16 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Axium Prime Detachable Coil System
FDA 510(k)
FDA Class 2
·Neurology
EASY CUFF
FDA 510(k)
FDA Class 2
·Anesthesiology
STERILIZATION POUCH WITH INDICATORS
FDA 510(k)
FDA Class 2
·General Hospital
EXPRESS SD RENAL/BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 22, 2025
EXPRESS SD RENAL/BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 22, 2025
EXPRESS SD RENAL/BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·September 3, 2025
EXPRESS SD RENAL/BILIARY
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 27, 2025
EXPRESS SD RENAL/BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 12, 2025
EXPRESS SD RENAL/BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·May 13, 2026
WEREWOLF RF 20000 CONTROLLER
FDA Adverse Event
Malfunction
·ARTHROCARE CORP.·Product code GEI·June 29, 2020
AMISTEM H FEMORAL STEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code KWY·June 5, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 15, 2011
ITREL II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·September 16, 2008
EXPRESS SD RENAL/BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 11, 2025
C-FLEX MULTI-LENGTH URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·January 24, 2020
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026