9 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AZURION
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·August 25, 2025
AZURION
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code OWB·January 12, 2026
TriVerse Tibial Offset Cutting Block
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215099763·
R&D INNOVATION PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OPTILUX 501
FDA 510(k)
FDA Class 2
·Dental
RUNWAY GUIDE CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code DQY·October 31, 2008
TERUMO ROCSAFE FLEXIBLE RESERVOIR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code KFM·August 9, 2011
PROMOTE RF CRT-D
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2013