138 results
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44ms
·
Sources: EU EUDAMED, US FDA
Titan 3 Low Speed Angle Attachments
FDA 510(k)
FDA Class 1
·Dental
ECHO(TM) HIP SYSTEM INSTRUMENTATION
FDA UDI
Biomet Orthopedics, LLC·00880304463547·
Echo® Hip System Instrumentation
FDA UDI
Biomet Orthopedics, LLC·00887868474477·
SENTINEL
FDA 510(k)
FDA Class 2
·Cardiovascular
KYPHON XPEDE BONE CEMENT
FDA 510(k)
FDA Class 2
·Orthopedic
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·February 25, 2020
CAPSURE SP NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·October 10, 2014
VERIFLEX (TM)
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code MAF·July 14, 2011
EON MINI
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 6, 2013
KYPHON XPEDE BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·November 6, 2019
KYPHON XPEDE BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·July 30, 2019
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·April 2, 2019
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·April 2, 2019
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·January 9, 2020
ACTIVOS¿ BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·October 22, 2024
KYPHON XPEDE BONE CEMENT
FDA Adverse Event
Malfunction
·CARDIAC SURGERY MFG KERKRADE·Product code NDN·November 10, 2025
KYPHON XPEDE BONE CEMENT
FDA Adverse Event
Malfunction
·CARDIAC SURGERY MFG KERKRADE·Product code NDN·November 10, 2025
KYPHON® ACTIVOS¿ BONE CEMENT WITH HYDROXYAPATITE
FDA Adverse Event
Malfunction
·CARDIAC SURGERY MFG KERKRADE·Product code NDN·November 29, 2024
KYPHON® ACTIVOS¿ BONE CEMENT WITH HYDROXYAPATITE
FDA Adverse Event
Malfunction
·CARDIAC SURGERY MFG KERKRADE·Product code NDN·April 29, 2025
KYPHON® MIXER
FDA Adverse Event
Malfunction
·CARDIAC SURGERY MFG KERKRADE·Product code NDN·May 19, 2025