7 results
·
22ms
·
Sources: EU EUDAMED, US FDA
MODEL K110SX CENTRIFUGE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SBI ULNAR HEAD IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
Radixact Treatment Delivery System
FDA 510(k)
FDA Class 2
·Radiology
RELIA DR
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NVZ·June 10, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·October 8, 2010
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·November 2, 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