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

CFR 1980-10-03

F/LS MCA APPLICATION SOFTWARE

Applicant Instrumentation Laboratory CO

K-Number K801456

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HED 1980-10-03

DOUCHE TRAY-DISPOS. VAGINAL TRAY W/POVID

Applicant The Healthcare Group Laboratories, Inc.

K-Number K800954

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DWF 1980-10-03

PRESSURE GAUGE ACCESSORY KIT/DILATATION

Applicant Stanco Medical, Inc.

K-Number K802261

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CBK 1980-10-03

NEWBOURNS INFANT VENTILATOR

Applicant Bourns Medical Systems, Inc.

K-Number K802051

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HRS 1980-10-03

POLYETHYLENE FILLED BONE PLATE

Applicant Zimmer, Inc.

K-Number K801603

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FPA 1980-10-03

DISPOSABLE CONSTRAST DELIVERY SPIKE KIT

Applicant Stanco Medical, Inc.

K-Number K802329

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LEJ 1980-10-03

CABANNA TAN SUNLAMP

Applicant The Marketing Exchange, Inc.

K-Number K801925

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DSA 1980-10-03

CORROSION PROOF DUAL PURPOSE ECG WIRES

Applicant Custom Cardio Components

K-Number K802237

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FJS 1980-10-03

BETA-CAP II

Applicant Quinton, Inc.

K-Number K801679

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KOP 1980-10-03

OHIO THORACIC SUCTION REGULATOR

Applicant Ohio Medical Products

K-Number K802285

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HGX 1980-10-03

OXFORD HUMAN MILK PASTEURISER

Applicant Vickers America Medical Corp.

K-Number K801246

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DRG 1980-10-03

TELEMETRY TRANSMITTER, #TLT-3

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K-Number K802273

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