9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
515A NEO-TRAK NEONATAL MONITOR
FDA 510(k)
FDA Class 2
·Anesthesiology
JOBST Maternity
FDA UDI
BSN MEDICAL, INC.·04042809642933·OPAQUE MATERNITY 20-30 MM HG THIGH HIGH ZIG ZAG...
IVAC 260 SERIES VOLUME TRIC INFUSION CON
FDA 510(k)
FDA Class 2
·General Hospital
APTUS® Coronoid 2.0
FDA 510(k)
FDA Class 2
·Orthopedic
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 28, 2014
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·October 8, 2010
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·December 7, 2012
BD 10ML SYRINGE LUER-LOK TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·June 18, 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