FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
K812140 |
07/28/1981 |
BIRD MEAN AIRWAY PRESSURE MONITOR |
3M COMPANY |
|
K812003 |
07/14/1981 |
A-GENT THEOPHYLLINE |
ABBOTT LABORATORIES |
|
K812004 |
07/14/1981 |
GASTRIN RIA DIAGNOSTIC KIT |
ABBOTT LABORATORIES |
|
K812078 |
07/23/1981 |
GONOZYME (10 COPIES FRWD. W/ORIG. TO BG) |
ABBOTT LABORATORIES |
|
K812114 |
07/27/1981 |
LIFECARE 1000 CONTROLLER |
ABBOTT LABORATORIES |
|
K811840 |
07/01/1981 |
BILIRUBINOMETER |
ADVANCED INSTRUMENTS, INC. |
|
K812094 |
07/24/1981 |
AIRCAST PNEUMATIC KNEE BRACE |
AIRCAST, INC. |
|
K811890 |
07/01/1981 |
DISPOSABLE TRACH T OXYGENATOR |
AIRLIFE, INC. |
|
K811908 |
07/01/1981 |
IMV MANIFOLDS |
AIRLIFE, INC. |
|
K812067 |
07/21/1981 |
INSPIRATORY FORCE PRESSURE ADAPTOR |
AIRLIFE, INC. |
|
K812066 |
07/21/1981 |
PERCENTO MASK, PEDIATRIC, UNDER-THE-CHIN |
AIRLIFE, INC. |
|
K812172 |
07/30/1981 |
CONTACT LENS CLEANER |
ALCON LABORATORIES |
|
K812021 |
07/20/1981 |
VOLUMETRIC INFUSION PUMP |
AMERICAN EDWARDS LABORATORIES |
|
K811936 |
07/06/1981 |
CHEMICAL AUTOCLAVE INDICATOR TAPE |
AMERICAN HOSPITAL SUPPLY CORP. |
|
K811915 |
07/01/1981 |
MONITOR/VITAL SIGNS TRAY |
AMERICAN HOSPITAL SUPPLY CORP. |
|
K811916 |
07/01/1981 |
OPERATING ROOM KIT |
AMERICAN HOSPITAL SUPPLY CORP. |
|
K811918 |
07/02/1981 |
AMP MARK IV INFUSION PUMP |
AMERICAN MEDICAL PRODUCTS, INC. |
|
K811917 |
07/02/1981 |
I.V. ADMIN. SETS FOR THE AMP MARK IV PMP |
AMERICAN MEDICAL PRODUCTS, INC. |
|
K811986 |
07/13/1981 |
THE AMP 80/2 PEDIATRIC CYCLER SYSTEM |
AMERICAN MEDICAL PRODUCTS, INC. |
|
K811979 |
07/13/1981 |
ATT-1 DENTAL COMPOSITE RESTORATIVE SYS |
AMERICAN MIDWEST |
|
K812051 |
07/21/1981 |
PHOTOLITE AOLITE TINTOMATIC LENS |
AMERICAN OPTICAL CORP. |
|
K812063 |
07/21/1981 |
SR-1V DATA PRINTER |
AMERICAN OPTICAL CORP. |
|
K812136 |
07/28/1981 |
AMERLEX TSH RIA KIT |
AMERSHAM CORP. |
|
K812105 |
07/24/1981 |
ANOGO DISPOSABLE SHOE COVER |
ANAGO, INC. |
|
K811998 |
07/14/1981 |
STAPH-IDENT |
ANALYTICAL PRODUCTS, INC. |
|
K811982 |
07/13/1981 |
STAPHASE* |
ANALYTICAL PRODUCTS, INC. |
|
K811955 |
07/01/1981 |
CALIBRATED BREATHING SYSTEM COLLECTION |
ANCHOR BRUSH CO., INC. |
|
K811990 |
07/13/1981 |
TRACH CLEANING TRAY |
ASSOCIATED MEDICAL PRODUCTS CO. |
|
K811910 |
07/01/1981 |
VEIN-TRAP TM |
ATRIUM MEDICAL CORP. |
|
K811956 |
07/09/1981 |
AUTONORM & NERV-A-NORM |
AUTONOMIC EQUIPMENT SUPPLY CO, |
|
K811933 |
07/06/1981 |
GUARDIAN, VOLUMETRIC CONTROL DELIVERY |
AVI, INC. |
|
K812135 |
07/28/1981 |
BARNES-HIND WEEKLY CLEANER |
BARNES-HIND, INC. |
|
K812137 |
07/28/1981 |
B-D HEPARINIZED LONGDWEL I.V. CATHETER |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K811957 |
07/09/1981 |
CAMPYPAK |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K812120 |
07/27/1981 |
GINGI-PLAIN CORDS & BRAIDS |
BELPORT CO., INC. |
|
K812009 |
07/17/1981 |
CARDIOTOMY RESERVOIR W/FILTER#BCR-3500 |
BENTLEY LABORATORIES, INC. |
|
K812008 |
07/17/1981 |
CORDIOTOMY RESERVOIR |
BENTLEY LABORATORIES, INC. |
|
K811856 |
07/01/1981 |
FLUOROMATIC THEOPHYLLINE FIA |
BIO-RAD |
|
K812108 |
07/27/1981 |
LOW FIBRINOGEN CONTROL |
BIO/DATA CORP. |
|
K812163 |
07/29/1981 |
AIRE-CUF TRACHEOSTOMY TUBE |
BIOANA SURGICAL INSTRUMENTS, INC. |
|
K812060 |
07/21/1981 |
BI-ASO SLIDE TEST |
BIOLOGICS INTL., INC. |
|
K811928 |
07/06/1981 |
LIFESOUND ESOPHAGEAL STETHOSCOPE |
BIOMEDICAL CONCEPTS, INC. |
|
K812111 |
07/27/1981 |
PRUITT ARTERIAL OCCLUSION CHOLANG. CATH |
BIONOMY, INC. |
|
K812076 |
07/22/1981 |
ANTI-GM & ANTI-KM TYPING SERUMS |
BIOTEST-SERUM-INSTITUT |
|
K812095 |
07/24/1981 |
ENXYMATIC CREATININE TEST |
BOEHRINGER MANNHEIM CORP. |
|
K811921 |
07/02/1981 |
HITACHI 705 CALIBRATOR |
BOEHRINGER MANNHEIM CORP. |
|
K811999 |
07/11/1981 |
BO MED BIA |
BOMED MEDICAL MFR., LTD. |
|
K811848 |
07/01/1981 |
MODEL SIX BEAM SYSTEM |
BRAINTECH, INC. |
|
K811925 |
07/02/1981 |
UROFLOWMETER |
C.R. BARD, INC. |
|
K812149 |
07/28/1981 |
CARDIO-DATA SYSTEM, #MARK III |
CARDIO DATA |
|
K812079 |
07/22/1981 |
DISPOSABLE PILLOW |
CARPENTER CO. |
|
K812047 |
07/20/1981 |
IDS BETA-LACTAMASE DISC |
CARR-SCARBOROUGH MICROBIOLOGICALS, INC. |
|
K812048 |
07/20/1981 |
IDS RAPIDS NH SYSTEMS |
CARR-SCARBOROUGH MICROBIOLOGICALS, INC. |
|
K812006 |
07/16/1981 |
LEGIONELLA DIRECT FLUORESCENT ANTIBODY |
CENTERS FOR DISEASE CONTROL AND PREVENTION |
|
K812007 |
07/16/1981 |
LEGIONELLA INDIRECT FLUOR. ANTIBODY |
CENTERS FOR DISEASE CONTROL AND PREVENTION |
|
K811901 |
07/01/1981 |
CENTURY BATHING SYSTEM |
CENTURY MANUFACTURING CO. |
|
K811902 |
07/01/1981 |
CENTURY BIRTHING CHAIR |
CENTURY MANUFACTURING CO. |
|
K811904 |
07/01/1981 |
CENTURY HYDRO-SAN THERAPY TANK |
CENTURY MANUFACTURING CO. |
|
K811903 |
07/01/1981 |
CENTURY HYDROTHERAPY PUMP |
CENTURY MANUFACTURING CO. |
|
K811899 |
07/01/1981 |
CENTURY LIFT TRANSFER SYSTEM |
CENTURY MANUFACTURING CO. |
|
K811900 |
07/01/1981 |
CENTURY SAF-LIFT & SAF-KARY |
CENTURY MANUFACTURING CO. |
|
K811897 |
07/01/1981 |
LIC TURNOVER BED |
CENTURY MANUFACTURING CO. |
|
K812130 |
07/27/1981 |
SPIKE GUARD |
CLINIPAD CORP. |
|
K812093 |
07/24/1981 |
COBE HEAT EXCHANGER RESERVOIR MODULE |
COBE LABORATORIES, INC. |
|
K811879 |
07/01/1981 |
MODEL A UNIPOLAR ENDOCARDIAL LEAD |
COOK PACEMAKER CORP. |
|
K811878 |
07/01/1981 |
MODEL B BIPOLAR ENDOCARDIAL LEAD |
COOK PACEMAKER CORP. |
|
K811877 |
07/01/1981 |
MODEL C UNIPOLAR ENDOCARDIAL LEAD |
COOK PACEMAKER CORP. |
|
K811876 |
07/01/1981 |
MODEL D BIPOLAR ENDOCARDIAL LEAD |
COOK PACEMAKER CORP. |
|
K812126 |
07/27/1981 |
ULTRASONIC TIPS |
COOPERVISION, INC. |
|
K811892 |
07/01/1981 |
CORDIS DOW SERA FLO TM TRANSDUCER PROT |
CORDIS CORP. |
|
K812168 |
07/30/1981 |
CORDIS DUCOR PERCUT. TRANS. ANGIO. CATH. |
CORDIS CORP. |
|
K811971 |
07/10/1981 |
CORDIS DUCOR PTR SYSTEM |
CORDIS CORP. |
|
K811927 |
07/06/1981 |
1F BLOCKING ANTIBODY(57 CO) RADIOASSAY |
CORNING MEDICAL & SCIENTIFIC |
|
K811896 |
07/01/1981 |
902 NA/K |
CORNING MEDICAL & SCIENTIFIC |
|
K811953 |
07/08/1981 |
IMMOPHASE INSULIN (125I) RADIOASSAY |
CORNING MEDICAL & SCIENTIFIC |
|
K811870 |
07/01/1981 |
UVA SUN TANNING EQUIPMENT |
CPC SYSTEMS, INC. |
|
K812151 |
07/29/1981 |
MJ NEONATAL PERCUSSOR |
CUSSIONAIR THERAPY PRODUCTS, INC. |
|
K812099 |
07/24/1981 |
CASH ORTHOSIS |
DAVID HENDRICKS, C.P.O. |
|
K812012 |
07/17/1981 |
TOWNLEY UNICONDYLAR KNEE |
DEPUY, INC. |
|
K811922 |
07/02/1981 |
45DEGREES SWIVEL ELBOW |
DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. |
|
K811860 |
07/01/1981 |
EASY-FLO ARTERIAL BLOOD GAS KIT |
DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. |
|
K812166 |
07/30/1981 |
PERCUSSOR |
DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP. |
|
K812129 |
07/27/1981 |
COAT-A-COUNT DIGITOXIN RIA KIT |
DIAGNOSTIC PRODUCTS CORP. |
|
K811932 |
07/06/1981 |
COAT-A-COUNT DIGOXIN RIA |
DIAGNOSTIC PRODUCTS CORP. |
|
K811844 |
07/01/1981 |
COAT-A-COUNT GENTAMICIN RIA KIT |
DIAGNOSTIC PRODUCTS CORP. |
|
K812053 |
07/21/1981 |
SILASTIC HEMI WRIST IMPLANT H.P. (RAD.) |
DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS |
|
K811851 |
07/01/1981 |
S-610 SHUNT ADAPTOR SET |
DRAVON MEDICAL, INC. |
|
K812134 |
07/28/1981 |
INCISION & DRAINAGE TRAY |
E.M. ADAMS |
|
K812132 |
07/28/1981 |
STERILE SUTURE REMOVAL KIT |
E.M. ADAMS |
|
K812133 |
07/28/1981 |
WOUND CLOSURE INSTRUMENT TRAY |
E.M. ADAMS |
|
K811919 |
07/02/1981 |
KODAK EKTACHEM 400 ANALYZER |
EASTMAN KODAK COMPANY |
|
K812030 |
07/20/1981 |
KODAK EKTACHEM CLIN. CHEM. SLIDES (ALB) |
EASTMAN KODAK COMPANY |
|
K812027 |
07/20/1981 |
KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL) |
EASTMAN KODAK COMPANY |
|
K812028 |
07/20/1981 |
KODAK EKTACHEM CLIN. CHEM. SLIDES (TP) |
EASTMAN KODAK COMPANY |
|
K812029 |
07/20/1981 |
KODAK EKTACHEM CLIN. CHEM. SLIDES (TRIG) |
EASTMAN KODAK COMPANY |
|
K812020 |
07/20/1981 |
EGNELL COMPACT, TYPE EHV |
EGNELL, INC. |
|
K811988 |
07/13/1981 |
EAGLE I HEARING AID |
ELECTONE, INC. |
|
K812014 |
07/17/1981 |
DYNEX-44 DIAGNOSTIC ULTRASOUND IMAGING |
ELSCINT, INC. |
|
K811994 |
07/14/1981 |
RADIOIMMUNOASSAY LUTEINIZING HORMONE |
ENDOCRINE-METABOLIC CENTER |
|
K811993 |
07/14/1981 |
RADIOIMMUNOASSAY, FOLLICLE STIMULATING |
ENDOCRINE-METABOLIC CENTER |
|
K811974 |
07/13/1981 |
MICROCOIL 150 DIALYZER |
ERIKA, INC. |
|
K812169 |
07/30/1981 |
VISIO-FIL |
ESPE GMBH (US) |
|
K812115 |
07/27/1981 |
KETAC-CHEM |
ESPE-PREMIER SALES CO. |
|
K812118 |
07/27/1981 |
NIMETIC POLISHING PASTE |
ESPE-PREMIER SALES CO. |
|
K812119 |
07/27/1981 |
NIMETIC-DISPERS |
ESPE-PREMIER SALES CO. |
|
K812116 |
07/27/1981 |
PERMAGUM |
ESPE-PREMIER SALES CO. |
|
K812117 |
07/27/1981 |
PERMAGUM ADHESIVE |
ESPE-PREMIER SALES CO. |
|
K811935 |
07/06/1981 |
PROLENE POLYPROPYLENE LIGATING CLIP |
ETHICON, INC. |
|
K811872 |
07/01/1981 |
TEFLON PLEDGET SUTURE BUTTRESS |
ETHICON, INC. |
|
K811972 |
07/10/1981 |
EXTRASENSR ULTRAFILTRATION MONITOR |
EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
|
K811944 |
07/07/1981 |
GAMBRO LUNDIA PLATE HIGH FLUX DIALYZER |
GAMBRO, INC. |
|
K812131 |
07/28/1981 |
PORTAPULSE |
GAVON, INC. |
|
K812064 |
07/21/1981 |
POLI-AXIAL KNEE CAGE |
GENERATION II ORTHOTICS, INC. |
|
K811886 |
07/01/1981 |
CESIUM DILUENT 7.5M |
GILFORD DIAGNOSTICS |
|
K812110 |
07/27/1981 |
GILCHEM CALCIUM REAGENT |
GILFORD DIAGNOSTICS |
|
K812109 |
07/27/1981 |
GILCHEM CREATININE REAGENT |
GILFORD DIAGNOSTICS |
|
K812061 |
07/21/1981 |
MODEL S10VS VISUAL STIMULATOR |
GRASS INSTRUMENT CO. |
|
K811980 |
07/13/1981 |
ELECTRONIC BLOOD PRESSURE TRANSDUCER MAN |
H.R. BIOMEDICAL, LTD. |
|
K812098 |
07/24/1981 |
MINI NICHOLES |
HEALTHCARE IND. |
|
K812075 |
07/22/1981 |
NICHOLE'S "99 |
HEALTHCARE IND. |
|
K812077 |
07/22/1981 |
HELENA SICKLE-THAL QUIK COLUMN METHOD |
HELENA LABORATORIES |
|
K811912 |
07/01/1981 |
HELENA VMA-SMC CONTROL |
HELENA LABORATORIES |
|
K812167 |
07/30/1981 |
MODEL 78850 OXYGEN MONITOR |
HEWLETT-PACKARD CO. |
|
K812068 |
07/21/1981 |
PROPOSED CONTROLS FOR DOSIMETRIC RELEASE |
HEXCEL MEDICAL |
|
K812103 |
07/24/1981 |
ESOPHAGEAL MOTILITY APPARATUS |
HONEYWELL, INC. |
|
K811959 |
07/09/1981 |
TANDEM PAP KIT - (PARTS I & II) |
HYBRITECH, INC. |
|
K812035 |
07/20/1981 |
IMED ACCUSET CASSETTE |
IMED CORP. |
|
K811906 |
07/01/1981 |
DHEA-SULFATE DIRECT RIA KIT(125I) |
IMMUNALYSIS CORPORATION |
|
K811905 |
07/01/1981 |
FOLLICLE STIMULATING HORMONE DIRECT RIA |
IMMUNALYSIS CORPORATION |
|
K811907 |
07/01/1981 |
PROGESTERONE DIRECT RIA KIT (125I) |
IMMUNALYSIS CORPORATION |
|
K811954 |
07/08/1981 |
COMBO-FER IRON DIAGNOSTIC |
IMMUNO ASSAY CORP. |
|
K812054 |
07/21/1981 |
ENDAB DIGOXIN KIT |
IMMUNOTECH CORP. |
|
K811997 |
07/14/1981 |
SHARPS SAFE |
INSTRA-METICS, INC. |
|
K812016 |
07/17/1981 |
VS600 JET VENTILATOR |
INSTRUMENT DEVELOPMENT CORP. |
|
K812036 |
07/20/1981 |
NEUROGAR III |
INTER MED INDUSTRIES, INC. |
|
K811938 |
07/06/1981 |
ADAPTAID LEAD ADAPTER #365-25 |
INTERMEDICS, INC. |
|
K811920 |
07/02/1981 |
ADAPTAID LEAD ADAPTER, #365-17 |
INTERMEDICS, INC. |
|
K812112 |
07/27/1981 |
MARRIA-HPRL RIA KIT |
INTL. IMMUNOASSAY LABORATORIES, INC. |
|
K812017 |
07/17/1981 |
X-RAY DETECTABLE BAND |
ISRAMED, INC. |
|
K812018 |
07/17/1981 |
X-RAY DETECTABLE THREAD |
ISRAMED, INC. |
|
K811867 |
07/01/1981 |
SR-ALGICAP |
J. ADERER, INC. |
|
K812101 |
07/24/1981 |
BAK-ON SP PORCELAIN ALLOY |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
|
K811983 |
07/13/1981 |
JOHNSON & JOHNSON O.B. TAMPONS |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
|
K812001 |
07/14/1981 |
OSCILLAIRE |
JONES MEDICAL INSTRUMENT CO. |
|
K812139 |
07/28/1981 |
VACUUM SUCTION FILTER |
K & G HEALTHCARE IND., INC. |
|
K812026 |
07/20/1981 |
K-MED SILICONE SUMP DRAIN |
K-MED, INC. |
|
K812025 |
07/20/1981 |
K-MED SILICONE SUMP DRAIN W/ SHEATH |
K-MED, INC. |
|
K812050 |
07/21/1981 |
KALLESTAD ANTISERA TO GENTAMICIN |
KALLESTAD LABORATORIES, INC. |
|
K811858 |
07/01/1981 |
KHI CPRAM BREATHING CIRCUIT |
KHI, INC. |
|
K811882 |
07/01/1981 |
KING DIAGNOSTICS GLUCOSE TEST |
KING DIAGNOSTICS, INC. |
|
K811883 |
07/01/1981 |
KING DIAGNOSTICS GLUCOSE-O TEST |
KING DIAGNOSTICS, INC. |
|
K812127 |
07/27/1981 |
KING DIAGNOSTICS HEMOGLOBIN TEST |
KING DIAGNOSTICS, INC. |
|
K811881 |
07/01/1981 |
KING DIAGNOSTICS TOTAL BILIRUBIN TEST |
KING DIAGNOSTICS, INC. |
|
K812011 |
07/17/1981 |
BLADE GAUGE |
KOI, INC. |
|
K812097 |
07/24/1981 |
KOI LACREMAL HOOK & DILATOR |
KOI, INC. |
|
K812010 |
07/17/1981 |
KOI LACRIMAL INTUBATION SYSTEM |
KOI, INC. |
|
K812031 |
07/20/1981 |
LPC II |
LABTRONIX CORP. |
|
K812142 |
07/28/1981 |
LIC 180 MEDICAL LAMPS |
LADA INTL., INC. |
|
K812141 |
07/28/1981 |
LIC OBSTETRICAL TABLE |
LADA INTL., INC. |
|
K812058 |
07/21/1981 |
AKRON URINARY DRAINAGE BAT |
LATEX IND., INC. |
|
K812102 |
07/24/1981 |
O.N.A.T. |
LATEX MEDICAL DEVICES, INC. |
|
K812156 |
07/29/1981 |
CONCEP-7-BHCG |
LEECO DIAGNOSTICS, INC. |
|
K811880 |
07/01/1981 |
LEECO FERRITIN-QUANT DIAG. TEST KIT |
LEECO DIAGNOSTICS, INC. |
|
K812145 |
07/28/1981 |
CARDIORATER CR-3 |
LIFE SCIENCE INSTRUMENTATION, INC. |
|
K812146 |
07/28/1981 |
CARDIORATER CR-5 |
LIFE SCIENCE INSTRUMENTATION, INC. |
|
K812147 |
07/28/1981 |
CARDIORATER CR-7 |
LIFE SCIENCE INSTRUMENTATION, INC. |
|
K812144 |
07/28/1981 |
CENTERAL MONITOR 360 |
LIFE SCIENCE INSTRUMENTATION, INC. |
|
K812158 |
07/29/1981 |
LKB-BROMMA 2188 ULTROTOME NOVA |
LKB INSTRUMENTS, INC. |
|
K812157 |
07/29/1981 |
LKB-BROMMA 2218 HISTORANGE MICROTOME |
LKB INSTRUMENTS, INC. |
|
K812019 |
07/13/1981 |
LOXLEY EMERGENCY CERVICAL COLLAR |
LOXLEY MEDICAL |
|
K812123 |
07/27/1981 |
CYTOMEGELISA TEST KIT |
M.A. BIOPRODUCTS |
|
K811943 |
07/07/1981 |
MACHIDA NASOPHARYNGO-LARYNGOSCOPE |
MACHIDA AMERICA, INC. |
|
K811862 |
07/01/1981 |
HI-LO TEMP ESOPHAGEAL STETHOSCOPE |
MALLINCKRODT CRITICAL CARE |
|
K811888 |
07/01/1981 |
LINDHOLM ANATOMICAL TRACHEAL TUBE |
MALLINCKRODT CRITICAL CARE |
|
K812000 |
07/14/1981 |
PEDIATRIC DOUBLE SWIVEL CONNECTOR |
MALLINCKRODT CRITICAL CARE |
|
K812059 |
07/21/1981 |
SPHGOMOMANOMETER |
MED-TEK CORP. |
|
K812124 |
07/27/1981 |
MLA ELECTRA 700 |
MEDICAL LABORATORY AUTOMATION SYSTEMS, INC. |
|
K812152 |
07/29/1981 |
MEDI VIEW |
MEDICAL SYNERGY |
|
K811837 |
07/01/1981 |
I.V. ADMINISTRATION SET |
MEDISYSTEMS CORP. |
|
K811839 |
07/01/1981 |
MEDISYSTEM NEGATIVE PRESSURE |
MEDISYSTEMS CORP. |
|
K811838 |
07/01/1981 |
MEDISYSTEMS FISTULA NEEDLE |
MEDISYSTEMS CORP. |
|
K812045 |
07/21/1981 |
INFANT APNEA MONITOR MODEL 100 |
MEDIX MEDICAL ELECTRONICS (U.S.A.), INC. |
|
K812042 |
07/21/1981 |
INFUSION PUMP MODEL 200/201 |
MEDIX MEDICAL ELECTRONICS (U.S.A.), INC. |
|
K812040 |
07/21/1981 |
OXYGEN MONITOR 140/141 |
MEDIX MEDICAL ELECTRONICS (U.S.A.), INC. |
|
K812044 |
07/21/1981 |
RESPIRATION RATE MONITOR 120/121 |
MEDIX MEDICAL ELECTRONICS (U.S.A.), INC. |
|
K812039 |
07/21/1981 |
SPIROMETER 210/211 |
MEDIX MEDICAL ELECTRONICS (U.S.A.), INC. |
|
K812037 |
07/21/1981 |
TEMPERATURE MONITOR 130/131/133 |
MEDIX MEDICAL ELECTRONICS (U.S.A.), INC. |
|
K812046 |
07/21/1981 |
TIDAL VOLUME MONITOR 150 |
MEDIX MEDICAL ELECTRONICS (U.S.A.), INC. |
|
K812041 |
07/21/1981 |
VENTI-MONITOR MODEL 101 |
MEDIX MEDICAL ELECTRONICS (U.S.A.), INC. |
|
K812154 |
07/29/1981 |
MEDTRONIC #3484 PISCES EPIDURAL LEAD |
MEDTRONIC VASCULAR |
|
K812155 |
07/29/1981 |
MEDTRONIC DUAL CHANNEL SPINAL CORD STIM |
MEDTRONIC VASCULAR |
|
K812096 |
07/24/1981 |
MEDTRONIC ENERTRAX MODEL 7100 |
MEDTRONIC VASCULAR |
|
K812153 |
07/29/1981 |
MEDTRONIC SPECTRAX |
MEDTRONIC VASCULAR |
|
K812162 |
07/29/1981 |
HEMODIALYSIS TRANSDUCER PROTECTOR |
MEMBRANA |
|
K811909 |
07/01/1981 |
CARDIOPULMUNARY RESUSCITATOR |
MICHIGAN INSTRUMENTS, INC. |
|
K811854 |
07/01/1981 |
GALACTOSID-ASE TUBES |
MICROCHEMICAL SPECIALITIES, CO. |
|
K811853 |
07/01/1981 |
PHOLPHORYL-ASE TUBES |
MICROCHEMICAL SPECIALITIES, CO. |
|
K811852 |
07/01/1981 |
REDUCT-ASE TUBES |
MICROCHEMICAL SPECIALITIES, CO. |
|
K811952 |
07/07/1981 |
AMES TDA CARBAMAZEPINE TEST |
MILES LABORATORIES, INC. |
|
K812100 |
07/24/1981 |
SERALYZER |
MILES LABORATORIES, INC. |
|
K811891 |
07/01/1981 |
NORELCO MASSAGER PLUS HEAT BELT |
NORTH AMERICAN PHILIPS CORP. |
|
K811968 |
07/10/1981 |
VIVONEX TUNGSTEN TIP |
NORWICH EATON PHARMACEUTICALS, INC. |
|
K811893 |
07/01/1981 |
NOVAMETRIX PHYSIOLOGICAL MONITOR #910 |
NOVAMETRIX MEDICAL SYSTEMS, INC. |
|
K812005 |
07/14/1981 |
CAPILLARY PERFUSION MONITOR #LD5000 |
NUCLEAR PACIFIC, INC. |
|
K811951 |
07/07/1981 |
DRESSING CHANGE TRAYS & STERILE SPONGES |
O.R. SPECIALTIES, INC. |
|
K811855 |
07/01/1981 |
SKIN SCRUB KITS |
OEM MEDICAL DIV. |
|
K811941 |
07/06/1981 |
NEOCEPT |
ORGANON, INC. |
|
K811940 |
07/06/1981 |
OREIA II, B-HCG |
ORGANON, INC. |
|
K812002 |
07/14/1981 |
ELUAID |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
|
K811894 |
07/01/1981 |
ORTHO SICKLE CELL CONTROLS |
ORTHO DIAGNOSTIC SYSTEMS, INC. |
|
K811987 |
07/13/1981 |
OXY-QUIK MARK IV OXYGEN INHALATOR |
OXEQUIP HEALTH IND. |
|
K811985 |
07/13/1981 |
ULTIPOR SQ40S BLOOD TRANSFUSION FILTER |
PALL BIOMEDICAL PRODUCTS CO. |
|
K811995 |
07/13/1981 |
FORAMATRON APICAL FORAMEN LOCATOR |
PARKER LABORATORIES, INC. |
|
K812092 |
07/23/1981 |
BETA POST |
PAUL B. HELLER, D.M.D. |
|
K811992 |
07/13/1981 |
ASSURE NATURAL FIT TAMPON |
PERSONAL PRODUCTS CO. |
|
K811970 |
07/10/1981 |
AP X-RAY TUBE ANGULATION DEVICE |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
|
K811967 |
07/10/1981 |
CP-625 SEE-THRU FILM CHANGER |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
|
K811934 |
07/06/1981 |
DSS 500 |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
|
K811969 |
07/10/1981 |
DUAL PEDESTAL TABLE |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
|
K812159 |
07/29/1981 |
INTRAVASCULAR CATHETER |
PIONEER VIGGO, INC. |
|
K812089 |
07/22/1981 |
POLAROID RADIOGRAPHIC FILM CASSETTE |
POLAROID CORP. |
|
K812088 |
07/22/1981 |
POLAROID RADIOGRAPHIC FILM PROCESSOR |
POLAROID CORP. |
|
K812128 |
07/27/1981 |
RECON 1 |
PRECISION METERING, INC. |
|
K811868 |
07/01/1981 |
SCENTED MENSTRUAL PADS |
PROCTER & GAMBLE MFG. CO. |
|
K811869 |
07/01/1981 |
UNSCENTED MENSTRUAL PADS |
PROCTER & GAMBLE MFG. CO. |
|
K812125 |
07/27/1981 |
LAPIN CLEAR CUT II |
PROMED CORP. |
|
K811911 |
07/01/1981 |
SINGLE CHANNEL NON-FADE OSCILLOSCOPE |
QUINTON, INC. |
|
K812056 |
07/21/1981 |
SPECTRO FEIRITIN |
RAMCO LABORATORIES, INC. |
|
K812083 |
07/22/1981 |
BILE DISK |
REMEL CO. |
|
K812082 |
07/22/1981 |
KANAMYCIN DISK |
REMEL CO. |
|
K812084 |
07/22/1981 |
SPS DISK |
REMEL CO. |
|
K811977 |
07/13/1981 |
HEMASITE ACCESS MONITOR (TENT.) #RS-8200 |
RENAL SYSTEMS, INC. |
|
K812107 |
07/27/1981 |
RENALAB TRANSDUCER PROTECTOR, .22 MICRON |
RENALAB |
|
K811863 |
07/01/1981 |
STERI-TRACT |
ROGO ENT. |
|
K812070 |
07/21/1981 |
BORES* ADJUSTABLE BLADE HOLDER |
SANTA BARBARA MEDCO, INC. |
|
K812069 |
07/21/1981 |
BORES* DEPTH GAUGE |
SANTA BARBARA MEDCO, INC. |
|
K812071 |
07/21/1981 |
RK IV SURGICAL BLADES |
SANTA BARBARA MEDCO, INC. |
|
K812091 |
07/23/1981 |
FAST CHOLES-CINET |
SCLAVO, INC. |
|
K811847 |
07/01/1981 |
SEA MEDICAL PRODUCTS LO-VOL |
SEA MEDICAL PRODUCTS, INC. |
|
K811926 |
07/06/1981 |
SE WON(ALUMINUM) DENTAL FLOSS HOLDER |
SEWON INDUSTRY |
|
K811937 |
07/06/1981 |
ARGYLE TARTAN TRACHEAL TUBE |
SHERWOOD MEDICAL CO. |
|
K812023 |
07/20/1981 |
MONOJECT STERILE M506 6CC SYRINGES |
SHERWOOD MEDICAL CO. |
|
K812104 |
07/24/1981 |
SIEMENS-ELEMA PSA 376 |
SIEMENS CORP. |
|
K811843 |
07/01/1981 |
BIOPSY TRANSDUCER |
SIEMENS GAMMASONICS, INC. |
|
K811842 |
07/01/1981 |
IMAGER 2000 REAL TIME SYSTEM |
SIEMENS GAMMASONICS, INC. |
|
K812032 |
07/20/1981 |
MEVATRON 67E |
SIEMENS MEDICAL LABORATORIES, INC. |
|
K811887 |
07/01/1981 |
SKIN STAPLE EXTRACTOR |
SIERRA LABORATORIES, INC. |
|
K811864 |
07/01/1981 |
SIGMA PROCEDURE 265-UV |
SIGMA CHEMICAL CO. |
|
K811849 |
07/01/1981 |
ESKAFLOW TEST FOR GLUCOSE |
SMITH KLINE DIAGNOSTICS, INC. |
|
K811850 |
07/01/1981 |
ESKAFLOW TEST FOR TRIGLYCERIDES |
SMITH KLINE DIAGNOSTICS, INC. |
|
K812015 |
07/17/1981 |
GLAUKON |
SONOMETRICS SYSTEMS, INC. |
|
K812052 |
07/21/1981 |
MYOCATH CATOLOG NO. MCK-A |
SORENSEN RESEARCH |
|
K812013 |
07/17/1981 |
FLUORESCENT ANTIBODY CONJUGATE FOR GP.A |
SPRINGWOOD MICROBIOLOGICALS |
|
K812049 |
07/21/1981 |
STOCKERT CARDIAC PACING ELECTRODES |
STOECKERT INSTRUMENTE |
|
K811861 |
07/01/1981 |
ARTHROSCOPIC LEG HOLDER |
STRYKER CORP. |
|
K811889 |
07/01/1981 |
R & S SERIES FITTING TOOLS |
SUNCOAST DENTAL CORP. |
|
K811923 |
07/02/1981 |
R & S SERIES IMPLANTS |
SUNCOAST DENTAL CORP. |
|
K811973 |
07/10/1981 |
FORDER RETRACTOR |
SURGEMED MARKETING, INC. |
|
K811871 |
07/01/1981 |
BACTERICIDAL INCISE DRAPE |
SURGIKOS, INC. |
|
K812087 |
07/22/1981 |
EA 50 |
SURGIPATH |
|
K812086 |
07/22/1981 |
EA 65 |
SURGIPATH |
|
K811950 |
07/07/1981 |
KENL-ECG |
SUZUKEN CO., LTD. |
|
K811949 |
07/07/1981 |
KENL-ECG-3 |
SUZUKEN CO., LTD. |
|
K812148 |
07/28/1981 |
ELECTRONIC STETHOSCOPE #S-50 |
SYPHGMOSTAT |
|
K811931 |
07/06/1981 |
NEEDLE GUIDE ATTACHMENT |
TECHNICARE CORP. |
|
K811978 |
07/13/1981 |
TECHNICON H6000 (90/HR) HEMATOLOGY SYS |
TECHNICON INSTRUMENTS CORP. |
|
K811996 |
07/15/1981 |
GATOR DRAPES |
THE ANSPACH EFFORT, INC. |
|
K811958 |
07/09/1981 |
BOUNDARY REINFORCED OR GOWN |
THE BUCKEYE CELLULOSE CORP. |
|
K812033 |
07/20/1981 |
THE LYMAN BATHCHAIR |
THE LYMAN BATHCHAIR CORP. |
|
K811991 |
07/13/1981 |
SIMVAC |
THE LYNN TERRELL CO. |
|
K811942 |
07/07/1981 |
J & S IRON SATURATING REAGENT |
THYROID DIAGNOSTICS, INC. |
|
K811924 |
07/02/1981 |
PRE-FILLED SYRINGE & CYSTOFLO URINARY BG |
TRAVENOL LABORATORIES, S.A. |
|
K811859 |
07/01/1981 |
BACTASHIELD |
TRI-MED, INC. |
|
K811981 |
07/13/1981 |
ISOLATER THP |
TRI-MED, INC. |
|
K812057 |
07/21/1981 |
VANCE CYSTOSCOPIC |
VANCE PRODUCTS, INC. |
|
K811914 |
07/01/1981 |
FLU VEN I.V. SETS |
VENUSA LTD. |
|
K811865 |
07/01/1981 |
VMA PEDIATRIC APNEA MATTRESS |
VICKERS AMERICA MEDICAL CORP. |
|
K811960 |
07/10/1981 |
VISITEC NEDDLE TANGE (SURGERY) |
VISITEC CO. |
|
K811963 |
07/10/1981 |
VISITEC NEEDLE RANGE (ANESTHESIOLOGY) |
VISITEC CO. |
|
K811964 |
07/10/1981 |
VISITEC NEEDLE RANGE (CARDIOVASCULAR) |
VISITEC CO. |
|
K811965 |
07/10/1981 |
VISITEC NEEDLE RANGE (GASTERUROLOGY) |
VISITEC CO. |
|
K811966 |
07/10/1981 |
VISITEC NEEDLE RANGE (GENERAL HOSPITAL) |
VISITEC CO. |
|
K811961 |
07/10/1981 |
VISITEC NEEDLE RANGE (ORTHOPAEDIC) |
VISITEC CO. |
|
K811939 |
07/06/1981 |
VITATRON 88 |
VITATRONICS |
|
K812121 |
07/27/1981 |
DIGICLOT 2-#820 |
VOLU SOL MEDICAL INDUSTRIES |
|
K812122 |
07/27/1981 |
MULTI CLOT-#819 |
VOLU SOL MEDICAL INDUSTRIES |
|
K812160 |
07/29/1981 |
MICROSURGICAL BLADE |
VXTRA CORP. |
|
K811841 |
07/01/1981 |
GORE-TEX CARDIOVASCULAR PATCH |
W.L. GORE & ASSOCIATES,INC |
|
K812081 |
07/22/1981 |
WAKO NEFA C TEST |
WAKO CHEMICALS, USA, INC. |
|
K812080 |
07/22/1981 |
AEGIS I.V. STRIPS |
WARNER-LAMBERT CO. |
|
K812073 |
07/21/1981 |
DESERET CATHETER DRESSING |
WARNER-LAMBERT CO. |
|
K811975 |
07/13/1981 |
MODEL 480 VARIABLE WAVELENGTH ULTRA VIOL |
WATERS ASSOC., INC. |
|
K811857 |
07/01/1981 |
SELECT-A-FLOW |
WENMAR INTL. CORP. |
|
K812138 |
07/28/1981 |
TENS DEVICE |
WESTERN ADVANCED TECHNOLOGY, INC. |
|
K812143 |
07/28/1981 |
INTRODUCER, PERCUTANEOUS |
WILLSON |
|
K812024 |
07/20/1981 |
XEROX 128 CASSETTE CHANGER |
XEROX MEDICAL SYSTEMS |
|
K811885 |
07/01/1981 |
30-30-2 700 SYRINGE EXTENSION SET |
Y |
|
K811884 |
07/01/1981 |
IVAC 700 SYRINGE INFUSION PUMP |
Y |
|
K812022 |
07/20/1981 |
ZEE MANUAL RESUSCITATOR |
ZEE MEDICAL PRODUCTS CO., INC. |
|
K812085 |
07/22/1981 |
HERPES VIRUS HOMINIS ANTIBODY TEST SYS. |
ZEUS SCIENTIFIC, INC. |
|