7 results
·
16ms
·
Sources: EU EUDAMED, US FDA
LECTRON II CONDUCTIVE GEL/CADWELL ELECTRODE GEL
FDA 510(k)
FDA Class 2
·Neurology
BIOANCHOR WITH DISPOSABLE DRIVER
FDA 510(k)
FDA Class 2
·Orthopedic
Resonic Rapid Acoustic Pulse Device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FRESENIUS 2008K
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·June 23, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 29, 2013
MESH - COMPOSIX
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·December 14, 2010
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025