7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
MEDTRONIC MODEL 8501 ACCESS PORT
FDA 510(k)
FDA Class 2
·General Hospital
Streamline OCT Occipito-Cervico-Thoracic System
FDA 510(k)
FDA Class 2
·Orthopedic
ALLOFIX ANCHOR, 5.0 MM ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
CAPSUREFIX
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
CAPSUREFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 8, 2010
ENDO ILS, 29MM, CURVED
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·December 7, 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