77 results
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9ms
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Sources: EU EUDAMED, US FDA
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N025; b) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N030; c) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N035
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025; b) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P030; c) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P035; d) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P040; e) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P045; f) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P050; g) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P055
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
FDA Enforcement
Class I
·Ongoing·NOXBOX LTD·October 15, 2025
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
FDA Enforcement
Class I
·Ongoing·NOXBOX LTD·October 15, 2025
ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150
FDA Enforcement
Class I
·Completed·ResMed Ltd.·February 12, 2020
Ellume COVID-19 Home Test
FDA Enforcement
Class I
·Ongoing·ELLUME LTD·November 17, 2021
AirFit N10 Nasal Masks and User Guide
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·December 27, 2023
AirFit N20 Nasal Mask and User Guide
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·December 27, 2023
AirTouch N20 Nasal Mask and User Guide
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·December 27, 2023
AirFit F20 Full Face Mask and User Guide
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·December 27, 2023
Astral 100 and Astral 150 ventilators
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·November 1, 2023
AirFit F30 Full Face Mask and User Guide
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·December 27, 2023
AirTouch F20 Full Face Mask and User Guide
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·December 27, 2023
AirFit F30i Full Face Mask and User Guide
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·December 27, 2023
NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device
FDA Enforcement
Class I
·Terminated·NOXBOX LTD·June 21, 2023
Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)
FDA Enforcement
Class I
·Ongoing·Given Imaging Ltd.·July 16, 2025
ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038-990-075U/ 7.5, 038-990-070U/ 7.0, 038-990-065U/ 6.5 *Note: product list updated per 12/23/2020 letter to customers
FDA Enforcement
Class I
·Terminated·Flexicare Medical Ltd.·December 2, 2020
ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric intraocular lenses are posterior chamber lenses intended as optical implants designed to replace the human crystalline lens in adult patients following cataract surgery. The lenses subject to this correction are manufactured specifically for Japan.
FDA Enforcement
Class I
·Terminated·Alcon Research, Ltd.·August 19, 2015
Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intra-hospital transport.
FDA Enforcement
Class I
·Terminated·Event Medical LTD·November 25, 2015