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FDA 510(k) Applications Submitted by Esther Moreno Garcia
FDA 510(k) Number
Submission Date
Device Name
Applicant
K240701
03/14/2024
Drill Guide; Drill Bit; Spine & Trauma Navigation
Brainlab AG
K242569
08/28/2024
Mixed Reality Spine Navigation
Brainlab AG
K223288
10/25/2022
Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI
Brainlab AG
K243698
11/29/2024
Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT
Brainlab AG
K223734
12/13/2022
ENT EM
Brainlab AG
K234047
12/21/2023
Automatic Registration
Brainlab AG
K223864
12/23/2022
Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial
Brainlab AG
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