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

CBK 1980-12-18

INFANT VENTILATOR, (RESPIRATOR) PLAN B

Applicant Healthdyne, Inc.

K-Number K802583

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FJI 1980-12-18

CLIRANS TH13 HOLLOW FIBER DIALYZER

Applicant Terumo America, Inc.

K-Number K802122

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DHR 1980-12-18

RHEUMATOID FACTOR TEST SYSTEMS

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K-Number K802688

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JSJ 1980-12-18

CLOSTRIDIUM DIFFICILE AGAR BASE

Applicant Oxoid U.S.A., Inc.

K-Number K802495

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DXK 1980-12-18

PFIZONIC 100 ULTRASOUND SCANNER

Applicant Pfizer Medical Systems, Inc.

K-Number K802529

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FJI 1980-12-18

HF-100 DIALYZER

Applicant Bio-Med Corp.

K-Number K802092

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KPF 1980-12-18

GAMBRO PERITONEAL DIALYSIS MONITOR

Applicant Gambro, Inc.

K-Number K802831

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JXG 1980-12-18

AMERICAN HEYER-SCHULTE LOW PROFILE VALVE

Applicant American Heyer Schulte

K-Number K802586

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IYO 1980-12-18

PFIZONIC 300 ULTRASOUND SCANNER

Applicant Pfizer Medical Systems, Inc.

K-Number K802532

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GOL 1980-12-18

RUBELISA IGM TEST KIT

Applicant M.A. Bioproducts

K-Number K802508

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LFJ 1980-12-18

MEDCOMP SUBCLAVIAN CATHETER

Applicant Medical Components, Inc.

K-Number K801672

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GOL 1980-12-18

RUBELLA ELISA REAGENTS RUBELLA IGG ANTI

Applicant Calbiochem-Behring Corp.

K-Number K802102

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