Atlas FDA

1984

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

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RecordFirmDate
TOTAL PROTEIN REAGENT BIURET (K841466)Reagents Applications, Inc.1984-05-16
CLAYMAN-PAREL CAPSULE COUPEUR (K841101)Miami Eye Technology, Inc.1984-05-16
ARIES MEDICAL MODEL 700 (K833632)Aries Medical, Inc.1984-05-16
IMPLANTABLE PROGRAMMABLE PULSE GENER (K840737)Telectronics, Inc.1984-05-16
SUN BEDS (K841614)Sunworld Corp.1984-05-16
ULTRA CHEM ENZYMATIC TRIGLYCERIDE (K841471)Em Diagnostic Systems, Inc.1984-05-16
ACUFEX SHOULDER HOLDER (K841388)Acufex Microsurgical, Inc.1984-05-16
INSULIN RADIOIMMUNOASSAY KIT (K841573)Sorin Biomedica, Fiat, USA, Inc.1984-05-16
QUANTUM, UNIPOLAR, MULTI-PROGRAMMABLE (K841073)Intermedics, Inc.1984-05-16
COMA TOXICOLOGY CONTROL (K841439)American Dade1984-05-16
PHYSIOLOGICAL PRESSURE TRANSDUCER 1290C (K840121)Hewlett-Packard Co.1984-05-16
CARCIAC PULSE GENERATOR 254-20 (K841075)Intermedics, Inc.1984-05-16
DUPONT THEOPHYLLINE DIT CALIBRATOR (K841655)E.I. Dupont DE Nemours & Co., Inc.1984-05-16
UNIPAK 100 ANALYZER, 65156 & CHEMISTR (K840883)Emd Chemicals, Inc.1984-05-16
DIRECT BILIRUBIN REAGENT (K841572)Hi Chem, Inc.1984-05-16
POTASSIUM CHLORIDE SOLUTION -2 MOLAR (K841417)Reagent Laboratory, Inc.1984-05-16
7200 MICROPROCESSOR VENTILATOR (K841757)Puritan Bennett Corp.1984-05-16
HEARING AID AUDIO-STARR A (K840906)Jade Electronics Corp.1984-05-16
CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEP (K841834)Microline Scientific1984-05-14
ORTHO ENZYME IMMUNOASSAY HOME PREG.TEST (K834270)Advanced Care Products1984-05-14
MUELLER-HINTON AGAR (K841755)The Montana Deaconess Medical Center1984-05-14
FRC 85 SERIES SPIROMETER (K840929)Medical Equipment Designs, Inc.1984-05-14
GLAS IONOMER CEMENT (K841195)Shofu Dental Corp.1984-05-14
MASS SPECTROMETER INTERFACE (K841722)Dryden Corp.1984-05-14
KYOTEST 5V (K840827)Kyoto Diagnostics, Inc.1984-05-14
PROVIDER IV MODEL 2000 INFUSIN SYS (K841373)Pancretec, Inc.1984-05-14
ULTRA-LITE PREMIER (K841830)Everest & Jennings, Inc.1984-05-14
KYOTEST 8V (K840828)Kyoto Diagnostics, Inc.1984-05-14
SELENITE CYSTINE BROTH BASE (K841660)Oxoid U.S.A., Inc.1984-05-14
MEDTRONIC RESUME SE-4 3587-LEAD-SPINAL (K841584)Medtronic Vascular1984-05-14
CULTURE MEDIUM FOR PATHOGENIC NEISSER (K841833)Microline Scientific1984-05-14
DELTA MULTIPLE NON RETURN CONNECTOR (K841106)Tefra Med, Inc.1984-05-14
ANESTHETIC GAS MONITOR SYS (K840966)Marquest Medical Products, Inc.1984-05-14
SPHYGOMANO METER (K833799)Fraser Harlake, Inc.1984-05-14
COROMETRICS 815 FETAL ECG RECORDER (K841477)Ge Medical Systems Information Technologies1984-05-14
ISOSTATION SHOULDER MACHINE (K841849)Isotechnologies, Inc.1984-05-14
YD STRIP GPH U21 (K834387)Yd Pharmaceutical Corp.1984-05-14
YD STRIP GP U20 (K834386)Yd Pharmaceutical Corp.1984-05-14
SELECTIVE CULTURE MED. TRICHOMONAS (K841836)Microline Scientific1984-05-14
CHESTAC-25F SPIROMETER (K840908)Medical Equipment Designs, Inc.1984-05-14
C02 MONITOR-OIR-7101 (K841498)Nihon Kohden America, Inc.1984-05-14
FEMORAL CEMENT REMOVAL INSTRUMENT (K840735)Amtech Scientific, Inc.1984-05-14
BBL GASPAK POUCH (K841307)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-05-14
MULTIPURPOSE CULTURE MEDIUM (K841835)Microline Scientific1984-05-14
H-H SHUNT PASSERS (K841553)Holter-Hausner Intl.1984-05-14
SCRATCH & SNIFF FOR ANESTHESIA (K840431)Dryden Corp.1984-05-14
ULTRACLONE ECL-01-800 CELL LINE (K841337)Earl-Clay Laboratories, Inc.1984-05-11
TDX ACETAMINOPHEN (K840941)Abbott Laboratories1984-05-11
SYNTHETIC BROTH A.O.A.C. (K841661)Oxoid U.S.A., Inc.1984-05-11
ACA TRICYCLIC ANTIDEPRESSANTS SCREEN (K841533)E.I. Dupont DE Nemours & Co., Inc.1984-05-11
OMNIDIRECTIONAL POWERED WHEEL CHAIR (K841542)Kinetic Concepts, Inc.1984-05-11
ULTRACLONE ECL-01-1000 CELL LINE (K841341)Earl-Clay Laboratories, Inc.1984-05-11
PROLACTIN RIABEAD PROLACTIN RADIOIMM (K841118)Abbott Laboratories1984-05-11
KF STREPTOCOCCUS AGAR (K841658)Oxoid U.S.A., Inc.1984-05-11
OBSTETRICAL ULTRASOUND COMPUTER (K840623)R & S Systems1984-05-11
DYNAMIC CONDYLAR SCREW OR D.C.S. (K840954)Synthes (Usa)1984-05-11
ULTRA CLONE ECL-01-700 CELL LINE (K841339)Earl-Clay Laboratories, Inc.1984-05-11
OPAQUE COATING & SURFACE STAIN (K840751)Dentsply Intl.1984-05-11
SODIUM & POTASSIUM STANDARD SOLUT (K841419)Reagent Laboratory, Inc.1984-05-11
ULTRACLONE ECL-01-400 CELL LINE (K841342)Earl-Clay Laboratories, Inc.1984-05-11
SODIUM & POTASSIUM STANDARD SOL 80 (K841420)Reagent Laboratory, Inc.1984-05-11
WALK & ROLL (K841700)Maddak, Inc.1984-05-11
CREATININE - A.A.S. (K841377)Advanced Analytical Systems, Inc.1984-05-11
FILTRARE TM ALLVENT TM (K834376)Alltek, Inc.1984-05-11
DIFFU-GEN APOLIPOPROTEIN A-I RADIAL - (K834218)Tago, Inc.1984-05-11
PRESTON CAMPYLOBACTER SELECTIVE SUPP (K840330)Oxoid U.S.A., Inc.1984-05-11
CAMPYLOBACTER AGAR BASE (K840332)Oxoid U.S.A., Inc.1984-05-11
DULBECCO'S PHOSPHATE BUFFERED SALINE (K841744)Sigma Chemical Co.1984-05-11
SURGICAL CURETTE, VARIOUS (K841004)Premier Dental Products Co.1984-05-11
ULTRACLONE ECL-01-100 CELL LINE (K841343)Earl-Clay Laboratories, Inc.1984-05-11
LEGIONELLA BMPA SELECTIVE SUPPLE (K840333)Oxoid U.S.A., Inc.1984-05-11
VENTRESCREEN, MULTIPLE ALLERGEN DISCS (K841516)Ventrex Laboratories, Inc.1984-05-11
ULTRACLONE ECL-01-600 CELL LINE (K841338)Earl-Clay Laboratories, Inc.1984-05-11
ULTRACLONE ECL-01-200 CELL LINE (K841346)Earl-Clay Laboratories, Inc.1984-05-11
ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN (K840867)Intl. Diagnostic Technology1984-05-11
DAILY WASH SOLUTION 5 (K841421)Reagent Laboratory, Inc.1984-05-11
HEKTOEN ENTERIC AGAR (K841745)The Montana Deaconess Medical Center1984-05-11
ULTRACLONE ECL-01-900 CELL LINE (K841340)Earl-Clay Laboratories, Inc.1984-05-11
YD STRIP GLUCOSE U19 (K834385)Yd Pharmaceutical Corp.1984-05-11
LEGIONELLA MWY SELECTIVE SUPPLEMENT (K840331)Oxoid U.S.A., Inc.1984-05-11
HY-BOND ZINC OXIDE EUGENOL TEMP. (K841196)Shofu Dental Corp.1984-05-11
VOLUME TEST DYE 6 (K841422)Reagent Laboratory, Inc.1984-05-11
OPTIMATE DIGOXIN TEST (K841582)Miles Laboratories, Inc.1984-05-11
ULTRACLONE ECL-01-500 CELL LINE (K841345)Earl-Clay Laboratories, Inc.1984-05-11
ULTRACLONE ECL-01-300 CELL LINE (K841344)Earl-Clay Laboratories, Inc.1984-05-11
HEAT PACK (K841698)Maddak, Inc.1984-05-10
IN-THE-EAR HEARING AID RX10 & 20 (K840891)Audio-Aid, Inc.1984-05-10
MEDIUM FREQ. ELECTRICAL MUSCLE STIMULA (K841598)Chattanooga Group, Inc.1984-05-10
MEDPAR SURGICAL IMPLANTS (K832283)Porex Medical1984-05-10
CRAWLER (K841695)Maddak, Inc.1984-05-10
MULTIPLEX I, INTERFERENTIAL CURRENT (K841579)Houwers Enterprises , Ltd.1984-05-10
STERILIZATION PROCESS INDICATOR (K841168)Parke-Davis Co.1984-05-09
ASTRA SYS INORGANIC PHOSPHORUS CHEM (K841181)Beckman Instruments, Inc.1984-05-09
REPLACE-A-TIP RECHARG. LOW TEMP. (K841325)Suncoast Medical Manufacturers, Inc.1984-05-09
INTELECT 210 PORTABLE ULTRASOUND (K841447)Chattanooga Group, Inc.1984-05-09
LACHRYMAL PROBES-VARIOUS (K841002)Premier Dental Products Co.1984-05-09
DIASONICS DLA-100 (K833667)Diasonics, Inc.1984-05-09
SUN-LITE PEN LIGHT (K840428)Suncoast Medical Manufacturers, Inc.1984-05-09
SPECTACLE INDIRECT OPHTHALMOSCOPE (K841292)Keller Instruments, Inc.1984-05-09
KOLLMANN URETHRAL DILATOR (K841386)Imm Enterprises , Ltd.1984-05-09
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Track 1984 automatically

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