7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
UNISUN
FDA 510(k)
FDA Class 1
·Ophthalmic
SUNGLASSES
FDA 510(k)
FDA Class 1
·Ophthalmic
3M 6830 ELECTRODE
FDA 510(k)
FDA Class 2
·Neurology
MEDTRONIC.SIGMA
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code NVZ·February 11, 2013
UV-FLASH SOLUTION TRANSFER SET(SHORT) - JAPAN
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·January 10, 2011
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·INVACARE CONTINUING CARE·Product code FNJ·July 24, 2014
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