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

NFB 1983-04-02

OXYMIZER

Applicant Chad Therapeutics, Inc.

K-Number K830009

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N/A 1983-04-01

EMINEX LS-8 SYSTEM

Applicant Elscint, Inc.

K-Number K837181

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N/A 1983-04-01

AUTOFOCUS PROBE FOR USE WITH ULTRASOUND AUTOSECTOR SYSTEM

Applicant Technicare Corp.

K-Number K837046

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N/A 1983-03-31

END TIDAL CO2 ANALYZER #411

Applicant Andros Incorporated

K-Number K830253

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DSI 1983-03-31

SIRECUST 400

Applicant Analogic Corp.

K-Number K830029

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DTB 1983-03-31

MODEL KY PACEMAKER LEAD - VARIOUS

Applicant Oscor, Inc.

K-Number K823891

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FRG 1983-03-31

OR PREP KIT

Applicant Clinipad Corp.

K-Number K830476

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HLZ 1983-03-31

ERG-JET ELECTRODE

Applicant Universo S.A.

K-Number K830557

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KEQ 1983-03-31

SCOTTS TAP WATER SUBSTITUTE CONCENTRATE

Applicant Surgipath Medical Industries, Inc.

K-Number K830515

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N/A 1983-03-31

STAINLESS STEEL SUTURE 316L

Applicant Sharpoint, Inc.

K-Number K830522

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FOG 1983-03-31

ENDO-GUARD

Applicant Jayco Pharmaceuticals

K-Number K830781

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FRN 1983-03-31

IMS MINIATURE VOLUMETRIC INFUSION PUMP

Applicant Ziehm International, Inc.

K-Number K830454

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