Data / Medical devices / United States / Axonics, Inc.

Axonics, Inc.: FDA-registered device maker in Irvine, CA, United States, 3 PMA approvals

Name: Axonics, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Axonics, Inc. is registered with the FDA (registration 3002968685) in Irvine, CA, United States. It lists 3 device types. The FDA files 3 PMA approvals under its listings, the newest dated January 28, 2020. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Axonics, Inc.

FDA registration number: 3002968685
Address: 15515 Sand Canyon Ave, Irvine, CA, United States, 92618
Owner or operator: Boston Scientific Corporation (9912058)
Roles: Manufacturer, Specification developer
First device listed: December 11, 2024
Registered through: 2026
Brand names listed: Axonics, Axonics Affirm Trial Stimulator, Axonics Rechargeable Sacral Neuromodulation System, Axonics SNM System, Axonics SNM Therapy, Axonics Sacral Neuromodulation System, Axonics Sacral Neuromodulation Therapy, Axonics System and more

Devices it lists

Device	Product code	Class	Role	Source
Agent, Bulking, Injectable For Gastro-Urology Use	LNM	3	Specification developer	accessdata.fda.gov
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence	QON	3	Manufacturer, Specification developer	accessdata.fda.gov
Stimulator, Electrical, Implantable, For Incontinence	EZW	3	Manufacturer, Specification developer	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
January 28, 2020	P170023	Bulkamid Urethral Bulking System	LNM	21	July 1, 2026	accessdata.fda.gov
November 13, 2019	P180046	Axonics Sacral Neuromodulation System	EZW	103	August 7, 2026	accessdata.fda.gov
September 6, 2019	P190006	Axonics Sacral Neuromodulation System	QON	103	August 7, 2026	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
July 15, 2024	99907	Class II	Ongoing	PNE Lead Implant Kit REF: 1701	Retroactively Reported: 10mL luer lock syringes included in kit may leak, break or experience other issues that may pose a risk to users.	accessdata.fda.gov
June 3, 2021	88141	Class II	Terminated	BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476	Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized	accessdata.fda.gov

Compare with other makers

Updated October 16, 2026. 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.