Atlas FDA

1984

4,397 FDA 510(k) clearances · Clearance year

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RecordFirmDate
ENI BLOOD UREA NITROGEN REAGENT (K844065)Electro-Nucleonics Laboratories, Inc.1984-11-27
CUSTOM LITE (K844321)Buchmann Optical Industries1984-11-27
ERGOTEST 40 & 45 (K843855)Erich Jaeger, Inc.1984-11-27
LAUF-ERGOTEST JUNIOR (K843859)Erich Jaeger, Inc.1984-11-27
SERACON TM SR III (K844027)Bhp Diagnostix, Inc.1984-11-27
MENDEZ U/S CYSTOTOME (K843386)CooperVision, Inc.1984-11-27
ULTRA LYTE POTASSIUM REAGENT KIT (K843454)Ultra Quest Diagnostics, Inc.1984-11-27
ACTH RIA (K844181)Syncor Intl. Corp.1984-11-27
UNIVERSAL-ERGOTEST (K843850)Erich Jaeger, Inc.1984-11-27
WET DRESSING WATER-STERILE (K844095)Absorbent Cotton Co., Inc.1984-11-27
IOCARE IRRIGATION/ASPIRATION PACK (K843275)Chiron Vision Corp.1984-11-27
ENZYME IMMUNOASSAY FOR DETECTION HORM (K841545)Btc Diagnostics, Inc.1984-11-27
LYTETEK 1000 NA/K SODIUM/POTASSIUM ANALYZER (K844044)Medica Corp.1984-11-27
IOCARE ULTRASONIC TITANIUM TIPS (K843278)Chiron Vision Corp.1984-11-27
PORTA-STAT (K843340)Porta-Stat, Inc.1984-11-27
ULTRA LYTE SODIUM REAGENT KIT (K843453)Ultra Quest Diagnostics, Inc.1984-11-27
MOSS LIMB LOAD MONITOR LM101-1 (K844202)Moss Rehabilation Hospital1984-11-27
COBAS FLUORESCENCE POLARIZATION MODULE (K843914)Roche Diagnostic Systems, Inc.1984-11-27
FLOOR MOUNTED X-RAY TUBESTAND (K843335)Medicor USA , Ltd.1984-11-27
PHARMACIA STREP A DIRECT SWAB TEST (K844107)Pharmacia, Inc.1984-11-27
CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA (K842979)CooperVision, Inc.1984-11-27
SGOT REAGENT SET (K844322)Livonia Diagnostics, Inc.1984-11-27
TRIGLYCERIDES REAGENT SYSTEM (K843832)Fermco Biochemics, Inc.1984-11-27
BIOTIS ANAEROBIC KBE AGAR (K844195)Otisville Biotech, Inc.1984-11-27
ULTIMA CHIROPRACTIC TABLES (K843877)Elenex Medequip, Inc.1984-11-27
STRESS CONTROL BIOFEEDBACK CARD (K843413)Pilgrim Plastic Products Co.1984-11-27
PETIT BANDS (K843587)Micori Gifts, Inc.1984-11-27
LAUF-ERGOTEST (K843853)Erich Jaeger, Inc.1984-11-27
MOBILIMB HAND UNIT (K844033)Danninger Medical Technology, Inc.1984-11-27
SGPT REAGENT SET (K844283)Livonia Diagnostics, Inc.1984-11-27
LOW PROFILE STEERABLE BALLOON DILATION (K843880)Advanced Cardiovascular Systems, Inc.1984-11-27
GAS TRAK BRAND CO-OXIMETER CONTROLS 1,2 & 3 (K844018)United Diagnostics, Inc.1984-11-27
MEI MAMMOGRAPHY SYS MX-2049 (K843437)Moti Enterprises, Inc.1984-11-27
POCKET OPHTHALMOSCOPE GH (K843897)Design Med. Corp.1984-11-27
STAT-TRAK PLUS LIQUID CHEMISTRY CONTROLS 1,2 & 3 (K843986)United Diagnostics, Inc.1984-11-27
SERACON TM SR IV (K844026)Bhp Diagnostix, Inc.1984-11-27
ADD-1 (K844114)Abbott Laboratories1984-11-27
BIPOLAR ENDOCARDIAL LEAD 406L (K841227)Siemens Elema AB1984-11-27
RICH-MAR DELTA 330 HV (K844217)Rich-Mar Corp.1984-11-27
KARECO INT'L WHEELCHAIR (K843688)Kareco Intl., Inc.1984-11-23
EIXO THERMUS HEATING PADS (K844224)Eixo Thermus1984-11-23
MEDI-TECH DILATATION CATHETERS (K844292)Medi-Tech, Inc.1984-11-23
PDB II VIBRATING DRAINAGE BED (K843572)Invacare Corp.1984-11-23
HEALTH PULSE FA-222 POWER MUSCLE STIMUL (K843638)Therapeutic Equipment Corp.1984-11-23
VANISH ORTHODONTIC BRACKET (K844067)A Company, Inc.1984-11-23
ORAL IRRIGATION TIP (K844318)Pro Pulse, Inc.1984-11-23
ISOSTATION ANKLE/SUBTALAR MACHINE A-100 (K844060)Isotechnologies, Inc.1984-11-23
BONE STAPLING FIXATION SYS (K840566)3M Company1984-11-23
PHARMA-PLAST SUCTION SET TYPE YANKAUER (K843468)Zimmar Consulting , Ltd.1984-11-23
ARK TONGUE CLEANER (K844291)Arkay Co.1984-11-23
SHURE GRIP TYING FORCEPS (K844129)Mentor O & O, Inc.1984-11-21
OPERAID NUCLEUS (K841807)Jedmed Instrument Co.1984-11-21
BINOCULAR INDIRECT OPHTHALMOSCOPE (K843304)Mentor O & O, Inc.1984-11-21
BRILLETTE MODEL (K842835)Cillus Company, Inc.1984-11-21
OPERAID SURGICAL DRAIN (K841721)Jedmed Instrument Co.1984-11-21
SUPERPETT (K843366)Scanditronix, Inc.1984-11-21
CILCOR OPHTHALMIC INSTRUMENTS (K843992)Cilco, Inc.1984-11-21
QUEST BETA HCG ENZYME IMMUNOASSAY KIT (K844082)Quidel Corp.1984-11-21
PRISTINE (K844236)Medical Dimensions1984-11-21
HESLIN DISPOS. TUBING SET (K843041)Innovative Surgical Products, Inc.1984-11-21
SITE ANTERIOR CAPSULOTOMER (K843039)Chiron Vision Corp.1984-11-21
MAMIYA SLIT LAMP P-1 (K843099)Okada Corp.1984-11-21
KONAN CLINIC MICROSCOPE CLM-100-150 (K844323)Keeler Instruments, Inc.1984-11-21
CRISTY/COTE (K843096)Titmus Optical, Inc.1984-11-21
AUTOMATED INTRAOCULAR SCISSORS (K842471)Medical Instrument Development Laboratories, Inc.1984-11-21
NORTA SILICONIZED LATEX BALLOON CATH. (K842420)Beiersdorf, Inc.1984-11-21
9 FRENCH 42LONG POLYURETHANE GRADUATED ENTERIC FE (K843975)Superior Plastic Products Corp.1984-11-20
TOGGLE LOCKING PLIERS-STRAIGHT JAW, CURVED JAW (K844146)Med-Tool, Inc.1984-11-20
SIEGEN NEUROSCOPE (K843464)Siegen Corp.1984-11-20
RECOMED CARDIAC OUTPUT METER 236067- (K840439)Litton Medical Electronics1984-11-20
LIQUID CHROMATOGRAPH 400 (K843568)The Perkin-Elmer Corp.1984-11-20
AMYLASE REAGENT CS-726 (K844168)Fisher Scientific Co., LLC1984-11-20
MODEL {M-102 I-CHANNEL ELECTRO CARDIOGRAPH UNIT (K843934)Future Impex Corp.1984-11-20
SUCTION CATHETER KIT (K843076)Travenol Laboratories, S.A.1984-11-20
FLOW-DIRECTED PEDIATRIC THERMODIL- CATH (K843410)Andover Medical, Inc.1984-11-20
B-1000 (K844226)Biotrine Corp.1984-11-20
ACCUMETER ELECTRONIC URINEMETER SYSTEM (K844030)Travenol Laboratories, S.A.1984-11-20
EMG/NCV & EVOKED RESPONSE, DESIGN W/ (K843253)Neurodiagnostics, Inc.1984-11-20
PIN CUTTER (K844148)Med-Tool, Inc.1984-11-20
FLOW DIRECTED THERMODILUTION CATH W/VEN (K843412)Andover Medical, Inc.1984-11-20
ALKALINE PHOSPHATASE REAGENT SET (K844237)Livonia Diagnostics, Inc.1984-11-20
WIRE TWISTERS (K844147)Med-Tool, Inc.1984-11-20
TURBOAIRE CHALLANGER ENVIRONMENTAL AIR CONTROLLER (K843996)Equilibrated Bio Systems, Inc.1984-11-20
SPIROMETRICS 2451 & SMI I (K844333)Spirometrics, Inc.1984-11-20
ELECATH VENTRICULAR PACING THERMAL DILUTION CATH (K844022)Electro-Catheter Corp.1984-11-20
CHLORIDE STANDARD (K844235)Shaban Mfg. Co.1984-11-20
GENERAL SURGICAL FILES (K844145)Med-Tool, Inc.1984-11-20
SERVOMED ARRHYCOMP CENTRAL MONITOR SYS (K840899)Litton Medical Electronics1984-11-20
FACTOR X DEFICIENT PLASMA, BLOD HUMAN (K843310)Sigma Chemical Co.1984-11-19
PHARMA-PLAST OXYGEN CATHETER (K843466)Zimmar Consulting , Ltd.1984-11-19
FLASH GUARD PLASTIC VERSION (K844286)Sparco, Inc.1984-11-19
WET DRESSING SALINE-STERILE (K844096)Absorbent Cotton Co., Inc.1984-11-19
EPISCLERAL VENOUS PRESSURE (K843354)Eyetech, LLC1984-11-19
PHARMA-PLAST SUCTION TIP, TYPE ORTHOPAE- (K843469)Zimmar Consulting , Ltd.1984-11-19
HEART-AID MODEL 80 (K843358)Cardiac Resucitator Corp.1984-11-19
XTRACETEZE SURGICAL SKIN STAPLE REMOVER 2001 (K844110)Pelco, Inc.1984-11-19
BAILEY LENS SHOOTER (K841730)Intermedics Intraocular, Inc.1984-11-19
DOCUMENTOR (K842715)Life Technology1984-11-19
SEERAM BLADE (K844073)Seeram Products Development1984-11-19
BNS 40 (K842224)Myo-Tronics Research, Inc.1984-11-19
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Track 1984 automatically

Every clearance here is in the API, with alerts when new ones post.