510(k) Report

FDA applicant

Northern Digital, Inc.

Dundas, CA1 decision2004–200428 recalls

FDA records 1 decision for Northern Digital, Inc. (Dundas, CA) in 2004: 1 510(k) clearance. All are in product code HAW (Neurological Stereotaxic Instrument). 28 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Northern Digital, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Northern Digital, Inc. since 2007.

Recalls per year

3in 2026

2014: 252026 (partial year): 3
2007high 25 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Northern Digital, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Northern Digital, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • HAWNeurological Stereotaxic Instrument1decision

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K033621Ndi Passive SpheresNorthern Digital, Inc. · 20043cite it

What has FDA decided for it lately?

  • K033621Ndi Passive SpheresNorthern Digital, Inc. · 200428 recalls

The one decision as Northern Digital, Inc. →

What has been recalled?

28 recalls linked to its devices; the latest:

  • K033621Medtronic NDI Passive Spheres REF: 8801074, Sterile EO, 4/Tray 12 Pk., RxonlyAug 31, 2026Class II
  • K033621Medtronic NDI Passive Spheres REF: 8801075, Sterile EO, 5/Tray 12 Pk., RxonlyAug 31, 2026Class II
  • K033621Medtronic NDI Passive Spheres REF: 8801071, Sterile EO, 1/Tray 12 pk., RxonlyAug 31, 2026Class II
  • K001284Disp 9730950 STRL Sphere, 1 PK InsertApr 24, 2014Class II
  • K001284Tumor Resection Kit 9733607 Non-InvasiveApr 24, 2014Class II
  • K001284Disp 9730951 STRL Sphere, 5PK InsertApr 24, 2014Class II