8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
DISPOSABLE BERMAN AND GUEDEL AIRWAYS
FDA 510(k)
FDA Class 1
·Anesthesiology
JOBST Maternity
FDA UDI
BSN MEDICAL, INC.·04042809640359·OPAQUE MATERNITY 15-20 MM HG KNEE HIGH ZIG ZAG ...
LEKSELL GAMMAPLAN
FDA 510(k)
FDA Class 2
·Radiology
Advanced Breast Template System
FDA 510(k)
FDA Class 2
·Radiology
SPRINT FIDELIS
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 10, 2014
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·October 8, 2010
STATAK SOFT TISSUE ANCHOR
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code KGS·November 28, 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