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

GAG 1980-12-30

PROXIMATE*II DISPOSABLE SKIN STAPLER

Applicant ETHICON, Inc.

K-Number K803038

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GZJ 1980-12-30

MENTOR 402 TRANSCUTANEOUS ELEC. STIMULAT

Applicant George H. Frisch

K-Number K803113

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GXY 1980-12-30

SHUR-PATCH TAPE PATCH

Applicant Shur Medical Corp.

K-Number K803012

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KIT 1980-12-30

SERUM FREE TISSUE CULTURE MEDIA

Applicant Cartaya Assoc.

K-Number K803041

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FQM 1980-12-30

ELASTIC GAUZE

Applicant Abco Dealers, Inc.

K-Number K802992

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DZP 1980-12-30

JOTA DIAMOND DENTAL BURS

Applicant Swiss American Metal Craft Corp.

K-Number K802987

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KDD 1980-12-23

CUSTOM DRESSING TRAY WET TO DRY

Applicant American Medical Disposable, Inc.

K-Number K803117

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KDD 1980-12-22

SIMPLE DRESSING TRAY #82028

Applicant American Medical Disposable, Inc.

K-Number K803118

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DTN 1980-12-22

INTERSEPT* VENOUS RESERVOIR BAG & HOLDER

Applicant Extracorporeal Medical Specialities, Inc.

K-Number K803059

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DON 1980-12-22

DIGOXIN RIABEAD DIAGNOSTIC KIT

Applicant Abbott Laboratories

K-Number K803075

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KME 1980-12-22

PATIENT CARE DISPOSABLE INFANT SHIRTS

Applicant American Convertors Div., American Pharmaseal

K-Number K802998

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KYG 1980-12-22

INTRAJECT

Applicant General Medical Engineering Corp.

K-Number K802332

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