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

CHH 1979-09-04

ENZYMATIC REAGENT SET, 4X250 ML.

Applicant Macomb Chemical Co.

K-Number K791511

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JSI 1979-09-04

ENDO AGAR

Applicant Isle Media and Sterile Products, Inc.

K-Number K791479

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IMD 1979-09-04

KWICK KOOLER

Applicant Stahlex Corp.

K-Number K791675

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N/A 1979-09-04

AXIOM FILTERED CONNECTOR

Applicant Axiom Medical, Inc.

K-Number K791508

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CDP 1979-09-04

DAC-CEL T3

Applicant Burroughs Wellcome Co.

K-Number K791232

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HGM 1979-09-04

FETASONDE FETAL HEART RATE VARIABILITY

Applicant Roche Medical Electronics, Inc.

K-Number K791039

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JSF 1979-09-04

.E.C MEDIUM (ESCHERICHIA COLI MEDIUM)

Applicant Isle Media and Sterile Products, Inc.

K-Number K791476

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DEW 1979-09-04

ANTISERUM, HUMAN, IGG H & L CHAIN

Applicant Kent Laboratories, Inc.

K-Number K790702

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IWZ 1979-09-04

KODAK ORTHO M FILM

Applicant Eastman Kodak Company

K-Number K791360

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OMA 1979-09-04

CEREBRAL FUNCTION MONITOR 870

Applicant Applied Medical Research

K-Number K791580

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DZE 1979-09-04

BIOLITE CARBON COATED DENTAL IMPLANT

Applicant Carbomedics, Inc.

K-Number K791491

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HGM 1979-09-04

FETASONDE FETAL ACTIVITY MONITOR

Applicant Roche Medical Electronics, Inc.

K-Number K791035

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