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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 38 Results
ProductCode: HAW Applicant: BRAINLAB AG Decision Date To: 01/29/2023
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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
microscope navigation software Brainlab AG K172820 03/01/2018
brainlab trauma BRAINLAB AG K110204 08/05/2011
iplan BRAINLAB AG K101627 06/03/2011
vectorvision cranial, vectorvision ent, kolibri cranial, kolibri ent, cranial essential, cranial unlimited BRAINLAB AG K092467 05/06/2010