9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
VENTRE/SEP
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TSRH® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978042879·CROSSLINK 811-423 1/4 LP L 2.15-2.95TI
INPULSE DENTAL LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CS 1600 INTRAORAL CAMERA
FDA 510(k)
FDA Class 2
·Dental
SMR HUMERAL HEAD Ø48 MM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWT·February 20, 2024
PRIMEADVANCED
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 15, 2014
CONSULTA CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·October 31, 2012
4 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