12 results
·
21ms
·
Sources: EU EUDAMED, US FDA
DRY COMFORT DISPOSABLE UNDERPAD
FDA 510(k)
FDA Class 1
·General Hospital
BANANA KNIFE - K841969-LABELING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CAMELBACK HANDLE-K841969-LABELING
FDA 510(k)
FDA Class 1
·Orthopedic
2.5MM & 4MM PROBE K841969-LABELING
FDA 510(k)
FDA Class 1
·Orthopedic
ASNIS GUIDED SCREW SYSTEMS
FDA 510(k)
FDA Class 1
·Ophthalmic
BLOOD, HEMATOLOGY REFERENCE CONTROL
FDA 510(k)
FDA Class 2
·Hematology
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 7, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 7, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 7, 2024
JOSTENT GRAFTMASTER
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MAF·June 18, 2014
TENDRIL ST
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·December 20, 2012
840 VENTILATOR
FDA Adverse Event
Malfunction
·PURITAN BENNETT CORP.·Product code CBK·October 12, 2010