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

HFS 1981-08-03

AXICARE BREAST SHELL

Applicant Neonatal Corp.

K-Number K811364

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CDT 1981-08-03

KODAK EKTACHEM CLIN. CHEM. SLIDES (TRIG)

Applicant Eastman Kodak Company

K-Number K812029

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JHJ 1981-08-03

OREIA II, B-HCG

Applicant Organon, Inc.

K-Number K811940

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DSP 1981-08-03

MODEL 84 TRANSPORT SYSTEM

Applicant Datascope Corp.

K-Number K811372

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DTB 1981-08-03

MODEL A UNIPOLAR ENDOCARDIAL LEAD

Applicant Cook Pacemaker Corp.

K-Number K811879

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CIX 1981-08-03

KODAK EKTACHEM CLIN. CHEM. SLIDES (ALB)

Applicant Eastman Kodak Company

K-Number K812030

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BZA 1981-08-03

PEDIATRIC DOUBLE SWIVEL CONNECTOR

Applicant Mallinckrodt Critical Care

K-Number K812000

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CEK 1981-08-03

KODAK EKTACHEM CLIN. CHEM. SLIDES (TP)

Applicant Eastman Kodak Company

K-Number K812028

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FPA 1981-08-03

FLU VEN I.V. SETS

Applicant Venusa , Ltd.

K-Number K811914

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DTB 1981-08-03

MODEL D BIPOLAR ENDOCARDIAL LEAD

Applicant Cook Pacemaker Corp.

K-Number K811876

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BYF 1981-08-03

PERCENTO MASK, PEDIATRIC, UNDER-THE-CHIN

Applicant Airlife, Inc.

K-Number K812066

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BTR 1981-07-31

ARGYLE TARTAN TRACHEAL TUBE

Applicant Sherwood Medical Co.

K-Number K811937

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