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
25–48 of 109
Cleared Mar 28, 2003
RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS
K023918
Rusch Intl.
Anesthesiology · 123d
Cleared Aug 15, 2001
THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY
K011210
Rusch Intl.
Anesthesiology · 118d
Cleared Apr 14, 1998
RUSCH SINGLE USE CRYSTAL TRACHEOSTOMY TUBE SET
K972546
Rusch Intl.
Anesthesiology · 280d
Cleared Feb 13, 1998
RUSCH TRACHEOFIX-SET
K972423
Rusch Intl.
Anesthesiology · 231d
Cleared Oct 10, 1997
RUSCH ULTRA TRACHEOFLEX FENESTRATED KIT CUFFED,UNCUFFED/ RUSCH TRACHEOFLEX TRACHEOSTOMY KIT UNCUFFED STERILE
K964056
Rusch Intl.
Anesthesiology · 366d
Cleared Sep 25, 1997
SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUF
K971267
Mallinckrodt Medical
Anesthesiology · 174d
Cleared Jun 26, 1997
PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA
K963732
Mallinckrodt Medical
Anesthesiology · 282d
Cleared Oct 04, 1996
SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES
K962173
Mallinckrodt Medical
Anesthesiology · 121d
Cleared Mar 13, 1996
SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE
K955680
Mallinckrodt Medical
Anesthesiology · 90d
Cleared Jan 24, 1996
MALLINCKRODT SHILEY 15MM CAP
K954749
Mallinckrodt Medical
Anesthesiology · 100d
Cleared Oct 31, 1995
SUPERSLICK
K952700
Bivona Medical Technologies
Anesthesiology · 140d
Cleared Jan 13, 1995
MALLINCKRODT SHILEY NEONATAL, PEDIATRIC, LONG PEDIATRIC TRACHEOSTOMY TUBE
K945513
Mallinckrodt Medical
Anesthesiology · 65d
Cleared Oct 27, 1994
BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES
K944178
Bivona Medical Technologies
Anesthesiology · 62d
Cleared Oct 01, 1993
SALINE SOLUTION-STERILE
K933412
Trinity Laboratories, Inc.
Anesthesiology · 80d
Cleared Jul 07, 1993
TRACHEOSTOMY CARE KIT (STERILE)
K925020
Customed, Inc.
Anesthesiology · 286d
Cleared Jan 07, 1993
BIVONA HYPERFLEX TRACHEOSTOMY TUBE
K922665
Bivona Medical Technologies
Anesthesiology · 220d
Cleared Dec 29, 1992
BIVONA CUSTOMIZED TRACHEOSTOMY TUBES
K923878
Bivona Medical Technologies
Anesthesiology · 148d
Cleared Dec 11, 1992
TRACHEOSTOMY TUBE AND TUBE CUFF
K924660
Applied Medical Resources
Anesthesiology · 87d
Cleared Jan 30, 1992
BIVONA FOME-CUF(R) & AIR CUF(R), MODIFICATION
K913859
Bivona Medical Technologies
Anesthesiology · 156d
Cleared Oct 23, 1991
BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE
K914088
Bivona Medical Technologies
Anesthesiology · 42d
Cleared Oct 23, 1991
BIVONA CUFF MAINTENANCE DEVICE (CMD)
K914183
Bivona Medical Technologies
Anesthesiology · 35d
Cleared Aug 09, 1991
BIVONA FOME-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE
K913270
Bivona Medical Technologies
Anesthesiology · 17d
Cleared Jul 17, 1991
BIVONA AIRE-CUF TRACHEOSTOMY TUBE W/TALK ATTACH.
K912967
Bivona Medical Technologies
Anesthesiology · 9d
Cleared Apr 08, 1991
TRACHEOSTOMY CARE KIT
K910362
Megadyne Medical Products, Inc.
Anesthesiology · 69d