSTRUMENTS |
|
K800999 |
04/25/1980 |
CAM-10 EXSUFFLATION BELT #11-001 |
LIFECARE SERVICES, INC. |
|
K800890 |
04/18/1980 |
LINEBERGER EXTERNAL MALE CATHETER |
LINEBERGER EXTERNAL CATHETER CO. |
|
K800789 |
04/08/1980 |
RUBELLA BIO-BEAD TITRATION KIT |
LITTON BIONETICS |
|
K800830 |
04/14/1980 |
SIEMENS-ELECTROGERATE GMBH MICRO-INHALER |
MACBETH SALES CORP. |
|
K800868 |
04/17/1980 |
FERRO-QUANT TM FE 59 TEST KIT |
MALLINCKRODT CRITICAL CARE |
|
K800832 |
04/14/1980 |
VIRAL CULTURETTE HANK'S BAL. SALT SOL. |
MARION HEALTH & SAFETY, INC. |
|
K800860 |
04/16/1980 |
OMNISTIK, MQ 501GS |
MARQUEST MEDICAL PRODUCTS, INC. |
|
K800847 |
04/15/1980 |
ENTELLAN |
MCB MANUFACTURING CHEMISTS, INC. |
|
K800767 |
04/07/1980 |
MOD. MCI 17 MANUAL CUFF INFLATOR |
MEDASONICS, INC. |
|
K800768 |
04/07/1980 |
VASCULAB BI-DIRECTIONAL DOPPLER, #D10 |
MEDASONICS, INC. |
|
K800841 |
04/15/1980 |
MEDEBAR M |
MEDEFIELD PTY. LTD. |
|
K800842 |
04/15/1980 |
MEDEBAR XAC-90 |
MEDEFIELD PTY. LTD. |
|
K800844 |
04/15/1980 |
MEDEBAR XL |
MEDEFIELD PTY. LTD. |
|
K800843 |
04/15/1980 |
MEDEFIZZ A & MEDEFIZZ B |
MEDEFIELD PTY. LTD. |
|
K800840 |
04/15/1980 |
MEDEFOAM-2 |
MEDEFIELD PTY. LTD. |
|
K800839 |
04/15/1980 |
MEDESCAN |
MEDEFIELD PTY. LTD. |
|
K800741 |
04/03/1980 |
CENTRAL VEIN CATHETERIZATION KIT |
MEDICAL COMPONENTS, INC. |
|
K800823 |
04/14/1980 |
QUICK FILL |
MEDRAD, INC. |
|
K800944 |
04/22/1980 |
MEDTRONIC MODEL 69575 |
MEDTRONIC VASCULAR |
|
K800870 |
04/17/1980 |
MEDTRONIC MODEL 6958 |
MEDTRONIC VASCULAR |
|
K800816 |
04/11/1980 |
HIPPUR-ASE TUBES |
MICROCHEMICAL SPECIALITIES, CO. |
|
K800724 |
04/01/1980 |
AMES LAB MANAGEMENT SYSTEM |
MILES LABORATORIES, INC. |
|
K800899 |
04/18/1980 |
LAB-TEK ANACULT ANAEROBIC CULTURE CHAMBE |
MILES LABORATORIES, INC. |
|
K800943 |
04/22/1980 |
PENTEX BOVINE ALBUMIN 30% SOLUTION |
MILES LABORATORIES, INC. |
|
K800848 |
04/15/1980 |
SERALYZER URIC ACID REAGENT STRIPS - |
MILES LABORATORIES, INC. |
|
K800918 |
04/22/1980 |
MODIFIED FEEDING JEJUNOSTOMY TUBE |
MITCHELL V. KAMINSKI, JR., M.D. |
|
K800963 |
04/23/1980 |
BIOPSY FORCEPS W/NEEDLE M.R. ASSOC. |
MR ASSOCIATES, INC. |
|
K800967 |
04/23/1980 |
M.R. ASSOC. ALLIGATOR GRASPONG FORCEPS |
MR ASSOCIATES, INC. |
|
K800964 |
04/23/1980 |
M.R. ASSOC. BALL TYPE COAGULATOR |
MR ASSOCIATES, INC. |
|
K800970 |
04/23/1980 |
M.R. ASSOC. BASKET RETRIEVERS |
MR ASSOCIATES, INC. |
|
K800969 |
04/23/1980 |
M.R. ASSOC. CANNULAS |
MR ASSOCIATES, INC. |
|
K800966 |
04/23/1980 |
M.R. ASSOC. CYTOLOGY BRUSHES |
MR ASSOCIATES, INC. |
|
K800973 |
04/23/1980 |
M.R. ASSOC. HOT BIOPSY FORCEPS |
MR ASSOCIATES, INC. |
|
K800971 |
04/23/1980 |
M.R. ASSOC. MAGNETIC EXTRACTOR |
MR ASSOCIATES, INC. |
|
K800974 |
04/23/1980 |
M.R. ASSOC. POWER CORD |
MR ASSOCIATES, INC. |
|
K800968 |
04/23/1980 |
M.R. ASSOC. RAT TOOTH GRASP FORCEPS |
MR ASSOCIATES, INC. |
|
K800965 |
04/23/1980 |
M.R. ASSOC. SNARES; CRESCENT SNARE WIRE |
MR ASSOCIATES, INC. |
|
K800972 |
04/23/1980 |
M.R. ASSOC. TRIPOD GRASPING FORCEPS |
MR ASSOCIATES, INC. |
|
K800975 |
04/23/1980 |
M.R. ASSOC. TRUE-FEEL HANDLE |
MR ASSOCIATES, INC. |
|
K800976 |
04/23/1980 |
M.R. ASSOC. W TYPE GRASPING FORCEPS |
MR ASSOCIATES, INC. |
|
K800962 |
04/23/1980 |
M.R. ASSOC. WASHING TUBE/MEASURING TUBE |
MR ASSOCIATES, INC. |
|
K800829 |
04/14/1980 |
MYERSON R&KENSON R PORCELAIN ANT&POS.- |
MYERSON TOOTH CORP. |
|
K800828 |
04/14/1980 |
MYERSON'S SPECIAL CROWN & BRIDGE RESIN |
MYERSON TOOTH CORP. |
|
K801005 |
04/28/1980 |
MLT TUBE MICROLARYNGEAL TRACHEAL TUBE) |
NATIONAL CATHETER CO. DIV. MALLINCKRODT |
|
K800920 |
04/21/1980 |
NORDICLAB ESTRADIOL RIA TEST |
NORDICLAB INTL. |
|
K800922 |
04/21/1980 |
NORDICLAB PROGESTERONE RIA TEST |
NORDICLAB INTL. |
|
K800921 |
04/21/1980 |
NORDICLAB TESTOSTERONE RIA TEST |
NORDICLAB INTL. |
|
K800748 |
04/04/1980 |
SNAP-WAY HEADGEAR |
NORTHWEST ORTHODONTICS, INC. |
|
K800988 |
04/24/1980 |
NOVAMETRIX TCOMETTE #809 TRANS. MONITOR |
NOVAMETRIX MEDICAL SYSTEMS, INC. |
|
K800754 |
04/04/1980 |
NICKERSON'S MED. SELECTIVE CULTURE MEDIU |
ORTHO PHARMACEUTICAL CORP. |
|
K800752 |
04/04/1980 |
PRE-PADDED PLASTER/PARIS BAND/SPLINTS |
ORTHO-CARE, INC. |
|
K801002 |
04/28/1980 |
OTICON EARETTE HEARING AID #E17 HC |
OTICON CORP. |
|
K801003 |
04/28/1980 |
OTICON EARETTE HEARING AID #E17CF |
OTICON CORP. |
|
K800826 |
04/14/1980 |
FIBRINOGEN SCREEN |
PACIFIC HEMOSTASIS |
|
K800952 |
04/23/1980 |
PAPER-PAK OB PADS |
PAPER-PAK PRODUCTS, INC. |
|
K800737 |
04/02/1980 |
DEBRISAN (DEXTRANOMER) PASTE |
PHARMASEAL LABORATORIES |
|
K800874 |
04/17/1980 |
PELVIC EXAM TRAY |
PHARMASEAL LABORATORIES |
|
K800805 |
04/10/1980 |
LINEAR ARRAY SCANNER |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
|
K801022 |
04/30/1980 |
ULTRA-CHEK PACEMAKER MONITOR |
POWERS MEDICAL SYSTMES |
|
K800736 |
04/02/1980 |
PRE-DENT SYSTEM |
PRE-DENT SYSTEM |
|
K800827 |
04/14/1980 |
PREMIER ABSORBENT POINTS |
PREMIER DENTAL PRODUCTS CO. |
|
K800900 |
04/18/1980 |
PREMIER TRIPLE TRAY |
PREMIER DENTAL PRODUCTS CO. |
|
K800873 |
04/17/1980 |
TIME STEAM AUTOCLAVE TAPE |
PROFESSIONAL TAPE CO., INC. |
|
K800981 |
04/23/1980 |
CHOCOLATE AGAR W/ENRICHMENTS |
QUALITY ASSURANCE LABORATORY, INC. |
|
K800984 |
04/23/1980 |
EOSIN METHYLENE BLUE AGAR, LEVINE |
QUALITY ASSURANCE LABORATORY, INC. |
|
K800980 |
04/23/1980 |
HEXTOEN ENTERIC AGAR |
QUALITY ASSURANCE LABORATORY, INC. |
|
K800983 |
04/23/1980 |
MACCONKEY AGAR |
QUALITY ASSURANCE LABORATORY, INC. |
|
K800979 |
04/23/1980 |
MUELLER HINTIN AGAR W/5% SHEEP BLOOD |
QUALITY ASSURANCE LABORATORY, INC. |
|
K800987 |
04/23/1980 |
MUELLER HINTON AGAR |
QUALITY ASSURANCE LABORATORY, INC. |
|
K800982 |
04/23/1980 |
SALMONELLA SHIGELLA AGAR |
QUALITY ASSURANCE LABORATORY, INC. |
|
K800977 |
04/23/1980 |
THAYER-MARTIN AGAR |
QUALITY ASSURANCE LABORATORY, INC. |
|
K800985 |
04/23/1980 |
THIOGLYCOLLATE MED. W/O INDICATOR |
QUALITY ASSURANCE LABORATORY, INC. |
|
K800986 |
04/23/1980 |
TRYPTICASE SOY AGAR W5% SHEEP BLOOD |
QUALITY ASSURANCE LABORATORY, INC. |
|
K800978 |
04/23/1980 |
XYLOSE LYSINE DESOXYCHOLATE AGAR |
QUALITY ASSURANCE LABORATORY, INC. |
|
K800825 |
04/14/1980 |
EXTENSION SET QUEST CODE #3000 |
QUEST MEDICAL, INC. |
|
K800786 |
04/08/1980 |
INJECTION SITE, CODE NO. 3100 |
QUEST MEDICAL, INC. |
|
K800932 |
04/21/1980 |
ECG-RF-CHOKE CABLE-ADAPTER #'S 121,120 |
R2 CORP. |
|
K800935 |
04/21/1980 |
R2 APEX-POST.,ANT.&POST. ELECT.(12 MODS) |
R2 CORP. |
|
K800933 |
04/21/1980 |
R2 ELECTROSURG. RETURN ELECT. #225ETC. |
R2 CORP. |
|
K800934 |
04/21/1980 |
R2 ESU CABLE-ADAPTER MODELS 160,161 |
R2 CORP. |
|
K800936 |
04/21/1980 |
R2 PADDLE TYPE CABLE-ADAPTOR #S 170,171 |
R2 CORP. |
|
K800937 |
04/21/1980 |
R2 PLATE TYPE CABLE-ADAPTOR #S 175,176 |
R2 CORP. |
|
K800931 |
04/21/1980 |
R2(TM) ECG CABLE-ADAPTOR #'S 120-121-122 |
R2 CORP. |
|
K800930 |
04/21/1980 |
R2(TM) ECG ELECTRODE SET-#'S305-306 ETC. |
R2 CORP. |
|
K800792 |
04/08/1980 |
ADJUSTABLE HEAD & FACE HOLDER |
RADIATION PRODUCTS DESIGN, INC. |
|
K800760 |
04/04/1980 |
BITE BLOCK SYSTEM |
RADIATION PRODUCTS DESIGN, INC. |
|
K800759 |
04/04/1980 |
ELEV. BACK SUPPORT W/ADJ. ARM POSITIONER |
RADIATION PRODUCTS DESIGN, INC. |
|
K800791 |
04/08/1980 |
MYLAR WINDOW-TABLE INSERT PANEL |
RADIATION PRODUCTS DESIGN, INC. |
|
K800761 |
04/04/1980 |
POINT TO POINT LEVEL |
RADIATION PRODUCTS DESIGN, INC. |
|
K800790 |
04/08/1980 |
TENNIS RACKET-TABLE INSERT PANEL |
RADIATION PRODUCTS DESIGN, INC. |
|
K800945 |
04/22/1980 |
RADIOEAR MODEL REI HEARING AID |
RADIOEAR CORP. |
|
K800751 |
04/04/1980 |
RADX VENT-AL MECHANICAL RESPORATOR |
RADX CORP. |
|
K800745 |
04/03/1980 |
CELLIBIOSE-ARGININE-LYSINE AGAR (CAL) |
REMEL CO. |
|
K800803 |
04/10/1980 |
NITRATE SWAB-RAPID TEST |
REMEL CO. |
|
K800734 |
04/02/1980 |
RAPID FERMENTATION AGAR (RFA) |
REMEL CO. |
|
K800904 |
04/21/1980 |
TONOTEST BLOOD PRESSURE MONITOR |
RETLIF, INC. |
|
K800914 |
04/21/1980 |
NO-BOIL FOLATE KIT #RP-500 |
RIA PRODUCTS, INC. |
|
K800738 |
04/02/1980 |
RIONET &/OR RION HEARING AID MOD. HB-67S |
RION ACOUSTIC INSTRUMENTS, INC. |
|
K800739 |
04/02/1980 |
RIONET &/OR RION HEARING AID MODEL HA-82 |
RION ACOUSTIC INSTRUMENTS, INC. |
|
K800947 |
04/22/1980 |
MIDSTREAM COLLECTION KIT |
SAGE PRODUCTS, INC. |
|
K800946 |
04/22/1980 |
URINARY CATHETER SAMPLING KIT |
SAGE PRODUCTS, INC. |
|
K800780 |
04/08/1980 |
SANDARE LYOPHILIZED HEMOGLOBIN CONTROLS |
SANDARE CHEMICAL CO., INC. |
|
K800938 |
04/22/1980 |
TRI-CHECK |
SCIENTIFIC STANDARDS, INC. |
|
K800902 |
04/18/1980 |
BUN-COLOR 2, BLOOD UREA NITROGEN TEST |
SCLAVO, INC. |
|
K800770 |
04/07/1980 |
SLAVO CHOLESTEROL STAND. DIAGNOSTIC KIT |
SCLAVO, INC. |
|
K800769 |
04/07/1980 |
Y-GT TEST, Y-GLUTAMYL TRANSFERASE TEST |
SCLAVO, INC. |
|
K800778 |
04/08/1980 |
DIGITAL ELECTRONIC B.P. MONITOR 2155 |
SEARS, ROEBUCK & CO. |
|
K800905 |
04/21/1980 |
SIEMENS-ELEMA AB O2-AIR MIXER 960 |
SIEMENS ELEMA AB |
|
K800788 |
04/08/1980 |
SIREGRAPH C |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
|
K800910 |
04/21/1980 |
GAL-PUT CONTROLS, NORMAL&DEFICIENT |
SIGMA CHEMICAL CO. |
|
K800824 |
04/14/1980 |
MODEL SKI-200 ABDOMINAL SCANNER |
SMITH KLINE DIAGNOSTICS, INC. |
|
K800861 |
04/16/1980 |
SNYDER HEMOVAC CHEST DRAINAGE SOLUTION |
SNYDER LABORATORIES, INC. |
|
K800858 |
04/15/1980 |
FETAL HEART DETECTOR #'S D102 & D102R |
SONICAID, INC. |
|
K800859 |
04/15/1980 |
FETAL HEART DETECTOR #D206 |
SONICAID, INC. |
|
K800775 |
04/07/1980 |
ALDOCTK-125 |
SORIN BIOMEDICA, FIAT, USA, INC. |
|
K800773 |
04/07/1980 |
DIGOCTK 125 |
SORIN BIOMEDICA, FIAT, USA, INC. |
|
K800774 |
04/07/1980 |
RENCTK |
SORIN BIOMEDICA, FIAT, USA, INC. |
|
K800776 |
04/07/1980 |
TESTOK-125 |
SORIN BIOMEDICA, FIAT, USA, INC. |
|
K800801 |
04/10/1980 |
ANALGESIA UNITS, OXYGEN & NITRATE DEVICE |
SPICA, INC. |
|
K800750 |
04/04/1980 |
STOMAHESIVE STERILE WAFER |
SQUIBB & SONS, INC. |
|
K800733 |
04/01/1980 |
DOUBLE-EDGE CURETTE |
STAINLESS MFG., INC. |
|
K800731 |
04/01/1980 |
MENISCAL SAW |
STAINLESS MFG., INC. |
|
K800732 |
04/01/1980 |
MENISCOTOME |
STAINLESS MFG., INC. |
|
K800729 |
04/01/1980 |
PROBE |
STAINLESS MFG., INC. |
|
K800730 |
04/01/1980 |
RETROGRADE KNIFE |
STAINLESS MFG., INC. |
|
K801014 |
04/28/1980 |
STANBIO ACETAMINOPHEN TEST SET #0850 |
STANBIO LABORATORY |
|
K800744 |
04/03/1980 |
SUNTANA SUNBED #SB-1 & SUNBRELLA #SU-1 |
SUN IND., INC. |
|
K800777 |
04/08/1980 |
TAMPAX TAMPONS |
TAMPAX, INC. |
|
K801017 |
04/30/1980 |
TANIT COMMERCIAL SUNTAN BOOTH |
TANIT, INC. |
|
K800950 |
04/23/1980 |
TANIT HOME SUNTANNING UNIT |
TANIT, INC. |
|
K800892 |
04/18/1980 |
NUCLEAR STRESS TABLE (NST-1) |
TECHNICARE CORP. |
|
K800793 |
04/09/1980 |
IMPLANTABLE PROGRAM. CARDIAC PACEMAKER |
TELECTRONICS, INC. |
|
K800891 |
04/18/1980 |
RESTERILIZATION OF IMPLANTABLE ELECTRODE |
TELECTRONICS, INC. |
|
K800919 |
04/21/1980 |
ORAVIEW BY WATER PIK |
TELEDYNE, INC. |
|
K801025 |
04/28/1980 |
ODOR MASKING AGENT FOR CONTENTS OF ALL |
THE BUCKEYE CELLULOSE CORP. |
|
K801024 |
04/28/1980 |
ODOR MASKING AGENT IN BOUNDARY OBSTETRI. |
THE BUCKEYE CELLULOSE CORP. |
|
K800960 |
04/23/1980 |
1500 ML DISPOSABLE ENEMA CONTAINER(1110) |
THE HEALTHCARE GROUP LABORATORIES, INC. |
|
K800956 |
04/23/1980 |
DOUCH TRAY-DISPOSABLE VAGINAL TRAY W/BEN |
THE HEALTHCARE GROUP LABORATORIES, INC. |
|
K800954 |
04/23/1980 |
DOUCHE TRAY-DISPOS. VAGINAL TRAY W/POVID |
THE HEALTHCARE GROUP LABORATORIES, INC. |
|
K800957 |
04/23/1980 |
DOUCHE UNIT-1500 ML DISP. CONTAINER |
THE HEALTHCARE GROUP LABORATORIES, INC. |
|
K800961 |
04/23/1980 |
ENEMA CONTAINER DISP. FOR EMEMA ADMIN. |
THE HEALTHCARE GROUP LABORATORIES, INC. |
|
K800959 |
04/23/1980 |
LARGE VOLUME ENEMA CONTAINER DISPOSABLE |
THE HEALTHCARE GROUP LABORATORIES, INC. |
|
K800958 |
04/23/1980 |
PERSONAL SITZ BATH KIT |
THE HEALTHCARE GROUP LABORATORIES, INC. |
|
K800955 |
04/23/1980 |
TUBE FEEDING CONTAINER 1500 ML DISPOSE. |
THE HEALTHCARE GROUP LABORATORIES, INC. |
|
K801020 |
04/30/1980 |
GAMMA PROLACTIN RADIOIMMUNOASSAY KIT- |
TRAVENOL LABORATORIES, S.A. |
|
K800916 |
04/22/1980 |
P1 BLOOD GROUP SUBSTANCE |
TRAVENOL LABORATORIES, S.A. |
|
K800753 |
04/04/1980 |
STERILE WATER & SALINE IN PLASTIC BTL. |
TRAVENOL LABORATORIES, S.A. |
|
K800866 |
04/16/1980 |
ROYAL |
TRIDENT DENTAL, INC. |
|
K800865 |
04/16/1980 |
WINDSOR |
TRIDENT DENTAL, INC. |
|
K800917 |
04/22/1980 |
TRU-COLD THERAPY PAK |
TRU-EZE MFG. CO., INC. |
|
K800951 |
04/23/1980 |
CASTA-LLOY |
U.S. SHIZAI CORP. |
|
K800765 |
04/07/1980 |
CENTRIFICHEM CHOLESTEROL |
UNION CARBIDE CORP. |
|
K801021 |
04/30/1980 |
URINEBAG |
UNOVEX OF DENMARK |
|
K800882 |
04/17/1980 |
ANTICONVULSANTS TOXICOLOGY CONTROL |
UTAK LABORATORIES, INC. |
|
K800885 |
04/17/1980 |
BARBITURATES TOXICOLOGY CONTROL |
UTAK LABORATORIES, INC. |
|
K800883 |
04/17/1980 |
CARDIACS I TOXICOLOGY CONTROL |
UTAK LABORATORIES, INC. |
|
K800884 |
04/17/1980 |
CARDIACS II TOXICOLOGY CONTROL |
UTAK LABORATORIES, INC. |
|
K800886 |
04/17/1980 |
HYPNOTICS PLUS ACETAMINOPHEN TX CONTROL |
UTAK LABORATORIES, INC. |
|
K800887 |
04/17/1980 |
HYPNOTICS PLUS SALICYLATE TX CONTROL |
UTAK LABORATORIES, INC. |
|
K800889 |
04/17/1980 |
TRICYCLIC ANTIDEPRESSANT II TX CONTROL |
UTAK LABORATORIES, INC. |
|
K800888 |
04/17/1980 |
TRICYCLIC ANTIDEPRESSANTS I TX CONTROL |
UTAK LABORATORIES, INC. |
|
K800834 |
04/14/1980 |
SER-TEX |
V.S.S.I., INC. |
|
K800763 |
04/07/1980 |
MISER INHALATION DEVICE, PART NO. 700 |
VIX BREATHING EQUIPMENT CO. |
|
K800942 |
04/22/1980 |
VOLU-SOL EOSIN Y STAIN |
VOLU SOL MEDICAL INDUSTRIES |
|
K800907 |
04/21/1980 |
TOMAC WET DRESSING WARMER |
W.G. WHITNEY CORP. |
|
K800800 |
04/10/1980 |
PATELLAR COMPONENT FOR LUBINUS PATELLAR |
WALDEMAR LINK GMBH & CO. KG |
|
K800896 |
04/18/1980 |
WOLFF SYSTEM |
WOLFF SYSTEM GMBH |
|
K800727 |
04/01/1980 |
GOODE T-TUBE, BIOLITE COATED SILICONE/TU |
XOMED, INC. |
|
K800728 |
04/01/1980 |
PAPARELL TYPE 2, BIOLITE COATED SILI- |
XOMED, INC. |
|