Mallinckrodt Medical

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
43
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K082520SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBESOctober 2, 2008
K051416SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULAJune 16, 2005
K972258HI-CARE CLOSED SUCTION SYSTEMDecember 29, 1997
K971267SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROSeptember 25, 1997
K963732PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER June 26, 1997
K955721CUFFED OROPHARYNGEAL AIRWAY (COPA)March 28, 1997
K965132HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBESMarch 20, 1997
K962045ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KITNovember 26, 1996
K962173SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIESOctober 4, 1996
K955680SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFEDMarch 13, 1996
K954749MALLINCKRODT SHILEY 15MM CAPJanuary 24, 1996
K954146UTK-DTE AUTILARY SHIELDDecember 6, 1995
K953400GUEDEL AIRWAYOctober 24, 1995
K953295ANESTHESIA FACE MASKAugust 11, 1995
K952036FLEXLIFEJune 8, 1995
K945513MALLINCKRODT SHILEY NEONATAL, PEDIATRIC, LONG PEDIATRIC TRACHEOSTOMY TUBEJanuary 13, 1995
K943739SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETERNovember 15, 1994
K943276WARMTOUCH PLASTIC WARMING COVERSeptember 19, 1994
K944124SPIROBAC ADAPTERSSeptember 8, 1994
K942392AIRWAY CONNECTOR WITH FLEX TUBEAugust 22, 1994