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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 112 of 112 Results
ProductCode: joh Decision Date To: 10/03/2022
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regulator, pressure, cuff BOEHRINGER LABORATORIES K760453 09/13/1976
shiley fenestrated low press. cuffed SHILEY, INC. K812302 09/08/1981
aire-cuf tracheostomy tube BIOANA SURGICAL INSTRUMENTS, INC. K812163 09/21/1981
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
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
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
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
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 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
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(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
tracheostomy care kit (sterile) CUSTOMED, INC. K925020 07/07/1993
tracheostomy tube and tube cuff APPLIED MEDICAL RESOURCES K924660 12/11/1992
tracheostomy care kit TRANSIDYNE GENERAL CORP. K924243 06/16/1993
tracheostomy kit AJS MEDICAL CO., INC. K925288 08/27/1993
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 tray ORION LIFE SYSTEMS, INC. K923156 08/18/1993
tracheostomy care tray MEDIKMARK, INC. K921733 06/15/1994
bivona customized tracheostomy tubes BIVONA MEDICAL TECHNOLOGIES K923878 12/29/1992
percutaneous tracheostomy kit SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. K936133 03/23/1994
tracheostomy care tray CLINIPAD CORP. K932016 11/03/1993
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
reusable cannula tracheostomy tubes, modified heads MALLINCKRODT MEDICAL TPI, INC. K936224 08/30/1994
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
rusch ultra tracheoflex tracheostomy set, cuffed, sterile RUSCH, INC. K955564 06/28/1996
montgomery tracheostomy speaking valve BOSTON MEDICAL PRODUCTS, INC. K955516 12/22/1995
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
shiley cuffed pediatric tracheostomy tube; long cuffed MALLINCKRODT MEDICAL K955680 03/13/1996
superslick BIVONA MEDICAL TECHNOLOGIES K952700 10/31/1995
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
rusch single use crystal tracheostomy tube set RUSCH INTL. K972546 04/14/1998
rusch tracheofix-set RUSCH INTL. K972423 02/13/1998
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
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
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
passy-muir low-profile tracheostomy speaking valve pmv 2020 (clear) jit PASSY-MUIR, INC. K990905 06/11/1999
shiley tracheosoft xlt extended length tracheostomy tube and disposable inner cannula MALLINCKRODT, INC. K003315 11/08/2000
sterile water or o.9% sodium chloride, model al4100 & al4109 AUTOMATIC LIQUID PACKAGING, INC. K000964 04/25/2000
the percuquick set for percutaneous dilation tracheostomy RUSCH INTL. K011210 08/15/2001
provox hme cassette, model 7240; provox adhesive, model 7251 ATOS MEDICAL AB K014102 02/21/2002
melker emergency cricothyrotomy catheter set COOK, INC. K013916 12/20/2001
melker cuffed emergency cricothyrotomy catheter COOK, INC. K010016 10/09/2001
trach vox ENGINEERED MEDICAL SYSTEMS K013728 07/30/2002
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
per-fit percutaneous dilational tracheostomy kit PORTEX, INC. K031057 07/18/2003
shiley flextra tracheostomy tube NELLCOR PURITAN BENNETT, INC. K030787 11/14/2003
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
marpac messenger model #501 MARPAC, INC. K041485 08/02/2004
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
shiley tracheosoft xlt extended length tracheostomy tube and inner cannula MALLINCKRODT MEDICAL K051416 06/16/2005
ciaglia blue dolphin (tm) balloon percutaneous tracheostomy introducer COOK, INC. K072148 10/03/2007
provox micron hme ATOS MEDICAL AB K072582 05/30/2008
bivona adjustable and fixed neckflange hyperflex tracheostomy tubes SMITHS MEDICAL ASD, INC. K081440 09/12/2008
bivona tracheostomy tubes SMITHS MEDICAL ASD, INC. K083641 02/23/2009
ciaglia blue dolphin balloon percutaneous tracheostomy introducer, model: multiple, prefix c-ptbs COOK, INC. K093469 01/08/2010
shikani speaking valve SHIKANI MEDICAL, LLC K100995 06/25/2010
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
rusch tracflex plus tracheostomy tube set Teleflex Medical, Inc. K122235 09/06/2013
shiley neonatal tracheostomy tube cuffless, shiley pediatric tracheostomy tube cuffless, shiley pediatric tracheostomy t COVIDIEN K122531 10/09/2012
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
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
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
melker cuffed emergency cricothyrotomy catheter sets, melker universal cricothyrotomy catheter set COOK INCORPORATED K160200 02/17/2017
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
portex blue line ultra paediatric tracheosomy tube Smiths Medical ASD, Inc. K170720 12/07/2017
tracoe silcosoft tracheostomy tube TRACOE medical GmbH K172720 04/27/2018
shiley neonatal/pediatric tracheostomy tube Covidien K182861 03/22/2019
weinmann tracheostomy exchange set Cook Incorporated K180034 05/07/2018
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
scalpelcric VBM Medizintechnik GmbH K200190 10/30/2020
tracoe vario TRACOE medical GmbH K203362 08/05/2021
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
 
 
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