8 results
·
22ms
·
Sources: EU EUDAMED, US FDA
MEDCARE HEMOSTATS (STRAIGHT, CURVED, MOSQUITO-TIP)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Shoreline™ ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981177164·Modular Trial, 16 x 14 x 7mm, 7 Deg Lordosis
BEAMSCAN
FDA 510(k)
FDA Class 2
·Radiology
SPI ART ABUTMENTS
FDA 510(k)
FDA Class 2
·Dental
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
REVEAL XT
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code DSI·October 8, 2010
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·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