8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
COBEAU
FDA 510(k)
FDA Class 2
·Dental
ERA® Implant Abutment Micro Ang. Base, 6mm Cuff (BE)
FDA UDI
STERNGOLD DENTAL LLC·00841549104046·Implant retained overdentures are an establishe...
Accucuff Cuff Pressure Indicator
FDA 510(k)
FDA Class 2
·Anesthesiology
ALTOMEC ARTHROSCOPE
FDA 510(k)
FDA Class 2
·Orthopedic
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN·Product code BTR·May 2, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 31, 2012
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·August 10, 2010
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 30, 2015