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

BTO 1983-01-08

COMMUNITRACH TUBE

Applicant Implant Technology, Inc.

K-Number K823291

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KNG 1983-01-08

PROGRAMALITH PROGRAMMER

Applicant Pacesetter Systems

K-Number K823242

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GFK 1983-01-08

TENS MAX

Applicant Fujisawa Electronics Co.

K-Number K823388

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HRN 1983-01-08

CLIRANS TE08 HOLLOW FIBER DIALYZER

Applicant Terumo Medical Corp.

K-Number K823768

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HLF 1983-01-08

ERG-JET ELECTRODE

Applicant Life-Tech Intl., Inc.

K-Number K823767

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KAG 1983-01-08

CPI PRINTER

Applicant Cardiac Pacemakers, Inc.

K-Number K822857

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CGX 1983-01-07

COBAS REAGENT FOR CREATININE

Applicant Hoffmann-La Roche, Inc.

K-Number K823573

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LFT 1983-01-07

ADVANCE EMIT-AED PRIMEDONE ASSAY

Applicant Syva Co.

K-Number K823741

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JTO 1983-01-07

GRAM NEGATIVE BACTERIAL IDENTIF- PANELS

Applicant Micro-Media Systems, Inc.

K-Number K823738

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KOC 1983-01-07

GAMMA STERILIZED CAPILLARY FLOW DIALYZ

Applicant Travenol Laboratories, S.A.

K-Number K823778

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EWL 1983-01-07

LOW PRESSURE BLOM-SINGER VOICE PROSTHES

Applicant Bivona Medical Technologies

K-Number K823749

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ESE 1983-01-07

SAY

Applicant Kells Medical, Inc.

K-Number K823118

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