13 results · 29ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

AXIOS STENT AND DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·XLUMENA INC.·Product code PCU·November 12, 2014

AXIOS STENT AND DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·XLUMENA INC.·Product code PCU·October 14, 2014

NAVIX ACCESS DEVICE

FDA Adverse Event
Malfunction ·XLUMENA INC.·Product code GCJ·May 16, 2013

CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code KNS·August 13, 2024

CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code KNS·August 13, 2024

OCTARAY MAPPING CATHETER

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code MTD·January 26, 2024

LASSOSTAR, 10P, DIA 15MM LOOP SIZE

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DRF·May 16, 2023

OCTARAY MAPPING CATHETER

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code MTD·November 4, 2025

PENTARAY NAV

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code MTD·May 12, 2026

LASSOSTAR, 10P, DIA 15MM LOOP SIZE

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DRF·July 8, 2022

GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

FDA Adverse Event
Malfunction ·W. L. GORE & ASSOCIATES, INC.·Product code NIP·December 31, 2024

PROTEK DUO VENO-VENOUS CANNULA

FDA Adverse Event
Malfunction ·CARDIACASSIST INC.·Product code DWF·March 29, 2022

BARDEX® ALL-SILICONE FOLEY CATHETER

FDA Adverse Event
Malfunction ·C.R. BARD, INC. (COVINGTON) -1018233·Product code EZL·July 19, 2019