14 results
·
32ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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