8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
EZ STIM
FDA 510(k)
FDA Class 2
·Anesthesiology
CCI CORNEAL SCARIFIER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CARDIMAX FX-406U
FDA 510(k)
FDA Class 2
·Cardiovascular
PROTECTA XT CRT-D
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code LWS·February 11, 2013
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·December 14, 2010
FRESENIUS 2008K
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE·Product code KDI·July 17, 2014
VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 135DX20H, 140DX16H, 140DX18H, 140DX20H, 145DX16H, 145DX18H, 145DX20H, 150DX16H, 150DX18H, 150DX20H
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017