12 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IMAGENET 5 PC SOFTWARE SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
AGXO
FDA UDI
Oticon A/S·05707131257604·H150, BTE 13 WL 85 SIL AGXO
Aileron Posterior Fusion System
FDA UDI
Life Spine, Inc.·00190837000585·
Aileron Posterior Fusion System
FDA UDI
Life Spine, Inc.·00190837000592·
PRIMALOK FACET FIXATION SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
ENDURANT
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·May 29, 2013
OBGYN TRANSTAR
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·June 14, 2011
ARCHITECT ANTI-HBC II
FDA Adverse Event
Malfunction
·ABBOTT GERMANY·Product code LOM·October 1, 2014
RHYTHMIA HDX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·October 16, 2025
THERMAGE CPT SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code GEI·November 12, 2020
THERMAGE CPT SYSTEM TIP
FDA Adverse Event
Injury
·SOLTA MEDICAL INC·Product code GEI·November 30, 2022