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

GCX 1981-11-16

ARGYLE YANKAUER SUCTION TUBE

Applicant Sherwood Medical Co.

K-Number K813066

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GCX 1981-11-16

SURGICAL SUCTION INSTRUMENTS-DISPOS.

Applicant Abco Dealers, Inc.

K-Number K812845

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KDJ 1981-11-16

PERITONEAL DIALYSIS CYCLER SET

Applicant American Medical Products, Inc.

K-Number K813069

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DXK 1981-11-16

SKI 5000

Applicant Smithkline Diagnostics, Inc.

K-Number K812646

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GAD 1981-11-16

SURGICAL LOOPS

Applicant Berkeley Medevices

K-Number K812389

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DTB 1981-11-16

INTERMEDICS POLYFLEX-MODEL 483-03 LEAD

Applicant Intermedics, Inc.

K-Number K812990

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KKX 1981-11-16

BOUNDARY PROCESS CHANGE

Applicant The Buckeye Cellulose Corp.

K-Number K812738

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CAE 1981-11-16

RIND AIRWAY

Applicant Rind Medical Development

K-Number K812822

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JOL 1981-11-13

STERILE WATER 4OZ.

Applicant Superior Plastic Products Corp.

K-Number K812312

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LFR 1981-11-10

ULTRACHEM GLUC-DH SET, ITEM #65048

Applicant Harleco

K-Number K813042

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KOD 1981-11-10

PRE-FILLED SYRINGE & CYSTOFLO URINARY BG

Applicant Travenol Laboratories, S.A.

K-Number K811924

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CEK 1981-11-10

ULTRACHEM TP, ITEM #64974

Applicant Harleco

K-Number K813038

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