7 results
·
21ms
·
Sources: EU EUDAMED, US FDA
BAKTERIETTE-VI-PAK
FDA 510(k)
FDA Class 1
·Microbiology
ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D SYSTEM ACCESSORY
FDA 510(k)
FDA Class 2
·Radiology
PICOSURE WORKSTATION
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 13, 2014
ONYX
FDA Adverse Event
Injury
·EV3 NEUROVASCULAR·Product code MFE·November 20, 2012
ZIMMER TRABECULAR METAL HUMERAL STEM
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code HSD·September 17, 2010
Colonoscope, Model Number PCF-H190DL.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·March 6, 2024