146 results
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20ms
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Sources: EU EUDAMED, US FDA
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Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES
FDA 510(k)
FDA Class 2
·Ophthalmic
Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX
FDA 510(k)
FDA Class 2
·Ophthalmic
Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360º Spinal Fixatoin System, Title 2 Polyaxial Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI
FDA 510(k)
FDA Class 2
·Orthopedic
VITREA 2 CT PERFUSION OPTION
FDA 510(k)
FDA Class 2
·Radiology