Axonics Inc

FDA Filings

This page includes the latest FDA filings for Axonics Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMN K843712 AXONICS, INC.	AUDIT TM V	1985-04-05
PMN K833298 AXONICS, INC.	AUDIT V AX 135	1983-12-01
PMN K831870 AXONICS, INC.	ALLERGENETICS FLUORO-FAST READER	1983-08-12
PMN K822335 AXONICS, INC.	AUDIT	1983-02-07
PMN K823494 AXONICS, INC.	TOTAL IGE-FAST TEST	1983-01-14

Similar & Related FDA Registered Companies

Axonics Modulation Technologies, Inc.
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP180046 Supplement NumberS064 Date Received01/10/2023 Decision Date02/01/2023 Product Code EZW Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP190006 Supplement NumberS064 Date Received01/10/2023 Decision Date02/01/2023 Product Code QON Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP180046 Supplement NumberS062 Date Received09/29/2022 Decision Date12/19/2022 Product Code EZW Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP190006 Supplement NumberS062 Date Received09/29/2022 Decision Date12/19/2022 Product Code QON Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP190006 Supplement NumberS061 Date Received09/19/2022 Decision Date11/01/2022 Product Code QON Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Track Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP180046 Supplement NumberS061 Date Received09/19/2022 Decision Date11/01/2022 Product Code EZW Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Track Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP170023 Supplement NumberS013 Date Received09/27/2022 Decision Date10/26/2022 Product Code LNM Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP170023 Supplement NumberS012 Date Received09/27/2022 Decision Date10/26/2022 Product Code LNM Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP190006 Supplement NumberS059 Date Received08/11/2022 Decision Date09/08/2022 Product Code QON Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP180046 Supplement NumberS059 Date Received08/11/2022 Decision Date09/08/2022 Product Code EZW Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP180046 Supplement NumberS060 Date Received08/15/2022 Decision Date09/07/2022 Product Code EZW Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP190006 Supplement NumberS060 Date Received08/15/2022 Decision Date09/07/2022 Product Code QON Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP170023 Supplement NumberS010 Date Received07/08/2022 Decision Date08/05/2022 Product Code LNM Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP170023 Supplement NumberS009 Date Received07/08/2022 Decision Date08/05/2022 Product Code LNM Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP170023 Supplement NumberS011 Date Received07/08/2022 Decision Date08/05/2022 Product Code LNM Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP180046 Supplement NumberS057 Date Received06/30/2022 Decision Date07/20/2022 Product Code EZW Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP190006 Supplement NumberS057 Date Received06/30/2022 Decision Date07/20/2022 Product Code QON Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP180046 Supplement NumberS055 Date Received04/15/2022 Decision Date05/13/2022 Product Code EZW Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP190006 Supplement NumberS055 Date Received04/15/2022 Decision Date05/13/2022 Product Code QON Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP180046 Supplement NumberS052 Date Received03/24/2022 Decision Date04/20/2022 Product Code EZW Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP190006 Supplement NumberS052 Date Received03/24/2022 Decision Date04/20/2022 Product Code QON Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP180046 Supplement NumberS051 Date Received02/07/2022 Decision Date03/03/2022 Product Code EZW Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP190006 Supplement NumberS051 Date Received02/07/2022 Decision Date03/03/2022 Product Code QON Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

NCAGE Code	4JGL9	AXONICS, INC.
CAGE Code	4JGL9	AXONICS, INC.
DUNS	031718943	AXONICS, INC.
SEC	0000705010	AXONICS INC