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Panels › Anesthesiology › Product code BTR · Class 2

Tube, Tracheal (W/Wo Connector)

Regulation 868.5730

2510(k)s in 12 months (242 all time)
1recalls in 12 months (227 all time)
203recalls that name a 510(k)
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Top companies in BTR

DateFirm and productCodeLinked 510(k)
Jun 19, 2019Teleflex Medical
Hudson RCI Sheridan: 1) Uncuffed 6.0 mm, Product Code 5-10412 2) Uncuffed 6.5 mm, Product Code 5-10413 3) Uncuffed 7.0 mm, Product Code 5-10414 Product Usage: Tracheal tube/airway management
Terminated
BTRK822082
Jun 19, 2019Teleflex Medical
Hudson RCI Sheridan: 1) Preformed 6.0 mm, Product Codes: a) 5-22212, b) 5-22312, c) 5-22112, d) 5-22012, 2) Preformed 6.5 mm, Product Codes: a) 5-22313, b) 5-22213, c) 5-22013, d) 5-22113,
Terminated
BTRK822082
Jun 19, 2019Teleflex Medical
Hudson RCI Sheridan: 1) EZ-ENDO 6.0 mm, Product Code 5-22512 2) EZ-ENDO 6.5 mm, Product Code 5-22513 3) EZ-ENDO 7.0 mm, Product Code 5-22514 4) EZ-ENDO 7.5 mm, Product Code 5-22515 5) EZ-ENDO 8.0 mm,
Terminated
BTRK822082
Jun 19, 2019Teleflex Medical
Hudson RCI Sheridan: 1) CF 6.0 mm, Product Codes: 5-10112, 5-10212 2) CF 6.5 mm, Product Codes: 5-10113, 5-10213 3) CF 7.0 mm, Product Codes: 5-10114, 5-10214 4) CF 7.5 mm, Product Codes: V5-10115
Terminated
BTRK822082
Jun 19, 2019Teleflex Medical
Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway management
Terminated
BTRK822082
Apr 1, 2019Teleflex Medical
RUSCH LASERTUBE (Rubber), Order No. : 102004-000080, REF 102004, SIZE I.D. mm 8,0
Terminated
BTRK935842
Apr 1, 2019Teleflex Medical
RUSCH LASERTUBE (Rubber), Order No. : 102004-000070, REF 102004, SIZE I.D. mm 7,0
Terminated
BTRK935842
Apr 1, 2019Teleflex Medical
RUSCH LASERTUBE (Rubber), Order No. : 102004-000060, REF 102004, SIZE I.D. mm 6,0
Terminated
BTRK935842
Apr 1, 2019Teleflex Medical
RUSCH LASERTUBE (Rubber), Order No. : 102004-000050, REF 102004, SIZE I.D. mm 5,0
Terminated
BTRK935842
Apr 1, 2019Teleflex Medical
RUSCH LASERTUBE (Rubber), Order No. : 102004-000040, REF 102004, SIZE I.D. mm 4,0
Terminated
BTRK935842
Feb 9, 2017Teleflex Medical
Sheridan/CF, Cuffed Tracheal Tube, Catalog # 5-10114 and Sheridan/HVT Cuffed Tracheal Tube, Catalog # 5-10315 A tracheal tube is inserted into a patients mouth or nose for airway management
Terminated
BTRK822082
Nov 9, 2016Teleflex Medical
LMA MADett, Endotracheal tube Mucosal Atomization Device, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal
Terminated
BTRK021044
Jul 19, 2016Parker Medical
Parker Trach-Vac Endotracheal Tubes. Tyvek pouches, 10 per box. Product Usage: The product is an endotracheal tube with sub-glottic suction channel to remove secretions. It is used for intubating pat
Terminated
BTRK110269
Jun 9, 2016Teleflex Medical
Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube, Ref: V5-10314, ID: 7.0 mm, Rx Only, Manufactured by: Teleflex Incorporated. A tracheal tube is inserted into a patients mouth or nose for airwa
Terminated
BTRK822082
Apr 4, 2016Stryker Sustainability Solutions
Launcher Guiding Catheter Model #LA6EBU30. Used in the coronary or peripheral vascular system..
Terminated
BTRK082520
Apr 4, 2016Stryker Sustainability Solutions
Mallinckrodt Evac Tracheal Tubes Model #124170-MALLINCKRODT & 124175
Terminated
BTRK082520
Feb 17, 2015Teleflex, Inc.
RSCH Curved Reinforced Endotracheal Tube: Rusch Reinforced Endotracheal Tube is designated for oral or nasal intubation and are indicated for airway management. The product may be used to reduce the p
Terminated
BTRK990619
Feb 10, 2015Teleflex Medical
Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only, Sterile, Teleflex Medical.
Terminated
BTRK822082
Dec 24, 2014Halyard Health
KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 9.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of se
Terminated
BTRK131254
Dec 24, 2014Halyard Health
KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.5 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of se
Terminated
BTRK131254
Dec 24, 2014Halyard Health
KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of se
Terminated
BTRK131254
Dec 24, 2014Halyard Health
KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.5 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of se
Terminated
BTRK131254
Dec 24, 2014Halyard Health
KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of se
Terminated
BTRK131254
Dec 12, 2014Teleflex Medical
Sheridan/CF Cuffed Tracheal Tube, Sterile, Rx only, Teleflex Medical, Research Triangle Park, NC 27708. Designed for oral and nasal intubation and are indicated for airway management.
Terminated
BTRK822082
Aug 28, 2014Smiths Medical ASD, Inc.
H4052 Endo Tube Holder, Pedi 3.0mm Pediatric Endotracheal Intubation Kit
Terminated
BTRNone listed
Aug 28, 2014Smiths Medical ASD, Inc.
H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit
Terminated
BTRNone listed
Aug 28, 2014Smiths Medical ASD, Inc.
H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder Pediatric Endotracheal Intubation Kit
Terminated
BTRK790312
Aug 28, 2014Smiths Medical ASD, Inc.
H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
Terminated
BTRK790312
Aug 28, 2014Smiths Medical ASD, Inc.
H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotracheal Intubation Kit
Terminated
BTRK790312
Aug 28, 2014Smiths Medical ASD, Inc.
4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
Terminated
BTRK790312
Jun 23, 2014Teleflex Medical
RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube, cuffed, Teleflex Medical, Willy-Rusch, GmbH. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and use
Terminated
BTRK935842
Jun 11, 2014Smiths Medical ASD, Inc.
Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The connector is used to attach the endotracheal tube to the patient breathing circuit. The low dead space connector minimizes mec
Terminated
BTRK790312
Feb 21, 2014Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 9.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or m
Terminated
BTRK091761
Feb 21, 2014Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 8.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or m
Terminated
BTRK091761
Feb 21, 2014Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 8.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or m
Terminated
BTRK091761
Feb 21, 2014Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 7.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or m
Terminated
BTRK091761
Feb 21, 2014Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 7.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or m
Terminated
BTRK091761
Feb 21, 2014Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 6.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or m
Terminated
BTRK091761
Feb 21, 2014Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 6.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or m
Terminated
BTRK091761
Feb 21, 2014Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 9.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to main
Terminated
BTRK091761
Feb 21, 2014Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to main
Terminated
BTRK091761
Feb 21, 2014Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to mai
Terminated
BTRK091761
Feb 21, 2014Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to main
Terminated
BTRK091761
Feb 21, 2014Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maint
Terminated
BTRK091761
Feb 21, 2014Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maint
Terminated
BTRK091761
Feb 21, 2014Teleflex Medical
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to main
Terminated
BTRK091761
Jul 17, 2012LMA North America Inc
LMA Esophageal Intubation Detector (EID), Catalog Number EID100 The device is used to assist verification of placement of the endotracheal tube or esophageal/tracheal double lumen tube. This device i
Terminated
BTRK930741
Nov 12, 2009Centurion Medical Products
Tri-State Hospital Supply Corp., Centurion Healthcare Products, Full Term Meconium Packs, 50, sterile, Tri-State Hospital Supply Corp., Howell, MI; code no. LM115.
Terminated
BTRNone listed
Nov 12, 2009Centurion Medical Products
Tri-State Hospital Supply Corp., Centurion Healthcare Products Premie Packs, 50, sterile, Tri-State Hospital Supply Corp., Howell, MI; code no. LM110. Aspiration tray containing Portex uncuffed pedi
Terminated
BTRNone listed
Sep 18, 2009Smiths Medical
Portex Polar Preformed Tracheal Tube, South Oral, Murphy Eye, Clear 3.5 mm Product Code: 100/134/035. Intended for oral and/or nasal intubation for airway management.
Terminated
BTRNone listed

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