8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
LAMB SERUM - STERILE FILTERED
FDA 510(k)
FDA Class 1
·Hematology
Shoreline™ ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981177188·Modular Trial, 16 x 14 x 9mm, 7 Deg Lordosis
ARTEGRAL IMCROWN
FDA 510(k)
FDA Class 2
·Dental
ShurFit CpTi-HA ACIF Interbody Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
CAPSURE SP NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 10, 2014
MARQUIS VR
FDA Adverse Event
Malfunction
·MEDTRONIC S.A.·Product code LWS·October 8, 2010
VERSAFITCUP DM ACETABULAR SHELL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code MEH·November 29, 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