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

DBM 1983-06-15

AUTOANTIBODY SCREEN TEST SYSTEM

Applicant Zeus Scientific, Inc.

K-Number K831358

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KCT 1983-06-15

INSTRUMENT GUARD CAPSULE

Applicant Treace Medical, Inc.

K-Number K831588

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IQI 1983-06-15

DROP FOOT BRACE

Applicant Edward Dilauro, Jr.

K-Number K831615

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HAW 1983-06-15

PMT VAXIOM STEREOTACTIC SYS #FX001

Applicant Progress Mankind Technology

K-Number K831329

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JPK 1983-06-15

WHITE BLOOD CELL CONTROL

Applicant Control Diagnostics

K-Number K830864

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FRN 1983-06-15

PULSAMAT MODEL 1050

Applicant Ferring Laboratories, Inc.

K-Number K830906

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EJS 1983-06-15

STROMA II

Applicant Unitek Corp.

K-Number K831096

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EQH 1983-06-15

T-TUBE INSERTER

Applicant Treace Medical, Inc.

K-Number K831590

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DRX 1983-06-15

QUIK-SILVER RESTING ECG ELECTRODE

Applicant Quinton, Inc.

K-Number K830655

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DRT 1983-06-15

CENTRAL STATION DISPLAY/RECORDER MATRIX

Applicant Marquette Electronics, Inc.

K-Number K830517

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EJS 1983-06-15

CONCERTO

Applicant Unitek Corp.

K-Number K831097

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DXY 1983-06-15

COMMAND ULTRA I

Applicant Cardiac Pacemakers, Inc.

K-Number K831161

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