12 results
·
23ms
·
Sources: EU EUDAMED, US FDA
OLYMPIC PASTEURMATIC SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
VITA ENAMIC Implant Solutions (IS)
FDA 510(k)
FDA Class 2
·Dental
MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS
FDA 510(k)
FDA Class 2
·Cardiovascular
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 29, 2024
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 29, 2024
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 29, 2024
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 29, 2024
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·July 1, 2011
SPRINT QUATTRO
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·February 9, 2013
EASYTRAK 2
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code OJX·January 10, 2011
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 23, 2014
Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·July 10, 2024