Medical Device Manufacturer · US , St Louis , MO

Mallinckrodt Medical - FDA 510(k) Cleared Devices

43 submissions · 42 cleared · Since 1990

43

Total

42

Cleared

0

Denied

FDA 510(k) Regulatory Record - Mallinckrodt Medical Anesthesiology ✕

22 devices

1-12 of 22

Cleared Oct 02, 2008

SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES

Anesthesiology · 30d

Cleared Jun 16, 2005

SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA

Anesthesiology · 15d

Cleared Dec 29, 1997

HI-CARE CLOSED SUCTION SYSTEM

Anesthesiology · 195d

Cleared Sep 25, 1997

SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL...

Anesthesiology · 174d

Cleared Jun 26, 1997

PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE...

Anesthesiology · 282d

Cleared Mar 28, 1997

CUFFED OROPHARYNGEAL AIRWAY (COPA)

Anesthesiology · 466d

Cleared Mar 20, 1997

HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES

Anesthesiology · 87d

Cleared Oct 04, 1996

SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES

Anesthesiology · 121d

Cleared Mar 13, 1996

SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE

Anesthesiology · 90d

Cleared Jan 24, 1996

MALLINCKRODT SHILEY 15MM CAP

Anesthesiology · 100d

Cleared Oct 24, 1995

Anesthesiology · 96d

Cleared Aug 11, 1995

ANESTHESIA FACE MASK

Anesthesiology · 28d