|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
portex bluxl extra length tracheostomy tube, bluxl suctionaid extra length tracheostomy tube, bluxl extra length tracheostomy inner cannula
|
Smiths Medical ASD, Inc.
|
K210833 |
11/26/2021
|
scalpelcric
|
VBM Medizintechnik GmbH
|
K200190 |
10/30/2020
|
tracoe vario
|
TRACOE medical GmbH
|
K203362 |
08/05/2021
|
blue rhino g1-multi percutaneous tracheostomy introducer set, blue rhino g1-multi percutaneous tracheostomy introducer tray, blue rhino g2-multi percutaneous tracheostomy introducer set, blue rhino g2-multi percutaneous tracheostomy introducer tray, weinmann-multi percutaneous tracheostomy exchange
|
Cook Incorporated
|
K193133 |
12/12/2019
|
shiley adult flexible evac tracheostomy tube with taperguard cuff
|
Covidien
|
K193077 |
06/01/2020
|
weinmann tracheostomy exchange set
|
Cook Incorporated
|
K180034 |
05/07/2018
|
shiley neonatal/pediatric tracheostomy tube
|
Covidien
|
K182861 |
03/22/2019
|
portex blue line ultra paediatric tracheosomy tube
|
Smiths Medical ASD, Inc.
|
K170720 |
12/07/2017
|
bluperc percutaneous dilation tracheostomy kit with bluselect tube, bluperc percutaneous dilation tracheostomy kit with bluselect suctionaid tube, blugriggs percutaneous dilation tracheostomy kit with bluselect tube, blugriggs percutaneous dilation tracheostomy kit with bluselect suctionaid tube
|
Smiths Medical ASD, Inc.
|
K173912 |
05/08/2018
|
tracoe silcosoft tracheostomy tube
|
TRACOE medical GmbH
|
K172720 |
04/27/2018
|
melker cuffed emergency cricothyrotomy catheter sets, melker universal cricothyrotomy catheter set
|
COOK INCORPORATED
|
K160200 |
02/17/2017
|
protrach dualcare
|
ATOS MEDICAL AB
|
K151404 |
02/12/2016
|
shiley adult flexible tracheostomy tube cuffless, reusable inner cannula, shiley adult flexible tracheostomy tube with taperguard cuff, reusable inner cannula
|
COVIDIEN
|
K150844 |
07/14/2015
|
shiley adult flexible tracheostomy tube cuffless, disposable inner cannula; shiley adult flexible tracheostomy tube with taperguard cuff, disposable inner cannula
|
Covidien
|
K142296 |
02/24/2015
|
shiley neonatal, pediatric & pediatric long tracheostomy tubes with taperguard cuff
|
Covidien
|
K142298 |
02/13/2015
|
rusch tracflex plus pediatric tracheostomy tube set
|
Teleflex Medical, Inc.
|
K133173 |
05/23/2014
|
ciaglia percutaneous tracheostomy introducer set/tray, ciaglia blue rhino percutaneous tracheostomy introducer set/tray
|
COOK, INC.
|
K133597 |
04/18/2014
|
h&h emergency cricothyrotomy kit
|
H&H MEDICAL CORPORATION
|
K133528 |
07/03/2014
|
fahl tracheostomy tubes (multiple)
|
ANDREAS FAHL MEDIZINTECHNIK-VERTRIEB GMBH
|
K123699 |
08/12/2013
|
shiley neonatal tracheostomy tube cuffless, shiley pediatric tracheostomy tube cuffless, shiley pediatric tracheostomy t
|
COVIDIEN
|
K122531 |
10/09/2012
|
spiro speaking valve with oxygen port spiro speaking valve without oxygen port
|
FOGLESS INTERNATIONAL AB
|
K122932 |
12/23/2013
|
rusch tracflex plus tracheostomy tube set
|
Teleflex Medical, Inc.
|
K122235 |
09/06/2013
|
shikani speaking valve
|
SHIKANI MEDICAL, LLC
|
K100995 |
06/25/2010
|
ciaglia blue dolphin balloon percutaneous tracheostomy introducer, model: multiple, prefix c-ptbs
|
COOK, INC.
|
K093469 |
01/08/2010
|
bivona tracheostomy tubes
|
SMITHS MEDICAL ASD, INC.
|
K083641 |
02/23/2009
|
bivona adjustable and fixed neckflange hyperflex tracheostomy tubes
|
SMITHS MEDICAL ASD, INC.
|
K081440 |
09/12/2008
|
provox micron hme
|
ATOS MEDICAL AB
|
K072582 |
05/30/2008
|
ciaglia blue dolphin (tm) balloon percutaneous tracheostomy introducer
|
COOK, INC.
|
K072148 |
10/03/2007
|
shiley tracheosoft xlt extended length tracheostomy tube and inner cannula
|
MALLINCKRODT MEDICAL
|
K051416 |
06/16/2005
|
ciaglia cheetah percutaneous tracheostomy introducer set
|
COOK, INC.
|
K041044 |
07/29/2004
|
percutaneous dilation tracheostomy kit with single stage dilator and soft introducers for sizes 7, 8 and 9mm tubes only
|
PORTEX LTD.
|
K040014 |
02/13/2004
|
portex ultraperc percutaneous dilation tracheostomy kit_with serial dilators or single stage dilator, blue line ultra
|
SMITHS MEDICAL
|
K041348 |
07/13/2004
|
tracoe phon assist i - speaking valves, reference models: phon assist i-650-t/to and 650-s/so
|
TRACOE MEDICAL GMBH
|
K043160 |
02/18/2005
|
marpac messenger model #501
|
MARPAC, INC.
|
K041485 |
08/02/2004
|
per-fit percutaneous dilational tracheostomy kit
|
PORTEX, INC.
|
K031057 |
07/18/2003
|
shiley flextra tracheostomy tube
|
NELLCOR PURITAN BENNETT, INC.
|
K030787 |
11/14/2003
|
portex percutaneous dilatational tracheostomy kits
|
MENTOR MEDICAL LIMITED
|
K022212 |
03/21/2003
|
rusch crystal clear tracheostomy sets, cuffed and cuffless
|
RUSCH INTL.
|
K023918 |
03/28/2003
|
provox hme cassette, model 7240; provox adhesive, model 7251
|
ATOS MEDICAL AB
|
K014102 |
02/21/2002
|
melker cuffed emergency cricothyrotomy catheter
|
COOK, INC.
|
K010016 |
10/09/2001
|
trach vox
|
ENGINEERED MEDICAL SYSTEMS
|
K013728 |
07/30/2002
|
melker emergency cricothyrotomy catheter set
|
COOK, INC.
|
K013916 |
12/20/2001
|
the percuquick set for percutaneous dilation tracheostomy
|
RUSCH INTL.
|
K011210 |
08/15/2001
|
sterile water or o.9% sodium chloride, model al4100 & al4109
|
AUTOMATIC LIQUID PACKAGING, INC.
|
K000964 |
04/25/2000
|
shiley tracheosoft xlt extended length tracheostomy tube and disposable inner cannula
|
MALLINCKRODT, INC.
|
K003315 |
11/08/2000
|
passy-muir low-profile tracheostomy speaking valve pmv 2020 (clear) jit
|
PASSY-MUIR, INC.
|
K990905 |
06/11/1999
|
per-fit percutaneous dilational tracheostomy kit with specialty tracheostomy tube and disposable inner cannula
|
SIMS PORTEX, INC.
|
K980466 |
02/24/1998
|
shikani-french speaking valve
|
PILLING WECK SURGICAL
|
K982128 |
10/23/1998
|
disposable cannula tracheostomy tube, with inner cannula;disposable cannula fenestrated tracheostomy tube, with inner cn
|
PNEUMOCARE, INC.
|
K970811 |
11/13/1998
|
fenestrated flexible d.i.c. tracheostomy tube cuffed
|
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
|
K972385 |
01/20/1998
|
passy-muir o2 adapter; pma2000
|
PASSY-MUIR, INC.
|
K970365 |
02/12/1997
|
shiley extended length, disposable cannula, tracheostomy tube: cuffed, distal extension, cuffed, proximal extension, cuf
|
MALLINCKRODT MEDICAL
|
K971267 |
09/25/1997
|
irrigation bottle
|
AUTOMATIC LIQUID PACKAGING, INC.
|
K973829 |
02/23/1998
|
rusch single use crystal tracheostomy tube set
|
RUSCH INTL.
|
K972546 |
04/14/1998
|
rusch tracheofix-set
|
RUSCH INTL.
|
K972423 |
02/13/1998
|
passy-muir low-profile tracheostomy and ventilator speaking valve; product number pmv 2000 or pmtsv 2000
|
PASSY-MUIR, INC.
|
K962714 |
10/28/1996
|
per-fit percutaneous tracheostomy kit w/portex tracheostmy tube & disp. inner cannula
|
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
|
K960429 |
05/02/1996
|
rusch ultra tracheoflex fenestrated kit cuffed,uncuffed/ rusch tracheoflex tracheostomy kit uncuffed sterile
|
RUSCH INTL.
|
K964056 |
10/10/1997
|
shikey tracheostomy tubes and accessories
|
MALLINCKRODT MEDICAL
|
K962173 |
10/04/1996
|
tracheostomy cleaning tray w/suction catheter
|
CONTINENTAL MEDICAL LABORATORIES, INC.
|
K962078 |
10/11/1996
|
portex adjustable flange tracheostomy tube
|
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
|
K962175 |
01/17/1997
|
percutaneous dual cannula tracheostomy tube with low pressure/low profile cuff and disposable inner cannula
|
MALLINCKRODT MEDICAL
|
K963732 |
06/26/1997
|
tracheostomy tubes tracoe-flex
|
TRACOE MEDICAL GMBH
|
K961449 |
09/13/1996
|
superslick
|
BIVONA MEDICAL TECHNOLOGIES
|
K952700 |
10/31/1995
|
rusch ultra tracheoflex tracheostomy set, cuffed, sterile
|
RUSCH, INC.
|
K955564 |
06/28/1996
|
shiley cuffed pediatric tracheostomy tube; long cuffed
|
MALLINCKRODT MEDICAL
|
K955680 |
03/13/1996
|
mallinckrodt shiley 15mm cap
|
MALLINCKRODT MEDICAL
|
K954749 |
01/24/1996
|
the zipper medical combination ventilator anti-disconncet device & tracheostomy tube neckband. tracheostomy tube holder,
|
ZIPPER MEDICAL, INC.
|
K954661 |
01/19/1996
|
montgomery tracheostomy speaking valve
|
BOSTON MEDICAL PRODUCTS, INC.
|
K955516 |
12/22/1995
|
euromedical poly tracheotomy tube
|
REGULATORY & MARKETING SERVICES, INC.
|
K945874 |
12/27/1994
|
mallinckrodt shiley neonatal, pediatric, long pediatric tracheostomy tube
|
MALLINCKRODT MEDICAL
|
K945513 |
01/13/1995
|
passy-muir tracheostomy speaking valves (one-way tracheostomy speaking valves)
|
PASSY-MUIR, INC.
|
K944451 |
07/07/1995
|
bivona flextend pediatric & neonatal tracheostromy tubes
|
BIVONA MEDICAL TECHNOLOGIES
|
K944178 |
10/27/1994
|
percutaneous tracheostomy tube kit
|
CRANDALL MEDICAL DEVICES
|
K931611 |
08/27/1993
|
shiley fenestrated reusable inner cannula, modif
|
MALLINCKRODT MEDICAL TPI, INC.
|
K930895 |
07/02/1993
|
reusable cannula tracheostomy tubes, modified heads
|
MALLINCKRODT MEDICAL TPI, INC.
|
K936224 |
08/30/1994
|
saline solution-sterile
|
TRINITY LABORATORIES, INC.
|
K933412 |
10/01/1993
|
percutaneous tracheostomy kit
|
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
|
K936133 |
03/23/1994
|
tracheostomy care tray
|
CLINIPAD CORP.
|
K932016 |
11/03/1993
|
bivona customized tracheostomy tubes
|
BIVONA MEDICAL TECHNOLOGIES
|
K923878 |
12/29/1992
|
bivona hyperflex tracheostomy tube
|
BIVONA MEDICAL TECHNOLOGIES
|
K922665 |
01/07/1993
|
combination trach tie & ventilator antidisconnect
|
AGA MEDICAL PRODUCTS, INC.
|
K925438 |
02/17/1993
|
tracheostomy care kit
|
TRANSIDYNE GENERAL CORP.
|
K924243 |
06/16/1993
|
tracheostomy kit
|
AJS MEDICAL CO., INC.
|
K925288 |
08/27/1993
|
tracheostomy care tray
|
ORION LIFE SYSTEMS, INC.
|
K923156 |
08/18/1993
|
tracheostomy care kit (sterile)
|
CUSTOMED, INC.
|
K925020 |
07/07/1993
|
tracheostomy care tray
|
MEDIKMARK, INC.
|
K921733 |
06/15/1994
|
tracheostomy tube and tube cuff
|
APPLIED MEDICAL RESOURCES
|
K924660 |
12/11/1992
|
bivona fome-cuf(r) & air cuf(r), modification
|
BIVONA MEDICAL TECHNOLOGIES
|
K913859 |
01/30/1992
|
hygiena-trach
|
APDYNE MEDICAL CO.
|
K911080 |
05/20/1991
|
bivona fome-cuf(r) pediatric tracheostomy tube
|
BIVONA MEDICAL TECHNOLOGIES
|
K913270 |
08/09/1991
|
tracheostomy care kit
|
MEGADYNE MEDICAL PRODUCTS, INC.
|
K910362 |
04/08/1991
|
bivona aire-cuf tracheostomy tube w/talk attach.
|
BIVONA MEDICAL TECHNOLOGIES
|
K912967 |
07/17/1991
|
bivona aire-cuf(r) pediatric tracheostomy tube
|
BIVONA MEDICAL TECHNOLOGIES
|
K914088 |
10/23/1991
|
bivona cuff maintenance device (cmd)
|
BIVONA MEDICAL TECHNOLOGIES
|
K914183 |
10/23/1991
|
needlecric
|
AJS MEDICAL CO., INC.
|
K914471 |
06/29/1992
|
passy-muir tracheostomy speaking valve 15mm / 22mm
|
PASSY & PASSY, INC.
|
K903699 |
09/04/1990
|
shiley specialized tracheostomy tube
|
SHILEY, INC.
|
K903435 |
10/02/1990
|
bivona aire-cuf adjustable tracheostomy tube
|
BIVONA MEDICAL TECHNOLOGIES
|
K894614 |
10/13/1989
|
modified fome-cuf silicone tracheostomy tube
|
BIVONA MEDICAL TECHNOLOGIES
|
K896547 |
01/22/1990
|
hood speaking valve
|
HOOD LABORATORIES
|
K897059 |
03/12/1990
|
bivona fome-cuf adjustable tracheostomy tube
|
BIVONA MEDICAL TECHNOLOGIES
|
K894613 |
10/13/1989
|
blom-singer(r) silicone laryngectomy tube
|
HELIX MEDICAL, INC.
|
K897005 |
03/16/1990
|
hydrasorb(tm)
|
AVITAR, INC.
|
K897102 |
04/23/1990
|
modified aire-cuf silicone tracheostomy tube
|
BIVONA MEDICAL TECHNOLOGIES
|
K896548 |
01/22/1990
|
modified decannulation stopper
|
PREMIER MEDICAL
|
K894050 |
08/01/1989
|
shiley specialized tracheostomy tube
|
SHILEY, INC.
|
K890194 |
07/20/1989
|
modified aire-cuf silicone tracheostomy tube
|
BIVONA MEDICAL TECHNOLOGIES
|
K885130 |
02/27/1989
|
modified fome-cuf silicone tracheostomy tube
|
BIVONA MEDICAL TECHNOLOGIES
|
K885129 |
02/27/1989
|
shiley fenestrated low press. cuffed
|
SHILEY, INC.
|
K812302 |
09/08/1981
|
aire-cuf tracheostomy tube
|
BIOANA SURGICAL INSTRUMENTS, INC.
|
K812163 |
09/21/1981
|
regulator, pressure, cuff
|
BOEHRINGER LABORATORIES
|
K760453 |
09/13/1976
|