9 results
·
20ms
·
Sources: EU EUDAMED, US FDA
DUOCENTRIC REVERSED SHOULDER PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
Oticon
FDA UDI
Oticon A/S·05707131261298·H11, BTE 13 WL 85 STG
EARLY CLEAVAGE MEDIUM (ECM)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
OCELOT CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
VERSAFITCUP CC PE LINER O 32 E
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LZO·March 14, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·May 29, 2013
PENTA 3MM, 60 CM 16-ELECTRODE PADDLE LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 15, 2011
MIC-KEY LOW-PROFILE-JEJUNAL FEEDING TUBE
FDA Adverse Event
Malfunction
·AVENT SA DE R.L. DE C.V.·Product code KNT·August 22, 2008
Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021