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Navident
Claronav Inc · Model 955-ND-ND, plus kits · UDI-DI 07540209955006
3
510(k) clearances
9
Adverse events
3
Recalls
4
Facilities
Description
Navident Surgical Navigation System - Packaged System (including kits/accessories)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-03-04 | X-NAV Technologies, LLC | The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental ha |
| 2024-03-04 | X-NAV Technologies, LLC | The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental ha |
| 2022-09-28 | X-NAV Technologies, LLC | Product missing one of two welds connecting the tip to the shaft, if the remaining weld breaks, it is possible that the tip could fall out during X-Mark registration and fall into |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.