7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
MODIFICATION OF SUNTANA SUN SYSTEM BED
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NORDICLAB FERRITIN IRMA TEST
FDA 510(k)
FDA Class 2
·Immunology
PREMIUM Implant Systems SHELTA Implant Systems
FDA 510(k)
FDA Class 2
·Dental
TENAX
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 10, 2014
LCS COMP RP INSERT LG 10MM
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code NJL·October 7, 2010
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·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