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

FSM 1980-07-14

MICRO CLIP STERILIZING CASE #65199

Applicant Edward Weck, Inc.

K-Number K801470

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HED 1980-07-14

DOUCHE UNIT-1500 ML DISP. CONTAINER

Applicant The Healthcare Group Laboratories, Inc.

K-Number K800957

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DRS 1980-07-14

MODEL P-380 PHYSIOLOGICAL PRESSURE TRAN.

Applicant Gics Pharmaceuticals

K-Number K801138

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JPK 1980-07-14

WHITE BLOOD CELL COUNT CONTROL LEVELS

Applicant Bioscientific

K-Number K801265

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EIA 1980-07-14

LARES AIR PRESSURE GAUGE

Applicant Lares Manufacturing Co., Inc.

K-Number K801534

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KHG 1980-07-14

HEMOGLOBIN CONTROL LEVELS

Applicant Bioscientific

K-Number K801268

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DTP 1980-07-14

CARDIOTOMY RESERVOIR WITH FILTER

Applicant Travenol Laboratories, S.A.

K-Number K801360

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JAF 1980-07-08

VASCULAB BI-DIRECTIONAL DOPPLER, #D10

Applicant Medasonics, Inc.

K-Number K800768

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KWH 1980-07-08

KAMPNER HINGED TOE PROSTHESIS

Applicant Biomedics

K-Number K801345

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KOC 1980-07-08

BIONICS BI-FLO SAFE(DOUBLE LUMEN CATHET

Applicant Cordis Corp.

K-Number K801356

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JTO 1980-07-08

HIPPUR-ASE TUBES

Applicant Microchemical Specialities, Co.

K-Number K800816

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CFT 1980-07-08

GAMMA PROLACTIN RADIOIMMUNOASSAY KIT-

Applicant Travenol Laboratories, S.A.

K-Number K801020

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