Axonics
Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Boston ScientificLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
- 510(k) clearances: 5
- Device recalls: 1
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
Latest Records
Newest first across sources; each opens the record| Date | Record | Source |
|---|---|---|
| Jul 15, 2024 | PNE Lead Implant Kit REF: 1701Class II · Retroactively Reported: 10mL luer lock syringes included in kit may leak , break or experience other issues that may p | Device recalls |
| Apr 5, 1985 | AUDIT TM VK843712 · GWF | 510(k) clearances |
| Dec 1, 1983 | AUDIT V AX 135K833298 · GWK | 510(k) clearances |
| Aug 12, 1983 | ALLERGENETICS FLUORO-FAST READERK831870 · JZT | 510(k) clearances |
| Feb 7, 1983 | AUDITK822335 · EWO | 510(k) clearances |
| Jan 14, 1983 | TOTAL IGE-FAST TESTK823494 · DGC | 510(k) clearances |
Canada and Imports
Matched by company name- Active Health Canada device licences
- 6, as of Nov 10, 2026
Names and Identifiers
- Appears as
- Website
- bostonscientific.com
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built