FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
K810996 |
04/14/1981 |
ENTERNAL PUMP SET W/INTEGRAL CONTAINER |
ABBOTT LABORATORIES |
|
K811185 |
04/29/1981 |
N-D0-SURE |
ACKRAD LABORATORIES |
|
K811120 |
04/24/1981 |
SURGICAL STAPLE REMOVER |
ACME UNITED CORP. |
|
K811134 |
04/24/1981 |
ACU-DESOXYCHOLATE AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811038 |
04/16/1981 |
BAIRD-PARKER AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811054 |
04/16/1981 |
BIGGY AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811043 |
04/16/1981 |
BISMUTH SULFITE AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811055 |
04/16/1981 |
BLOOD AGAR BASE PH 7.4 |
ACUMEDIA MANUFACTURERS, INC. |
|
K811056 |
04/16/1981 |
BRAIN HEART INFUSION |
ACUMEDIA MANUFACTURERS, INC. |
|
K811041 |
04/16/1981 |
BRILLIANT GREEN AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811057 |
04/16/1981 |
BRILLIANT GREEN BILE BROTH 2% |
ACUMEDIA MANUFACTURERS, INC. |
|
K811128 |
04/24/1981 |
BRUCELLA AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811040 |
04/16/1981 |
CETRIMEDE AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811135 |
04/24/1981 |
COLUMBIA BLOOD AGAR BASE |
ACUMEDIA MANUFACTURERS, INC. |
|
K811137 |
04/24/1981 |
COLUMBIA CNA AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811133 |
04/24/1981 |
EOSIN-METHYLENE BLUE AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811132 |
04/24/1981 |
EUGON BROTH |
ACUMEDIA MANUFACTURERS, INC. |
|
K811047 |
04/16/1981 |
FLUID THIOGLYCOLLATE MEDIUM |
ACUMEDIA MANUFACTURERS, INC. |
|
K811053 |
04/16/1981 |
GC AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811131 |
04/24/1981 |
HEKTOEN ENTERIC AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811130 |
04/24/1981 |
LACTOSE BROTH |
ACUMEDIA MANUFACTURERS, INC. |
|
K811129 |
04/24/1981 |
LAURYL SULFATE BROTH |
ACUMEDIA MANUFACTURERS, INC. |
|
K811045 |
04/16/1981 |
LEVIN EOSIN-METHYLENE BLUE AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811048 |
04/16/1981 |
MACCONKEY AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811037 |
04/16/1981 |
MANNITAL SALT AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811049 |
04/16/1981 |
MUELLER HINTON AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811136 |
04/24/1981 |
MUELLER HINTON BROTH |
ACUMEDIA MANUFACTURERS, INC. |
|
K811138 |
04/24/1981 |
NUTRIENT AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811046 |
04/16/1981 |
STERILITY TEST BROTH |
ACUMEDIA MANUFACTURERS, INC. |
|
K811044 |
04/16/1981 |
TRIPLE SUGAR IRON AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811051 |
04/16/1981 |
TRYPTIC SOY AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811052 |
04/16/1981 |
TRYPTIC SOY AGAR W/LECITHIN & TWEEN 80 |
ACUMEDIA MANUFACTURERS, INC. |
|
K811050 |
04/16/1981 |
TRYPTIC SOY BROTH |
ACUMEDIA MANUFACTURERS, INC. |
|
K811039 |
04/16/1981 |
VOGEL & JOHNSON AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811042 |
04/16/1981 |
XLD AGAR |
ACUMEDIA MANUFACTURERS, INC. |
|
K811095 |
04/21/1981 |
TRANSCUTANEOUS ELECTRICAL NERVE |
ACUTEC CORPORATION, INC. |
|
K810886 |
04/01/1981 |
ADEL MEDICAL BIRTHING BED, #LD-500 |
ADEL MEDICAL LTD. |
|
K810946 |
04/07/1981 |
ADULT & PEDIATRIC TRACHEOSTOMY MASKS |
AIRLIFE, INC. |
|
K810947 |
04/07/1981 |
AIR ENTRAINMENT TRACH "T" |
AIRLIFE, INC. |
|
K811161 |
04/28/1981 |
HUMIDIFIER W/ OR W/OUT ADAPTOR |
AIRLIFE, INC. |
|
K810938 |
04/07/1981 |
MASS SPECTROMETER-MEDSPECT II |
ALLIED HEALTHCARE PRODUCTS, INC. |
|
K810939 |
04/07/1981 |
NEBULIZER/HUMIDIFIER HUMIDITY CENTER-MI. |
ALLIED HEALTHCARE PRODUCTS, INC. |
|
K810927 |
04/06/1981 |
RESPIRATORY INTENSIVE CARE SYSTEM (RICS) |
ALLIED HEALTHCARE PRODUCTS, INC. |
|
K811105 |
04/23/1981 |
SEMI-CONSTRAINT KEE JOINT HINGE PROSTH |
ALLO PRO CORP. |
|
K811119 |
04/24/1981 |
WEBER/STUEHMER HIP JOINT ENDOPROSTHESIS |
ALLO PRO CORP. |
|
K811113 |
04/23/1981 |
RIESS-LUHR |
ALLOMEDIC |
|
K811075 |
04/20/1981 |
BALANCE ARTICULATOR |
ALMORE INTL., INC. |
|
K810897 |
04/03/1981 |
ALPHA PLASTIC PLASMA BOTTLE |
ALPHA THERAPEUTIC CORP. |
|
K811152 |
04/27/1981 |
DADE RPR CARD TEST |
AMERICAN DADE |
|
K811069 |
04/20/1981 |
FIBRINOGEN CONTROL PLASMA |
AMERICAN DADE |
|
K811094 |
04/21/1981 |
CARDIAC 1000 TM |
AMERICAN EDWARDS LABORATORIES |
|
K810894 |
04/03/1981 |
FOGARTY FLEXIBLE CALIBRATOR |
AMERICAN EDWARDS LABORATORIES |
|
K811181 |
04/28/1981 |
MODEL FBS-1, FLEXIBLE BRONCHOSCOPE |
AMERICAN OPTICAL CORP. |
|
K811180 |
04/28/1981 |
ULTRAMATIC PROJECT-O-CHART OPHTH. PROJ |
AMERICAN OPTICAL CORP. |
|
K811117 |
04/24/1981 |
EYE CARE TRAY |
AMERICAN PHARMASEAL DIV. AHSC |
|
K811004 |
04/13/1981 |
MANIFOLD |
AMERICAN PHARMASEAL DIV. AHSC |
|
K810937 |
04/07/1981 |
ANIS IRRIGATING SPATULA |
AMERICAN V. MUELLER |
|
K811169 |
04/28/1981 |
PROSTATIC ACID PHOSPHATASE (PAP) RDA KIT |
AMERSHAM CORP. |
|
K811016 |
04/15/1981 |
CC-100 |
ANTHRO-METRICS CORP. |
|
K810922 |
04/06/1981 |
ARALUEN SKY GRAB BRIDLE |
ARALUEN, INC. |
|
K810979 |
04/10/1981 |
ARROW NEEDLE-CATHETER JEJUNOSTOMY KIT |
ARROW INTL., INC. |
|
K810962 |
04/08/1981 |
ARROW VESSEL CATHETER. KIT W/20GA INDWEL |
ARROW INTL., INC. |
|
K811111 |
04/23/1981 |
AUTOMATIC ELISA READER |
ARTEK SYSTEMS CORP. |
|
K811060 |
04/17/1981 |
POLYETHYLENE MEDULLARY PLUG |
ARTHUR A. CHECCHI, INC. |
|
K810969 |
04/09/1981 |
ISOSIT C & B MATERIAL |
BAUER, CHENG & ASSOCIATES, INC. |
|
K810970 |
04/09/1981 |
ISOSIT TEETH |
BAUER, CHENG & ASSOCIATES, INC. |
|
K810972 |
04/09/1981 |
THE GNATHOMETER-M |
BAUER, CHENG & ASSOCIATES, INC. |
|
K810971 |
04/09/1981 |
THE GNATOMET |
BAUER, CHENG & ASSOCIATES, INC. |
|
K811144 |
04/27/1981 |
ARIA II INSULIN RIA |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K811192 |
04/30/1981 |
VAC-RITE SUNCTION COLLECTION |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K811142 |
04/27/1981 |
BELMONT PODIATRY MODEL 065 X-RAY |
BELMONT EQUIPMENT CORP. |
|
K811177 |
04/28/1981 |
QUANTA PHASE VITAMIN B-12/FOLATE RAD |
BIO-RAD |
|
K811109 |
04/23/1981 |
THROMBIN CLOTTING TIME |
BIO/DATA CORP. |
|
K811189 |
04/29/1981 |
CHEMSTRIP L |
BIODYNAMICS CORP. |
|
K810904 |
04/03/1981 |
BOVINE CALF SERUM |
BIOLABS, INC. |
|
K810903 |
04/03/1981 |
NEWBORN BOVINE SERUM |
BIOLABS, INC. |
|
K810975 |
04/10/1981 |
MINITONE |
BLOOMEX INTERNATIONAL, INC. |
|
K811114 |
04/23/1981 |
MODEL P-8 PROFESSIONAL |
BLOOMEX INTERNATIONAL, INC. |
|
K810964 |
04/08/1981 |
BIO SET TM PHOSPHOROUS CALIBRATOR |
BOEHRINGER MANNHEIM CORP. |
|
K810963 |
04/08/1981 |
BIO SET TM SUBSTRATE CALIBRATORS |
BOEHRINGER MANNHEIM CORP. |
|
K811194 |
04/30/1981 |
HITACHI 705 AUTOMATIC BLOOD CHEMISTRY |
BOEHRINGER MANNHEIM CORP. |
|
K810978 |
04/10/1981 |
MONTGOMERY SILICONE TRACHEAL T-TUBE |
BOSTON MEDICAL PRODUCTS, INC. |
|
K810940 |
04/07/1981 |
THE BETA |
BURDICK CORP. |
|
K811062 |
04/17/1981 |
CAMPBRIDGE COMPUTRACE |
CAMBRIDGE INSTRUMENTS, INC. |
|
K811121 |
04/24/1981 |
CENTRAL STATION MONITORING SYSTEMS |
CAMBRIDGE INSTRUMENTS, INC. |
|
K811101 |
04/21/1981 |
HYDROXYLAPATITE |
CARBOMEDICS, INC. |
|
K811028 |
04/16/1981 |
PACE AID |
CARDIAC RESUCITATOR CORP. |
|
K811079 |
04/21/1981 |
SYPHGMOLOG |
CARDIODYNE GENERAL, INC. |
|
K810945 |
04/07/1981 |
SCANEL 100 |
CGR MEDICAL CORP. |
|
K811193 |
04/30/1981 |
BUN RATE REAGENT |
CHEM-ELEC, INC. |
|
K811165 |
04/28/1981 |
GLUCOSE OXIDASE RATE REAGENT |
CHEM-ELEC, INC. |
|
K810967 |
04/08/1981 |
IN-VITRO TBG RADIOIMMUNOASSAY TEST |
CLINICAL ASSAYS, INC. |
|
K810907 |
04/03/1981 |
COLTENE ORALLY |
COLTENE, INC. |
|
K810895 |
04/03/1981 |
ESOPHAGEAL PILL ELECTRODE |
CON MED EQUIPMENT, INC. |
|
K810896 |
04/03/1981 |
VENTI-GARD JR. |
CON MED EQUIPMENT, INC. |
|
K810995 |
04/13/1981 |
PREFILLED PULSATOR SYRINGE |
CONCORD LABORATORIES, INC. |
|
K811009 |
04/15/1981 |
PREFILLED PULSATOR SYRINGE |
CONCORD LABORATORIES, INC. |
|
K810884 |
04/01/1981 |
#325 PROGRAMMABLE CARD. PULSE GENERATOR |
COOK PACEMAKER CORP. |
|
K810885 |
04/01/1981 |
#326 PROGRAMMABLE CARD. PULSE GENERATOR |
COOK PACEMAKER CORP. |
|
K810999 |
04/13/1981 |
CORDIS TCPO2 TRANCUTANEOUS OXYGEN PRESS |
CORDIS CORP. |
|
K811000 |
04/13/1981 |
ABNORMAL GLYCOSYLATED HEMOGLOBIN CONTROL |
CORNING MEDICAL & SCIENTIFIC |
|
K810952 |
04/07/1981 |
CORNING VITAMIN B12 FOLATE DEFIC. CONTR. |
CORNING MEDICAL & SCIENTIFIC |
|
K811107 |
04/23/1981 |
IV SETS |
CRITIKON COMPANY,LLC |
|
K811088 |
04/21/1981 |
DRESSING TRAY MERCY HOSPITAL |
CUNNINGHAM WOODLAND, INC. |
|
K811090 |
04/21/1981 |
MAJOR DRESSING TRAY |
CUNNINGHAM WOODLAND, INC. |
|
K811087 |
04/21/1981 |
MIKA SKIN SCRUB TRAY PRE OPERATIVE W/GEL |
CUNNINGHAM WOODLAND, INC. |
|
K811091 |
04/21/1981 |
MINOR DRESSING TRAY |
CUNNINGHAM WOODLAND, INC. |
|
K811089 |
04/21/1981 |
ONE STEP PREP KIT |
CUNNINGHAM WOODLAND, INC. |
|
K811086 |
04/21/1981 |
SUTURE REMOVAL SET(DISPLSABLE) |
CUNNINGHAM WOODLAND, INC. |
|
K810965 |
04/08/1981 |
DATA-ZYME TRIGLYCERIDE |
DATA MEDICAL ASSOCIATES, INC. |
|
K811030 |
04/16/1981 |
APPOSE SKIN STAPLER |
DAVIS & GECK, INC. |
|
K811191 |
04/30/1981 |
DAVIS & GECK NEEDLE/SHARPS COUNTER |
DAVIS & GECK, INC. |
|
K811122 |
04/24/1981 |
DEL MAR AVIONICS MODELS 9400 & 9401 |
DEL MAR AVIONICS |
|
K810913 |
04/06/1981 |
CAVITY VARNISH |
DENTSPLY INTL. |
|
K811023 |
04/15/1981 |
ROOT CANAL KIT |
DENTSPLY INTL. |
|
K811183 |
04/29/1981 |
DENVER PERITONEO-VENOUS SHUNT |
DENVER BIOMEDICALS, INC. |
JOHN B NEWKIRK |
K810891 |
04/02/1981 |
COAT-A-COUNT CORTISOL RIA KIT |
DIAGNOSTIC PRODUCTS CORP. |
|
K811063 |
04/17/1981 |
LASER-CAL |
DIAGNOSTIC TECHNOLOGY, INC. |
|
K811017 |
04/15/1981 |
HUCKSTEP INTRAMEDULLARY NAIL |
DOWNS SURGICAL LTD. |
|
K811157 |
04/28/1981 |
BLADE, TONGUE |
DYN-A-MED PRODUCTS |
|
K810968 |
04/09/1981 |
BCD-HPP41C INTERFACE |
DYNATECH CORP. |
|
K811001 |
04/13/1981 |
MICROERMA SYSTEM |
DYNATECH CORP. |
|
K811159 |
04/28/1981 |
DYNASOUND 801 |
DYNAWAVE, CORP. |
|
K810966 |
04/08/1981 |
DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT |
E. R. SQUIBB & SONS, INC. |
|
K811163 |
04/28/1981 |
SUR-FIT DISPOSABLE FANGE CAP |
E. R. SQUIBB & SONS, INC. |
|
K811160 |
04/28/1981 |
SUR-FIT IRRIGATION SLEEVE |
E. R. SQUIBB & SONS, INC. |
|
K810887 |
04/01/1981 |
ELA MEDICAL UNILITH 7540 PULSE GENERATOR |
ELA MEDICAL, INC. |
|
K811093 |
04/21/1981 |
BRAEGEN EEG TRANSMITTER/RECEIVER SYS |
ELECTRO-BIO-MEDICAL SERVICES, INC. |
|
K811199 |
04/30/1981 |
MARZ-175 |
EMDE CORP. |
|
K811061 |
04/17/1981 |
AUTOMATED GASTRIC LAVAGE |
EMERGENCY MEDICINE |
JOSEPH P RUDOLPH |
K810948 |
04/07/1981 |
RADIOIMMUNOASSAY THYROID STIM. HORM. KIT |
ENDOCRINE-METABOLIC CENTER |
|
K810925 |
04/06/1981 |
NATURALYTE BICARBONATE DIALYSATE CONCEN. |
ERIKA, INC. |
|
K810950 |
04/07/1981 |
VISIO-SEAL |
ESPE DENTAL PRODUCTS |
|
K810902 |
04/03/1981 |
IP-758 BURN WOUND DRESSING |
EXOPACK |
|
K811182 |
04/28/1981 |
MULTIANALYTE CONTROLS, ALL KINDS |
FISHER SCIENTIFIC CO., LLC. |
|
K811179 |
04/28/1981 |
OSMOMETER MODEL OM-6010 |
FISKE MED SCIENCE |
|
K811068 |
04/17/1981 |
BYPASS COIL |
G.D. SEARLE AND CO. |
|
K811071 |
04/20/1981 |
VENOUS OXYGEN PROBE |
G.D. SEARLE AND CO. |
|
K811100 |
04/22/1981 |
GELMAN ELECTROPHORESIS CONTROL |
GELMAN SCIENCES, INC. |
|
K811103 |
04/23/1981 |
GE 900 |
GENERAL ELECTRIC CO. |
|
K811036 |
04/16/1981 |
FILTER SAMPLER BLOOD SERUM FILTER |
GLASROCK PLASTICS, INC. |
|
K810961 |
04/09/1981 |
CAMPYLOBACTER MED. (PLATE) |
GRANITE DIAGNOSTICS, INC. |
|
K811155 |
04/28/1981 |
MODEL RXO2 OXYGEN RICH AIR SUPPLY |
GREENE & KELLOGG, INC. |
|
K810992 |
04/13/1981 |
HELENA VMA-SMC COLUMN METHOD |
HELENA LABORATORIES |
|
K810893 |
04/02/1981 |
HEWLETT-PACKARD VENTILATOR |
HEWLETT-PACKARD CO. |
|
K810956 |
04/07/1981 |
MARCOVE HUMERAL ROD |
HEXCEL MEDICAL |
|
K810957 |
04/07/1981 |
MARCOVE INTRAMEDULLARY ROD |
HEXCEL MEDICAL |
|
K811164 |
04/28/1981 |
URETHANE ORTHOPAEDIC CASTING TAPE |
HEXCEL MEDICAL |
|
K811116 |
04/24/1981 |
HCG RADIOIMMUNOASSAY |
HOFFMANN-LA ROCHE, INC. |
|
K810905 |
04/03/1981 |
ISOMUNE-CK |
HOFFMANN-LA ROCHE, INC. |
|
K811151 |
04/27/1981 |
COLLARLESS TOTAL HIP FEMORAL COMP. SYS |
HOWMEDICA CORP. |
|
K811154 |
04/28/1981 |
HOYT ECONO-TRAY |
HOYT LABORATORIES |
|
K811125 |
04/24/1981 |
AIM SYSTEM (FOR IGA) |
ICL SCIENTIFIC |
|
K811126 |
04/24/1981 |
AIM SYSTEM (FOR IGG) |
ICL SCIENTIFIC |
|
K811124 |
04/24/1981 |
AIM SYSTEM (FOR IGM) |
ICL SCIENTIFIC |
|
K810917 |
04/06/1981 |
KOVA TROL I HUMAN URINE (DRIED) |
ICL SCIENTIFIC |
|
K811024 |
04/15/1981 |
LUTEINIZING HORMONE DIRECT RIA KIT 125/I |
IMMUNALYSIS CORPORATION |
|
K811022 |
04/15/1981 |
ANA TEST KIT |
IMMUNO-DIAGNOSTIC PRODUCTS, INC. |
|
K811021 |
04/15/1981 |
HERPES |
IMMUNO-DIAGNOSTIC PRODUCTS, INC. |
|
K810981 |
04/13/1981 |
ANTI NDNA IMMUNOFLOURESCENT TEST SYS |
IMMUNO-PRODUCTS INDUSTRIES |
|
K810984 |
04/13/1981 |
ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST |
IMMUNO-PRODUCTS INDUSTRIES |
|
K810985 |
04/13/1981 |
ANTINUCLEAR ANTIBODY IMMUNOFLUORESCENT |
IMMUNO-PRODUCTS INDUSTRIES |
|
K810983 |
04/13/1981 |
ANTISMOOTH MUSCLE ANTIBODY TEST SYS |
IMMUNO-PRODUCTS INDUSTRIES |
|
K810982 |
04/13/1981 |
ANTITHYROID ANTIBODY IMMUNOFLUORESCENT |
IMMUNO-PRODUCTS INDUSTRIES |
|
K811014 |
04/15/1981 |
RESPIRATORY SENSOR |
IMPACT INSTRUMENTATION, INC. |
|
K811145 |
04/27/1981 |
PNEUMATIC DENTAL SCALER |
INNOVATE, INC. |
|
K811143 |
04/27/1981 |
PH/BLOOD GAS CONTROL (ABC) |
INSTRUMENTATION LABORATORY CO. |
|
K810901 |
04/03/1981 |
INSULATIVE COATING FOR CARD. PULSE GEN |
INTERMEDICS, INC. |
|
K811106 |
04/23/1981 |
INTERMEDICS POLY FLEX ENDOCARDIAL PACING |
INTERMEDICS, INC. |
|
K811066 |
04/17/1981 |
MODEL 230-06 CYBERLITH TM I BIPOLAR IN |
INTERMEDICS, INC. |
|
K810989 |
04/13/1981 |
IBM 5880 ACQUISITION & ANALYSIS CART TEL |
INTL. BUSINESS MACHINES |
|
K810988 |
04/13/1981 |
IBM 5885 DIGITAL ECG ACQUISITION CART |
INTL. BUSINESS MACHINES |
|
K811070 |
04/20/1981 |
125 I-T4 RIA TEST KIT |
INTL. IMMUNOASSAY LABORATORIES, INC. |
|
K810976 |
04/10/1981 |
ALPHA-THAL SCREEN TM CONTROL |
ISOLAB, INC. |
|
K810919 |
04/06/1981 |
HEMOGLOBIN ELECTROPHORESIS CONTROL |
ISOLAB, INC. |
|
K810892 |
04/02/1981 |
ELECTRO-SUCTION UNIT |
JEDMED INSTRUMENT CO. |
|
K811085 |
04/21/1981 |
VENES II |
JUNG PRODUCTS, INC. |
|
K810909 |
04/03/1981 |
MICRO CAUTERY |
KEY MEDICAL, INC. |
|
K811175 |
04/28/1981 |
RECOH ROOT CANAL IRRIGATOR |
KOEI INTERNATIONAL, INC. |
|
K811083 |
04/21/1981 |
ESOPHAGEAL MOTILITY PROBE |
KONIGSBERG INSTRUMENTS, INC. |
|
K811020 |
04/15/1981 |
REVERSIBLE HYDROCOLLOID IMPRESSION |
KOTTLER LABORATORIES |
|
K811084 |
04/21/1981 |
LABTRONIX PLATELET COUNTER(L/O/C.) |
LABTRONIX CORP. |
|
K810923 |
04/06/1981 |
LEE ENDOFILL, ROOT CANAL FILLING RESIN |
LEE PHARMACEUTICALS |
|
K811162 |
04/28/1981 |
FLOWLOCK OXYGEN METER |
LIFEGUARD MEDICAL PRODUCTS, INC. |
|
K810993 |
04/13/1981 |
GLUCOSCAN TEST STRIPS |
LIFESCAN, INC. |
|
K811019 |
04/15/1981 |
LKB 4460 FLUORIMETER |
LKB INSTRUMENTS, INC. |
|
K810915 |
04/06/1981 |
THE SCOTT DIALMENZENSERT |
LONE STAR MEDICAL PRODUCTS, INC. |
|
K811153 |
04/27/1981 |
COHERENT FLOUROTRON MASTER |
LUMENIS, INC. |
|
K810958 |
04/08/1981 |
GLYCOHEMOGLOBIN |
MACOMB CHEMICAL CO. |
|
K811150 |
04/27/1981 |
URINE PREGNANCY TEST STANDARD/CONTR. PK |
MALLINCKRODT CRITICAL CARE |
|
K811067 |
04/17/1981 |
BIO-BAG TM ENVIRONMENTAL CHAMBER TYPE M |
MARION LABORATORIES, INC. |
|
K811118 |
04/24/1981 |
KRYPTON MASKS & TUBING |
MEDI-PHYSICS INC. DBA NYCOMED AMERSHAM IMAGING |
|
K810954 |
04/07/1981 |
NORFOLK/NORWICH PRESSURE INFUSION BOX |
MEDICAL INNOVATIONS CORP. |
|
K810890 |
04/02/1981 |
NEOLOOPS |
MEDICAL MARKETING SYSTEMS |
|
K810944 |
04/07/1981 |
PENILE ERECTION MONITOR |
MEDICAL MONITORING SYSTEMS, INC. |
|
K810924 |
04/06/1981 |
MEDRAD HIGH PRESSURE CONECTING TUBE |
MEDRAD, INC. |
|
K811187 |
04/29/1981 |
MEDTRONIC A2 CLINICAL IMAGING SYSTEM |
MEDTRONIC VASCULAR |
|
K811123 |
04/24/1981 |
MEDTRONIC PULSE GENERATOR |
MEDTRONIC VASCULAR |
|
K811178 |
04/28/1981 |
HUMAN IGG-ALBUMIN TEST KIT |
MELOY LABORATORIES, INC. |
|
K810949 |
04/07/1981 |
MRI PROLACTIN RIA KIT |
MICROANALYTIC RESEARCH, INC. |
|
K810951 |
04/07/1981 |
REAGENTS FOR QUANT. ENZYMATIC DETER.-TR. |
MID TECH, INC. |
|
K811190 |
04/29/1981 |
THREE MODELS OF TABLES, STOOLS, & LIGHTS |
MIDMARK CORP. |
|
K810942 |
04/07/1981 |
AMES TDA GENTAMICIN TEST |
MILES LABORATORIES, INC. |
|
K810943 |
04/07/1981 |
AMES TDA THEOPHYLLINE TEST |
MILES LABORATORIES, INC. |
|
K811026 |
04/16/1981 |
AMES TDA TM AMIKACIN TEST |
MILES LABORATORIES, INC. |
|
K810994 |
04/13/1981 |
AMES TDA TM PHENOBARBITAL TEST |
MILES LABORATORIES, INC. |
|
K811025 |
04/16/1981 |
AMES TDA TM PHENYTOIN TEST |
MILES LABORATORIES, INC. |
|
K811007 |
04/14/1981 |
AMES TDA TM PRIMIDONE TEST |
MILES LABORATORIES, INC. |
|
K810941 |
04/07/1981 |
AMES TDA TOBRAMYCIN TEST |
MILES LABORATORIES, INC. |
|
K810912 |
04/06/1981 |
ALLOY COMPOSITE POLISH |
MOYCO INDUSTRIES, INC. |
|
K810953 |
04/07/1981 |
MODEL 533 PHOTOTHERAPY UNIT |
NARCO AIR-SHIELDS |
|
K810920 |
04/06/1981 |
NDM DIATEMP INFANT ELECTROSURG. DISP. P. |
NDM CORP. |
|
K811188 |
04/29/1981 |
NORELCO BLOOD PRESSURE METER |
NORTH AMERICAN PHILIPS CORP. |
|
K810906 |
04/03/1981 |
TRI-LEVEL NDI CONTROL |
NUCLEAR DIAGNOSTICS, INC. |
|
K810936 |
04/07/1981 |
CHORIO-SHURE |
NUCLEAR MEDICAL LABORATORIES, INC. |
|
K811012 |
04/15/1981 |
TENS-O-MATIC |
O-MATIC, INC. |
|
K810990 |
04/13/1981 |
OHIO NONCONDUCTIVE RBS TYPE FACE MASK |
OHIO MEDICAL PRODUCTS |
|
K810883 |
04/01/1981 |
OMED SILICONE INSTRUMENT COVERS |
OMEGA-MED INTL., INC. |
|
K811158 |
04/28/1981 |
OMNI |
OMNI HEARING SYSTEMS |
|
K811170 |
04/28/1981 |
D-3160 SORBENT CARTRIDGE |
ORGANON TEKNIKA CORP. |
|
K811015 |
04/15/1981 |
POSITIVE CLOSURE ANESTHETIC VALVE |
ORTHOPEDIC SYSTEMS, INC. |
|
K810986 |
04/16/1981 |
EARETTE HEARING AID OTICON #E25F |
OTICON CORP. |
|
K810987 |
04/13/1981 |
EARETTE HEARING AID OTICON #E27F |
OTICON CORP. |
|
K811172 |
04/28/1981 |
VICON |
OXFORD MEDILOG, INC. |
|
K810930 |
04/06/1981 |
BACILLUM PUMILUS SPORE STRIPS |
OXOID U.S.A., INC. |
|
K810929 |
04/06/1981 |
PERFRINGENS AGAR BASE |
OXOID U.S.A., INC. |
|
K810931 |
04/06/1981 |
SS AGAR (MODIFIED) |
OXOID U.S.A., INC. |
|
K810932 |
04/06/1981 |
VITOX |
OXOID U.S.A., INC. |
|
K810933 |
04/06/1981 |
VOTEL-JOHNSON AGAR (MODIFIED) |
OXOID U.S.A., INC. |
|
K811200 |
04/30/1981 |
PACEPATH IMPLANTABLE ENDOCARD. PACING LD |
PACESETTER SYSTEMS |
|
K811010 |
04/15/1981 |
CONTACT LENS MATERL |
PARAGON OPTICAL CO. |
|
K811059 |
04/17/1981 |
PENTAX BRONCHOFIBERSCOPE #FB-15A |
PENTAX PRECISION INSTRUMENT CORP. |
|
K811198 |
04/30/1981 |
ECCO GENERATOR |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
|
K810973 |
04/10/1981 |
SYSTEM 400 |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
|
K811171 |
04/28/1981 |
VASCULON II I.V. CATHETER |
PIONEER VIGGO, INC. |
|
K811082 |
04/21/1981 |
BETA I & BETA II |
PORTA RAY, INC. |
|
K810977 |
04/10/1981 |
ENDODONTIC POST SYSTEMS |
PREAT CORP. |
|
K810918 |
04/06/1981 |
ROLL-A-SET |
PRINCIPLE BUSINESS ENT. |
|
K810921 |
04/06/1981 |
MALE LUER LOCK PLUGS |
PROCEDURE PRODUCTS, INC. |
|
K811108 |
04/23/1981 |
RMI TRANSILLUMINATION LIGHT METER #295 |
RADIATION MEASUREMENTS, INC. |
|
K811074 |
04/20/1981 |
GLUCOSE REAGENT-ENZYMATIC-COLOR 500 |
REAGENTS APPLICATIONS, INC. |
|
K811073 |
04/20/1981 |
A QUAPAK |
RESPIRATORY CARE, INC. |
|
K810991 |
04/13/1981 |
HEADSTRAP |
RESPIRONICS, INC. |
|
K811002 |
04/13/1981 |
ENDER PINS |
RICHARD'S MEDICAL EQUIP., INC. |
|
K811035 |
04/16/1981 |
PRO COMFORT TENNIS ELBOW SUPPORT/WRIST |
SCHOLL, INC. |
|
K810959 |
04/08/1981 |
"SECURE" |
SCI-PHARM, INC. |
|
K811098 |
04/22/1981 |
SERO-STAT STAPHYLOCOCCUS TEST |
SCOTT LABORATORIES, INC. |
|
K811141 |
04/27/1981 |
SECHRIST INFANT VENTRILATOR MODEL IV-100 |
SECHRIST INDUSTRIES, INC. |
|
K811065 |
04/17/1981 |
PISTON SYRINGE |
SHERWOOD MEDICAL CO. |
|
K811033 |
04/15/1981 |
SHILEY LOW PRESSURE THIN-CUFFED TRACH |
SHILEY, INC. |
|
K811013 |
04/15/1981 |
SUMMAR NON-PRECIOUS, CERAMIC ALLOY |
SHOFU DENTAL CORP. |
|
K811149 |
04/27/1981 |
PANDOROS 1200A |
SIEMENS CORP. |
|
K811102 |
04/21/1981 |
SIEMENS-ELEMA AB SERVO VENTILATOR 900 C |
SIEMENS ELEMA AB |
|
K810974 |
04/10/1981 |
GAMMA CAMERA |
SIEMENS GAMMASONICS, INC. |
|
K811011 |
04/15/1981 |
HISTOCHEMICAL DEMONSTRATION OF LEUKOCYTE |
SIGMA CHEMICAL CO. |
|
K810914 |
04/06/1981 |
5CM SMALL PARTS SCANNER |
SMITH KLINE DIAGNOSTICS, INC. |
|
K811184 |
04/29/1981 |
SPENCO DERMAL PADS |
SPENCO MEDICAL CORP. |
|
K811167 |
04/28/1981 |
FOCUS STERILE SYRINGES |
STANFORD LABORATORIES |
|
K811006 |
04/14/1981 |
SOLUTION ADMINISTRATION SET |
SURU CHEMICALS & PHARMACEUTICALS, LTD. |
|
K810900 |
04/03/1981 |
CASTLE PROCEDURE AND RITTER EXAM. TABLES |
SYBRON CORP. |
|
K811034 |
04/16/1981 |
EMIT-CAD N-ACETYLPROCAINAMIDE ASSAY |
SYVA CO. |
|
K810899 |
04/03/1981 |
TECHNICON AUTOGROUPER 16-C SYSTEM |
TECHNICON INSTRUMENTS CORP. |
|
K811196 |
04/30/1981 |
ALLMEC 90/15 |
TECNOMED, INC. |
|
K811195 |
04/30/1981 |
ARGOSTAT |
TECNOMED, INC. |
|
K811197 |
04/30/1981 |
SUPERIX 120 |
TECNOMED, INC. |
|
K811092 |
04/21/1981 |
STERILE PACKAGING |
TELECTRONICS, INC. |
|
K811031 |
04/16/1981 |
TELESONIC & ARCON |
TELESONIC, INC. |
|
K811081 |
04/21/1981 |
MEDULLARY CANAL SCRAPERS |
THE ANSPACH EFFORT, INC. |
|
K811115 |
04/23/1981 |
SUPERFLOW CANNULA FOR ARTHROS. SURGERY |
THE ANSPACH EFFORT, INC. |
|
K810888 |
04/02/1981 |
BOUNDARY TUBING HOLDERS |
THE BUCKEYE CELLULOSE CORP. |
|
K811176 |
04/28/1981 |
TIGGES SPINAL |
THE TIGGS CO. |
|
K811078 |
04/20/1981 |
RADIATION STERILIZED ADMIN. SET |
TRAVENOL LABORATORIES, S.A. |
|
K811174 |
04/28/1981 |
HEARING AID, UNITRON MODEL C5-H |
UNITRON INDUSTRIES, INC. |
|
K810960 |
04/08/1981 |
NASOPHARYNGEAL AIRWAY |
VESTA, INC. |
|
K811148 |
04/27/1981 |
VITA-STAT MODEL 9000-S |
VIAT-STAT |
|
K811146 |
04/27/1981 |
VITA-STAT MODEL 8000-C |
VITA-STAT |
|
K811147 |
04/27/1981 |
VITA-STAT MODEL 9000-A |
VITA-STAT |
|
K810928 |
04/06/1981 |
ENDOCARDIAL ELECTRODE |
VITATRON MEDICAL BV |
|
K811166 |
04/28/1981 |
SURGICAL DRESSING SET |
WASHINGTON-GREENE COUNTY BRANCH PENNSYLVANIA ASSOC |
|
K811173 |
04/28/1981 |
STRUVA & MEDI |
WECO |
|
K811029 |
04/16/1981 |
SUNLAMP |
WILLIAMS & CONNOLLY |
|
K810997 |
04/13/1981 |
WORTHINGTON CK (NAC) REAGENT SET |
WORTHINGTON DIAGNOSTIC SYSTEMS |
|
K811110 |
04/23/1981 |
MODELS: 52-01-0, 52-01-1 |
Y |
|
K811005 |
04/14/1981 |
CORB TM COUNTERROTATING BIOPSY NEEDLE |
ZIMMER, INC. |
|