9 results
·
21ms
·
Sources: EU EUDAMED, US FDA
DNA MEDICAL DURACATH
FDA 510(k)
FDA Class 2
·Anesthesiology
Tranquil-C™
FDA UDI
NEXUS SPINE, L.L.C.·B6788224360·Cervical Trial +DS 5x12x12 Lordotic
COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Latitud Hip Replacement System
FDA 510(k)
FDA Class 2
·Orthopedic
GENESYS HTA PROCERVA®
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code MNB·May 20, 2014
MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F
FDA Adverse Event
Injury
·ACCESSCLOSURE, INC.·Product code MGB·June 27, 2012
PULSE GEN MODEL 102R
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·August 26, 2010
MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.
FDA Enforcement
Class II
·Terminated·Mentor Texas, LP.·January 21, 2015
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