8 results
·
35ms
·
Sources: EU EUDAMED, US FDA
DISPOSABLE NEEDLE ELECTRODE (ALM), DISPOSABLE NEEDLE ELECTRODE (DLM)
FDA 510(k)
FDA Class 2
·Neurology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471156050·K-WIRE - SINGLE TROCAR 1.1mm DIA x 230mm
PROFILE COLLARED HIP PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
INTERFERENTIAL CURRENT UNIT
FDA 510(k)
FDA Class 2
·Neurology
AXON ECLIPSE CONTROLLER
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code GWF·February 19, 2013
PRECISION TEST STRIPS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 31, 2011
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·August 1, 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