9 results
·
20ms
·
Sources: EU EUDAMED, US FDA
UNIMETER 330K
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Tranquil-C™
FDA UDI
NEXUS SPINE, L.L.C.·B6788224410·Cervical Trial +DS 10x12x12 Lordotic
Ultrasound System 2300
FDA 510(k)
FDA Class 2
·Radiology
STERRAD SEALSURE CHEMICAL INDICATOR TAPE
FDA 510(k)
FDA Class 2
·General Hospital
RD180 SUTURING DEVICE
FDA Adverse Event
Injury
·LSI SOLUTIONS, INC.·Product code GAT·December 22, 2021
NC QUANTUM APEX?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·May 20, 2014
MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F
FDA Adverse Event
Injury
·ACCESSCLOSURE, INC.·Product code MGB·June 7, 2012
RESTORE ULTRA
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·August 26, 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