# Axonics Inc.

> Medical device manufacturer record on deviCERTS, compiled from public registries. Axonics Inc. is a medical device manufacturer based in the United States, with 29 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (EU AIMDD; FDA Class II and I) and 1 FDA recall as of 15 Nov 2026.

- Canonical page: <https://devicerts.com/manufacturers/axonics-inc>
- Country: United States (from SRN)
- EUDAMED actor status: active
- Role: Manufacturer
- Registrations: EUDAMED
- EUDAMED SRN: US-MF-000008413

## Figures

- Devices: 29
- EU certificates: 2
- FDA recalls (matched to the firm by name): 1, 1 ongoing

## Registry facts

*Every device of the manufacturer. A device listed in two registries counts in both.*

- Registries: EUDAMED 24, FDA GUDID 22, FDA 510(k) 5
- Device classes: EU AIMDD 24, FDA Class II 4, FDA Class I 1
- EMDN [J02 Implantable neurostimulators](https://devicerts.com/categories/emdn/J02): 24 devices

## Sites and related companies

- Authorised representative: [Emergo Europe B.V.](https://devicerts.com/representatives/emergo-europe-bv-nl-ar-000000116) (Netherlands)

## Devices

The first 29 of 29, in the order of the canonical page, which lists them all.

- [Total Ige-Fast Test](https://devicerts.com/devices/total-ige-fast-test-dgc) · ref K823494 · Class II · 510(k) · status: Active · decision 1983-01-14
- [Axonics Lead Implant Kit](https://devicerts.com/devices/axonics-lead-implant-kit-1801) · ref 1801 · Active implantable (AIMDD) · EUDAMED, GUDID · status: Active
- [Axonics PNE Lead Implant Kit](https://devicerts.com/devices/axonics-pne-lead-implant-kit-1701) · ref 1701 · Active implantable (AIMDD) · EUDAMED, GUDID · status: Active
- [Axonics Accessory, Lead Extension Cable](https://devicerts.com/devices/axonics-accessory-lead-extension-cable-9009) · ref 9009 · Active implantable (AIMDD) · EUDAMED, GUDID · status: Active
- [Axonics Accessory, Stimulation Ground Cable](https://devicerts.com/devices/axonics-accessory-stimulation-ground-cable-9003) · ref 9003 · Active implantable (AIMDD) · EUDAMED, GUDID · status: Active
- [Axonics PNE Lead](https://devicerts.com/devices/axonics-pne-lead-1901) · ref 1901 · Active implantable (AIMDD) · EUDAMED, GUDID · status: Active
- [Audit](https://devicerts.com/devices/audit-ewo) · ref K822335 · Class II · 510(k) · status: Active · decision 1983-02-07
- [Audit Tm V](https://devicerts.com/devices/audit-tm-v-gwf) · ref K843712 · Class II · 510(k) · status: Active · decision 1985-04-05
- [Allergenetics Fluoro-Fast Reader](https://devicerts.com/devices/allergenetics-fluoro-fast-reader-jzt) · ref K831870 · Class I · 510(k) · status: Active · decision 1983-08-12
- [Audit V Ax 135](https://devicerts.com/devices/audit-v-ax-135-gwk) · ref K833298 · Class II · 510(k) · status: Active · decision 1983-12-01
- [Axonics Accessory, Basic Trial Cable](https://devicerts.com/devices/axonics-accessory-basic-trial-cable-9014) · ref 9014 · Active implantable (AIMDD) · EUDAMED, GUDID · status: Active
- [Axonics Accessory, Charging Belt - Regular Size](https://devicerts.com/devices/axonics-accessory-charging-belt-regular-size-9008-r) · ref 9008-R · Active implantable (AIMDD) · EUDAMED, GUDID · status: Active
- [Axonics Accessory, Lead Stimulation Cable](https://devicerts.com/devices/axonics-accessory-lead-stimulation-cable-9007) · ref 9007 · Active implantable (AIMDD) · EUDAMED, GUDID · status: Active
- [Axonics Tined Lead](https://devicerts.com/devices/axonics-tined-lead-1201) · ref 1201 · Active implantable (AIMDD) · EUDAMED, GUDID · status: Active
- [Axonics Trial Stimulator](https://devicerts.com/devices/axonics-trial-stimulator-1601) · ref 1601 · Active implantable (AIMDD) · EUDAMED, GUDID · status: Active
- [Axonics Charging System](https://devicerts.com/devices/axonics-charging-system-1401) · ref 1401 · Active implantable (AIMDD) · EUDAMED, GUDID · status: Active
- [Axonics Accessory, Foramen Needle - Long](https://devicerts.com/devices/axonics-accessory-foramen-needle-long-9001-l) · ref 9001-L · Active implantable (AIMDD) · EUDAMED, GUDID · status: Active
- [Axonics Tined Lead (with Percutaneous Extension)](https://devicerts.com/devices/axonics-tined-lead-with-percutaneous-extension-2201) · ref 2201 · Active implantable (AIMDD) · EUDAMED, GUDID · status: Active
- [Axonics Remote Control](https://devicerts.com/devices/axonics-remote-control-2301) · ref 2301 · Active implantable (AIMDD) · EUDAMED, GUDID · status: Active
- [Axonics Accessory, Charging Belt - Extended Size](https://devicerts.com/devices/axonics-accessory-charging-belt-extended-size-9008-e) · ref 9008-E · Active implantable (AIMDD) · EUDAMED, GUDID · status: Active
- [Axonics Accessory, Charging System Adhesive Carriers](https://devicerts.com/devices/axonics-accessory-charging-system-adhesive-carriers-9005) · ref 9005 · Active implantable (AIMDD) · EUDAMED, GUDID · status: Active
- [Axonics Accessory, Foramen Needle - Short](https://devicerts.com/devices/axonics-accessory-foramen-needle-short-9001-s) · ref 9001-S · Active implantable (AIMDD) · EUDAMED, GUDID · status: Active
- [Axonics Accessory Dilator and Sheath](https://devicerts.com/devices/axonics-accessory-dilator-and-sheath-9011) · ref 9011 · Active implantable (AIMDD) · EUDAMED, GUDID · status: Active
- [Axonics Neurostimulator](https://devicerts.com/devices/axonics-neurostimulator-1101) · ref 1101 · Active implantable (AIMDD) · EUDAMED, GUDID · status: Active
- [Axonics Accessory Tunneling Tool and Directional Guide](https://devicerts.com/devices/axonics-accessory-tunneling-tool-and-directional-guide-9012) · ref 9012 · Active implantable (AIMDD) · EUDAMED · status: Active
- [Axonics Clinician Programmer (EPG/IPG)](https://devicerts.com/devices/axonics-clinician-programmer-epg-ipg-2501) · ref 2501 · Active implantable (AIMDD) · EUDAMED, GUDID · status: Active
- [Axonics Accessory Tunneling Tool](https://devicerts.com/devices/axonics-accessory-tunneling-tool-9010) · ref 9010 · Active implantable (AIMDD) · EUDAMED · status: Active
- [Axonics Accessory, J-Clip Stimulation Cable](https://devicerts.com/devices/axonics-accessory-j-clip-stimulation-cable-9006) · ref 9006 · Active implantable (AIMDD) · EUDAMED, GUDID · status: Active
- [Axonics Accessory, Torque Wrench](https://devicerts.com/devices/axonics-accessory-torque-wrench-9004) · ref 9004 · Active implantable (AIMDD) · EUDAMED, GUDID · status: Active

## EU certificates

- MDR 755438 · Quality management system · MDR · notified body BSI Group The Netherlands B.V. · issued 2024-12-17 · expires 2029-03-11 · status: amended
- MDR 755443 · Technical documentation · MDR · notified body BSI Group The Netherlands B.V. · issued 2026-07-13 · expires 2029-03-11 · status: supplemented

## FDA recalls (matched by name, newest first)

- Z-0198-2027 · Not yet classified · Ongoing · initiated 2024-07-15 · product code EZW: Retroactively Reported: 10mL luer lock syringes included in kit may leak , break or experience other issues that may pose a risk to users.

## Source and citation

- Cite as: Axonics Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/axonics-inc (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- EUDAMED record synced: 2026-11-07
- FDA recall data as of: 2026-11-01
- Data as of: 2026-11-15
- JSON: <https://devicerts.com/manufacturers/axonics-inc.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/manufacturers/axonics-inc
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.