7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
VENTILATOR SET - CODE 2C7109
FDA 510(k)
FDA Class 2
·Anesthesiology
GRAVITY Syndesmosis LP
FDA 510(k)
FDA Class 2
·Orthopedic
ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H
FDA 510(k)
FDA Class 2
·Clinical Chemistry
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 10, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·October 3, 2012
MBT CEM KEEL TIB TRAY SZ2
FDA Adverse Event
Injury
·DEPUY-COR, A DIVISION OF DEPUY ORTHOPAEDICS·Product code NJL·July 21, 2010
Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172
FDA Enforcement
Class II
·Terminated·Vision RT Ltd·October 10, 2018