Atlas FDA

1987

4,160 FDA 510(k) clearances · Clearance year

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RecordFirmDate
TANGENT SCREEN (K873919)Richmond Products, Inc.1987-10-28
ALTA SYSTEMS TIBIAL/UPPER EXTREMITY DIAPHYSEAL PLT (K873459)Howmedica Corp.1987-10-28
PREMIER-TOTAL (TM) HIP (K873999)Intermedics Orthopedics1987-10-28
EMIT GENTAMICIN ASSAY (K873854)Syva Co.1987-10-28
CARBAMAZEPINE (FPIA) CALIBRATOR KIT (K873281)Windsor Laboratories, Inc.1987-10-28
RAPID DIAGNOSTIC SYSTEM FOR CHLAMYDIA TRACHOMATIS (K871878)Gen-Probe, Inc.1987-10-28
REVISED LABELING FOR SYVA PROPOXYPHENE ASSAYS (K874200)Syva Co.1987-10-28
MEDIA FOR ANAEROBIC/MICROAERPHILIC ISOLATION (K873265)Central Media1987-10-28
MAINTENANCE & CARBOHYDRATE FERMENTATION MEDIA (K873263)Central Media1987-10-28
COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEM (K873671)Coltene, Inc.1987-10-27
HICKMAN PLASTIC SUBCUTANEOUS PORT (K873213)C.R. Bard, Inc.1987-10-27
USI BASIC. AG 1050. AG 1090 (K873146)Cranston Ind., Inc.1987-10-27
BAKER TWIN-CUFF INTESTINAL DECOMP/PLICATION TUBE (K873441)Bissell Medical Products, Inc.1987-10-27
IN THE EAR & IN THE CANAL HEARING AID FACE PLATE (K871884)Hearing Services, Inc.1987-10-27
TELSTAR PREWIRE SERIES (K871731)Telstar Electronics, Inc.1987-10-27
CM 5000R REMOTE AIRWAY PRESSURE (K873953)Canadian Monaghan , Ltd.1987-10-27
SINTERLOY (K873373)Denpac Corp.1987-10-27
#24L SYSTEM (K873878)Pentron Corp.1987-10-27
PULP PEN (K873644)The Hygenic Corp.1987-10-27
SURGICAL PENCIL/ ELECTROSURGICAL PENCIL (K873595)Yuntek International, Inc.1987-10-26
ELECTROBLOC TRANS. ELECTRICAL NERVE BLOCK GENERA. (K873357)Th Charters, Inc.1987-10-26
CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL (K873689)Dentsply Intl.1987-10-26
MPG-50 X-RAY GENERATOR (K873544)Thomson-Cgr Medical Corp.1987-10-26
DISPOSABLE, MANUAL PULMONARY RESUSCITATOR (K873286)Hospitak, Inc.1987-10-26
SOPHY SERIES OF NUCLEAR MEDICINE COMPUTER SYSTEMS (K872132)Sopha Medical Systems, Inc.1987-10-26
MODIFIED Q4000 & Q3040 ELECTROCARDIOGRAPH MONITOR (K873584)Quinton, Inc.1987-10-26
MODEL 7200A WITH PULSE OXIMETRY (K873065)Puritan Bennett Corp.1987-10-26
INFANT MONITOR, MODEL 2400 (K872631)Arvee Medical, Inc.1987-10-26
CEDAR(TM) PELVIC CUSHION (K873690)Cedar Surgical, Inc.1987-10-26
GAMBRO BICART SYSTEM (K873155)Gambro, Inc.1987-10-26
NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEM (K873535)Nicolet Biomedical Instruments1987-10-26
ANEUROPLASTIC, ACRYLIC ANEURYOMORRHAPLY MATERIAL (K873688)Dentsply Intl.1987-10-26
SMK SLUYTER-MEHTA CANNULAE, RF POLE, POLE,FLEXIBLE (K870028)Radionics, Inc.1987-10-26
GLUCOSE REAGENT KIT (K873128)A-Kem, Inc.1987-10-23
NON-CORING HUBER TYPE NEEDLES (K873957)Advantage Medical Systems, Inc.1987-10-23
MICRO CULTURE MEDIA P3528, P3137, P3149, P3139 (K873951)Lakewood Biochemical Co., Inc.1987-10-23
SMITH & NEPHEW DAYLIGHTER(TM) (K873786)Smith & Nephew, Inc.1987-10-23
LMI CHOLANGIOGRAM TRAY (K873471)Lazarus Medical Innovations, Inc.1987-10-23
PHENYLETHYL ALCOHOL AGAR(PEA) W/5% SHEEP #P3323 (K873975)Lakewood Biochemical Co., Inc.1987-10-23
MODEL 1330 EXTENSION SET (K873042)Pharmacia Deltec, Inc.1987-10-23
CREATININE REAGENT KIT (K873131)A-Kem, Inc.1987-10-23
RETROBULBAR NEEDLE (K873848)Healthtek, Inc.1987-10-23
CARBON DIOXIDE REAGENT KIT (K873129)A-Kem, Inc.1987-10-23
GORSK INSTRUMENT REST (K873554)Gorsk, Inc.1987-10-23
AMK TOTAL KNEE SYSTEM, PATELLA COMPONENT (K873197)Depuy, Inc.1987-10-23
LASER RESISTANT DRAPE (K873141)Baxter Healthcare Corp1987-10-23
CHLORIDE REAGENT KIT (K873127)A-Kem, Inc.1987-10-23
BUN REAGENT KIT (K873132)A-Kem, Inc.1987-10-23
WASH SOLUTION KIT (K873130)A-Kem, Inc.1987-10-23
MICROS(TM) (K871995)Controlled Release Technologies, Inc.1987-10-23
10CC CONTROL SYRINGE (K873588)Medi-Plast Intl., Inc.1987-10-23
DHEA-S RIA KIT (K872879)Endocrine Associates, Inc.1987-10-23
SODIUM/POTASSIUM REAGENT KIT (K873126)A-Kem, Inc.1987-10-23
GORSK SPONGE CONTAINMENT SYSTEM (K873555)Gorsk, Inc.1987-10-23
ADR-22 AUTOMATIC DIALYZER REPROCESSOR (K874034)Biodynamics Corp.1987-10-23
8810 PUMP-PUMP SINGLE NEEDLE DEVICE (K873279)Cd Medical, Inc.1987-10-23
UNIVERSAL TOURNIQUET (K873928)Dryden Corp.1987-10-23
PHARMACIA DELTEC BAG SPIKE SET (K873876)Pharmacia Deltec, Inc.1987-10-23
HD-400-A/B/C HEMODIALYSIS SYSTEMS & ACCESSORIES (K873487)Water Pure, Inc.1987-10-23
MICRO CULTURE MEDIA P3141, P3136, P3148, P3748 (K873952)Lakewood Biochemical Co., Inc.1987-10-23
TECNOL SURGEON'S CAP (K873830)Tecnol New Jersey Wound Care, Inc.1987-10-23
RESUBMITTED MICRON TRANSFUSION FILTER (K873873)Travenol Laboratories, S.A.1987-10-22
TMO-1000, TMO-3000, TMO-10,000 NON-INVAS. THERMO. (K871529)Western Medical Equipment Corp.1987-10-22
PROVIDER IV. MODEL 5000 INFUSION DEVICE (K871806)Pancretec, Inc.1987-10-22
MODIFIED MODELS 1025M & 1026T PACING LEAD (K873931)Pacesetter Systems1987-10-22
LOOK FLUID DISTRIBUTION SET (K872945)Look, Inc.1987-10-22
SODIUM AND POTASSIUM BY ION SELECTIVE (K873074)American Monitor Corp.1987-10-20
TITAN GEL CPK REP SYSTEM (K873399)Helena Laboratories1987-10-20
HAPTOGLOBIN (K873866)Unipath , Ltd.1987-10-20
RORERTAZZI NASOPHARYNGEAL AIRWAY (K873949)Penn Medical Devices, Inc.1987-10-20
EUROGENETICS CRP ELISA (K872539)Eurogenetics1987-10-20
OXYGEN ANALYZER MODEL 800 SERIES (K873068)Salter Instrumentation, Inc.1987-10-20
PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISC (K872946)Pharmacia, Inc.1987-10-20
BAKER TDM THEOPHYLLINE ASSAY (K873596)Baker Instructions Corp.1987-10-20
ALBUMIN IN SERUM (K873862)Unipath , Ltd.1987-10-20
VENTRESCREEN CAPILLARY BLOOD COLLECTION TUBE (K873647)Ventrex Laboratories, Inc.1987-10-20
HOLOGIC MODELS BLK-1, DPA/QDR-1 & QCT-1 (K871446)Hologic, Inc.1987-10-20
IGE IMMUNO RESPONSE TEST (IRT) COMP. FOR MOD. RAST (K873814)Incstar Corp.1987-10-20
AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437) (K873984)Travenol Laboratories, S.A.1987-10-20
ECONO-MIST PORTABLE COMPRESSOR DRIVEN NEBULIZER (K873677)Mountain Medical Equipment, Inc.1987-10-20
NUTRIPUMP (K872741)I M, Inc.1987-10-20
INTERNATIONAL MODEL XP BEHIND-THE-EAR (K873798)Int'L Hearing Aids, Inc.1987-10-20
INTERNATIONAL MODEL XM BEHIND-THE-EAR (K873800)Int'L Hearing Aids, Inc.1987-10-20
PORTABLE PH, MV, TEMP METER W/AUTO. TEMP COMPENSA. (K871922)Chemfet Corp.1987-10-20
ESOPHAGEAL STETHOSCOPE W/THERMISTOR (K873344)Medical Components, Inc.1987-10-20
DIASCAN* BLOOD GLUCOSE SELF-MONITORING TEST STRIPS (K872505)Home Diagnostics, Inc.1987-10-20
BLOCK, BITE, INTUBATION (K873491)B&B Medical Technologies, Inc.1987-10-20
VASCULAR ACCESS CATHETER W/ANTIMICROBIAL CUFF (K873050)C.R. Bard, Inc.1987-10-20
PHARMACIA IGE EIA (K873077)Pharmacia, Inc.1987-10-20
RESULT PLUS/HCG PREGNANCY TEST (K872730)Ortho Diagnostic Systems, Inc.1987-10-20
PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISC (K873112)Pharmacia, Inc.1987-10-20
ACA URINE BARBITURATES SCREEN METHOD (K873623)E.I. Dupont DE Nemours & Co., Inc.1987-10-20
SECURLINE FRANSEENE NEEDLE (K873369)Precision Dynamics Corp.1987-10-20
BERMUDA GRASS ALLERGEN DISC (K873770)Incstar Corp.1987-10-20
HOYER SOLVET (K873395)Infrasonics Corp.1987-10-20
CHEMELIA ENZYME IMMUNOASSAY FOR (TSH) (K873625)Boots-Celltech Diagnostics, Inc.1987-10-20
BREAST-SCAN(TM) (K872962)Thermascan, Inc.1987-10-20
ACS INDEFLATOR PLUS (MODIFICATION #2) (K872981)Advanced Cardiovascular Systems, Inc.1987-10-20
IL 35260, IL TEST AMYLASE REAGENT (K873572)Instrumentation Laboratory CO1987-10-20
BILE ACIDS CONTROLS (K873342)Sigma Diagnostics, Inc.1987-10-20
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Every clearance here is in the API, with alerts when new ones post.