16 results
·
36ms
·
Sources: EU EUDAMED, US FDA
DINAMAP MPS PORTABLE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
ALLTHREAD PEEK ANCHOR WITH TANTALUM MARKER
FDA 510(k)
FDA Class 2
·Orthopedic
AUTOSTREAKER
FDA 510(k)PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·February 21, 2013
PIN LNR CONS NEUT +4 36IDX60OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWZ·July 31, 2014
VISCOJECT 1.8 DELIVERY SYSTEM
FDA Adverse Event
Injury
·BAUSCH & LOMB·Product code MSS·January 24, 2011
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EGS·April 26, 2018
NSK
FDA Adverse Event
Injury
·NAKANISHI, INC.·Product code EGS·May 12, 2015
NSK
FDA Adverse Event
Malfunction
·NAKANISHI INC.·Product code EGS·October 9, 2025
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EGS·December 19, 2016
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EGS·March 1, 2018
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EGS·January 15, 2018
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EGS·June 6, 2018
DA-800C5L
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EGS·May 2, 2016
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EGS·April 26, 2018
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021