8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
ISOPORE TAPE
FDA 510(k)
FDA Class 1
·General Hospital
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970560·
SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1
FDA 510(k)
FDA Class 2
·Dental
HAMMER TOE IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
CAPSURE SP NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010
5.0CM SHORT ATTACHMENT
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 9, 2014
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·December 27, 2012
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021