11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ULTRACISION 5MM HARD SHEATH LAPAROSONIC BLADE
FDA 510(k)
FDA Unclassified
·Unknown
Sklar®
FDA UDI
SKLAR CORPORATION·50649111063365·HALSEY NH SMOOTH 5" STER CS/50
CHARNLEY ELITE
FDA UDI
DEPUY INTERNATIONAL LTD·10603295243236·CHARNLEY / ELITE BROACH FL45 EH
PRESSIO ICP MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
VersaOne Bladeless Trocar
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STOPCOCK MANIFOLD GANGS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FMG·June 17, 2020
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·February 14, 2013
FLEXIMA BILIARY CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code FGE·January 18, 2011
DUROM ACETABULAR COMPONENT 54/48 CODE N
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·July 14, 2014
BIVONA
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code JOH·August 6, 2020
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