BEUDAMED
    155 results · 16ms · Sources: EU EUDAMED, US FDA

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    Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    TELSTAR MAGNETIC NAVIGATION SYSTEMS [MNS}, TELSTAR BI-PLANE DIGITAL IMAGING SYSTEM, NIOBE ELECTROPHYSIOLOGY MAPPING CATH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid

    FDA 510(k)
    FDA Class 2 ·Neurology

    A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH PACE.

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPACING), (2-6-2 MM ELECTRODE SPACING)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0)

    FDA 510(k)
    FDA Class 2 ·Radiology

    NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE MAPPING PROBE, NEURO-TRACE III NERVE BG

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode

    FDA 510(k)
    FDA Class 2 ·Neurology

    Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)

    FDA 510(k)
    FDA Class 2 ·Radiology

    POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP™ EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE™ 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE™ CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE™ Pressure Sensor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular