7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
VACUUM BLOOD COLLECTING SYSTEM (NEO-TUBE)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SYNGO EXPERT-1
FDA 510(k)
FDA Class 2
·Radiology
HammerTech Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·October 8, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 13, 2014
75MM SELECTABLE NEW TLC
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·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