8 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TeleScan
FDA 510(k)
FDA Class 2
·Radiology
K-Systems
FDA UDI
Coopersurgical, Inc.·00888937025033·G95 Mini Incubator
ES BOND
FDA 510(k)
FDA Class 2
·Dental
ADVANTA SST BIFURCATED GRAFT
FDA 510(k)
FDA Class 2
·Cardiovascular
ASCENSIA ELITE XL
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·October 31, 2008
CONSERVE(R) PLUS CUP
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code KWA·August 23, 2011
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·July 8, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025