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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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KimVent* Multi-Access Port Replacement Catheter for Adults, Endotracheal,16 F (Product Code 240165-5) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.
FDA Enforcement
Class II
·Terminated·Halyard Health, Inc·September 9, 2015
MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038.
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·August 10, 2016
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030; c) PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , Product Code/List Number/Item Code 60P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM UNCUFFED , Product Code/List Number/Item Code 60P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM UNCUFFED , Product Code/List Number/Item Code 60P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM UNCUFFED , Product Code/List Number/Item Code 60P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM UNCUFFED , Product Code/List Number/Item Code 60P055
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025