8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
WORTHINGTON HDL PRECIPITATING REAGENT SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ND YAG Q-switch Laser Therapy Machine
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CORONIS 2MP AND MDCG 2121 - CB
FDA 510(k)
FDA Class 2
·Radiology
TRANSVENE RV
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code LWS·June 10, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·ANIMAS CORP.·Product code LZG·October 4, 2010
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·December 7, 2012
MEDISLIM
FDA Adverse Event
Injury
·MEDICREATIONS, LLC·Product code GEX·April 27, 2020
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