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Panels › Anesthesiology › Product code JOH · Class 2

Tube Tracheostomy And Tube Cuff

Regulation 868.5800

1510(k)s in 12 months (109 all time)
5recalls in 12 months (131 all time)
114recalls that name a 510(k)
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Top companies in JOH

DateFirm and productCodeLinked 510(k)
May 29, 2026Covidien LLC
COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in providing tracheal access for airway management. Shiley Tracheost
Open, Classified
JOHK812302
Apr 6, 2026Cook Incorporated
COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073
Open, Classified
JOHNone listed
Apr 6, 2026Cook Incorporated
COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092; Reference Part Number C-PTIS-100-HC, Order Number G12115.
Open, Classified
JOHK133597
Apr 6, 2026Cook Incorporated
COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order Numbe
Open, Classified
JOHK193133
Apr 6, 2026Cook Incorporated
COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685; Reference Part Number C-PTIS-100-HC-G-NA, Order Number G5768
Open, Classified
JOHK193133
Mar 25, 2025Covidien
Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
Open, Classified
JOHK150844
Oct 31, 2023Smiths Medical ASD Inc.
Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
Open, Classified
JOHK083641
May 10, 2023Cook Incorporated
Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G57725), C-PTISYJ-100-HC-G-NA-FLEX7.5 (G57720), C-PTISYJ-100-HC-G-NA-FLEX8.5 (G57721
Open, Classified
JOHK193133
May 10, 2023Cook Incorporated
Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695), C-PTIS-100-HC-G-EU-FLEX8.5 (G57696), C-PTIS-100-HC-G-NA-FLEX7.5 (G57691), C-PT
Open, Classified
JOHK193133
Apr 19, 2023Covidien
Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable Inner Cannula or Reusable Inner Cannula (REF, Product Description): 10CN10H, 10.0MM SHILEY CUFFED TRACH CAN; 10CN
Open, Classified
JOHK142296
K150844
May 14, 2021Smiths Medical ASD Inc.
PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a controlled setting such as an Intensive Care Unit or operating room with the assistance
Terminated
JOHK041348
Jan 18, 2021Smiths Medical ASD Inc.
Tube Tracheostomy and Tube Cuff, Bivona Cuffless Neonatal/Pediatric FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) V Neck Flange 4.5mm - Product Usage: intended to pro
Terminated
JOHK944178
Dec 15, 2020Smiths Medical ASD Inc.
PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45
Terminated
JOHK944178
Aug 28, 2020Smiths Medical ASD Inc.
Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to 10 times for single
Terminated
JOHK083641
K914088
May 26, 2020Smiths Medical ASD Inc.
Pediatric Adjustable Flange Tracheostomy Tube Cuffless
Terminated
JOHK081440
Aug 14, 2017Smiths Medical ASD Inc.
UniPerc(R) Adjustable Flange Tracheostomy Tube kit, Reorder Number 100/897/080 CZ The UniPerc(R) Tracheostomy Tubes can be used during the surgical placement of a stoma or as a replacement tube t
Terminated
JOHK962175
Feb 9, 2017Smiths Medical ASD Inc.
Bivona TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.
Terminated
JOHK083641
Oct 18, 2016Teleflex Medical
Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas. When using cannulas with curr. For short te
Terminated
JOHK964056
Jul 15, 2016Smiths Medical ASD, Inc.
Custom Made Tracheostomy Device The CADD Administration Sets with Flow Stop are designed to be used with a variety of CADD ambulatory infusion pumps to allow fluid delivery from an IV bag.
Terminated
JOHNone listed
Jul 9, 2015Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing tracheal access for airway managements.
Terminated
JOHK122531
Jul 9, 2015Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless. Model Numbers: 2.5NEF,3.0NEF,3.5NEF,4.0NEF,4.5NEF,2.5PEF,3.0PEF,3.5PEF,4.0PEF,4.5PEF,5.0PEF,5.5PEF,5.0PELF,5.5PELF,6.0PELF,6
Terminated
JOHK142298
Aug 10, 2012Nellcor Puritan Bennett Inc. (dba Covidien LP)
Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide) 8LPC, 8FEN; (Outside U.S.) 8FENJ, 8FENJ-S, 8LPC-S, 8FEN-S. Product Usage: The product is intended for use
Terminated
JOHK962173
Mar 21, 2012Customed, Inc
Tracheotomy care kit, catalog# 900-110
Terminated
JOHK925020
Jun 29, 2011Teleflex Medical
RUSCH Percutwist Set with Crystal Clear Sterile Crystal Clear Tracheostomy Tube is a device inserted into a patient's trachea surgically via the neck to maintain an open airway.
Terminated
JOHK023918
Jun 29, 2011Teleflex Medical
RUSCH Crystal Clear PDT, Sterile Crystal Clear Tracheostomy Tube is a device inserted into a patients trachea surgically via the neck to maintain an open airway.
Terminated
JOHNone listed
Jun 29, 2011Teleflex Medical
RUSCH CrystalClear Tracheostomy Tube, Cuffed, Sterile Pack Crystal Clear Tracheostomy Tube is a device inserted into a patients trachea surgically via the neck to maintain an open airway.
Terminated
JOHK023918
Jul 26, 2010Cook, Inc.
Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Tray, G51972, C-PTBSYJC-2800-PERC8.
Terminated
JOHK093469
Jul 26, 2010Cook, Inc.
Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Tray, G49507, C-PTBSY-2800-PERC8.
Terminated
JOHK093469
Jul 26, 2010Cook, Inc.
Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Tray, G36117, C-PTBS-2800-PERC8.
Terminated
JOHK093469
Jul 26, 2010Cook, Inc.
Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Tray, G51971, C-PTBSYJC-2600-PERC6.
Terminated
JOHK093469
Jul 26, 2010Cook, Inc.
Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Tray, G36118, C-PTBSY-2600-PERC6.
Terminated
JOHK093469
Jul 26, 2010Cook, Inc.
Cook Medical Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Tray, G36116, C-PTBS-2600-PERC6.
Terminated
JOHK093469
Jul 26, 2010Cook, Inc.
Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-WCE-HC-G-PERC8, G53170.
Terminated
JOHK093469
Jul 26, 2010Cook, Inc.
Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-WCE-HC-G-PERC6, G53169.
Terminated
JOHK093469
Jul 26, 2010Cook, Inc.
Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTISY-100-HC-G-PERC6, G53178.
Terminated
JOHK093469
Jul 26, 2010Cook, Inc.
Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTISY-100-HC-PERC8, G12565.
Terminated
JOHK093469
Jul 26, 2010Cook, Inc.
Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-HC-PERC8-CA, G36038.
Terminated
JOHK093469
Jul 26, 2010Cook, Inc.
Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-HC-PERC8, G12523.
Terminated
JOHK093469
Jul 26, 2010Cook, Inc.
Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTISY-100-HC-PERC6, G13166.
Terminated
JOHK093469
Jul 26, 2010Cook, Inc.
Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-HC-PERC6-CA, G36037.
Terminated
JOHK093469
Jul 26, 2010Cook, Inc.
Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-HC-PERC6, G13165.
Terminated
JOHK093469
Jul 26, 2010Cook, Inc.
Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTISY-100-A-HC-PERC8, G12566.
Terminated
JOHK093469
Jul 26, 2010Cook, Inc.
Cook Medical Ciaglia Blue Rhino G2 Advanced Percutaneous Tracheostomy Introducer Set, C-PTIS-100-A-HC-PERC8, G12403.
Terminated
JOHK093469
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Specialized Tracheostomy Tube, M8DCT, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions,
Terminated
JOHK903435
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Specialized Tracheostomy Tube, M6DCT, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions,
Terminated
JOHK903435
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Specialized Tracheostomy Tube, MDCT, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions, p
Terminated
JOHK903435
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Specialized Tracheostomy Tube, M8LPC, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions,
Terminated
JOHK903435
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Specialized Tracheostomy Tube, M6LPC, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions,
Terminated
JOHK903435
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Specialized Tracheostomy Tube, MLPC, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions, p
Terminated
JOHK903435
May 6, 2010Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Shiley Specialized Tracheostomy Tube, M8FEN, Sterile EO, Made in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions,
Terminated
JOHK903435

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