8 results
·
23ms
·
Sources: EU EUDAMED, US FDA
GLENOID DRILL
FDA 510(k)
FDA Class 1
·Orthopedic
CONPHAR ADJUSTABLE CERVICAL COLLAR
FDA 510(k)
FDA Class 1
·Physical Medicine
KODAK INTENSIFYING SCREEN 80-175
FDA 510(k)
FDA Class 1
·Radiology
SEXTANT
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·October 1, 2010
CAPSUREFIX MRI SURESCAN
FDA Adverse Event
Malfunction
·MPRI·Product code NVN·June 10, 2014
MAXIMO II VR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code LWS·October 9, 2010
TOTALCARE BARIATRIC PLUS
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·November 1, 2012
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022