JOH · Class II · 21 CFR 868.5800

FDA Product Code JOH: Tube Tracheostomy And Tube Cuff

Leading manufacturers include Bivona Medical Technologies, Mallinckrodt Medical and Covidien.

109
Total
109
Cleared
152d
Avg days
1976
Since
109 devices
49–72 of 109
Cleared Oct 02, 1990
SHILEY SPECIALIZED TRACHEOSTOMY TUBE
K903435
Shiley, Inc.
Anesthesiology · 63d
Cleared Jan 22, 1990
MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE
K896547
Bivona Medical Technologies
Anesthesiology · 68d
Cleared Jan 22, 1990
MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY TUBE
K896548
Bivona Medical Technologies
Anesthesiology · 68d
Cleared Oct 13, 1989
BIVONA FOME-CUF ADJUSTABLE TRACHEOSTOMY TUBE
K894613
Bivona Medical Technologies
Anesthesiology · 85d
Cleared Oct 13, 1989
BIVONA AIRE-CUF ADJUSTABLE TRACHEOSTOMY TUBE
K894614
Bivona Medical Technologies
Anesthesiology · 85d
Cleared Jul 20, 1989
SHILEY SPECIALIZED TRACHEOSTOMY TUBE
K890194
Shiley, Inc.
Anesthesiology · 184d
Cleared Feb 27, 1989
MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE
K885129
Bivona Medical Technologies
Anesthesiology · 77d
Cleared Feb 27, 1989
MODIFIED AIRE-CUF SILICONE TRACHEOSTOMY TUBE
K885130
Bivona Medical Technologies
Anesthesiology · 77d
Cleared Sep 08, 1981
SHILEY FENESTRATED LOW PRESS. CUFFED
K812302
Shiley, Inc.
Anesthesiology · 25d
Cleared Sep 13, 1976
REGULATOR, PRESSURE, CUFF
K760453
Boehringer Laboratories
Anesthesiology · 28d