12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SAVE GBR
FDA 510(k)
FDA Class 2
·Dental
MST/Dewey 1.1mm A1 Phaco Tip 45deg
FDA UDI
MICROSURGICAL TECHNOLOGY, INC.·00844685000333·
EXACTRAC VERO
FDA 510(k)
FDA Class 2
·Radiology
AUROPAL SOLDER W-2
FDA 510(k)
FDA Class 2
·Dental
HEMOSPHERE ALTA
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code QAQ·November 18, 2025
HEMOSPHERE ALTA
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code QAQ·August 20, 2025
HEMOSPHERE ALTA
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code QAQ·November 18, 2025
UNKNOWN DEPUY CUP
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWB·November 4, 2008
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 13, 2011
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 12, 2013
HEMOSPHERE ALTA
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code QAQ·November 18, 2025
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025