10 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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S-Patch (S-Patch ExL)
FDA 510(k)
FDA Class 2
·Cardiovascular
PORTASCAN BLADDER SCANNER, MODEL PA00146
FDA 510(k)
FDA Class 2
·Radiology
C-JAWS CERVICAL COMPRESSIVE STAPLE
FDA 510(k)
FDA Class 2
·Orthopedic
PORTASCAN
FDA Adverse Event
Malfunction
·MEDIWATCH UK LTD·Product code ITX·November 17, 2011
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·November 13, 2008
SMARTSET HV BONE CEMENT 40G
FDA Adverse Event
Injury
·DEPUY CMW·Product code LOD·September 6, 2011
LIBERTY CYCLER
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·July 16, 2013
BD INTIMA-II CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FPA·June 18, 2020
LEVEEN COACCESS ELECTRODE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code JOS·March 7, 2008
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025