7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
TRIGLYCERIDES
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BP 101 DIGITAL BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
SALVATION External Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·June 10, 2014
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·October 8, 2010
ADVANTAGE BALLOON CATHETER INFLATION DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code MAV·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