7 results
·
28ms
·
Sources: EU EUDAMED, US FDA
VEOLAR VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
MyNeWT Negative Pressure Wound Therapy System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HOSPIRA ENTERAL FEEDING SET, MODEL 20640
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·June 10, 2014
ATTAIN OTW
FDA Adverse Event
MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 8, 2010
TOTAL ASR ACET IMP SIZE 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·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