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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 14 Results
ProductCode: HAW Applicant: MEDTRONIC NAVIGATION, INC. Decision Date To: 06/30/2022
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synergy cranial v2.2.9, stealthstation cranial v3.1.4 Medtronic Navigation, Inc. K221087 06/10/2022
stealthstation cranial software v1.3.2 Medtronic Navigation, Inc. K203639 01/13/2021
stealth autoguide system, midas rex legend depth stop system Medtronic Navigation, Inc. K191597 11/01/2019
stealthconnect remote viewing, planning and collaboration system MEDTRONIC NAVIGATION, INC. K162655 04/21/2017
stealthstation s8 system platforms and stealthstation cranial software MEDTRONIC NAVIGATION, INC. K162309 03/31/2017
cranial reducing tubes MEDTRONIC NAVIGATION, INC. K162604 12/30/2016
stealthstation system with cranial software MEDTRONIC NAVIGATION, INC. K153660 09/14/2016
synergy cranial MEDTRONIC NAVIGATION, INC. K150216 06/11/2015
stylet, 23cm, skull-mount patient tracker, non-invasive patient tracker, tracer pointer, touch-n-go pointer, navigation MEDTRONIC NAVIGATION, INC. K141833 03/25/2015
stealthstation s7 / i7 / fusion navigation systems, axiem navigation system MEDTRONIC NAVIGATION, INC. K133444 07/25/2014