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U.S. Department of Health and Human Services

Medical Device Recalls
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510(K) Number: K162314
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Imactis Navigation Kit, REF 10100, Content Sterile Needle Holder Ref. A10010 CE 0459, Sensor Cover R... 2 01/22/2020 Imactis
Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction wi... 2 09/15/2020 Imactis
Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100 2 03/16/2021 Imactis
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