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

ESD 1980-02-11

TELESONIC (HEARING AID)

Applicant Telesonic, Inc.

K-Number K800105

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ITG 1980-02-11

COTTON UNDER CAST PADDING

Applicant Winn Hirsch & Assoc.

K-Number K800195

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IYO 1980-02-11

SEARLE PHO/SONIC ALPHA 2000

Applicant G.D. Searle and Co.

K-Number K800139

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JAF 1980-02-11

AMBIVASON DR-200

Applicant Kt Medical, Inc.

K-Number K800096

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JAF 1980-02-11

MINIVASON 9

Applicant Kt Medical, Inc.

K-Number K800097

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N/A 1980-02-08

DEXIDE DISPOSABLE PREP STICK W/IODOPHOR

Applicant Dexide, Inc.

K-Number K792270

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FMF 1980-02-07

ANESTHESIA & HOSPITAL SYRINGE HOLDER

Applicant Medical Innovations Corp.

K-Number K792520

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FRC 1980-02-06

UNILAB CULTURING SET

Applicant Sybron Corp.

K-Number K792648

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HQE 1980-02-06

X-FLO

Applicant Contemporary Surgical Systems, Inc.

K-Number K800110

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KDJ 1980-02-06

CAPD TRANSFER SET JC9044

Applicant Travenol Laboratories, S.A.

K-Number K792651

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DYN 1980-02-06

TONGUE HOLDER/SALIVA EJECTOR

Applicant Unitek Corp.

K-Number K800210

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KNT 1980-02-06

RECTAL LEAKAGE INHIBITOR

Applicant Augustin Jones, M.D.

K-Number K792597

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