Axonics, Inc.

Irvine, CA, US

AXONICS, INC. appears in FDA device records in Irvine, CA. FDA records list 5 510(k) clearances between 1983-01-14 and 1985-04-05, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 5
PMA records: 0
Recall records: 1
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Axonics, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Axonics Modulation Technologies, Inc.enforcement report, recall

510(k) clearance history

FDA records hold 5 510(k) clearances for Axonics, Inc. between 1983 and 1985. The busiest year on record is 1983, with 4. The most recent is 1985, with 1.

Clearances by year, as a table

510(k) clearance decisions for Axonics, Inc., by decision year
Year	Clearances
1983	4
1985	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K843712	AUDIT TM V	GWF	Substantially Equivalent	1985-04-05
K833298	AUDIT V AX 135	GWK	Substantially Equivalent	1983-12-01
K831870	ALLERGENETICS FLUORO-FAST READER	JZT	Substantially Equivalent	1983-08-12
K822335	AUDIT	EWO	Substantially Equivalent	1983-02-07
K823494	TOTAL IGE-FAST TEST	DGC	Substantially Equivalent	1983-01-14

Registered establishments

FDA registered establishments for Axonics, Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3002968685	3002968685	AXONICS, INC.	15515 Sand Canyon Ave, Irvine, CA 92618 US	2026	EZW LNM QON

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2077-2021	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	Class II	2021-06-03	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain