14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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JOURNEY II UK and ENGAGE Cementless Partial Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
Sklar®
FDA UDI
SKLAR CORPORATION·10649111175114·RAGNELL SCISS STR 5"
MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ELITE MONOPHASE
FDA 510(k)
FDA Class 2
·Dental
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·August 25, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·November 4, 2014
BIO-MOD ST.10X115 W/ALIGN HOLE
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code HSD·July 12, 2013
BD KIESTRA IDENTIFA
FDA Adverse Event
Malfunction
·BD KIESTRA LAB AUTOMATION·Product code QBN·October 8, 2025
SPRINT FIDELIS
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code LWS·May 25, 2023
BD KIESTRA¿ IDENTIFA
FDA Adverse Event
Malfunction
·BD KIESTRA LAB AUTOMATION·Product code QBN·December 9, 2024
MEDTRONIC LEAD
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code DXY·May 25, 2023
SPRINT FIDELIS
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code LWS·May 25, 2023
GEM DR
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code LWS·May 25, 2023
CAPSUREFIX NOVUS MRI SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DTB·May 25, 2023