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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
brainlab elements – trajectory planning (2.6), elements stereotaxy, elements lead localization, elements trajectory planning cranial Brainlab AG K223552 04/19/2023
brainlab knee essential, brainlab knee unlimited ci knee, ci knee unlimited BRAINLAB AG K073615 09/05/2008
brainlab trauma BRAINLAB AG K110204 08/05/2011
brainsuite net BRAINLAB AG K070556 09/25/2007
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
cranial em system Brainlab AG K213989 09/08/2022
cranial image guided surgery system BRAINLAB AG K082060 05/08/2009
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
cranial navigation, navigation software cranial, navigation software craniofacial, cranial em system, automatic registration imri Brainlab AG K223288 07/21/2023
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