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

FSE 1980-06-26

DISPOSABLE SURGICAL HEAD SUPPORT

Applicant Innovative Surgical Products, Inc.

K-Number K801382

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DXK 1980-06-26

CAMBRIDGE CARDIAC DIAGNOSTIC SYSTEM

Applicant Cambridge Instruments, Inc.

K-Number K801224

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GCY 1980-06-26

ARGYLE VAC-U-CARE 100CC SUCT. RESERVOIR

Applicant Sherwood Medical Co.

K-Number K801372

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FYH 1980-06-26

ORTHOPEDIC LOWER EXTREMITY SUSPENSION

Applicant Orthopedic Systems, Inc.

K-Number K801436

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HCC 1980-06-26

V.I.B.E. VIDEO INTERFACE BIOFEEDBACK EQU

Applicant Nebulae Productions

K-Number K801049

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IXW 1980-06-26

KODAK MEDICAL X-RAY DEVELOPER & REPLEN.

Applicant Eastman Kodak Company

K-Number K801209

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DXY 1980-06-26

MEDTRONIC MODELS 5966/5967, ETC.

Applicant Medtronic Vascular

K-Number K800069

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KNX 1980-06-20

LINEBERGER EXTERNAL MALE CATHETER

Applicant Lineberger External Catheter Co.

K-Number K800890

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LDP 1980-06-20

STANBIO ACETAMINOPHEN TEST SET #0850

Applicant Stanbio Laboratory

K-Number K801014

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CJE 1980-06-20

COBAS REAGENT FOR ALKALINE PHOSPHATASE

Applicant Roche Analytical Instruments, Inc.

K-Number K801242

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LCR 1980-06-20

FIAX TEST KIT FOR TOBRAMYCIN QUANTITA

Applicant Intl. Diagnostic Technology

K-Number K801308

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GDW 1980-06-20

PROXIMATE*(ILS) DISP. INTRALUMINAL STAP.

Applicant ETHICON, Inc.

K-Number K801154

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