FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
K802242 |
09/16/1980 |
3M HI-STRENGTH MED. TAPE #1534 |
3M COMPANY |
|
K802131 |
09/04/1980 |
CYBREX LIDOCAINE |
ABBOTT LABORATORIES |
|
K802309 |
09/23/1980 |
MS-2 IDENTIFICATION SYSTEM |
ABBOTT LABORATORIES |
|
K802150 |
09/08/1980 |
DIGITAL RADIOGRAPHY SYSTEM |
ADAC LABORATORIES |
|
K802323 |
09/23/1980 |
PEDIATRIC OXYGEN OR AEROSOL MASKS, |
AIRLIFE, INC. |
|
K802297 |
09/19/1980 |
PORTADIAL CARRY-ON KIDNEY MACHINE |
ALAN P. KENDAL, PH.D. |
|
K802317 |
09/23/1980 |
COMFORT CUSHION DRY BURN PADS, STERILE |
AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL |
|
K802359 |
09/26/1980 |
DISP. FENESTRATED SURG. DRAPE SHEETS |
AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL |
|
K802143 |
09/05/1980 |
CH-60 PLUS /ABNORMAL LOW/BLOOD PLATELET |
AMERICAN DADE |
|
K802141 |
09/05/1980 |
CH-60 PLUS WHOLE BLOOD PLATELET CONTROL |
AMERICAN DADE |
|
K802142 |
09/05/1980 |
CH-60 PLUS WHOLE BLOOD PLATELET/ABNORNAL |
AMERICAN DADE |
|
K802366 |
09/29/1980 |
NU-BORN BABY BATH KIT |
AMERICAN HOSPITAL SUPPLY CORP. |
|
K802360 |
09/26/1980 |
UTERINE VACUM ASPIRATING CURRETTE |
AMERICAN HOSPITAL SUPPLY CORP. |
|
K802379 |
09/30/1980 |
HEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZER |
AMERICAN INSTRUMENT CO. |
|
K802091 |
09/02/1980 |
AMERICAN MONITOR MAGNESIUM #'S 1036&4021 |
AMERICAN MONITOR CORP. |
|
K802331 |
09/23/1980 |
AO FLEXIBLE LARYNGOSCOPE, #LS-7 |
AMERICAN OPTICAL CORP. |
|
K802183 |
09/09/1980 |
SR-IV PROGRAMMED SUBJECTIVE REFRACTOR |
AMERICAN OPTICAL CORP. |
|
K802088 |
09/02/1980 |
AUXILIARY TRAY |
AMERICAN PHARMASEAL DIV. AHSC |
|
K802340 |
09/26/1980 |
SPECIMEN SET |
AMERICAN PHARMASEAL DIV. AHSC |
|
K802097 |
09/02/1980 |
SELF-RECORDING ADMITTANCE METER 709 |
AMPLAID USA, INC. |
|
K802186 |
09/10/1980 |
DISPOSABLE NURSES CAP |
ANAGO, INC. |
|
K802113 |
09/03/1980 |
SIRECUST 400 SYSTEM PATIENT MONITORING |
ANALOGIC CORP. |
|
K802312 |
09/23/1980 |
CC101 ECG MONITORING SYSTEM |
ANTHRO-METRICS CORP. |
|
K802335 |
09/23/1980 |
WHIRLPOOL BATHING UNIT-#2001 |
AQUA CARE CORP. |
|
K802367 |
09/29/1980 |
ARROW CATHETER CLAMP |
ARROW INTL., INC. |
|
K802375 |
09/30/1980 |
AMPCO SKIN SCRUB TRAY |
ASSOCIATED MEDICAL PRODUCTS CO. |
|
K802166 |
09/08/1980 |
MODEL AS* 7B AUTOSYRINGE INFUSION PUMP |
BAXTER HEALTHCARE CORP. |
|
K802136 |
09/04/1980 |
DELTA TEST TRIGLYCERIDES |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K802194 |
09/10/1980 |
MINOCYCLINE 30MCG. SENSI DISC |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K802273 |
09/17/1980 |
TELEMETRY TRANSMITTER, #TLT-3 |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
|
K802339 |
09/26/1980 |
EIA RUBELLA-G |
BECKMAN INSTRUMENTS, INC. |
|
K802133 |
09/04/1980 |
BENTLEY THEROMODILUTION CATHETER #BTD-7F |
BENTLEY LABORATORIES, INC. |
|
K802378 |
09/30/1980 |
QUICK PRIME LINES, #'S BPL-12, BPL-48 & |
BENTLEY LABORATORIES, INC. |
|
K802244 |
09/16/1980 |
VESSEL RETRACTOR, #600732 |
BENTLEY LABORATORIES, INC. |
|
K802092 |
09/02/1980 |
HF-100 DIALYZER |
BIO-MED CORP. |
|
K802356 |
09/26/1980 |
VON WILLEBRAND FACTOR ASSAY |
BIO/DATA CORP. |
|
K802127 |
09/03/1980 |
BACITRACIN DIFFERENTIATION DISC |
BIOMEDIA, INC. |
|
K802198 |
09/10/1980 |
BIOMETRIC SYSTOLIC TIME INTERVAL SYSTEM |
BIOMETRIC ANALYSIS GROUP, INC. |
|
K802227 |
09/12/1980 |
ANASTIM II TRANSCUTANEOUS ELECTRICAL |
BIOSTIM, INC. |
|
K802276 |
09/18/1980 |
FTA-ABS BIOPAK |
BIOWARE PRODUCTS |
|
K802299 |
09/19/1980 |
K/K (ASMA/ANA) UNIVERSAL BIOPAK |
BIOWARE PRODUCTS |
|
K802308 |
09/23/1980 |
T/K (ATA/AMA) UNIVERSAL BIOPAK |
BIOWARE PRODUCTS |
|
K802087 |
09/02/1980 |
BABYBIRD 2 VENTILATOR |
BIRD PRODUCTS CORP. |
|
K802304 |
09/23/1980 |
SOLAR TONE |
BLOOMEX INTERNATIONAL, INC. |
|
K802371 |
09/29/1980 |
URIC ACID/ALDH |
BOEHRINGER MANNHEIM CORP. |
|
K802118 |
09/04/1980 |
BEAR 2 ADULT VOL. VENTILATOR |
BOURNS MEDICAL SYSTEMS, INC. |
|
K802153 |
09/08/1980 |
CBC PAP TEST KIT |
CALBIOCHEM-BEHRING CORP. |
|
K802102 |
09/03/1980 |
RUBELLA ELISA REAGENTS RUBELLA IGG ANTI |
CALBIOCHEM-BEHRING CORP. |
|
K802089 |
09/02/1980 |
CARDIOTRAK |
CARDIAC PACEMAKERS, INC. |
|
K802352 |
09/25/1980 |
MICRO THIN-DII, #0521 |
CARDIAC PACEMAKERS, INC. |
|
K802353 |
09/25/1980 |
MICRO THIN-PII, #0523 |
CARDIAC PACEMAKERS, INC. |
|
K802230 |
09/16/1980 |
BELLCO SINGLE NEEDLE DOUBLE HEAD PUMP |
CARDIO MED SUPPLIES, INC. |
|
K802250 |
09/16/1980 |
DIALYSIS CONTROL UNIT-CENTRY 2000 |
COBE LABORATORIES, INC. |
|
K802137 |
09/04/1980 |
CHEEK EPIDURAL SCREW |
CODMAN & SHURTLEFF, INC. |
|
K802138 |
09/04/1980 |
CHEEK TOOL SET |
CODMAN & SHURTLEFF, INC. |
|
K802256 |
09/16/1980 |
TRIGLYCERIDES DETERMINATION |
COLEMAN LABORATORIES CORP. |
|
K802269 |
09/17/1980 |
FIGURETRIM |
COLNE MEDICAL CO. LTD. |
|
K802272 |
09/17/1980 |
COMPUTER ECG TERMINAL |
COMPUMED, INC. |
|
K802282 |
09/19/1980 |
ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON |
CONSOLIDATED MEDICAL EQUIPMENT, INC. |
|
K802221 |
09/12/1980 |
CHRONOCOR IV MODEL 250 |
CORDIS CORP. |
|
K802301 |
09/22/1980 |
CORDIS DOW INFUSION PUMP |
CORDIS CORP. |
|
K802338 |
09/26/1980 |
TORQUE CONTROL BALLOON CATHETER |
CORDIS CORP. |
|
K803060 |
09/12/1980 |
FOLATE 125I RADIOIMMUNOASSAY |
CORNING MEDICAL & SCIENTIFIC |
|
K802220 |
09/12/1980 |
VITAMIN B12 (57CO) RADIOIMMUNOASSAY |
CORNING MEDICAL & SCIENTIFIC |
|
K802320 |
09/23/1980 |
COULTER DACOS SERUM CHEM. ANALYZER |
COULTER ELECTRONICS, INC. |
|
K802208 |
09/11/1980 |
LEUKOCYTE VOL. ANALYSIS APPARATUS |
COULTER ELECTRONICS, INC. |
|
K802214 |
09/12/1980 |
COS-UPHOFF INT'L DS-5 DRAINAGE SYSTEM |
COX-UPHUFF INTL. |
|
K802185 |
09/10/1980 |
ARTERIAL BLOOD SAMPLING KIT |
CURRENT TECHNOLOGIES, INC. |
|
K802237 |
09/15/1980 |
CORROSION PROOF DUAL PURPOSE ECG WIRES |
CUSTOM CARDIO COMPONENTS |
|
K802236 |
09/15/1980 |
CORROSION PROOF SNAP ECG CONNECT WIRES |
CUSTOM CARDIO COMPONENTS |
|
K802105 |
09/03/1980 |
C-BLADE |
CUTTER LABORATORIES, INC. |
|
K802104 |
09/03/1980 |
C-SPLINT |
CUTTER LABORATORIES, INC. |
|
K802325 |
09/23/1980 |
CRITERION II PACING SYSTEM MONITORS |
DART MEDICAL EQUIPMENT |
|
K802167 |
09/08/1980 |
PERCOR DATASCOPE INTRA-AORTIC BALLOON |
DATASCOPE CORP. |
|
K802362 |
09/26/1980 |
ALGINATE IMPRESSION MATERIAL |
DENTSPLY INTL. |
|
K802125 |
09/04/1980 |
ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE |
DENTSPLY INTL. |
|
K802178 |
09/09/1980 |
MINOCYCLINE 30 MCG. SENSITIVITY DISCS |
DIFCO LABORATORIES, INC. |
|
K802140 |
09/04/1980 |
LEKSELL STEREOTACTIC SYSTEM |
DOWNS SURGICAL LTD. |
|
K803162 |
09/04/1980 |
X-RAY STAND & OPERATING CHAIR |
DOWNS SURGICAL LTD. |
|
K802168 |
09/08/1980 |
DRAGER AV2 ANESTHESIA VENTILATOR |
DRAEGER MEDICAL, INC. |
|
K802090 |
09/02/1980 |
DRAGER PRESSURE MONITOR, SELF-DIAGNOSTIC |
DRAEGER MEDICAL, INC. |
|
K802139 |
09/04/1980 |
SPATULA, CERVICAL CYTOLOGICAL CYTOLOGY |
DYN-A-MED PRODUCTS |
|
K802173 |
09/09/1980 |
URIHESIVE STRIPS |
E. R. SQUIBB & SONS, INC. |
|
K802172 |
09/09/1980 |
URIHESIVE SYSTEM |
E. R. SQUIBB & SONS, INC. |
|
K802270 |
09/17/1980 |
PROTECTIVE BAR FOR THE MA-1VENTILATOR |
EASTERN ANESTHESIA, INC. |
|
K802376 |
09/30/1980 |
KODAK EKTA-CHEM CLINICAL CHEM. SLIDES |
EASTMAN KODAK COMPANY |
|
K802171 |
09/09/1980 |
KODAK ORTHO L FILM |
EASTMAN KODAK COMPANY |
|
K802107 |
09/03/1980 |
EGS #300 BATTERY OPER. PORTA. MUSCLE STI |
ELECTRO-MED HEALTH INDUSTRIES, INC. |
|
K802374 |
09/29/1980 |
ROBERTSON OBTURATION MONITOR INSUFFLA |
ENDOTEK CORP. |
|
K802254 |
09/16/1980 |
GENERAL ULTRASOUND EXAM. TABLE |
ENGINEERING DYNAMICS CORP. |
|
K802364 |
09/29/1980 |
EXTRACORPOREAL'S EXP 400 PARALLEL PLATE |
EXTRACORPOREAL MEDICAL SPECIALITIES, INC. |
|
K802381 |
09/29/1980 |
LEWICKY ANTERIOR CHAMBER MAINTEN. SYS. |
FIBRA SONICS, INC. |
|
K802303 |
09/23/1980 |
VIRAL TRANSPORT MED. (46-995-04) |
FLOW LABORATORIES, INC. |
|
K802213 |
09/12/1980 |
WHITE KNIGHT BOVIE CORD/SUCTION TUBE |
G.D. SEARLE AND CO. |
|
K802280 |
09/18/1980 |
WHITE KNIGHT DRAPE SEAL |
G.D. SEARLE AND CO. |
|
K802389 |
09/29/1980 |
GAMBRO LUNDIA PLATE DISP. DIALYZER |
GAMBRO, INC. |
|
K802117 |
09/04/1980 |
FIBRI QUIK |
GENERAL DIAGNOSTICS |
|
K802103 |
09/03/1980 |
ECG RECALL & EDIT PRODUCT VERSION-A3601 |
GENERAL ELECTRIC CO. |
|
K802316 |
09/23/1980 |
PDS THERMAL DILUTION CARDIAC MODULE(OUT) |
GENERAL ELECTRIC CO. |
|
K802231 |
09/15/1980 |
AIR VIVA II |
GENERAL MEDICAL CO. |
|
K802332 |
09/23/1980 |
INTRAJECT |
GENERAL MEDICAL ENGINEERING CORP. |
|
K802313 |
09/23/1980 |
UTERINE CURETTE |
GYNEMETRICS, INC. |
|
K802315 |
09/23/1980 |
UTERINE SOUND |
GYNEMETRICS, INC. |
|
K802334 |
09/23/1980 |
IN-HOME EARLY PREGNANCY TEST KIT |
HEALTH DIAGNOSTICS CORP. |
|
K802205 |
09/11/1980 |
ECG/RESPIRATION STIMULATOR |
HEALTHDYNE, INC. |
|
K802350 |
09/25/1980 |
ATTENU-CHEK |
HEAR CO., INC. |
|
K802307 |
09/23/1980 |
WIDEX HEARING AID #'S A12+T & A12+H |
HEARING AID CO. |
|
K802306 |
09/23/1980 |
WIDEX HEARING AID #'S A18+T & A18+H |
HEARING AID CO. |
|
K802232 |
09/15/1980 |
AB-TROL COAGULATION CONTROL |
HELENA LABORATORIES |
|
K802233 |
09/15/1980 |
GLYCOSYLATED HEMOGLOBIN-SMC COLUMN |
HELENA LABORATORIES |
|
K802109 |
09/03/1980 |
KEMTROL SERUM CONTROL ABNORMAL |
HELENA LABORATORIES |
|
K802108 |
09/03/1980 |
KEMTROL SERUM CONTROL-NORMAL |
HELENA LABORATORIES |
|
K802191 |
09/10/1980 |
ATGM MODEL AT-80 |
HERALD OF AMERICA, INC. |
|
K802264 |
09/16/1980 |
WASH SOLUTION KIT, #88102 |
HI CHEM, INC. |
|
K802093 |
09/02/1980 |
GABBAY-FRATER SUTURE GUIDE |
HOWMEDICA CORP. |
|
K802124 |
09/04/1980 |
GRISTINA GLENOID PROSTHESIS |
HOWMEDICA CORP. |
|
K802106 |
09/03/1980 |
LEWIS TRAPEZO METACARPAL PROSTHESIS |
HOWMEDICA CORP. |
|
K802235 |
09/15/1980 |
MICRO-BOND HI-LIFE PROCELAIN & VIVERE |
HOWMEDICA CORP. |
|
K802123 |
09/04/1980 |
MONOSPHERICAL SHOULDER PROSTHESIS |
HOWMEDICA CORP. |
|
K802253 |
09/16/1980 |
AIR COMPRESSOR ADAPTOR KIT |
HUDSON OXYGEN THERAPY SALES CO. |
|
K802203 |
09/11/1980 |
CM-700A AUTO-INFLATE CONTROL MODULE |
INDUSTRIAL & BIOMEDICAL SENSORS CORP. |
|
K802204 |
09/11/1980 |
CT-1600 DIGITAL PULSE RATE MONITOR |
INDUSTRIAL & BIOMEDICAL SENSORS CORP. |
|
K802201 |
09/11/1980 |
SD-700 BLOOD PRESSURE MONITOR |
INDUSTRIAL & BIOMEDICAL SENSORS CORP. |
|
K802202 |
09/11/1980 |
SD-800 BLOOD PRESSURE MONITOR |
INDUSTRIAL & BIOMEDICAL SENSORS CORP. |
|
K802218 |
09/12/1980 |
SD-900 OSCILLOMETRIC BP MONITOR |
INDUSTRIAL & BIOMEDICAL SENSORS CORP. |
|
K802132 |
09/03/1980 |
105MM SPOT FILM CAMERA |
INSTRUMENTATION CAMERA, INC. |
|
K802310 |
09/23/1980 |
IL TOTAL PROTEIN REAGENT |
INSTRUMENTATION LABORATORY CO. |
|
K802294 |
09/19/1980 |
POLY FLEX IMPLANTABLE PACING LEAD |
INTERMEDICS, INC. |
|
K802295 |
09/19/1980 |
POLY FLEX IMPLANTABLE PACING LEAD |
INTERMEDICS, INC. |
|
K802293 |
09/19/1980 |
POLYFLEX IMPLANTABLE PACING LEAD |
INTERMEDICS, INC. |
|
K802357 |
09/26/1980 |
TELEMETRY PACEMAKER MONITOR |
INTERMEDICS, INC. |
|
K802343 |
09/26/1980 |
PREGNA B-ANTI HUMAN CHORIONIC GONADOTRO |
INTL. DIAGNOSTIC, INC. |
|
K802348 |
09/25/1980 |
TRIAXIAL |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
|
K802283 |
09/19/1980 |
ANTISERA TO HUMAN FREE KAPPA CHAINS |
KALLESTAD LABORATORIES, INC. |
|
K802284 |
09/19/1980 |
ANTISERA TO HUMAN FREE LAMBDA LIGHT CH. |
KALLESTAD LABORATORIES, INC. |
|
K802228 |
09/10/1980 |
BIOLOGICAL INDICATOR - KEMMED & BIOSURE |
KEM MEDICAL PRODUCTS CORP. |
|
K802229 |
09/10/1980 |
CHEMICAL INDICATOR - KEM MED & BIO SURE |
KEM MEDICAL PRODUCTS CORP. |
|
K802225 |
09/12/1980 |
TENDER-SORB DRAIN SPONGES |
KENDALL RESEARCH CENTER |
|
K802277 |
09/18/1980 |
KOTEX LIGHTDAYS DEODORANT PANTILINERS |
KIMBERLY-CLARK CORP. |
|
K802193 |
09/10/1980 |
KOTEX SECURITY TUBE TAMPONS |
KIMBERLY-CLARK CORP. |
|
K802262 |
09/16/1980 |
COMPOSITE RESTORATIVE |
L.D. CAULK CO. |
|
K802373 |
09/29/1980 |
SURGICAL FACE MASK |
LOUIS M. GERSON CO., INC. |
|
K802181 |
09/09/1980 |
WISCONSIN BONE MINERAL ANALYZER |
LUNAR RADIATION CORP. |
|
K802180 |
09/09/1980 |
WISCONSIN DUAL-PHOTON BONE ANALYZER |
LUNAR RADIATION CORP. |
|
K802182 |
09/09/1980 |
WISCONSIN HEART RATE MONITOR |
LUNAR RADIATION CORP. |
|
K802319 |
09/23/1980 |
HEMOTEMP TM |
MARION LABORATORIES, INC. |
|
K802234 |
09/15/1980 |
BEDSIDE TINNITUS MASKER #1500 |
MARPAC, INC. |
|
K802369 |
09/29/1980 |
12SSL ECG ANALYSIS PROG.(SCALER LEAD) |
MARQUETTE ELECTRONICS, INC. |
|
K802368 |
09/29/1980 |
OPTION 301 PACEMAKER EVAL. MODULE MAC-1 |
MARQUETTE ELECTRONICS, INC. |
|
K802361 |
09/26/1980 |
DIALYIS START CARE KIT |
MED-PAK CORP. |
|
K802216 |
09/12/1980 |
VIEW-LITE, MODEL-DL |
MED-WESTERN ELECTRONICS, INC. |
|
K802215 |
09/12/1980 |
VIEW-LITE, MODEL-S |
MED-WESTERN ELECTRONICS, INC. |
|
K802217 |
09/12/1980 |
VIEW-LITE, MODEL-SL |
MED-WESTERN ELECTRONICS, INC. |
|
K802223 |
09/12/1980 |
QUINTREX 0515 PROGRAMMABLE PULSE GEN. |
MEDCOR, INC. |
|
K802224 |
09/12/1980 |
QUINTREX 0516 PROG. PULSE GENERATOR SYS |
MEDCOR, INC. |
|
K802330 |
09/23/1980 |
HI-TEMP LOOPTIP SURGICAL CAUTERY |
MEDICAL PRODUCTS DEVELOPMENT, INC. |
|
K802184 |
09/10/1980 |
HS10 PORTABLE OPERATING ROOM MONITOR |
MEDTEL PTY. LTD. |
|
K802355 |
09/25/1980 |
METRICON #120 FLUOROPHOTOMETER |
METRICON, LTD. |
|
K802255 |
09/16/1980 |
AMES TDA PHENOBARBITAL TEST |
MILES LABORATORIES, INC. |
|
K802351 |
09/25/1980 |
F110 PHOTO BINOCULAR OPHTHALMOSCOPE |
MINAMI, TOMINE & LEW |
|
K802377 |
09/30/1980 |
MOTI PROTECTIVE X-RAY MASK |
MOTI ENTERPRISES, INC. |
|
K802134 |
09/04/1980 |
JK INT'L, INC. SOLTRON UVA TANNING BED |
MOTTEK INTL. CORP. |
|
K802126 |
09/04/1980 |
ISOLETTE INCUBATOR C-100 |
NARCO AIR-SHIELDS |
|
K802149 |
09/08/1980 |
TM-5 INTRACRANIAL PRESSURE MONITOR |
NICOLET BIOMEDICAL INSTRUMENTS |
|
K802305 |
09/23/1980 |
MLC-4200 CARDIAC OUTPUT COMPUTER |
NIHON KOHDEN AMERICA, INC. |
|
K802322 |
09/23/1980 |
MODEL SD-1 DISINTEGRATOR |
NORTHGATE RESEARCH, INC. |
|
K802300 |
09/22/1980 |
VIVONEX JEJUNOSTOMY KIT |
NORWICH EATON PHARMACEUTICALS, INC. |
|
K802120 |
09/04/1980 |
HEPA-SHURE -L |
NUCLEAR MEDICAL LABORATORIES, INC. |
|
K802365 |
09/29/1980 |
OHIO RADIANT WARMER |
OHIO MEDICAL PRODUCTS |
|
K802285 |
09/19/1980 |
OHIO THORACIC SUCTION REGULATOR |
OHIO MEDICAL PRODUCTS |
|
K802187 |
09/10/1980 |
STERILE DISPOSABLE CYTOLOGY BRUSH |
OLYMPUS CORP. |
|
K802206 |
09/11/1980 |
OMNI SCANNER CT 6000 |
OMNIMEDICAL |
|
K802263 |
09/16/1980 |
MINIVISOR TERMINAL |
ORGANON TEKNIKA CORP. |
|
K802114 |
09/03/1980 |
NEPHROSS DIALYZER |
ORGANON TEKNIKA CORP. |
|
K802358 |
09/26/1980 |
OREIA-Q-DIG |
ORGANON, INC. |
|
K802094 |
09/02/1980 |
ORTHO SPECTRUM |
ORTHO INSTRUMENTS |
|
K802164 |
09/08/1980 |
8-HYDROXYQUINOLINE, CRESOLPHTHALEIN COM. |
PANMED, INC. |
|
K802159 |
09/08/1980 |
AMMONIUM MOLYBDATE INORGANIC PHOSPHORUS |
PANMED, INC. |
|
K802157 |
09/08/1980 |
BCG REAGENT SERUM ALBUMIN W/TECHNICON |
PANMED, INC. |
|
K802161 |
09/08/1980 |
BIURET REAGENT & TOTAL PROTEIN BLANK SOL |
PANMED, INC. |
|
K802160 |
09/08/1980 |
BUN COLOR REAGENT & BUN ACID USED |
PANMED, INC. |
|
K802163 |
09/08/1980 |
CHLORIDE COLOR & CHLORIDE SAMPLE DILUENT |
PANMED, INC. |
|
K802162 |
09/08/1980 |
CO2 COLOR REAGENT & CO2 SAMPLE DILUENT |
PANMED, INC. |
|
K802158 |
09/08/1980 |
POSTASSIUM BUFFER SOL. & WASH SOLUTION |
PANMED, INC. |
|
K802156 |
09/08/1980 |
REAGENTS SERUM CREATINE USING TECHICON |
PANMED, INC. |
|
K802155 |
09/08/1980 |
REAGENTS SERUM SODIUM USING THE TECH. |
PANMED, INC. |
|
K802154 |
09/08/1980 |
REAGENTS USED-QUAN. MEASURE OF SERUM |
PANMED, INC. |
|
K802146 |
09/05/1980 |
AQUASONIC 100 ULTRASOUND TRANS. GEL, |
PARKER LABORATORIES, INC. |
|
K802337 |
09/26/1980 |
PHADEBACT PNEUMOCOCCUS TEST |
PHARMACIA, INC. |
|
K802101 |
09/03/1980 |
I.V. SENTRY ALARM DEVICE |
PIKE MEDICAL CO. |
|
K802148 |
09/08/1980 |
BOUNDARY SINGLE-USE DRAPE |
PROCTER & GAMBLE MFG. CO. |
|
K802192 |
09/10/1980 |
BOUNDARY SINGLE-USE DRAPES |
PROCTER & GAMBLE MFG. CO. |
|
K802247 |
09/16/1980 |
BOUNDARY SINGLE-USE DRAPES |
PROCTER & GAMBLE MFG. CO. |
|
K802249 |
09/16/1980 |
MICROLET FAMILY OF NEEDLE/DEPTH ELECT- |
PROGRESS MANKIND TECHNOLOGY |
|
K802152 |
09/08/1980 |
PMT DEPTHALON DEPTH " " #2102 |
PROGRESS MANKIND TECHNOLOGY |
|
K802151 |
09/08/1980 |
PMT DEPTHALON DEPTH CORTICOGRAPHY ELEC |
PROGRESS MANKIND TECHNOLOGY |
|
K802243 |
09/16/1980 |
VAXIOM FAMILY OF RF LESION PROBES & ELEC |
PROGRESS MANKIND TECHNOLOGY |
|
K802196 |
09/10/1980 |
GOAT ANTI-HUMAN COMPLEMENT C4 |
PROTOS LABORATORIES |
|
K802257 |
09/16/1980 |
GOAT ANTI-HUMAN IGG GAMMA CHAIN SPECIFIC |
PROTOS LABORATORIES |
|
K802177 |
09/09/1980 |
GOAT ANTI-HUMAN IGM |
PROTOS LABORATORIES |
|
K802100 |
09/03/1980 |
INTRACRANIAL PRESSURING MONITORING SYST. |
PUDENZ-SCHULTE MEDICAL RESEARCH CORP. |
|
K802116 |
09/04/1980 |
ANESTHESIA GAS MACHINE |
PURITAN BENNETT CORP. |
|
K802112 |
09/03/1980 |
PA-1 LOW PRESSURE ALARM |
PURITAN BENNETT CORP. |
|
K802190 |
09/10/1980 |
MODEL 633A THREE CHANNEL STRESS TEST |
QUINTON, INC. |
|
K802265 |
09/16/1980 |
CBC PLT-4 |
R & D SYSTEMS, INC. |
|
K802268 |
09/16/1980 |
CRC(CYANMETHEMOGLOBIN REAGENT CONCENT |
R & D SYSTEMS, INC. |
|
K802266 |
09/16/1980 |
HGB3 (1:251) |
R & D SYSTEMS, INC. |
|
K802267 |
09/16/1980 |
PLT-4 SIZE-CHECK |
R & D SYSTEMS, INC. |
|
K802195 |
09/10/1980 |
DEHYDROEPIANDROSTERONE SULFATE KIT RIA |
RADIOASSAY SYSTEMS LABORATORIES, INC. |
|
K802135 |
09/04/1980 |
TESTOSTERONE RADIOIMMUNOASSY KIT |
RADIOIMMUNOASSAY, INC. |
|
K802207 |
09/11/1980 |
RION DIAGNOSTIC AUDIOMETER |
RION ACOUSTIC INSTRUMENTS, INC. |
|
K802354 |
09/25/1980 |
PROPHYLACTIC W/SPERMICIDAL LUBRICANT |
SCHMID LABORATORIES, INC. |
|
K802333 |
09/23/1980 |
INSTANT BRIDGE |
SCIENTIFIC PHARMACEUTICALS, INC. |
|
K802210 |
09/12/1980 |
CONICAL TIPPED CENTRIFUGE TUBE 15M |
SCIENTIFIC SPECIALTIES, INC. |
|
K802211 |
09/12/1980 |
SERUM SEPARATOR |
SCIENTIFIC SPECIALTIES, INC. |
|
K802209 |
09/12/1980 |
SURETY COLUMN |
SCIENTIFIC SPECIALTIES, INC. |
|
K802226 |
09/12/1980 |
SECHRIST SERIES 3500 AIR-OXYGEN MIXER |
SECHRIST INDUSTRIES, INC. |
|
K802286 |
09/19/1980 |
ARGLE LATEX PENROSE TUBING |
SHERWOOD MEDICAL CO. |
|
K802318 |
09/23/1980 |
ARGYLE SILICONE THORACIC CATHETER |
SHERWOOD MEDICAL CO. |
|
K802174 |
09/09/1980 |
ARGYLE SUCTION CANISTER W/DISP. LINER |
SHERWOOD MEDICAL CO. |
|
K802281 |
09/19/1980 |
SHERWOOD NANO-MIST NEBULIZER W/MOUTHPIEC |
SHERWOOD MEDICAL CO. |
|
K802165 |
09/08/1980 |
SHERWOOD VENTILATORY MUSCLE TRAINER |
SHERWOOD MEDICAL CO. |
|
K802147 |
09/05/1980 |
SHILEY TEMPERATURE MONITOR |
SHILEY, INC. |
|
K802119 |
09/04/1980 |
SHILEY UTILITY RESERVOIR |
SHILEY, INC. |
|
K802296 |
09/19/1980 |
MINGOGRAF EEG10 |
SIEMENS CORP. |
|
K802292 |
09/19/1980 |
MINGOGRAF EEG21 |
SIEMENS CORP. |
|
K802200 |
09/11/1980 |
VERTIX 3D-U |
SIEMENS CORP. |
|
K802252 |
09/16/1980 |
HOT CYCLE, A CHEMICAL TYPE HOT PACK |
SIGNAL WEST |
|
K802341 |
09/26/1980 |
DIOSCAN |
SONOMETRICS SYSTEMS, INC. |
|
K802328 |
09/23/1980 |
DISP. TOUGY-BORST TYPE ADAPTOR W/PORT |
STANCO MEDICAL, INC. |
|
K802329 |
09/23/1980 |
DISPOSABLE CONSTRAST DELIVERY SPIKE KIT |
STANCO MEDICAL, INC. |
|
K802289 |
09/19/1980 |
PERICARDIOCENTESIS KIT |
STANCO MEDICAL, INC. |
|
K802261 |
09/16/1980 |
PRESSURE GAUGE ACCESSORY KIT/DILATATION |
STANCO MEDICAL, INC. |
|
K802326 |
09/23/1980 |
PRESSURE MONITORING LINES |
STANCO MEDICAL, INC. |
|
K802290 |
09/19/1980 |
REGIONAL INTRAVENOUS ANESTHESIA KIT |
STANCO MEDICAL, INC. |
|
K802287 |
09/19/1980 |
RIGHT ATRIAL LINE KIT |
STANCO MEDICAL, INC. |
|
K802327 |
09/23/1980 |
SHEATH DILATOR SET |
STANCO MEDICAL, INC. |
|
K802258 |
09/16/1980 |
STOPCOCK 2-WAY, 3-WAY & 4-WAY |
STANCO MEDICAL, INC. |
|
K802288 |
09/19/1980 |
SWAN GANZ CATHETER PLACEMENT KIT |
STANCO MEDICAL, INC. |
|
K802259 |
09/16/1980 |
TRANSVENOUS PACEMAKER ELECTRODE KIT |
STANCO MEDICAL, INC. |
|
K802260 |
09/16/1980 |
VASCULAR CATHETER WIREGUIDES |
STANCO MEDICAL, INC. |
|
K802291 |
09/19/1980 |
FLUORESCENT SUN LAMP FIXTURE |
STRATO-RAY CO. |
|
K802278 |
09/12/1980 |
IN VITRO DIAGNOSTIC STANDARDS |
SUPELCO, INC. |
|
K802170 |
09/08/1980 |
SURU BLOOD COLLECTION SET |
SURU CHEMICALS & PHARMACEUTICALS, LTD. |
|
K802169 |
09/08/1980 |
SURU INFUSION SET TYPE J |
SURU CHEMICALS & PHARMACEUTICALS, LTD. |
|
K802342 |
09/26/1980 |
PROXIMAL INTERPHALANGEAL JOINT IMPLANT |
SUTTER BIOMEDICAL, INC. |
|
K802245 |
09/16/1980 |
7 TRICYCLIC ANTIDE PRESSANTS |
TECHNICON INSTRUMENTS CORP. |
|
K802246 |
09/16/1980 |
ANALYTE T3 UPTAKE |
TECHNICON INSTRUMENTS CORP. |
|
K802179 |
09/09/1980 |
CARDIOSCOPE J200 |
TELECTRONICS, INC. |
|
K802175 |
09/09/1980 |
IMPLANTABLE VENTRICULAR-INHIBITED CARDI |
TELECTRONICS, INC. |
|
K802122 |
09/04/1980 |
CLIRANS TH13 HOLLOW FIBER DIALYZER |
TERUMO AMERICA, INC. |
|
K802271 |
09/17/1980 |
THE IMMOBILIZER FOR OPEN & ARTHROSCOPIC |
THE ANSPACH EFFORT, INC. |
|
K802311 |
09/23/1980 |
MO8 OXYGEN FLOWMETER |
TIMETER INSTRUMENT CORP. |
|
K802145 |
09/05/1980 |
2C 7140 HEATED HUMIDIFER CANNISTER |
TRAVENOL LABORATORIES, S.A. |
|
K802144 |
09/05/1980 |
2M8101 HEATED LIQUID LEVEL CONTROLLER |
TRAVENOL LABORATORIES, S.A. |
|
K802189 |
09/10/1980 |
DENTLOID |
U.S. SHIZAI CORP. |
|
K802199 |
09/10/1980 |
STAT-CRIT HEMATOCRIT MEASURING INSTRU |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
|
K802248 |
09/16/1980 |
DISARP ORIGINAL |
UNOPLAST A/S |
|
K802251 |
09/16/1980 |
SP 120 SOPHISTICATE |
VICKERS AMERICA MEDICAL CORP. |
|
K802279 |
09/18/1980 |
VIDA 55 PULSE-ECHO ULTRASONIC DEVICE |
VIDA, INC. |
|
K802095 |
09/02/1980 |
GORE-TEX VASCULAR GRAFT |
W.L. GORE & ASSOCIATES,INC |
|
K802324 |
09/23/1980 |
E1 SERIES HEARING AID |
WESTERN ADVANCED TECHNOLOGY, INC. |
|
K802222 |
09/12/1980 |
ANTERIOR KYPHOSIS DISTRACTION DEVICE |
ZIMMER, INC. |
|