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

FRO 1980-12-22

HYPERALIMENTATION DRESSING CHANGE TRAY

Applicant American Medical Disposable, Inc.

K-Number K803114

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EXB 1980-12-22

ADHESIVE PERISTOMAL COVERING W/WO CONN.

Applicant Johnson & Johnson Professionals, Inc.

K-Number K803082

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JSJ 1980-12-22

CDC ANAEROBE BL AGAR W/PHENYLETHYL ETC.

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K-Number K803027

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JJQ 1980-12-22

THE BIO-TEK CHROMOSCAN

Applicant Bio-Tek Instruments, Inc.

K-Number K803030

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KOD 1980-12-22

FOLEY CATHETER

Applicant American Hospital Supply Corp.

K-Number K803079

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DTB 1980-12-22

SIEMENS-ELEMA ENDOCARDIAL LEAD 402S

Applicant Siemens Elema AB

K-Number K803042

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DQR 1980-12-22

ELECATH FLUID-DRAIN ASSEMBLY

Applicant Electro-Catheter Corp.

K-Number K803002

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JSC 1980-12-22

PEPTONE YEAST EXTRACT GLUCOSE BROTH

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K-Number K803026

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JSJ 1980-12-22

MYCOLOGY CULTURE SYSTEM

Applicant Orion Diagnostica, Inc.

K-Number K802946

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CGN 1980-12-22

FOLATE 125I RADIOIMMUNOASSAY

Applicant Corning Medical & Scientific

K-Number K803060

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JBQ 1980-12-22

HELENA AT-III QUIPLATE PROCEDURE

Applicant Helena Laboratories

K-Number K802912

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KRJ 1980-12-22

PREBYPASS FILTER CAT.#K-5

Applicant Delta Medical Industries

K-Number K803101

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