8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SyMRI
FDA 510(k)
FDA Class 2
·Radiology
BI-METRIC HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304254480·
CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050
FDA 510(k)
FDA Unclassified
·Unknown
POLYSMITH SLEEP SYSTEM, MODEL NTI5498
FDA 510(k)
FDA Class 2
·Neurology
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·July 15, 2011
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 11, 2013
BD INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·September 5, 2008
Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·April 27, 2016