8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
PC POLYGRAF
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COMFORT ELECTRIC SCOOTER, LY-EW408
FDA 510(k)
FDA Class 2
·Physical Medicine
gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MINMED QUICK SET
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·May 27, 2024
SOFTCLIX ® LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·June 13, 2014
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·October 8, 2010
ISOLAZ SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC.·Product code GEX·December 13, 2012
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