7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
MECONIUM SUCTION DEVICE (MSD)
FDA 510(k)
FDA Class 2
·Anesthesiology
DYNATRON 1120 EPS (ELECTRICAL POINT STIMULATOR)
FDA 510(k)
FDA Class 2
·Neurology
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 19, 2014
ATTAIN ABILITY
FDA Adverse Event
Malfunction
·MPRI·Product code OJX·February 15, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·January 19, 2011
CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. Product Usage: The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers.
FDA Enforcement
Class II
·Terminated·Civco Medical Instruments Co. Inc.·August 29, 2018