8 results
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17ms
·
Sources: EU EUDAMED, US FDA
ANESTHESIOLOGY DEVICE
FDA 510(k)
FDA Class 1
·Anesthesiology
ERA® 11° DO Small Post Attachment SS
FDA UDI
STERNGOLD DENTAL LLC·00841549101953·This part contains: 1 female, 2 black, 2 white,...
LENSAR Laser System - fs 3D (LLS-fs 3D)
FDA 510(k)
FDA Class 2
·Ophthalmic
ACTIWARE-PLMS
FDA 510(k)
FDA Class 2
·Neurology
SPRINTER LEGEND RX
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO·Product code LOX·May 15, 2014
INSYNC III PROTECT
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code NIK·October 31, 2012
3 MOTOR ADVANCE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·August 17, 2010
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