81 results
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14ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c. RUSCHELIT Super Safety Clear Tracheal Tube, oral/nasal, Murphy. Intended for patients requiring endotracheal intubation
FDA Enforcement
Class II
·Ongoing·TELEFLEX LLC·February 1, 2023
Endotracheal Tube labeled as the following: a. Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c. Flexiset Super Safety Clear Tracheal Tube, oral/nasal with Cuff and Insertion Aid; d. RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill; e. RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Murphy. Intended for patients requiring endotracheal intubation
FDA Enforcement
Class II
·Ongoing·TELEFLEX LLC·February 1, 2023
The Introes Pocket Bougie is an endotracheal tube introducer. The device is an endotracheal tube introducer and it is used as a guide during intubation. Anesthesiology.
FDA Enforcement
Class II
·Terminated·Brathwaites Oliver Medical·October 19, 2016
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 patients and used with a ventilator to provide oxygen or anesthetic agents to the patient.
FDA Enforcement
Class II
·Terminated·Parker Medical·July 27, 2016
Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023070S
FDA Enforcement
Class II
·Ongoing·Sarnova HC, Llc·March 27, 2024
Dale Medical Stabilock Endotracheal Adhesive Base Product # 273 The Dale Stabilock Endotracheal Tube Bolder 270 is a 2 piece device consisting of an adhesive base, Dale product number 273, that attaches to the patient's skin and a cushioned neckband with tube channel that attaches with hook & loop closures. The 270 is used to secure and stabilize endotracheal tubes, preventing unnecessary movement which can help prevent accidental .extubation
FDA Enforcement
Class II
·Terminated·Dale Medical Products, Inc.·May 10, 2017
2.5 mm LifePort Endotracheal Tube Adapters 10-pack, Catalog: 9025; and 2.5 mm LifePort Endotracheal Tube Adaptors inside Patient Circuit Kits, Catalog: 938
FDA Enforcement
Class II
·Ongoing·Bunnell, Inc.·December 14, 2022
Dale Medical Stabilock Endotracheal Tube Holder Product # 270 The Dale Stabilock Endotracheal Tube Bolder 270 is a 2 piece device consisting of an adhesive base, Dale product number 273, that attaches to the patient's skin and a cushioned neckband with tube channel that attaches with hook & loop closures. The 270 is used to secure and stabilize endotracheal tubes, preventing unnecessary movement which can help prevent accidental .extubation
FDA Enforcement
Class II
·Terminated·Dale Medical Products, Inc.·May 10, 2017
Curaplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023060S
FDA Enforcement
Class II
·Ongoing·Sarnova HC, Llc·March 27, 2024
Curaplex Field Cric Kit with ET Tube, Item Number 36611. The kit provides healthcare professionals with an assortment of supplies to perform a cricothyrotomy.
FDA Enforcement
Class II
·Ongoing·Sarnova HC, Llc·January 24, 2024
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal. Intended for patients requiring endotracheal intubation
FDA Enforcement
Class II
·Ongoing·TELEFLEX LLC·February 1, 2023
Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm, Item Number 351631i-A. The kit provides healthcare professionals with an assortment of supplies to perform a cricothyrotomy.
FDA Enforcement
Class II
·Ongoing·Sarnova HC, Llc·January 24, 2024
Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip). Model Numbers: H-PFTDL-28-1, H-PFTDL-32-1, H-PFTDL-35-1, H-PFTDL-37-1, H-PFTDL-39-1, H-PFTDL-41-1. The product is an endotracheal tube with a double lumen for single lung isolation allowing for ventilation of one lung during a surgical procedure. Endotracheal tubes are used for intubating patients and used in conjunction with a ventilator to provide oxygen and anesthetic agents to the patient during surgeries
FDA Enforcement
Class II
·Terminated·Parker Medical·March 15, 2017
Bivona Aire-Cuf Endotracheal Tube
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·November 3, 2021
Bivona Uncuffed Wire Endotracheal Tubes,
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·November 3, 2021
NIM TRIVANTAGE EMG Endotracheal Tube
FDA Enforcement
Class II
·Ongoing·Medtronic Xomed, Inc.·March 16, 2022
AnchorFast, Oral Endotracheal Tube Fastener, REF 9799,
FDA Enforcement
Class II
·Ongoing·Hollister Incorporated·February 26, 2025
ClearPro T-Piece Closed Suction Catheter, Model DYNCPTP14, 14 Fr 21.3 IN FOR ENDOTRACHEAL TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial airways. Single use only.
FDA Enforcement
Class II
·Ongoing·Medline Industries Inc·August 5, 2020
ClearPro Closed Suction Catheter, Model DYNCPDS14T, 14 Fr FOR ENDOTRACHEAL TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial airways. Single use only.
FDA Enforcement
Class II
·Terminated·Medline Industries Inc·October 14, 2020
AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787,
FDA Enforcement
Class II
·Ongoing·Hollister Incorporated·February 26, 2025