Atlas FDA

1980

2,857 FDA 510(k) clearances · Clearance year

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RecordFirmDate
CMV BIO-BEAD TITRATION KIT (K801722)Litton Bionetics1980-09-16
HSV BIO-BEAD TITRATION KIT (K801721)Litton Bionetics1980-09-16
DATASON RTL (K801454)General Electric Co.1980-09-16
EYE APPLICATORS CAT.#980-983 (K802016)Pollak (Intl.), Ltd.1980-09-16
CHARLES PNEUMATIC INTRAOCULAR SCISSORS (K801850)Cooper Medical Devices Corp.1980-09-16
BECKMAN ELECTROLYTE-2 SODIUM/POTASSIUM (K801896)Beckman Instruments, Inc.1980-09-16
SHILEY UTILITY RESERVOIR (K802119)Shiley, Inc.1980-09-16
LACTI-QUANT (K801849)Nuclear Medical Laboratories, Inc.1980-09-16
BLEPHAROMETER (K801937)Aztec Medical Products, Inc.1980-09-16
DATA-ZYME AST(GOT) PROCEDURE (K801856)Data Medical Associates, Inc.1980-09-16
ARGYLE COMPACT CHEST DRAINAGE SYSTEM (K801979)Sherwood Medical Co.1980-09-16
SHILEY TEMPERATURE MONITOR (K802147)Shiley, Inc.1980-09-16
J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO (K801669)J.T. Baker Chemical Co.1980-09-16
WAKO TRIGLYCERIDE-G TEST (K801891)Wako Pure Chemical Industries, Ltd.1980-09-16
DEKNATEL GOOSEN VASCULAR PUNCH BLADES (K802079)Howmedica Corp.1980-09-16
HOLLOW FIBER DIALYZER HOLDER (K802075)Renal Devices, Inc.1980-09-16
PDS MODEL 3000 ADULT RESPIRATION MODULE (K802046)General Electric Co.1980-09-16
SLIT LAMP ATTACHMENT (K801877)Cavitron Corp.1980-09-16
SONATRON ULTRASONIC DENTAL SCANNER (K801689)Simplified Systems, Inc.1980-09-16
DIMENSION I REFRACTION SYSTEM (K801767)Smr1980-09-16
FIRST AID BANDAGE CAT.#198 OR 199 (K802013)Pollak (Intl.), Ltd.1980-09-16
GLUCOSE REAGENT(UV-HEXOKINASE) (K801765)Reagents Applications, Inc.1980-09-16
GUAZE SWABS CAT.#251-300 (SIZE & PLY) (K802010)Pollak (Intl.), Ltd.1980-09-16
PLASTIC FORCEPS CAT.#1001-1010 (K801991)Pollak (Intl.), Ltd.1980-09-16
SUN VALLEY TANS (K801543)Sun Valley Tans, Inc.1980-09-16
LAP SPONGES CAT.#801-850 (K802001)Pollak (Intl.), Ltd.1980-09-16
I.V. SENTRY ALARM DEVICE (K802101)Pike Medical Co.1980-09-16
J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH. (K801662)J.T. Baker Chemical Co.1980-09-16
BECKMAN ASTRA SYSTEMS TOTAL PROTEIN CHEM (K801749)Beckman Instruments, Inc.1980-09-16
NOVA 4 SODIUM/POTASSIUM/CHLORIDE/CARBON (K801882)Nova Biomedical Corp.1980-09-16
SUTURE REMOVAL SET CAT.#906 (K802019)Pollak (Intl.), Ltd.1980-09-16
TACKMER INCISE DRAPE (K802050)American Convertors Div., American Pharmaseal1980-09-16
PENTAX LARYNGO-STROBOSCOPE MODEL LS-1A (K801866)Pentax Precision Instrument Corp.1980-09-16
TISSUE-TEK III TISSUE EMBEDDING CENTER (K801956)Miles Laboratories, Inc.1980-09-16
SIEMENS-ELEMA PULSE GENERATOR 625 (K801508)Siemens Elema AB1980-09-16
GUAZE BANDAGES CAT.#101-169 (K801996)Pollak (Intl.), Ltd.1980-09-16
MUELLER STRETCH M TAPE (K802073)Mueller Chemical Co.1980-09-16
FENZL RETICLE (K801733)Robert E. Fenzl, M.D.1980-09-16
SPINAL FLUID CONTROL(HUMAN) (K801854)Environmental Chemical Specialties1980-09-16
RAMI ULTRAVIOLET A BOOTH (K801751)Rami-Tan1980-09-16
AMPCO SKIN SCRUB TRAYS, CAT.#SS824 (K802042)Associated Medical Products Co.1980-09-16
PEDIBAND CAT.#195-197 (K802021)Pollak (Intl.), Ltd.1980-09-16
DATA-ZYME LAT(GPT) PROCEDURE (K801857)Data Medical Associates, Inc.1980-09-16
BACITRACIN DIFFERENTIATION DISC (K802127)Biomedia, Inc.1980-09-16
TRIANGULAR BANDAGE CAT.#191 (K802006)Pollak (Intl.), Ltd.1980-09-16
DISPOSABLE HYPODERMIC NEEDLES (K801839)Martin'S Maine Exchange1980-09-16
T3(125) RADIOIMMUNOASSAY KIT (K801843)Technia Diagnostics , Ltd.1980-09-16
STAR (K801917)General Electric Co.1980-09-16
STREP B POLYVALENT FLUORO-KIT (K801876)Clinical Sciences, Inc.1980-09-16
BLOOD GLUCOSE TESTER (K801536)Broomer Research Corp.1980-09-16
THE MCSHIRLEY PERCUSSOR (K801982)Mcshirley Products, Inc.1980-09-16
AMPCO SKIN SCRUB TRAYS, CAT.#SS843 (K802043)Associated Medical Products Co.1980-09-16
TOXO BIO-BEAD TITRATION KIT (K801720)Litton Bionetics1980-09-16
ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES) (K801098)Flow Laboratories, Inc.1980-09-16
COMPOSITE RESTORATIVE (K802262)L.D. Caulk Co.1980-09-16
CATHETER INSERTION TRAY (K802083)Walpak Co.1980-09-16
CYNERGY MODEL 184 (K801596)Cynergy1980-09-16
CENTRIFICHEM PIPETTOR 1000 (K801851)Union Carbide Corp.1980-09-16
3390A REPORTING INTEGRATOR (K802031)Hewlett-Packard Co.1980-09-16
J.T. BAKER CERULOPLASMIN NEPHELOMETRIC (K801661)J.T. Baker Chemical Co.1980-09-16
ALGESIOMETER (K801907)Rowan Products, Inc.1980-09-16
BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT. (K801795)J.T. Baker Chemical Co.1980-09-16
ABSORBENT PAD CAT.#729, 732, 730, 731 (K802005)Pollak (Intl.), Ltd.1980-09-16
CORNING 60 VOLT POWER SUPPLY (K801893)Corning Medical & Scientific1980-09-16
C-BLADE (K802105)Cutter Laboratories, Inc.1980-09-16
BECKMAN ASTRA SYSTEMS ALBUMIN CHEMISTRY (K801750)Beckman Instruments, Inc.1980-09-16
MONOSPHERICAL SHOULDER PROSTHESIS (K802123)Howmedica Corp.1980-09-16
OHIO THORACIC COLLECTION UNIT (K801942)Ohio Medical Products1980-09-16
SUN ROOM TANNING BOOTH (K801674)Sun Tan Enterprises, Inc.1980-09-16
OXYGEN SUPPLY TUBING (K802071)Auburn Components1980-09-16
SPINE ALIGN (K801952)B.H. Richardson, D.C.1980-09-16
GUAZE BALLS CAT.#601-720 (K801999)Pollak (Intl.), Ltd.1980-09-16
QUINTREX 0515 PROGRAMMABLE PULSE GEN. (K802223)Medcor, Inc.1980-09-12
QUINTREX 0516 PROG. PULSE GENERATOR SYS (K802224)Medcor, Inc.1980-09-12
STERILE DISPOSABLE CYTOLOGY BRUSH (K802187)Olympus Corp.1980-09-10
ASSURE LEVEL I PROD. #30171 (K801538)Warner-Lambert Co.1980-09-09
SURGICAL BANDAGES/SUNLEEP DX (K801840)Martin'S Maine Exchange1980-09-09
VITAL SIGNS PEEP VALVE (K802070)Vital Signs, Inc.1980-09-09
EVALUATOR #9500 DYNAMIC ELEC/SCANNER (K801831)Del Mar Avionics1980-09-09
BIO-MED CORP. DISP. NON-STERILE TRANSDU (K801985)Bio-Med Corp.1980-09-09
INSULATING SHEATH (K801910)Cordis Corp.1980-09-09
URINE SPECIMEN CONTAINER #'S 1013-1016 (K802002)Pollak (Intl.), Ltd.1980-09-09
RHINOMETER (K801938)Aztec Medical Products, Inc.1980-09-09
BIOPHTAL CLINICAL ENDOTHELIAL MICROSCOPE (K801659)Coburn Optical Ind., Inc.1980-09-09
BREAKING CAST WIRE CAT.#1112-1115 (K802008)Pollak (Intl.), Ltd.1980-09-09
FINGER PAINGUARD CAT.#193-194 (K802015)Pollak (Intl.), Ltd.1980-09-09
PLASTIC DISPOSABLE RAZOR CAT.#1017,1018 (K802003)Pollak (Intl.), Ltd.1980-09-09
PEEP FACE MASK (K801883)Vital Signs, Inc.1980-09-09
DISP. TRANSDUCER DOMES TD200 & TD300 (K802069)Bio-Med Corp.1980-09-09
SAPCRILL THERMODETECT BREAST SCANNER DEV (K801573)California Cardiac Systems, Inc.1980-09-09
MEDTRONIC MODEL 2409 (K800226)Medtronic Vascular1980-09-09
TRIBAG, URINE BAG SYSTEM #1109,& 1301-12 (K802012)Pollak (Intl.), Ltd.1980-09-09
SPOR-TEST CULTURE MEDIA (K801980)Mdt Corp., Inc.1980-09-09
CAM-10 RESPIRATORY HOSE ASSEMBLIES (K801859)Lifecare Services, Inc.1980-09-09
VASCULAR GRAFT PROSTH. OF EXP. MICRO. (K801621)Impra, Inc.1980-09-09
LIFE CERVICAL ADJUSTING MACHINE (K801900)Life Chiropractic College, Inc.1980-09-09
ELASTIC BANDAGE CAT.#182-186 (WIDTH) (K801990)Pollak (Intl.), Ltd.1980-09-09
AMPCO SKIN SCRUB TRAYS, CAT.#SS612 (K802044)Associated Medical Products Co.1980-09-09
RIONET HEARING AID HB-70H (K801958)Rion Acoustic Instruments, Inc.1980-09-09
HDL CHOLESTEROL TEST KIT (K801726)Mallinckrodt Critical Care1980-09-09
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Track 1980 automatically

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