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

HXB 1980-02-19

ACUFEX PROBES

Applicant Acufex Microsurgical, Inc.

K-Number K800274

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FTC 1980-02-19

UVB LIGHT BOX - UVB LIGHT BOOTH

Applicant Sun Shanty, Inc.

K-Number K792500

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IOL 1980-02-19

TREADMILL MODEL 3060

Applicant Cambridge Instruments, Inc.

K-Number K792661

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EKW 1980-02-19

ENDEX BROACH, ENDODONTIC

Applicant Ipco Corp.

K-Number K800292

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EKS 1980-02-19

FILE, PULP CANAL

Applicant Ipco Corp.

K-Number K800293

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CZP 1980-02-19

IMMUNOGLOBULIN A REAGENT SYSTEM

Applicant Calbiochem-Behring Corp.

K-Number K800211

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IXA 1980-02-19

HUESTIS FLEXI-HOLDER

Applicant Huestis Machine Corp.

K-Number K792721

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FRL 1980-02-19

SURGITEK FOERSTER MAMMARY BANDAGE

Applicant Medical Engineering Corp.

K-Number K800249

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ILH 1980-02-19

DYNAMIC EXTENSOR SPLINT

Applicant Biomet, Inc.

K-Number K800143

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JTC 1980-02-13

SEROCLUSTER U AND V

Applicant Corning Costar Corp.

K-Number K800240

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CGJ 1980-02-13

FOLLICLE STIMULATING HORMONE

Applicant Radioimmunoassay, Inc.

K-Number K800107

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JSJ 1980-02-13

AZIDE BLOOD AGAR BASE W/&WTHOT SHP. BLD

Applicant Isle Media and Sterile Products, Inc.

K-Number K800158

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