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

JSH 1979-10-30

OF BASAL MEDIUM

Applicant Isle Media and Sterile Products, Inc.

K-Number K791946

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CGR 1979-10-30

CORTISOL RADIOIMMUNOASSAY SYSTEM

Applicant Radioimmunoassay, Inc.

K-Number K792036

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JQX 1979-10-30

BIOVATION NEPHELOMETER

Applicant Biovation, Inc.

K-Number K792045

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JJY 1979-10-30

LYOPHILIZED HDL CHOLESTEROL CONTROLS

Applicant Helena Laboratories

K-Number K792025

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N/A 1979-10-30

OREIA-TU THYROID UPTAKER RATIO ASSAY

Applicant Organon, Inc.

K-Number K791172

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HMX 1979-10-30

X-PAK

Applicant Contemporary Surgical Systems, Inc.

K-Number K791917

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ESD 1979-10-30

RIONET HEARING AID HB-67T

Applicant Rion Acoustic Instruments, Inc.

K-Number K791882

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KLK 1979-10-26

TC02M ELECTRODE ADHESIVE RINGS

Applicant Novametrix Medical Systems, Inc.

K-Number K792010

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EXB 1979-10-26

HOLLISTER STOMA POUCH WITH MICRO ADHES

Applicant Hollister, Inc.

K-Number K791535

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DSF 1979-10-26

50MM WRITER MODEL CVM 9529

Applicant C-V Monitors Corp.

K-Number K792099

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IYO 1979-10-26

DATASON-GS

Applicant General Electric Co.

K-Number K791755

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FPB 1979-10-26

BLOOD TRANSFUSION MICROFILTER

Applicant Pioneer Viggo, Inc.

K-Number K791809

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