7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GC RELINE
FDA 510(k)
FDA Class 2
·Dental
Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RUBBER BAND, STERILE
FDA 510(k)
FDA Class 1
·Dental
EAGLE EYE PLATINUM IVUX CATHETER
FDA Adverse Event
Malfunction
·VOLCANO CORP·Product code OBJ·February 21, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·ANIMAS CORP.·Product code LZG·February 2, 2011
XLD 110V L.A. NEW
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·July 24, 2014
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024