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 Jan 17, 1997
PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE
K962175
Smiths Industries Medical Systems, Inc.
Anesthesiology · 226d
Cleared Oct 28, 1996
PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING VALVE
K962714
Passy-Muir, Inc.
Anesthesiology · 108d
Cleared Oct 11, 1996
TRACHEOSTOMY CLEANING TRAY W/SUCTION CATHETER
K962078
Continental Medical Laboratories, Inc.
Anesthesiology · 136d
Cleared Oct 04, 1996
SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES
K962173
Mallinckrodt Medical
Anesthesiology · 121d
Cleared Sep 13, 1996
TRACHEOSTOMY TUBES TRACOE-FLEX
K961449
Tracoe Medical GmbH
Anesthesiology · 150d
Cleared Jun 28, 1996
RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE
K955564
Rusch, Inc.
Anesthesiology · 205d
Cleared May 02, 1996
PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA
K960429
Smiths Industries Medical Systems, Inc.
Anesthesiology · 92d
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 Jan 19, 1996
THE ZIPPER MEDICAL COMBINATION VENTILATOR ANTI-DISCONNCET DEVICE & TRACHEOSTOMY TUBE NECKBAND. TRACHEOSTOMY TUBE HOLDER,
K954661
Zipper Medical, Inc.
Anesthesiology · 101d
Cleared Dec 22, 1995
MONTGOMERY TRACHEOSTOMY SPEAKING VALVE
K955516
Boston Medical Products, Inc.
Anesthesiology · 18d
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 Dec 27, 1994
EUROMEDICAL POLY TRACHEOTOMY TUBE
K945874
Regulatory & Marketing Services, Inc.
Anesthesiology · 26d
Cleared Oct 27, 1994
BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES
K944178
Bivona Medical Technologies
Anesthesiology · 62d
Cleared Mar 23, 1994
PERCUTANEOUS TRACHEOSTOMY KIT
K936133
Smiths Industries Medical Systems, Inc.
Anesthesiology · 90d
Cleared Nov 03, 1993
TRACHEOSTOMY CARE TRAY
K932016
Clinipad Corp.
Anesthesiology · 194d
Cleared Oct 01, 1993
SALINE SOLUTION-STERILE
K933412
Trinity Laboratories, Inc.
Anesthesiology · 80d
Cleared Aug 18, 1993
TRACHEOSTOMY CARE TRAY
K923156
Orion Life Systems, Inc.
Anesthesiology · 415d
Cleared Jul 07, 1993
TRACHEOSTOMY CARE KIT (STERILE)
K925020
Customed, Inc.
Anesthesiology · 286d
Cleared Jun 16, 1993
TRACHEOSTOMY CARE KIT
K924243
Transidyne General Corp.
Anesthesiology · 296d
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