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

FXF 1980-05-28

ILLUMINATED SPECULUM

Applicant Designs For Vision, Inc.

K-Number K801058

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CIC 1980-05-28

REAGENTS FOR DETERM. CALCIUM IN HUMAN

Applicant Diagnostic Solutions, Inc.

K-Number K800680

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ESD 1980-05-28

TELESONIC, GENERIC & SOUNDEX C-102

Applicant Telesonic, Inc.

K-Number K801067

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CDH 1980-05-28

SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC

Applicant Diagnostic Solutions, Inc.

K-Number K800672

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LCI 1980-05-28

CENTRIA SYSTEM 2 AUTOMATED METHOD/RIA

Applicant Union Carbide Corp.

K-Number K801037

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JSG 1980-05-28

CHOCOLATE AGAR W/ENRICHMENTS

Applicant Quality Assurance Laboratory, Inc.

K-Number K800981

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DTB 1980-05-28

RESTERILIZATION OF IMPLANTABLE ELECTRODE

Applicant Telectronics, Inc.

K-Number K800891

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ESD 1980-05-28

TELESONIC, SOUNDEX & GENERIC V-101

Applicant Telesonic, Inc.

K-Number K801066

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KLK 1980-05-28

NOVAMETRIX TCOMETTE #809 TRANS. MONITOR

Applicant Novametrix Medical Systems, Inc.

K-Number K800988

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KLE 1980-05-28

DEN-MAT DENTIN BONDING AGENT

Applicant Den-Mat Corp.

K-Number K801216

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DTD 1980-05-28

ADAPTER KIT

Applicant Daig Corp.

K-Number K800353

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ESD 1980-05-28

OTICON EARETTE HEARING AID #E17CF

Applicant Oticon Corp.

K-Number K801003

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