Device type
Neurological Stereotaxic Instrument
Product code HAW · Class II · 21 CFR 882.4560 · Neurology
Recent 510(k)s
Oct 26, 2026
K261997
NeuroAlign
Medivis, Inc.
- HAW
- Class II
Oct 15, 2026
K262214
Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S)
Guangzhou Aimooe Technology Co., Ltd.
- HAW
- Class II
Sep 10, 2026
K253856
Geniant Cranial (Navigated Neurosurgical Positioning Robot)
Koh Young Technology, Inc.
- HAW
- Class II
Recent recalls
Nov 4, 2026
Z-0314-2027
Precision Pointer Electromagnetic (8000-050-001)
Stryker Leibinger GmbH & Co. KG
- HAW
- Class II
- Ongoing
Oct 28, 2026
Z-0197-2027
Medtronic Biopsy Needle Kit, REF: 9733068, Passive, Sterile EO, Rxonly
Medtronic Navigation, Inc.
- HAW
- Class II
- Ongoing
Oct 28, 2026
Z-0196-2027
Medtronic NDI Passive Spheres REF: 8801075, Sterile EO, 5/Tray 12 Pk., Rxonly
Medtronic Navigation, Inc.
- HAW
- Class II
- Ongoing
Oct 28, 2026
Z-0194-2027
Medtronic NDI Passive Spheres REF: 8801071, Sterile EO, 1/Tray 12 pk., Rxonly
Medtronic Navigation, Inc.
- HAW
- Class II
- Ongoing
Oct 28, 2026
Z-0195-2027
Medtronic NDI Passive Spheres REF: 8801074, Sterile EO, 4/Tray 12 Pk., Rxonly
Medtronic Navigation, Inc.
- HAW
- Class II
- Ongoing