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 Oct 03, 2007
CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER
K072148
Cook, Inc.
Anesthesiology · 61d
Cleared Jun 16, 2005
SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA
K051416
Mallinckrodt Medical
Anesthesiology · 15d
Cleared Feb 18, 2005
TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO
K043160
Tracoe Medical GmbH
Anesthesiology · 95d
Cleared Aug 02, 2004
MARPAC MESSENGER MODEL #501
K041485
Marpac, Inc.
Anesthesiology · 59d
Cleared Jul 29, 2004
CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
K041044
Cook, Inc.
Anesthesiology · 98d
Cleared Jul 13, 2004
PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA
K041348
Smiths Medical
Anesthesiology · 54d
Cleared Nov 14, 2003
SHILEY FLEXTRA TRACHEOSTOMY TUBE
K030787
Nellcor Puritan Bennett, Inc.
Anesthesiology · 247d
Cleared Jul 18, 2003
PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT
K031057
Portex, Inc.
Anesthesiology · 106d
Cleared Mar 28, 2003
RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS
K023918
Rusch Intl.
Anesthesiology · 123d
Cleared Jul 30, 2002
TRACH VOX
K013728
Engineered Medical Systems
Anesthesiology · 263d
Cleared Aug 15, 2001
THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY
K011210
Rusch Intl.
Anesthesiology · 118d
Cleared Apr 25, 2000
STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109
K000964
Automatic Liquid Packaging, Inc.
Anesthesiology · 29d
Cleared Jun 11, 1999
PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT
K990905
Passy-Muir, Inc.
Anesthesiology · 85d
Cleared Nov 13, 1998
DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA
K970811
Pneumocare, Inc.
Anesthesiology · 618d
Cleared Oct 23, 1998
SHIKANI-FRENCH SPEAKING VALVE
K982128
Pilling Weck Surgical
Anesthesiology · 128d
Cleared Apr 14, 1998
RUSCH SINGLE USE CRYSTAL TRACHEOSTOMY TUBE SET
K972546
Rusch Intl.
Anesthesiology · 280d
Cleared Feb 24, 1998
PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
K980466
Sims Portex, Inc.
Anesthesiology · 18d
Cleared Feb 23, 1998
IRRIGATION BOTTLE
K973829
Automatic Liquid Packaging, Inc.
Anesthesiology · 139d
Cleared Feb 13, 1998
RUSCH TRACHEOFIX-SET
K972423
Rusch Intl.
Anesthesiology · 231d
Cleared Jan 20, 1998
FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED
K972385
Smiths Industries Medical Systems, Inc.
Anesthesiology · 208d
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 Feb 12, 1997
PASSY-MUIR O2 ADAPTER
K970365
Passy-Muir, Inc.
Anesthesiology · 12d