7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
SINGLE AND DUAL TOURNIQUET CUFF
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
HEMA SCREEN SPECIFIC IFOBT
FDA 510(k)
FDA Class 2
·Hematology
Reliance Lumbar IBF System
FDA 510(k)
FDA Class 2
·Orthopedic
CAPSURE Z
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·October 7, 2010
NEXGEN CR-FLEX FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·December 5, 2012
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012