Atlas FDA

1986

4,347 FDA 510(k) clearances · Clearance year

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RecordFirmDate
CMI 3000 (K854233)Cardio Management, Inc.1986-01-08
HEMOSTATIC SIDEARM (K854397)Target Therapeutics1986-01-08
MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT (K854379)Bioclinical Systems, Inc.1986-01-07
ISOTRAK AMYLASE TEST AMYLASE ISOENZYME (K853951)Behring Diagnostics, Inc.1986-01-07
DRI-FORM UREAPLASMA DIFFERENTIAL BASAL AGAR MED.A8 (K855110)Gibco Laboratories Life Technologies, Inc.1986-01-07
NSI ASTRA TM CALCIUM REAGENT KIT NSI ITEM # 7909 (K854716)Nobel Scientific Industries, Inc.1986-01-07
DE12 RAPID TRACE AT-REST DIAGNOSTIC ECG ELECTRODES (K853038)Bio-Detek, Inc.1986-01-07
CLEARENE, CLEARING AGENT (K855109)Surgipath Medical Industries, Inc.1986-01-07
LEE-BEAD BETA LH (EIA) (K854838)Leeco Diagnostics, Inc.1986-01-07
CD-100 CARDIAC MONITOR (K854041)Cardio Display Corp.1986-01-07
MICROSAMPLE COAGULATION ANALYSER MODEL 110P (K854546)Bio/Data Corp.1986-01-07
PROGRAMALITH III MODELS 238 & 239 (K854195)Pacesetter Systems1986-01-07
CRITIC - SF, ASSAYED (K854967)Dimension Diagnostics1986-01-07
ADR 3160 W/PROBES PLB-308M, PLB-508M, & PLB-310M (K852947)Advanced Technology Laboratories, Inc.1986-01-06
GOODE T-TUBE WHITE SILICONE TYMPANOSTOMY TUBE (K852387)Xomed, Inc.1986-01-06
GODDE T-TUBE BLUE SILICONE TYMPANOSTOMY TUBE (K853641)Xomed, Inc.1986-01-06
DIATIMER-2 BLOOD PLASMA CLOT TIMING INSTRUMENT (K854090)Diatech, Inc.1986-01-06
TUBING SYRING (K854699)Almore Intl., Inc.1986-01-06
DIATIMER-1 BLOOD PLASMA CLOT TIMING INSTRUMENT (K854089)Diatech, Inc.1986-01-06
ANESTHESIA SHUTOFF VALVE POSITIVE CLOSURE (K854573)Artec Environmental Monitoring Division1986-01-03
IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST (K854447)American Micro Scan1986-01-03
ASSERA PLATE IX:AG KIT (K854014)American Bioproducts Co.1986-01-03
ACUTE HEMODIALYSIS TRAY, CAT.#09-9540-7 (K854612)Med-West, Inc.1986-01-03
SETMA HYGIA BATH MODEL ST 7200 (K854861)Setma, Inc.1986-01-03
THERACUSHION (K853710)General Physiotherapy, Inc.1986-01-03
IMAGEN RESPIRATORY SYNCYTIAL VIRUS TEST (K854081)Boots-Celltech Diagnostics, Inc.1986-01-03
BBL PORT-A-CUL AEROBIC TRANSPORT SYS, MODIFIED STU (K854986)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-01-03
AKUFON THERAPEUTIC MASSAGER (K850495)Jansson A/S1986-01-03
ELECTRA CHIROPRACT/EQUIP TABLE ELECTRA I&STATIONAR (K854635)Electra Equipment , Ltd.1986-01-03
CHURCHHILL LANCET (K854760)Churchill Corp.1986-01-03
ENDOTRACHEAL TUBE GUIDE OR INTUBATION STYLETTE (K854632)Respiratory Support Products, Inc.1986-01-03
ASSERACHROM PROTEIN C KIT (K854016)American Bioproducts Co.1986-01-03
VITATRON M (K852034)Elmed, Inc.1986-01-03
REHABILITATION TABLES (K854947)I-Rep, Inc.1986-01-03
OXYGEN CONCENTRATOR, MODEL BX-5000 (K854374)Healthdyne, Inc.1986-01-03
GAS/PRES MONIT ENDOT TUB CONN/ADOP W/ & W/O TUB (K852632)Medicomp, Inc.1986-01-03
SATALEC SEPTOSONIC SC 80/SC 120 (K852527)Spelna, Inc.1986-01-03
MEDAR APM FORCE TRANSDUCER (K853849)Medar Corp., Inc.1986-01-03
ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR (K854212)Respiratory Support Products, Inc.1986-01-03
CELL-DYN 1500 MULTI-PARAMETER HEMATOLOGY ANALYZER (K854368)Abbott Diagnostics1986-01-01
QBC CENTRIFUGAL HEMATOLOGY SYSTEM (K854242)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-01-01
KODAK M35 X-OMAT PROCESSOR (K854219)Eastman Kodak Company1986-01-01
TANDEM ICON RUBELLA IGG IMMUNOENZYMETRIC ASSAY KIT (K853069)Hybritech, Inc.1986-01-01
JECT-AID (K853031)Autoject Systems, Inc.1986-01-01
MINXRAY 500M MAMMOGRAPHIC SYSTEM (K854510)Minxray, Inc.1986-01-01
ACE COMPUTER SYSTEM (K853482)Cardiac Medical Systems Corp.1986-01-01
HYDRO-BAC FILTER (K852866)Medicomp, Inc.1986-01-01
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Every clearance here is in the API, with alerts when new ones post.