7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BLUEPRINT Patient Specific Instrumentation
FDA 510(k)
FDA Class 2
·Orthopedic
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MBT CEM TIBIAL TRAY SZ4
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code NJL·November 13, 2008
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·August 18, 2011
OMNIPOD INSULIN PUMP
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·July 9, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025