Mallinckrodt Critical Care

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
92
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K880343BURNEY GALLBLADDER CATHETER KITMay 1, 1989
K874605HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSORFebruary 2, 1988
K874514HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBEJanuary 29, 1988
K874568HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITORJanuary 6, 1988
K874404HI-LO TEMP(R) SKIN TEMPERATURE SENSORNovember 6, 1987
K873461LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)November 6, 1987
K873833THERMOCOUPLE ADAPTERNovember 3, 1987
K873004GUIDING CATHETERSeptember 15, 1987
K871204CUFFED TRACHEAL TUBE (MULTIPLE)April 21, 1987
K862666UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE)August 1, 1986
K862653LUER LOCK ADAPTER/NUTJuly 31, 1986
K860901LASER RESISTANT TRACHEAL TUBE (TENTATIVE)June 5, 1986
K861483ANGIOGRAPHIC CATHETER (CARDIOLOGY & RADIOLOGY)May 15, 1986
K853182DIAGNOSTIC INTRAVASCULAR CATHETERSJanuary 15, 1986
K852413LGT TUBESeptember 5, 1985
K852025BRANDT TRACHEAL TUBE(TENTATIVE)August 13, 1985
K852493UNCUFFED HI-LO JET TRACHEAL TUBEJuly 8, 1985
K845037PERCUTANEOUS ANGIOGRAPHIC NEEDLESJune 21, 1985
K844201HI-LO TEMP THERMOCOUPLE TO THERMISTER ADAPTORMarch 4, 1985
K844598LARIAT CATHETERFebruary 1, 1985