7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Ball Joint Guide Array (66295)
FDA 510(k)
FDA Class 2
·Neurology
ProntoPump Sterile Tube Set
FDA 510(k)
FDA Class 2
·General Hospital
IntelliCuff
FDA 510(k)
FDA Class 2
·Anesthesiology
CENTURY BED
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·December 2, 2008
SPIDER FX EMBOLIC PROTECTION DEVICE
FDA Adverse Event
Malfunction
·EV3·Product code NFA·September 12, 2011
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS·Product code LYJ·July 29, 2013
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