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

GAA 1980-02-06

EXTEMP/EXTEMP-V

Applicant Pharma-Filter, Inc.

K-Number K800153

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KSQ 1980-02-06

ROYCO MODEL 951 CELL MIXER

Applicant Royco Instruments

K-Number K800104

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KDJ 1980-02-06

CONTINUOUS AMBULATORY DIALYSIS (CAPD)

Applicant Norton Performance Plastics Corp.

K-Number K791512

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FJG 1980-02-06

GAMBRO LUNDIA PLATE DIALYZER

Applicant Gambro, Inc.

K-Number K792611

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GZB 1980-02-05

MEDTRONIC PISCES GENERATION II LEAD KIT

Applicant Medtronic Vascular

K-Number K800193

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FYA 1980-02-05

ULTRASOFT GOWN

Applicant Mars Mfg Co.

K-Number K800124

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HRY 1980-02-05

RMC KNEE METAL SHOE TIBIAL COMPONENTS

Applicant Richard'S Medical Equip., Inc.

K-Number K792619

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IPY 1980-02-05

WRIGHT DOW CORNING SOFTGOODS W/DOW

Applicant Dow Corning Wright

K-Number K792269

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N/A 1980-02-05

BRIOX MODEL-AEROMIST

Applicant Briox Technologies, Inc.

K-Number K800078

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GKZ 1980-02-05

TECHNICON C/90 SYSTEM

Applicant Technicon Instruments Corp.

K-Number K800121

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EFW 1980-02-05

TOTE-BRUSH

Applicant Anja Marketing, Inc.

K-Number K800154

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CBK 1980-02-05

PNEUPAC VENTILATOR/RESUSCITATOR #3

Applicant Pneupac , Ltd.

K-Number K792456

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