8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
TEW BYPASS INSTRUMENTS & DISSECTING KIT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PERFORMANCE HEALTH
FDA UDI
Asp Global, LLC·00840216112094·Rolyan Wrist/Thumb Wrap, L
ENTERIC 20
FDA 510(k)
FDA Class 1
·Microbiology
HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131
FDA 510(k)
FDA Class 2
·Cardiovascular
6600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 21, 2014
VIRTUOSO VR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·October 15, 2012
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE, INC.·Product code LFR·May 22, 2015
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025