13 results
·
8ms
·
Sources: EU EUDAMED, US FDA
CDX 200
FDA 510(k)
FDA Class 2
·Anesthesiology
POLY DIAGNOST CDX
FDA 510(k)
FDA Class 2
·Radiology
POMC/PCSK1/LEPR CDx Panel
FDA 510(k)
FDA Class 2
·Clinical Chemistry
2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CDX DIGITAL X-RAY IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
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
Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
Lumos 3DX
FDA 510(k)
FDA Class 2
·Dental
SCANORA 3DX
FDA 510(k)
FDA Class 2
·Radiology
Sphere-9Dx Diagnostic Catheter (AFR-00009)
FDA 510(k)
FDA Class 2
·Cardiovascular
KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)
FDA 510(k)
FDA Class 2
·Ophthalmic