7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Hoffmann LRF (Limb Reconstruction Frame) System
FDA 510(k)
FDA Class 2
·Orthopedic
GLIADIN IGA AND GLIADIN LGA
FDA 510(k)
FDA Class 2
·Immunology
CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283
FDA 510(k)
FDA Class 2
·Cardiovascular
POD4
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·October 8, 2014
CAPSURE SP NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 8, 2013
EON MINI 16-CHANNEL RECHARGEABLE IPG
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 30, 2011
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023