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Axonics Inc.

Active in EUDAMED

United Statesfrom SRN EUDAMED SRN US-MF-000008413

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.

Devices
29
Registrations
EUDAMED
FDA recalls
11 ongoing

Registry facts

Counted by deviCERTS from registry records, 15 Nov 2026

Registries
  • EUDAMED 24
  • FDA GUDID 22
  • FDA 510(k) 5

A device listed in two registries counts in both.

Device classes
  • EU AIMDD 24
  • FDA Class II 4
  • FDA Class I 1
Top EMDN categories
FDA recalls
Sites and related companies
Identifiers
  • EUDAMED SRN US-MF-000008413

At a glance

Counted by deviCERTS from registry records

EU certificates

2 of 2 in force.

See certificates

Market reach

European Union
EUDAMED actor, 2 certificates
United States
FDA recalls
Authorised rep.
Emergo Europe B.V.NL

What Axonics Inc. makes

Axonics Inc. manufactures sacral neuromodulation devices, including implantable leads (such as the Axonics Lead Implant Kit and Axonics PNE Lead), lead extension cables, and accessories like stimulation and trial cables. The company also produces diagnostic tools like the AUDIT series for medical imaging analysis, including the AUDIT TM V and AUDIT V AX 135, as well as a fluoroscopy reader for allergy testing, the Allergenetics Fluoro-Fast Reader. Additional components include charging belts and stimulation ground cables designed for neuromodulation therapy.

The company’s devices fall under Active Implantable Medical Device Directive (AIMDD) classifications, as well as Class I and Class II regulatory categories. These products are listed in the EU’s eudamed registry and have undergone 510(k) clearance through the FDA. Axonics Inc. is headquartered in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue29

Newest first, rows 1-29 of 29

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  • Total Ige-Fast Test Ref K823494

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Axonics Lead Implant Kit Ref 1801

    Active Regimes: CE MDR CE AIMDD Registry: EUDAMEDGUDID Class:Active implantable (AIMDD)

  • Axonics PNE Lead Implant Kit Ref 1701

    Active Regimes: CE MDR CE AIMDD Registry: EUDAMEDGUDID Class:Active implantable (AIMDD)

  • Axonics Accessory, Lead Extension Cable Ref 9009

    Active Regimes: CE MDR CE AIMDD Registry: EUDAMEDGUDID Class:Active implantable (AIMDD)

  • Axonics Accessory, Stimulation Ground Cable Ref 9003

    Active Regimes: CE MDR CE AIMDD Registry: EUDAMEDGUDID Class:Active implantable (AIMDD)

  • Axonics PNE Lead Ref 1901

    Active Regimes: CE MDR CE AIMDD Registry: EUDAMEDGUDID Class:Active implantable (AIMDD)

  • Audit Ref K822335

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Audit Tm V Ref K843712

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Allergenetics Fluoro-Fast Reader Ref K831870

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Audit V Ax 135 Ref K833298

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Axonics Accessory, Basic Trial Cable Ref 9014

    Active Regimes: CE MDR CE AIMDD Registry: EUDAMEDGUDID Class:Active implantable (AIMDD)

  • Axonics Accessory, Charging Belt - Regular Size Ref 9008-R

    Active Regimes: CE MDR CE AIMDD Registry: EUDAMEDGUDID Class:Active implantable (AIMDD)

  • Axonics Accessory, Lead Stimulation Cable Ref 9007

    Active Regimes: CE MDR CE AIMDD Registry: EUDAMEDGUDID Class:Active implantable (AIMDD)

  • Axonics Tined Lead Ref 1201

    Active Regimes: CE MDR CE AIMDD Registry: EUDAMEDGUDID Class:Active implantable (AIMDD)

  • Axonics Trial Stimulator Ref 1601

    Active Regimes: CE MDR CE AIMDD Registry: EUDAMEDGUDID Class:Active implantable (AIMDD)

  • Axonics Charging System Ref 1401

    Active Regimes: CE MDR CE AIMDD Registry: EUDAMEDGUDID Class:Active implantable (AIMDD)

  • Axonics Accessory, Foramen Needle - Long Ref 9001-L

    Active Regimes: CE MDR CE AIMDD Registry: EUDAMEDGUDID Class:Active implantable (AIMDD)

  • Axonics Tined Lead (with Percutaneous Extension) Ref 2201

    Active Regimes: CE MDR CE AIMDD Registry: EUDAMEDGUDID Class:Active implantable (AIMDD)

  • Axonics Remote Control Ref 2301

    Active Regimes: CE MDR CE AIMDD Registry: EUDAMEDGUDID Class:Active implantable (AIMDD)

  • Axonics Accessory, Charging Belt - Extended Size Ref 9008-E

    Active Regimes: CE MDR CE AIMDD Registry: EUDAMEDGUDID Class:Active implantable (AIMDD)

  • Axonics Accessory, Charging System Adhesive Carriers Ref 9005

    Active Regimes: CE MDR CE AIMDD Registry: EUDAMEDGUDID Class:Active implantable (AIMDD)

  • Axonics Accessory, Foramen Needle - Short Ref 9001-S

    Active Regimes: CE MDR CE AIMDD Registry: EUDAMEDGUDID Class:Active implantable (AIMDD)

  • Axonics Accessory Dilator and Sheath Ref 9011

    Active Regimes: CE MDR CE AIMDD Registry: EUDAMEDGUDID Class:Active implantable (AIMDD)

  • Axonics Neurostimulator Ref 1101

    Active Regimes: CE AIMDD Registry: EUDAMEDGUDID Class:Active implantable (AIMDD)

  • Axonics Accessory Tunneling Tool and Directional Guide Ref 9012

    Active Regimes: CE MDR CE AIMDD Registry: EUDAMED Class:Active implantable (AIMDD)

  • Axonics Clinician Programmer (EPG/IPG) Ref 2501

    Active Regimes: CE MDR CE AIMDD Registry: EUDAMEDGUDID Class:Active implantable (AIMDD)

  • Axonics Accessory Tunneling Tool Ref 9010

    Active Regimes: CE MDR CE AIMDD Registry: EUDAMED Class:Active implantable (AIMDD)

  • Axonics Accessory, J-Clip Stimulation Cable Ref 9006

    Active Regimes: CE MDR CE AIMDD Registry: EUDAMEDGUDID Class:Active implantable (AIMDD)

  • Axonics Accessory, Torque Wrench Ref 9004

    Active Regimes: CE MDR CE AIMDD Registry: EUDAMEDGUDID Class:Active implantable (AIMDD)

Rows 1-29 of 29

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000008413
EUDAMED status
Active
EUDAMED registered name
Axonics Inc.
EUDAMED abbreviated name
Axonics, Inc.
Registered address
15515, Sand Canyon Ave, 92618, Irvine, United States
Phone
+1 949-694-4017
PRRC contact
Salvadore Palomares(public in EUDAMED)

EUDAMED certificates2

2 certificates2 valid, 0 expiredMDR 2next expiry 11 Mar 2029

EUDAMED certificates (2)

BSI Group The Netherlands B.V. 2797 2 certificates

  • MDR 755438 Active Amended

    Quality management system EU MDR

    Issued
    17 Dec 2024
    Expires
    11 Mar 2029
    Reason
    Other
  • MDR 755443 Active Supplemented

    Technical documentation EU MDR

    Issued
    13 Jul 2026
    Expires
    11 Mar 2029
    Reason
    Other

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 1 recall initiated by Axonics Inc., initiated on 2024-07-15. By recorded status: 1 ongoing. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 1
  • 2025 0
  • 2026 0

  • 2024

    • 15 Jul 2024 Z-0198-2027 Not yet classified Ongoing Retroactively Reported: 10mL luer lock syringes included in kit may leak , break or experience other issues that may pose a risk to users. Distribution: US Nationwide distribution including in the states of FL, AL, NE, CA, NY,MI, SC, IL, NC, KY, VA, CO, KS, AZ, OH, MN, PA,…
      Full distribution text US Nationwide distribution including in the states of FL, AL, NE, CA, NY,MI, SC, IL, NC, KY, VA, CO, KS, AZ, OH, MN, PA, ND, MD, OK, GA, AR, WI, TX, SD, CT, IN, LA, WA, OR, WV, MA, TN, MT, NJ, DE, ME, NM, IA, NH, MO, NV, MS, DC, ID, VT, WY, UT and the countries of United Kingdom & Australia.
      Submission numbers: P190006, P180046

From the company website

Read 18 Sep 2026

Axonics® System is an FDA-approved, clinically proven Sacral Neuromodulation solution for the treatment of urinary and bowel dysfunction.

From the manufacturer's own website. Source

Frequently asked questions

How many devices does Axonics Inc. have in the registry?

The registry currently lists 29 devices for Axonics Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Axonics Inc.'s devices?

Among its 29 most recently registered devices, Axonics Inc. has devices listed in EUDAMED (24 devices), FDA 510(k) (5 devices) and FDA GUDID (22 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Axonics Inc.'s devices fall under?

Among its 29 most recently registered devices, the classes recorded for Axonics Inc.'s devices are Class I, Class II and active implantable (AIMDD). Each device page shows its own class and authorisation.

Are there FDA recall records for Axonics Inc.?

FDA recall records list 1 recall initiated by Axonics Inc., the most recent initiated on 15 Jul 2024. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What EUDAMED certificates are recorded for Axonics Inc.?

EUDAMED lists 2 certificates for Axonics Inc. (quality management system; technical documentation) under MDR. The most recent was issued on 13 Jul 2026.

What are the newest devices from Axonics Inc. in the registry?

The most recently registered devices listed for Axonics Inc. include TOTAL IGE-FAST TEST, Axonics Lead Implant Kit, Axonics PNE Lead Implant Kit and Axonics Accessory, Lead Extension Cable.

Generated automatically from registry data and not verified by a human reviewer.