7 results
·
33ms
·
Sources: EU EUDAMED, US FDA
MATRIX LR, LR 22A & LR/LASER RECORDER
FDA 510(k)
FDA Class 2
·Radiology
SURGICAL FACE MASK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IMPEDANCE TESTER (MODEL 4390)
FDA 510(k)PLM A+ SPANISH 110V
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·April 15, 2014
ASR ACETABULAR IMPLANT 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·December 6, 2012
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 22, 2015
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