8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QUADRA-COIL URETERAL STENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
7946296
FDA Adverse Event
Malfunction
·October 9, 2018
SAFE CONNECTOR
FDA 510(k)
FDA Class 2
·General Hospital
CELEBRITY SC400
FDA 510(k)
FDA Class 2
·Physical Medicine
PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·February 6, 2013
COBAS INTEGRA 800
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·January 4, 2011
NATURA 2 PC - DURAHESIVE (DH) FLEXIBLE WAFER
FDA Adverse Event
Injury
·CONVATEC INC.·Product code EXE·July 7, 2014
a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS55
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024