9 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Swoop® Portable MR Imaging System®
FDA 510(k)
FDA Class 2
·Radiology
CARDINAL HEALTH
FDA UDI
Cardinal Health 200, LLC·00885425556826·STERILE CHEST TUBE TRAY
NAUTILUS SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
APAX PACS SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·September 12, 2014
TRIMA ACCEL PLT, PLS, RBC SET
FDA Adverse Event
Malfunction
·CARIDIANBCT·Product code LKN·July 19, 2011
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·July 18, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
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