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

FWZ 1983-05-02

ACUFEX UNIVERSAL LEG HOLDER

Applicant Acufex Microsurgical, Inc.

K-Number K830707

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CAC 1983-05-02

BT 795/A AUTOTRANS

Applicant Electromedics, Inc.

K-Number K830735

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GBX 1983-05-02

I/A KIT

Applicant Surgeon Surgical Instrumentation, Inc.

K-Number K830859

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N/A 1983-05-02

UNKNOWN

Applicant Xanar, Inc.

K-Number K837224

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DTB 1983-04-30

MODEL RZ PACEMAKER LEAD VARIOUS

Applicant Dr. Ing. P. Osypka, GmbH

K-Number K823894

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FPA 1983-04-30

IV ADMINISTRATION SETS - MVP INFUSION

Applicant Ziehm International, Inc.

K-Number K830453

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DTB 1983-04-30

MODEL MF..D & MX..D PACEMAKER LEADS

Applicant Oscor, Inc.

K-Number K823898

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DTB 1983-04-30

MODEL SZ PACEMAKER LEAD-VARIOUS

Applicant Dr. Ing. P. Osypka, GmbH

K-Number K823892

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DTB 1983-04-30

MODEL MZ PACEMAKER LEAD-VARIOUS

Applicant Oscor, Inc.

K-Number K823893

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DTB 1983-04-30

MODEL JY PACEMAKER LEAD - VARIOUS

Applicant Oscor, Inc.

K-Number K823889

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DTB 1983-04-30

MODEL FF..D & FX..D PACEMAKER LEADS

Applicant Dr. Ing. P. Osypka, GmbH

K-Number K823896

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DTB 1983-04-30

MODEL SF. D&SX.D PACEMAKER LEADS

Applicant Oscor, Inc.

K-Number K823897

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