16 results · 23ms · Sources: EU EUDAMED, 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