Medical Device Manufacturer · US , Mchenry , IL

Mallinckrodt Critical Care

92 submissions · 92 cleared · Since 1976
92
Total
92
Cleared
0
Denied

Mallinckrodt Critical Care — FDA 510(k) Submissions

Mallinckrodt Critical Care has submitted 92 FDA 510(k) premarket notifications since 1976, of which 92 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Tube, Tracheal (w/wo Connector), Catheter, Intravascular, Diagnostic, Continuous Measurement Thermometer, Single (specified) Analyte Controls (assayed And Unassayed), Counter, Cell, Automated (particle Counter) . Use the specialty filter in the sidebar to narrow results.

92 devices
1–12 of 92
BURNEY GALLBLADDER CATHETER KIT
K880343 · FGE Stents, Drains And... · Gastroenterology & Urology
May 1989 461d
HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR
K874605 · KRI Accessory Equipment,... · Cardiovascular
Feb 1988 85d
HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE
K874514 · FLL Continuous Measurement... · General Hospital
Jan 1988 88d
HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR
K874568 · FLL Continuous Measurement... · General Hospital
Jan 1988 62d
LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)
K873461 · BTR Tube, Tracheal (w/wo... · Anesthesiology
Nov 1987 70d
HI-LO TEMP(R) SKIN TEMPERATURE SENSOR
K874404 · FLL Continuous Measurement... · General Hospital
Nov 1987 9d
THERMOCOUPLE ADAPTER
K873833 · FLL Continuous Measurement... · General Hospital
Nov 1987 43d
GUIDING CATHETER
K873004 · DQO Catheter, Intravascular,... · Cardiovascular
Sep 1987 42d
CUFFED TRACHEAL TUBE (MULTIPLE)
K871204 · BTR Tube, Tracheal (w/wo... · Anesthesiology
Apr 1987 27d
UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE)
K862666 · BTR Tube, Tracheal (w/wo... · Anesthesiology
Aug 1986 18d
LUER LOCK ADAPTER/NUT
K862653 · FPA Set, Administration,... · General Hospital
Jul 1986 17d
LASER RESISTANT TRACHEAL TUBE (TENTATIVE)
K860901 · BTR Tube, Tracheal (w/wo... · Anesthesiology
Jun 1986 87d

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