Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

DQC 1980-01-24

NIC-200 VENTRICULAR FUNCTION ANALYZER

Applicant Nicolet Biomedical Instruments

K-Number K792466

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JDG 1980-01-24

ANITOMIC TOTAL HIP SYSTEM

Applicant Hexcel Medical

K-Number K800050

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CGR 1980-01-23

QUANTIMUNE CORTISOL RIA CORTISOL RADIO-

Applicant Bio-Rad

K-Number K800045

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DRN 1980-01-23

CARDIASSIST EXTERNAL COUNTERPULSATION

Applicant Cardiassist Corp.

K-Number K792430

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LCQ 1980-01-23

FIAX TEST KIT FOR GENTAMICIN QUAN.

Applicant Intl. Diagnostic Technology

K-Number K800032

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JDG 1980-01-23

BIOPHASE IMPLANT MATERIAL

Applicant Richard'S Medical Equip., Inc.

K-Number K792329

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ESD 1980-01-23

HEARING AID, MODELS DRI-35/DL1-35

Applicant Unitron Industries, Inc.

K-Number K792643

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DOJ 1980-01-23

INTERSCI TEST FOR ALCOHOL IN BODY FLUIDS

Applicant Intersci Corp.

K-Number K792469

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LDG 1980-01-23

COE-SIL

Applicant Coe Laboratories, Inc.

K-Number K792428

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GMI 1980-01-23

CANDIDA ALBICANS, ANTISERUM

Applicant Meridian Diagnostics, Inc.

K-Number K792713

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ESD 1980-01-23

TELESONIC V-101

Applicant Telesonic, Inc.

K-Number K792644

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JFJ 1980-01-23

DELTA TEST AMYLASE UV

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K-Number K800049

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