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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 42 Results
ProductCode: HAW Applicant: BRAINLAB AG Decision Date To: 05/07/2024
 
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alignment system cranial, alignment software cranial, cirq alignment software cranial biopsy, cirq alignment software cranial seeg, varioguide alignment software cranial Brainlab AG K223864 09/09/2023
cranial navigation, navigation software cranial, navigation software craniofacial, cranial em system, automatic registration imri Brainlab AG K223288 07/21/2023
ent em Brainlab AG K223734 04/27/2023
brainlab elements – trajectory planning (2.6), elements stereotaxy, elements lead localization, elements trajectory planning cranial Brainlab AG K223552 04/19/2023
cranial em system Brainlab AG K213989 09/08/2022
cirq, cirq robotic alignment system, cirq robotic alignment module cranial, cirq robotic alignment module, cirq robotic alignment cranial and spine, cirq robotic alignment cranial and spine system Brainlab AG K210989 11/12/2021
trajectory planning, elements trajectory planning, elements lead localization Brainlab AG K211544 11/03/2021
disposable pre-calibrated suction Brainlab AG K201752 01/29/2021
cranial image guided surgery system, navigation software cranial, navigation software ent, registration software cranial, automatic registration 2.0, ultrasound navigation software (bk), intraoperative structure update Brainlab AG K192703 10/08/2020
microscope navigation Brainlab AG K190250 09/06/2019
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