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

FQL 1983-01-07

ELASTIC COMPRESSION ANKLET

Applicant Orthopaedic Resources Corp.

K-Number K823789

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BZW 1983-01-07

ESOPHAGEAL STETHOSCOPE

Applicant Rsp, Inc.

K-Number K823703

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JJX 1983-01-07

BIO INTERFERENCE BLANKING MATERIAL

Applicant American Monitor Corp.

K-Number K823687

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FKX 1983-01-07

STERILE, DISPOS. SPIKE PROTECTOR-5C4138

Applicant Travenol Laboratories, S.A.

K-Number K823777

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JJQ 1983-01-07

SPECTROPHOTOMETER

Applicant Macomb Chemical Co.

K-Number K823720

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KKX 1983-01-07

GORE-TEX BARRIER SURG. DRAPES & GOWNS

Applicant W. L. Gore & Associates, Inc.

K-Number K822641

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JHJ 1983-01-07

BETA FFIRM TEST

Applicant Organon, Inc.

K-Number K823682

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CIC 1983-01-07

COBAS REAGENT FOR CALCIUM

Applicant Hoffmann-La Roche, Inc.

K-Number K823577

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DLF 1983-01-07

ADVANCE EMIT-AED ETHOSUXIMIDE

Applicant Syva Co.

K-Number K823745

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LJG 1983-01-07

ATS PARASITOLOGY STAIN CONTROL SLIDE

Applicant Alpha-Tec Systems, Inc.

K-Number K823705

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CGX 1983-01-07

COBAS STANDARDS FOR CREATININE

Applicant Hoffmann-La Roche, Inc.

K-Number K823572

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FSM 1983-01-07

INSTRA-SAFE

Applicant Instranetics, Inc.

K-Number K823430

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