7 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Temporary Fixation Pins
FDA 510(k)
FDA Class 2
·Orthopedic
CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING
FDA 510(k)
FDA Class 2
·Radiology
SECRMARK BIOPSY SITE MARKING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP
FDA Adverse Event
Injury
·NORTH HAVEN - USS·Product code GDO·October 8, 2008
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 27, 2013
U BY KOTEX CLICK TAMPONS
FDA Adverse Event
Malfunction
·QINGDAO P&B CO LTD·Product code HEB·June 17, 2011
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018