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

HGP 1977-08-25

SPIRAL SCALP ELECTRODE, 14499A

Applicant Hewlett-Packard Co.

K-Number K771553

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CJM 1977-08-25

125 I ALDOSTERONE RIA KIT

Applicant Diagnostic Products Corp.

K-Number K771526

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DON 1977-08-25

CEBTRIA DIGOXIN RIA

Applicant Union Carbide Corp.

K-Number K771255

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IZF 1977-08-25

VERSATOME

Applicant Kermath Mfg. Corp.

K-Number K771549

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GJP 1977-08-25

PLATELET CONTROLS NORMAL & ABNORMAL

Applicant Dade, Baxter Travenol Diagnostics, Inc.

K-Number K771588

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ESD 1977-08-25

HEARING AID MODEL 775

Applicant Danavox, Inc.

K-Number K771607

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EBG 1977-08-25

TEMP. CROWN ACRYLIC RESIN

Applicant J. Palmero Sales Co., Inc.

K-Number K771530

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IZL 1977-08-25

MOBILE X-RAY SYS. MODEL 43820A

Applicant Hewlett-Packard Co.

K-Number K771571

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GTJ 1977-08-25

AGGLUTINATING SERUM W135

Applicant Burroughs Wellcome Co.

K-Number K771562

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CHL 1977-08-25

HEMOX-ANALYZER

Applicant 3M Company

K-Number K771253

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HGM 1977-08-25

FETAL MONITORING SYSTEM

Applicant Air-Shields, Inc.

K-Number K771541

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DNJ 1977-08-25

DIGOXIN RIA KIT

Applicant G.D. Searle and Co.

K-Number K771533

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