8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
PROPHY CARE SOLUTION
FDA 510(k)
FDA Class 1
·Dental
EndoEssentials™ Absorbent Paper Points 200 - ISO#15-.02 Taper
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172015011·Endodontic paper point
MINI-1 TRANSCUTANEOUS ELEC-NERVE STIM
FDA 510(k)
FDA Class 2
·Neurology
KONTRON MINIMON 7134 PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
TAXUS® LIBERTÉ®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·June 10, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·October 12, 2010
DHS®/DCS® LAG SCREW
FDA Adverse Event
Injury
·SYNTHES·Product code KTT·December 10, 2012
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021