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

LCP 1980-10-10

GLYCOSYLATED HEMOGLOBIN-SMC COLUMN

Applicant Helena Laboratories

K-Number K802233

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CAL 1980-10-10

AO FLEXIBLE LARYNGOSCOPE, #LS-7

Applicant American Optical Corp.

K-Number K802331

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KLW 1980-10-10

BEDSIDE TINNITUS MASKER #1500

Applicant Marpac, Inc.

K-Number K802234

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JPK 1980-10-10

CH-60 PLUS WHOLE BLOOD PLATELET CONTROL

Applicant American Dade

K-Number K802141

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DHR 1980-10-10

RF-II TEST KIT

Applicant Immuno-Diagnostic Products, Inc.

K-Number K801961

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JCA 1980-10-10

AUTOLET

Applicant Ulster Scientific, Inc.

K-Number K801815

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GDY 1980-10-10

STERILE TONSIL SPONGES

Applicant Medspec Corp.

K-Number K802060

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JPK 1980-10-10

CH-60 PLUS WHOLE BLOOD PLATELET/ABNORNAL

Applicant American Dade

K-Number K802142

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ESD 1980-10-10

WIDEX HEARING AID #'S A12+T & A12+H

Applicant Hearing Aid Co.

K-Number K802307

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CHJ 1980-10-10

CHLORIDE COLOR & CHLORIDE SAMPLE DILUENT

Applicant Panmed, Inc.

K-Number K802163

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LDQ 1980-10-10

NU-BORN BABY BATH KIT

Applicant American Hospital Supply Corp.

K-Number K802366

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DQX 1980-10-10

VASCULAR CATHETER WIREGUIDES

Applicant Stanco Medical, Inc.

K-Number K802260

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