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

FRC 1977-07-14

MONITOR, AERATION, TEC-TEST

Applicant Castle Co.

K-Number K770953

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IRT 1977-07-14

THERATHERM

Applicant Electro Therapeutic Devices, Inc.

K-Number K770686

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JMK 1977-07-14

ULTRAZYME PLUS HBD

Applicant Harleco

K-Number K770871

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DBY 1977-07-14

RHODAMINE-CONJUGATED ANTISERUM

Applicant Kent Laboratories, Inc.

K-Number K771144

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CHH 1977-07-14

ENZYMATIC CHOLESTEROL REAGENT SET

Applicant American Monitor Corp.

K-Number K770909

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FPA 1977-07-14

SURFLO WINGED INFUSION SET

Applicant Terumo America, Inc.

K-Number K771204

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FRN 1977-07-14

VOLUMET INFUSION PUMP, MODIFI. OF

Applicant Sigmamotor, Inc.

K-Number K770849

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HTD 1977-07-14

FORCEP, DISP., A CLAMP

Applicant Dravon Medical, Inc.

K-Number K771097

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KKX 1977-07-14

SHAVE PREP TRAY

Applicant Parke-Davis Co.

K-Number K771036

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FMF 1977-07-14

HYPODERMIC SYRINGE

Applicant Terumo America, Inc.

K-Number K771205

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CFR 1977-07-14

FLUCOSE U.V. TEST KIT

Applicant Mallinckrodt Critical Care

K-Number K770844

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CFR 1977-07-14

AUTO-ENZYMATIC GLUCOSE FOR ANALYZER

Applicant Harleco

K-Number K770886

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