Atlas FDA

1990

4,721 FDA 510(k) clearances · Clearance year

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RecordFirmDate
OSCILLOMETRIC PULSE DETECTION DEVICE (K902453)Thomas J. Fogarty, M.D.1990-08-23
MCR4000 & MCR4000F CARDIOTOMY RESERVOIR (K902355)Medtronic Vascular1990-08-23
MANAN ARTERIAL CATHETER NEEDLE (K900978)Manan Medical Products, Inc.1990-08-23
CENTRALSCOPE 12 (K901072)Marquette Electronics, Inc.1990-08-23
ACCUPROBE MYCOBACTERIUM AVIUM CULTURE TEST (K896494)Gen-Probe, Inc.1990-08-23
FUKUDA DENSHI MODEL FX-3101 (K901817)Fukuda Denshi USA, Inc.1990-08-23
IL THYROXINE (T4) ASSAY SYSTEM (K903095)Instrumentation Laboratory CO1990-08-23
LIQUICHEK CK/LD ISOENZYME CONTROL; LEVELS 1 AND 2 (K903430)Bio-Rad1990-08-23
CELL-DYN 3000 CONTROL (K902391)Unipath , Ltd.1990-08-22
PR CANNULAS (K902734)Olympus Corp.1990-08-22
MODIFIED FREEMAN ACETABULAR CUP (K902110)Turnkey Intergration USA, Inc.1990-08-22
MER MULTIPLANE RECTAL PROBE (MRP) (K901033)Medical Equipment Resources1990-08-22
METRICARE EMPTY CONTAINER SYSTEMS (K895922)Metrix Co.1990-08-22
ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER (K903316)Ge Medical Systems Information Technologies1990-08-22
1ST RESPONSE (TM) INFANT MANUAL RESUSCITATOR (K902733)Intertech Resources, Inc.1990-08-22
TRI-COUNT 16 (K902389)Hematronix, Inc.1990-08-22
STANBIO CSF/URINE TOTAL PROTEIN TEST SET (K902204)Stanbio Laboratory1990-08-22
NAVION SMART-WIRE(TM) CATHETER LOCATION SYSTEM (K901263)Navion Biomedical Corp.1990-08-22
IL TOBRAMYCIN ASSAY (K903192)Instrumentation Laboratory CO1990-08-22
REDITEST STREP A TEST KIT (K903194)Boehringer Mannheim Corp.1990-08-22
STEAMLINE (K895910)Propper Mfg. Co., Inc.1990-08-22
MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT (K903359)Immunotech Corp.1990-08-22
INNOFLUOR (TM) AMIKACIN CALIBRATOR SET (K903101)Innotron of Oregon, Inc.1990-08-22
LYMPHO SEP(TM) (K902445)Icn Biomedicals, Inc.1990-08-22
IL PHENYTOIN ASSAY SYSTEM (K902952)Instrumentation Laboratory CO1990-08-22
ORAL-NASAL MASK RESUSCITATION AND ANESTHETIC GAS (K902298)Rondex Products, Inc.1990-08-22
MULTI DOPPLEX, MD-1 (K900882)Huntleigh Technology, Inc.1990-08-22
HAEMOPHILUS TEST MEDIUM (HTM) BROTH (K903425)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-08-22
MODIFIED FREEMAN REVISION ACETABULAR CUP (K902111)Turnkey Intergration USA, Inc.1990-08-22
MAGNESIUM (K903341)Catachem, Inc.1990-08-22
KODATROL LIQUID CONTROL LEVELS I & II (K903189)Eastman Kodak Company1990-08-22
ULTRA-VU ANGIOSCOPE (K902329)Angiolaz, Inc.1990-08-22
GEOHESIVE (TM), MODEL NUMBERS 1022L, 1023L, 1026L (K903402)Medi-Source, Inc.1990-08-22
NATURAL-KNEE SYSTEM SYSTEM W/COCR/CSTI(TM) (K902335)Intermedics Orthopedics1990-08-22
FLORA-STAT URINE TRANSPORT SYSTEM (K902467)Wadley Biosciences Corp.1990-08-22
MER MULTIPLANE VAGINAL PROBE (MVP) (K901142)Medical Equipment Resources1990-08-22
CLP LOW LEVEL HDL CHOLESTEROL -LIPID CONTROL (K902909)Creative Laboratory Products, Inc.1990-08-22
EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA) (K902639)Incstar Corp.1990-08-22
GLOVE LEAK DETECTOR (K901237)Utah Medical Products, Inc.1990-08-21
CADD-PCA AMBULATORY INFUSION PUMPS (K896075)Pharmacia Deltec, Inc.1990-08-21
WHENEVER(R) UNSCENTED SUPER MAXI PAD (K901690)Marcal Paper Mills, Inc.1990-08-21
LUMISCOPE ALTERNATING PRESSURE PAD & PUMP (K901096)Lumiscope Co., Inc.1990-08-21
DANEK SACRAL HOOK (K901590)Danek Medical, Inc.1990-08-21
SCIVIEW SYSTEM, MODEL SC1250 AND PIXIE IMAGING SOF (K901422)Image Systems, Inc.1990-08-21
ADDITIONAL TRANSDUCERS FOR USE W/SDL 300 (K897073)Shimadzu Corp.1990-08-21
SABA CONFORT MENSTRUAL PAD (K902160)Valle & Assoc.1990-08-21
MCGRATH ORTHOPAEDIC BONE SCREWS (K901814)Mcgrath Surgical , Ltd.1990-08-21
LASER FORCEPS HANDPIECE (K901365)Lca, Inc.1990-08-21
LEVEEN PERITINEO-VENOUS SHUNT (K901360)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-08-21
O. B. PACK III (K902273)Customed, Inc.1990-08-21
KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELD (K902000)Kevtek Medical Products, Inc.1990-08-21
PATIENT EXAMINATION GLOVES (K903656)United Rubber Corp. (Sabah) Sdn. Bhd.1990-08-21
AU530 DIAGNOSTIC ULTRASONIC PULSED ECHO SYSTEM (K896356)Esaote Biomedica Spa1990-08-21
ADDITIONAL TRANSDUCERS FOR USE WITH SDU 500 (K896644)Shimadzu Corp.1990-08-21
INFUSION PUMP (K901065)Kendall Mcgaw Laboratories, Inc.1990-08-21
GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO. (K902311)Applied Imaging Corp.1990-08-20
RESPIRONICS BIPAP PRESSURE ALARM (BIPAP P.A.) (K902276)Respironics, Inc.1990-08-17
ANESTHESIA BREATHING CIRCUITS (K900428)Med-Tek Corp.1990-08-17
POWDER FREE, NON-STERILE EXAMINATION GLOVES (K903607)Tillotson Rubber Co., Inc.1990-08-17
COBAS READY CALCIUM REAGENT (K896224)Roche Diagnostic Systems, Inc.1990-08-17
SYSTEMATE AMYLASE (AMYL) ITEM NUMBER 65404 (K903332)Em Diagnostic Systems, Inc.1990-08-17
PERCOR STAT-DL 8.5 FR INTRA-AORTIC BALLOON (K896497)Datascope Corp.1990-08-17
MODIFIED PROSTATIC URETHROPLASTY BALLOON CATHETER (K902370)Boston Scientific Corp1990-08-17
RTS TECHNOLOGY IRIDIUM 192 SOURCES (K901589)Rts Technology, Inc.1990-08-17
EMIT ETHYL ALCOHOL CALIBRATORS AND CONTROLS (K903152)Syva Co.1990-08-17
MONI-TROL XL AND L UNASSAYED LIQUID CHEMISTRY (K903190)Medical Analysis Systems, Inc.1990-08-17
ASPARTATE AMINOTRANSFERASE TEST (K903197)Em Diagnostic Systems, Inc.1990-08-17
PHARMACIA DELFIA SYSTEM B2-MICRO (K903578)Pharmacia, Inc.1990-08-17
SINGLE PATIENT USE INFANT DISPOSABLE MANUAL RESUSC (K903570)Puritan Bennett Corp.1990-08-17
KODAK X-OMAT 460 RA PROCESSOR (K902732)Eastman Kodak Company1990-08-17
I.C. MEDICAL SMOKE EVACUATOR ACTIVATOR (K902611)I.C Medical, Inc.1990-08-17
CHALLENGE BRAND LIQUID MULTI-ENZYME LINEARITY CONT (K903225)Medical Analysis Systems, Inc.1990-08-17
COLLAGEN SHIELD FOR ACUTE CARE (K902558)Vitaphore Corp.1990-08-17
MAG RESON DIAG DEV ACCESS SPEC PURP REC ONLY COIL (K901952)Siemens Medical Solutions USA, Inc.1990-08-17
MOD PURITAN BENNETT SING PATIENT DISPOS MAN RESUS (K903438)Puritan Bennett Corp.1990-08-17
MODEL 900S APNEA/HEART MONITOR (K903287)Healthdyne, Inc.1990-08-17
SURGEON'S (SURGICAL) GLOVES (K903534)Straitscom1990-08-17
NORTECH MODEL 86901000 ELECTRODE (K903427)Andover Medical, Inc.1990-08-17
PRIME CARE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE (K901920)Primecare, Inc.1990-08-17
SYSTEMATE URIC ACID (URCA) ITEM NUMBER 65422 (K903335)Em Diagnostic Systems, Inc.1990-08-17
SYNERMED CREATININE REAGENT KIT (K903296)Synermed, Inc.1990-08-17
WINGED INFUSION SET (K902166)Therex Corp.1990-08-17
EMIT ETS PLUS ETHYL ALCOHOL ASSAY (K903228)Syva Co.1990-08-17
TEMP MARQ TEMPERATURE TREND INDICATOR (K903307)Marquest Medical Products, Inc.1990-08-17
MAGNETIC RESONANCE DIAGNOSTIC DEVICE (K903319)GE Medical Systems1990-08-17
XPEED COMPUTED TOMOGRAPHY X-RAY SYSTEM (K902557)Toshiba America Medical Systems, In.C1990-08-17
PINNACLE IMAGE PROCESSING SYSTEM (K902648)Medasys, Inc.1990-08-17
SUCTION CATHETER, STERILE (K902814)Orion Life Systems, Inc.1990-08-17
BUSSE BAC/SHIELD (K902297)Busse Hospital Disposables, Inc.1990-08-17
MODIFIED SINGLE PATIENT USE DISP MAN RESUSCITATOR (K903443)Puritan Bennett Corp.1990-08-17
CREATINE KINASE TEST (CK) ITEM NUMBER 65411 (K903333)Em Diagnostic Systems, Inc.1990-08-17
INFANT MANUAL RESUSCITATOR (PMR 2) (K903631)Puritan Bennett Corp.1990-08-17
STERI-SHIELD (K902677)Biomedical Devices, Inc.1990-08-17
PERNECZKY ANEURYSM CLIP (K901312)Von Zeppelin GmbH1990-08-17
SHAW II HEMOSTATIC SURGERY SYSTEM (K902307)Hemostatic Surgery Corp.1990-08-17
PENLON BREATHING SYSTEM PRESSURE MONITOR (K902381)Penlon, Inc.1990-08-17
PARKER MICROPUMP MODEL 2100 (K902309)Chathamborough Research Group, Inc.1990-08-17
PHILIPS INTEGRIS C2000 SYSTEM (K902542)Philips Medical Systems North America, Inc.1990-08-17
MILENIA(TM) PCP (K902960)Diagnostic Products Corp.1990-08-17
O. B. PACK I (K902271)Customed, Inc.1990-08-15
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