13 results
·
18ms
·
Sources: EU EUDAMED, US FDA
WAKO(TM) IGM-HA DIRECT
FDA 510(k)
FDA Class 2
·Immunology
ELEVATE™ Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169430815·SPACER 8880828 ELEVATE X-LOR 28X8MM
Natureplex Warm Touch Warming Jelly
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MOUNTAINEER OCT SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 7, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 6, 2024
ELEVATE SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code MAX·March 11, 2025
TRILOGY 202
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·April 9, 2014
NDEHP PP YSTE MACRO
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·October 1, 2010
TI SNAP-ON OPEN PARALLEL CONNECTOR 5.5MM/6.0MM W/2 SCR
FDA Adverse Event
Death
·SYNTHES BRANDYWINE·Product code NKB·December 20, 2012
ELEVATE¿ SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code MAX·August 22, 2023
ELEVATE¿ SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code MAX·November 15, 2021
Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025