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Neurosurgical Laser With Mr Thermography

FDA product code ONO · Class 2 · General, Plastic Surgery

30
Registered devices
1
Adverse events
1
Recalls
7
510(k) clearances

Devices with this code

Visualase — MEDTRONIC NAVIGATION, INC.Visualase — MEDTRONIC NAVIGATION, INC.Visualase — MEDTRONIC NAVIGATION, INC.Visualase — MEDTRONIC NAVIGATION, INC.NeuroBlate NB3 FullFire™ 1.6 Laser Probe — MONTERIS MEDICAL INCVisualase — MEDTRONIC NAVIGATION, INC.Thermoguide Workstation — Clinical Laserthermia Systems ABInstructions for use Tranberg Thermoguide Therapy System - US — Clinical Laserthermia Systems ABVisualase — MEDTRONIC NAVIGATION, INC.Visualase — MEDTRONIC NAVIGATION, INC.Visualase — MEDTRONIC NAVIGATION, INC.Laser Applicator Non-cooled — Clinical Laserthermia Systems ABVisualase V2 MRI-Guided Laser Ablation System — MEDTRONIC NAVIGATION, INC.Visualase — MEDTRONIC NAVIGATION, INC.MR Introducer — Clinical Laserthermia Systems ABVisualase — MEDTRONIC NAVIGATION, INC.Visualase — MEDTRONIC NAVIGATION, INC.Visualase — MEDTRONIC NAVIGATION, INC.Instructions for Use Laser applicator - Neuro — Clinical Laserthermia Systems ABVisualase — MEDTRONIC NAVIGATION, INC.Laser Applicator Non-cooled — Clinical Laserthermia Systems ABVISUALASE — MEDTRONIC NAVIGATION, INC.Visualase — MEDTRONIC NAVIGATION, INC.Visualase — MEDTRONIC NAVIGATION, INC.

Recent recalls

DateFirmReason
2022-10-14Medtronic Navigation, Inc.Due to a defect in the outer pouch sterile seal

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.