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

GZB 1980-07-08

MYELOSTAT DORSAL CORD STIMULATOR, ETC.

Applicant Medtronic Vascular

K-Number K801384

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DXY 1980-07-08

MULTICOR (GAMMA) MODEL 336 & MODEL 337

Applicant Cordis Corp.

K-Number K801106

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ELW 1980-07-08

CROWN DELTA SILICONE IMPRESSION MATERIAL

Applicant Crown Delta Corp.

K-Number K801380

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JFJ 1980-07-08

COBAS REAGENT FOR A-AMYLASE

Applicant Roche Analytical Instruments, Inc.

K-Number K801295

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JGS 1980-07-08

AVL #980 ELECTROLYTE ANALYZER

Applicant Gauntlet Technology Corp.

K-Number K801011

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GTQ 1980-07-08

ASO QUANTUM, ANTISTREPTOLYSIN O TEST

Applicant Sclavo, Inc.

K-Number K801177

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IZX 1980-07-08

COLLIMAX X-RAY COLLIMATOR # R-182

Applicant Ito X-Ray Corp.

K-Number K801168

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JIW 1980-07-08

DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL)

Applicant E.I. Dupont DE Nemours & Co., Inc.

K-Number K801300

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DSF 1980-07-08

SERIES 602 CKG RECORDER (MODIFIED)

Applicant Cardio Kinetics, Inc.

K-Number K801485

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LCP 1980-07-08

SANDARE LYOPHILIZED GLYCOHEMOGLOBIN CLS.

Applicant Sandare Chemical Co., Inc.

K-Number K801422

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DDG 1980-07-08

J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS

Applicant J.T. Baker Chemical Co.

K-Number K801434

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JXB 1980-07-08

NITRATE SWAB-RAPID TEST

Applicant Remel Co.

K-Number K800803

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