AXONICS MODULATION TECHNOLOGIES, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3002968685	3002968685	AXONICS MODULATION TECHNOLOGIES, INC.	1	N	2020-04-25	26 Technology Dr. Irvine CA US 92618

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
10810005340011	Axonics - Charging System	+1 (877) 929-6642	customersupport@axonics.com
10810005340233	Axonics - Carrier	+1 (877) 929-6642	customersupport@axonics.com

axonics.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
233186	1933912368	P190006	Axonics Sacral Neuromodulation System	QON	2019-09-06
233186	1631311889	P180046	Axonics Sacral Neuromodulation System	EZW	2019-11-13
233186	1748390785

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
EZW	2	2019-11-13

PMA#

Axonics Sacral Neuromodulation System
2023-02-01
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 Suppl...
Axonics Sacral Neuromodulation System
2023-02-01
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 Suppl...
Axonics Sacral Neuromodulation System (Urinary)
2022-12-19
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 Trac...
Axonics Sacral Neuromodulation System (bowel)
2022-12-19
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 Trac...
Axonics Sacral Neuromodulation System (Bowel)
2022-11-01
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 Trac...
Axonics Sacral Neuromodulation System (Urinary)
2022-11-01
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 Trac...
Bulkamid Urethral Bulking System
2022-10-26
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 Suppl...
Bulkamid Urethral Bulking System
2022-10-26
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 Suppl...
Axonics Sacral Neuromodulation System
2022-09-08
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 Suppl...
Axonics Sacral Neuromodulation System
2022-09-08
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 Suppl...
Axonics Sacral Neuromodulation System
2022-09-07
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 Suppl...
Axonics Sacral Neuromodulation System
2022-09-07
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 Suppl...
Bulkamid Urethral Bulking System
2022-08-05
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 Suppl...
Bulkamid Urethral Bulking System
2022-08-05
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 Suppl...
Bulkamid Urethral Bulking System
2022-08-05
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 Suppl...
Axonics Sacral Neuromodulation System
2022-07-20
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 Suppl...
Axonics Sacral Neuromodulation System
2022-07-20
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 Suppl...
Axonics Sacral Neuromodulation System
2022-05-13
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 Suppl...
Axonics Sacral Neuromodulation System
2022-05-13
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 Suppl...
Axonics Sacral Neuromodulation System
2022-04-20
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 Suppl...
Axonics Sacral Neuromodulation System
2022-04-20
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 Suppl...
Axonics Sacral Neuromodulation System
2022-03-03
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 Suppl...
Axonics Sacral Neuromodulation System
2022-03-03
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 Suppl...
Axonics Sacral Neuromodulation System
2022-02-10
Axonics Modulation Technologies, Inc.
Axonics Sacral Neuromodulation System
2022-02-10
Axonics Modulation Technologies, Inc.
Axonics Sacral Neuromodulation System
2022-01-25
Axonics Modulation Technologies, Inc.
Axonics Sacral Neuromodulation System
2022-01-25
Axonics Modulation Technologies, Inc.
Axonics Sacral Neuromodulation System
2022-01-14
Axonics Modulation Technologies, Inc.
Axonics Sacral Neuromodulation System
2022-01-14
Axonics Modulation Technologies, Inc.
Axonics Sacral Neuromodulation System
2021-12-28
Axonics Modulation Technologies, Inc.
Axonics Sacral Neuromodulation System
2021-12-28
Axonics Modulation Technologies, Inc.
Axonics Sacral Neuromodulation System
2021-11-22
Axonics Modulation Technologies, Inc.
Axonics Sacral Neuromodulation System
2021-11-22
Axonics Modulation Technologies, Inc.
Axonics Sacral Neuromodulation System
2021-11-15
Axonics Modulation Technologies, Inc.
Axonics Sacral Neuromodulation System
2021-11-15
Axonics Modulation Technologies, Inc.
Axonics Sacral Neuromodulation (SNM) System for Urinary Control
2021-05-25
Axonics Modulation Technologies, Inc.
Axonics Sacral Neuromodulation (SNM) System for Bowel Control
2021-05-25
Axonics Modulation Technologies, Inc.
Axonics Sacral Neuromodulation (SNM) System Bowel Control
2021-03-25
Axonics Modulation Technologies, Inc.
Axonics Sacral Neuromodulation (SNM) System Urinary Control
2021-03-25
Axonics Modulation Technologies, Inc.
Axonics Sacral Neuromodulation (SNM) System for Bowel Control
2021-03-16
Axonics Modulation Technologies, Inc.

82 records. Showing 1-40. Next

GUDID#

Axonics - Curved Charging Belt - Regular
AXONICS MODULATION TECHNOLOGIES, INC.
2020-11-03
Axonics - Curved Charging Belt - Extended
AXONICS MODULATION TECHNOLOGIES, INC.
2020-11-03
Axonics - Carrier
AXONICS MODULATION TECHNOLOGIES, INC.
2019-09-23
Axonics - Charging Belt - Regular
AXONICS MODULATION TECHNOLOGIES, INC.
2019-09-23
Axonics - Charging Belt - Extended
AXONICS MODULATION TECHNOLOGIES, INC.
2019-09-23
Axonics - Charging System
AXONICS MODULATION TECHNOLOGIES, INC.
2019-09-23
Axonics - Charging Station
AXONICS MODULATION TECHNOLOGIES, INC.
2019-09-23
Axonics - Charging Device
AXONICS MODULATION TECHNOLOGIES, INC.
2019-09-23
Axonics - Neurostimulator
AXONICS MODULATION TECHNOLOGIES, INC.
2023-09-08
Axonics - Neurostimulator
AXONICS MODULATION TECHNOLOGIES, INC.
2022-03-11
Axonics - Neurostimulator
AXONICS MODULATION TECHNOLOGIES, INC.
2019-09-23
Axonics - Axonics Foramen Finder
AXONICS MODULATION TECHNOLOGIES, INC.
2025-02-05
Bulkamid - Bulkamid Urethral Bulking System 2mL
AXONICS MODULATION TECHNOLOGIES, INC.
2023-09-12
Axonics - PE & Torque Wrench
AXONICS MODULATION TECHNOLOGIES, INC.
2024-07-29
Bulkamid - Bulkamid 3mL
AXONICS MODULATION TECHNOLOGIES, INC.
2023-08-30
Axonics - Curved Stylet
AXONICS MODULATION TECHNOLOGIES, INC.
2022-06-14
Axonics - Clinician Programmer
AXONICS MODULATION TECHNOLOGIES, INC.
2019-09-23
Axonics - Trial Stimulator
AXONICS MODULATION TECHNOLOGIES, INC.
2019-09-23
Axonics - Lead Implant Kit
AXONICS MODULATION TECHNOLOGIES, INC.
2019-09-23
Axonics - Remote Control
AXONICS MODULATION TECHNOLOGIES, INC.
2019-09-23
Axonics - PNE Lead
AXONICS MODULATION TECHNOLOGIES, INC.
2019-09-23
Axonics - PNE Lead Implant Kit
AXONICS MODULATION TECHNOLOGIES, INC.
2019-09-23
Axonics - Tined Lead Kit
AXONICS MODULATION TECHNOLOGIES, INC.
2019-09-23
Axonics - Tined Lead
AXONICS MODULATION TECHNOLOGIES, INC.
2019-09-23
Axonics - Foramen Needle - Short
AXONICS MODULATION TECHNOLOGIES, INC.
2019-09-23
Axonics - Foramen Needle - Long
AXONICS MODULATION TECHNOLOGIES, INC.
2019-09-23
Axonics - Stimulation Ground Cables
AXONICS MODULATION TECHNOLOGIES, INC.
2019-09-23
Axonics - Torque Wrench
AXONICS MODULATION TECHNOLOGIES, INC.
2019-09-23
Axonics - Needle Test Stim. Cable
AXONICS MODULATION TECHNOLOGIES, INC.
2019-09-23
Axonics - Tined Lead Test Stim. Cable
AXONICS MODULATION TECHNOLOGIES, INC.
2019-09-23
Axonics - Percutaneous Extension
AXONICS MODULATION TECHNOLOGIES, INC.
2019-09-23
Axonics - Dilator and Sheath
AXONICS MODULATION TECHNOLOGIES, INC.
2019-09-23
Axonics - Basic Trial Cable
AXONICS MODULATION TECHNOLOGIES, INC.
2019-09-23
Axonics - Clinician Programmer
AXONICS MODULATION TECHNOLOGIES, INC.
2019-09-23