8 results
·
21ms
·
Sources: EU EUDAMED, US FDA
MENTOR CORPORAL DILATORS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LEONE SPA
FDA UDI
LEONE SPA·08033707032649·WEB 1ST MOLAR BANDS n.LR 17
POINTER EXCEL
FDA 510(k)
FDA Class 2
·Neurology
ARIES System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 10, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·October 7, 2010
M2A-MAGNUM MOD HD SZ 46MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·December 6, 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