8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).)
FDA 510(k)
FDA Class 2
·Cardiovascular
SLEEPNET MOJO FULL FACE MASK -SMALL, MODEL NO. 53835, MEDIUM ,MODEL NO.53836,LARGE,MODEL NO. 53837
FDA 510(k)
FDA Class 2
·Anesthesiology
truFreeze System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WHITESTAR SIGNATURE SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code HQC·November 18, 2014
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·September 22, 2011
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·August 1, 2013
CRAGG-MCNAMARA
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·April 8, 2026
CRAGG-MCNAMARA
FDA Adverse Event
Death
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·April 8, 2026