7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
MARK III OXYGEN WALKER SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
RABEA CEMENT RESTRICTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
0.9% SODIUM CHLORIDE FLISH SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
GRANUFLO
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 8, 2014
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 6, 2012
45MM ARTICNG LNR CUTR/6 ROW BL
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC (CINCINNATI)·Product code GDW·August 16, 2007
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: FlexViewing PC Azurion Model Name - Model Number: Azurion 7 B12 722067; Azurion 7 B20 722068; Azurion 7 M12 722078 722223; Azurion 7 M20 722079;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024