14 results · 32ms · Sources: EU EUDAMED, US FDA

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METASURG SUBTALAR IMPLANT

FDA 510(k)
FDA Class 2 ·Orthopedic

ULTRASOUND TRANSDUCER COVER

FDA 510(k)
FDA Class 2 ·Radiology

STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT

FDA 510(k)
FDA Class 2 ·Neurology

CONTOUR

FDA Adverse Event
Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·March 26, 2013

CONTOUR USB

FDA Adverse Event
Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·December 14, 2012

CONTOUR NEXT

FDA Adverse Event
Injury ·BAYER HEALTHCARE LLC·Product code NBW·July 27, 2012

BD DISCARDIT¿ SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·April 16, 2022

AVANTA FLUID MANAGEMENT SYSTEM

FDA Adverse Event
Injury ·MEDRAD·Product code DXT·May 8, 2013

3002 SECURE II

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·May 18, 2011

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·August 14, 2008

TRIFORCE¿ PERIPHERAL CROSSING SET

FDA Adverse Event
Malfunction ·COOK INC·Product code KRA·August 1, 2015

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

Model Number L131, ESSENTIO DR EL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018