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

DSY 1980-10-10

GORE-TEX VASCULAR GRAFT

Applicant W. L. Gore & Associates, Inc.

K-Number K802095

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JPK 1980-10-10

CH-60 PLUS /ABNORMAL LOW/BLOOD PLATELET

Applicant American Dade

K-Number K802143

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ESD 1980-10-10

WIDEX HEARING AID #'S A18+T & A18+H

Applicant Hearing Aid Co.

K-Number K802306

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DYG 1980-10-10

TORQUE CONTROL BALLOON CATHETER

Applicant Cordis Corp.

K-Number K802338

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JHJ 1980-10-10

IN-HOME EARLY PREGNANCY TEST KIT

Applicant Health Diagnostics Corp.

K-Number K802334

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IYO 1980-10-10

AQUASONIC 100 ULTRASOUND TRANS. GEL,

Applicant Parker Laboratories, Inc.

K-Number K802146

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EWG 1980-10-10

CO2 MICROSURGICAL LASER SYSTEM #370

Applicant Metricon, Ltd.

K-Number K802034

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CDZ 1980-10-10

TESTOSTERONE RADIOIMMUNOASSY KIT

Applicant Radioimmunoassay, Inc.

K-Number K802135

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DRE 1980-10-10

SHEATH DILATOR SET

Applicant Stanco Medical, Inc.

K-Number K802327

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BTM 1980-10-10

AIR VIVA II

Applicant General Medical Co.

K-Number K802231

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KWQ 1980-10-10

ANTERIOR KYPHOSIS DISTRACTION DEVICE

Applicant Zimmer, Inc.

K-Number K802222

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KSE 1980-10-10

HEMOTEMP TM

Applicant Marion Laboratories, Inc.

K-Number K802319

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