8 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Exufiber Ag+
FDA 510(k)
FDA Unclassified
·Unknown
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221045294·Unitek(TM) Molar Band General Purpose Wide Regu...
AIR-N-GO
FDA 510(k)
FDA Class 1
·Dental
EBI ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
REVEAL DX
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code DSI·June 10, 2013
CAPSURE EPI
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DTB·July 13, 2011
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·September 16, 2008
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021