Data / Medical devices / Canada / Northern Digital, Inc.
Northern Digital, Inc.: FDA-registered device maker in WATERLOO Ontario, Canada, 2 510(k) clearances
Northern Digital, Inc. is registered with the FDA (registration 3002743211) in WATERLOO Ontario, Canada. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 14, 2010. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002743211
- Address
- 103 Randall Drive, WATERLOO Ontario, Canada, N2V 1C5
- Owner or operator
- NORTHERN DIGITAL, INC. (9059739)
- Roles
- Complaint file establishment, Exporter to the US, Specification developer
- First device listed
- December 20, 2007
- Registered through
- 2026
- Brand names listed
- Disposable Reflective Marker Sphere, NDI Passive Sphere
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Neurological Stereotaxic Instrument | HAW | 2 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Orthopedic Stereotaxic Instrument | OLO | 2 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 14, 2010 | K100038 | DISPOSABLE REFLECTIVE MARKER SPHERES | HAW | Substantially Equivalent | Brainlab AG | accessdata.fda.gov |
| January 27, 2004 | K033621 | NDI PASSIVE SPHERES | HAW | Substantially Equivalent | Northern Digital, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 10, 2015 | 69804 | Class II | Terminated | NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system. Product Usage: Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared t | Inadequate curing of adhesive, may cause the two halves of the spheres to separate. | accessdata.fda.gov |
| May 20, 2015 | 71350 | Class II | Terminated | NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery) system. Product Usage: Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tr | Inadequate curing of adhesive, which may cause the two halves of the spheres to separate. | accessdata.fda.gov |
Compare with other makers
Updated July 16, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.