|
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
|
shiley adult flexible evac tracheostomy tube with taperguard cuff
|
Covidien
|
K193077 |
06/01/2020
|
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
|
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
|
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
|
protrach dualcare
|
ATOS MEDICAL AB
|
K151404 |
02/12/2016
|
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
|
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
|
rusch tracflex plus pediatric tracheostomy tube set
|
Teleflex Medical, Inc.
|
K133173 |
05/23/2014
|
fahl tracheostomy tubes (multiple)
|
ANDREAS FAHL MEDIZINTECHNIK-VERTRIEB GMBH
|
K123699 |
08/12/2013
|
spiro speaking valve with oxygen port spiro speaking valve without oxygen port
|
FOGLESS INTERNATIONAL AB
|
K122932 |
12/23/2013
|
shiley neonatal tracheostomy tube cuffless, shiley pediatric tracheostomy tube cuffless, shiley pediatric tracheostomy t
|
COVIDIEN
|
K122531 |
10/09/2012
|
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
|
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
|
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
|
shiley flextra tracheostomy tube
|
NELLCOR PURITAN BENNETT, INC.
|
K030787 |
11/14/2003
|
per-fit percutaneous dilational tracheostomy kit
|
PORTEX, INC.
|
K031057 |
07/18/2003
|
rusch crystal clear tracheostomy sets, cuffed and cuffless
|
RUSCH INTL.
|
K023918 |
03/28/2003
|
portex percutaneous dilatational tracheostomy kits
|
MENTOR MEDICAL LIMITED
|
K022212 |
03/21/2003
|
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
|
provox hme cassette, model 7240; provox adhesive, model 7251
|
ATOS MEDICAL AB
|
K014102 |
02/21/2002
|
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
|
shiley extended length, disposable cannula, tracheostomy tube: cuffed, distal extension, cuffed, proximal extension, cuf
|
MALLINCKRODT MEDICAL
|
K971267 |
09/25/1997
|
rusch single use crystal tracheostomy tube set
|
RUSCH INTL.
|
K972546 |
04/14/1998
|
rusch tracheofix-set
|
RUSCH INTL.
|
K972423 |
02/13/1998
|
irrigation bottle
|
AUTOMATIC LIQUID PACKAGING, INC.
|
K973829 |
02/23/1998
|
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
|
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
|
per-fit percutaneous tracheostomy kit w/portex tracheostmy tube & disp. inner cannula
|
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
|
K960429 |
05/02/1996
|
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
|
passy-muir low-profile tracheostomy and ventilator speaking valve; product number pmv 2000 or pmtsv 2000
|
PASSY-MUIR, INC.
|
K962714 |
10/28/1996
|
rusch ultra tracheoflex fenestrated kit cuffed,uncuffed/ rusch tracheoflex tracheostomy kit uncuffed sterile
|
RUSCH INTL.
|
K964056 |
10/10/1997
|
portex adjustable flange tracheostomy tube
|
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
|
K962175 |
01/17/1997
|
montgomery tracheostomy speaking valve
|
BOSTON MEDICAL PRODUCTS, INC.
|
K955516 |
12/22/1995
|
rusch ultra tracheoflex tracheostomy set, cuffed, sterile
|
RUSCH, INC.
|
K955564 |
06/28/1996
|
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
|
superslick
|
BIVONA MEDICAL TECHNOLOGIES
|
K952700 |
10/31/1995
|
shiley cuffed pediatric tracheostomy tube; long cuffed
|
MALLINCKRODT MEDICAL
|
K955680 |
03/13/1996
|
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
|
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
|
reusable cannula tracheostomy tubes, modified heads
|
MALLINCKRODT MEDICAL TPI, INC.
|
K936224 |
08/30/1994
|
tracheostomy care kit (sterile)
|
CUSTOMED, INC.
|
K925020 |
07/07/1993
|
tracheostomy tube and tube cuff
|
APPLIED MEDICAL RESOURCES
|
K924660 |
12/11/1992
|
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
|
bivona customized tracheostomy tubes
|
BIVONA MEDICAL TECHNOLOGIES
|
K923878 |
12/29/1992
|
tracheostomy care tray
|
ORION LIFE SYSTEMS, INC.
|
K923156 |
08/18/1993
|
tracheostomy care tray
|
MEDIKMARK, INC.
|
K921733 |
06/15/1994
|
hygiena-trach
|
APDYNE MEDICAL CO.
|
K911080 |
05/20/1991
|
bivona fome-cuf(r) pediatric tracheostomy tube
|
BIVONA MEDICAL TECHNOLOGIES
|
K913270 |
08/09/1991
|
bivona aire-cuf tracheostomy tube w/talk attach.
|
BIVONA MEDICAL TECHNOLOGIES
|
K912967 |
07/17/1991
|
bivona cuff maintenance device (cmd)
|
BIVONA MEDICAL TECHNOLOGIES
|
K914183 |
10/23/1991
|
needlecric
|
AJS MEDICAL CO., INC.
|
K914471 |
06/29/1992
|
bivona aire-cuf(r) pediatric tracheostomy tube
|
BIVONA MEDICAL TECHNOLOGIES
|
K914088 |
10/23/1991
|
bivona fome-cuf(r) & air cuf(r), modification
|
BIVONA MEDICAL TECHNOLOGIES
|
K913859 |
01/30/1992
|
tracheostomy care kit
|
MEGADYNE MEDICAL PRODUCTS, INC.
|
K910362 |
04/08/1991
|
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 fome-cuf adjustable tracheostomy tube
|
BIVONA MEDICAL TECHNOLOGIES
|
K894613 |
10/13/1989
|
hydrasorb(tm)
|
AVITAR, INC.
|
K897102 |
04/23/1990
|
modified decannulation stopper
|
PREMIER MEDICAL
|
K894050 |
08/01/1989
|
shiley specialized tracheostomy tube
|
SHILEY, INC.
|
K890194 |
07/20/1989
|
modified fome-cuf silicone tracheostomy tube
|
BIVONA MEDICAL TECHNOLOGIES
|
K896547 |
01/22/1990
|
bivona aire-cuf adjustable tracheostomy tube
|
BIVONA MEDICAL TECHNOLOGIES
|
K894614 |
10/13/1989
|
hood speaking valve
|
HOOD LABORATORIES
|
K897059 |
03/12/1990
|
blom-singer(r) silicone laryngectomy tube
|
HELIX MEDICAL, INC.
|
K897005 |
03/16/1990
|
modified aire-cuf silicone tracheostomy tube
|
BIVONA MEDICAL TECHNOLOGIES
|
K896548 |
01/22/1990
|
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
|