6 results
·
18ms
·
Sources: EU EUDAMED, US FDA
LIQUID SCINTILLATION COUNTER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
REFLEXION HD HIGH-DENSITY MAPPING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird® NXG Spinal Fixation System; Phoenix® Minimally Invasive Spinal Fixation System; Phoenix® CDX Minimally Invasive Spinal Fixation System; JANUS® Midline Fixation Screw; JANUS® Fenestrated Screw
FDA 510(k)
FDA Class 2
·Orthopedic
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·October 10, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 7, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·August 3, 2010