7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MINI-TRACH KIT
FDA 510(k)
FDA Class 2
·Anesthesiology
PERCOR DATASCOPE INTRA-AORTIC BALLOON
FDA 510(k)
FDA Class 2
·Cardiovascular
Caphosol Artifical Saliva Tablets
FDA 510(k)
FDA Unclassified
·Unknown
PROTECTA XT CRT-D
FDA Adverse Event
Malfunction
·IPG MFG SWITZERLAND·Product code NIK·June 10, 2014
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 8, 2010
SYMIQ FRENCH SINGLE
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·December 5, 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