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Sources: EU EUDAMED, US FDA
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NAMIC CONVENIENCE KIT RENOWN REGIONAL MEDICAL CENTER, REF Catalog No. 65230029, UPN Product No. H965652300290, Product is packed as a box of 30 pieces, box label contains UPN Product No. H965652300291 Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire
FDA Enforcement
Class II
·Terminated·AngioDynamics Inc.·April 13, 2016
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Number/Item Code 67PFS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS55
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024