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

KLB 1979-09-04

QUANTIMUNE TOBRAMYCIN RIA RADIOIMMUNO

Applicant Bio-Rad

K-Number K791502

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CGA 1979-09-04

GLUCOSE GOD-PAP TRINDER METHOD TEST KIT

Applicant Fermco Biochemics, Inc.

K-Number K791066

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CDX 1979-09-04

DAC-CEL T4

Applicant Burroughs Wellcome Co.

K-Number K791231

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KZL 1979-09-04

MODEL 114 TREONIC H150 HAEMOHEATER

Applicant Vickers America Medical Corp.

K-Number K790936

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LCN 1979-09-04

TONGUE SCRAPER

Applicant Peter G. Finamore, Sr.

K-Number K790895

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DFK 1979-09-04

ANTISERA TO HUMAN FRAGMENT

Applicant Kent Laboratories, Inc.

K-Number K790711

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HGM 1979-09-04

FETASONDE LABOR STATUS DISPLAY

Applicant Roche Medical Electronics, Inc.

K-Number K791037

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JSF 1979-09-04

SIMMONS CITRATE AGAR

Applicant Isle Media and Sterile Products, Inc.

K-Number K791474

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DPS 1979-09-04

ELECTROCARDIOGRAPH MODEL ECG-5403

Applicant Nihon Kohden America, Inc.

K-Number K791540

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FRO 1979-09-04

JELONET PARAFFIN GAUZE DRESSINGS

Applicant Acme United Corp.

K-Number K791573

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CCK 1979-09-04

IL MODEL END TIDAL CO2 ANALYZER

Applicant Instrumentation Laboratory CO

K-Number K791570

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HGM 1979-09-04

FETASONDE UTERINE WORK MONITOR

Applicant Roche Medical Electronics, Inc.

K-Number K791036

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