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

LET 1982-05-24

PHENOBARBITAL FLUORESCENT IMMUNO

Applicant American Diagnostic Corp.

K-Number K821408

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HDF 1982-05-24

PEDERSON VAGINAL SPECULA

Applicant Conphar, Inc.

K-Number K821291

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CAI 1982-05-21

ESPREE' BREATHING CIRCUIT (W/ACCESS

Applicant Esp Plastics, Inc.

K-Number K821311

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KWH 1982-05-21

LESSER METATARSAL PHALANG. JOINT PROSTH

Applicant Sutter Biomedical, Inc.

K-Number K820813

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ITJ 1982-05-21

LIGHT WEIGHT ALUMINUM WALKER

Applicant Manuco Manufacturing Co., Inc.

K-Number K821404

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IKN 1982-05-21

NEUROMATIC 2000

Applicant Disa Electronics

K-Number K821237

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GCX 1982-05-21

THORACIC DRAINAGE SYSTEM

Applicant Howmedica Corp.

K-Number K821023

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CIX 1982-05-21

ALBUMIN REAGENT

Applicant Hi Chem, Inc.

K-Number K821225

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FJS 1982-05-21

GORE-TEX PERITONEAL CATHETERR

Applicant W. L. Gore & Associates, Inc.

K-Number K820909

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CAE 1982-05-21

ESPREE' GUEDEL ESPREE BERMAN AIRWAY

Applicant Esp Plastics, Inc.

K-Number K821308

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JOL 1982-05-21

METAL BACKED ACETABULAR COMPONENT

Applicant Intermedics Orthopedics

K-Number K821342

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BTA 1982-05-21

KEYMED KEY VAC SUCTION PUMP

Applicant Keymed, Inc.

K-Number K820739

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