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

GGP 1977-02-07

QUAN-8 MULT-COMP FACTOR VIII ASSAY KIT

Applicant Bio/Data Corp.

K-Number K761058

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KOC 1977-02-07

BARIOR

Applicant Tri-Med, Inc.

K-Number K770213

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DTB 1977-02-07

PERM. IMPLANT. ENDOCARDIAL PAC. LEAD

Applicant Daig Corp.

K-Number K770195

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N/A 1977-02-07

PELLET, CALIBRATION

Applicant Deringer-Ney, Inc.

K-Number K770172

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N/A 1977-02-07

HGA-2200 HEATED GRAPHITE ATOMIZER

Applicant The Perkin-Elmer Corp.

K-Number K761317

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JXR 1977-02-07

ABSORPTION SPECTROPHOTOMETERS

Applicant The Perkin-Elmer Corp.

K-Number K761316

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KHQ 1977-02-07

SPAC TM T3 UPTAKE KIT

Applicant Mallinckrodt Critical Care

K-Number K770033

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GKH 1977-02-07

MICROSAMPLE BLOOD COLLECTION DEVICE

Applicant Ortho Diagnostics, Inc.

K-Number K761137

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DXY 1977-02-07

LEAD MODIFICATION

Applicant Elema-Schonander, Inc.

K-Number K770135

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CDX 1977-02-07

SPAC TM T4 RIA KIT

Applicant Mallinckrodt Critical Care

K-Number K770156

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DTD 1977-02-07

LEAD EXTENDER MODEL 6516

Applicant Cardiac Pacemakers, Inc.

K-Number K770199

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DXY 1977-02-07

UNIPOLAR, ASYNCHRONOUS PULSE GENERATOR

Applicant Cardiac Pacemakers, Inc.

K-Number K770197

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