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

KPK 1980-08-27

FLUORO-MARK RADIOPAQUE ANATOMICAL MKR.

Applicant C.R. Bard, Inc.

K-Number K801637

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DSF 1980-08-27

MODEL 9300 ELECTROCARDIOVALIDATOR

Applicant Del Mar Avionics

K-Number K801830

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FRN 1980-08-27

THE SIMPLICITY PUMP #2100 INFUSION PUMP

Applicant Critikon Company, LLC

K-Number K801546

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LDR 1980-08-27

IVAC 260 SERIES VOLUME TRIC INFUSION CON

Applicant Y

K-Number K801861

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IPF 1980-08-27

NEUROGAR IV-EXTERNAL NEURO-MUSCLE STIM.

Applicant Inter Med Industries, Inc.

K-Number K801577

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KRA 1980-08-27

MEDI-TRACE DISP. FLUSHING DEV./MONITOR

Applicant Graphic Controls Corp.

K-Number K801829

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KLS 1980-08-27

FIAX TEST KIT FOR THEOPHYLLINE QUANT.

Applicant Intl. Diagnostic Technology

K-Number K801642

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EJJ 1980-08-27

PERMITE DENTAL AMALGAM ALLOY

Applicant Southern Dental Industries, Inc.

K-Number K801639

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FJG 1980-08-27

CYBER 120 HEMODIALYZER

Applicant Cyberex Corp.

K-Number K801377

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JSH 1980-08-27

MICROBIOLOGY CULTURE MEDIA, C.L.E.D.

Applicant Radiation Technology, Inc.

K-Number K801817

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DTL 1980-08-27

MEDI-TRACE DISP. STOPCOCKS/PHYSIO. PRESS

Applicant Graphic Controls Corp.

K-Number K801828

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KDI 1980-08-27

GAMBRO LUNDIA MAJOR HIGH FLUX HEMODIALYZ

Applicant Gambro, Inc.

K-Number K801480

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