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

Novidan, Inc.: FDA-registered device maker in Golden Valley, MN, United States, 1 510(k) clearance

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

Novidan, Inc. is registered with the FDA (registration 3015651976) in Golden Valley, MN, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 8, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3015651976
Address: 678 Mendelssohn Ave N, Golden Valley, MN, United States, 55427
Owner or operator: Novidan, Inc. (10061834)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer
First device listed: May 12, 2021
Registered through: 2026
Brand names listed: NoviMed BTE, NoviMed Hearing Pro R, NoviMed Hearing Pro W R, NoviMed Pro, NoviMed Pro Wireless, NoviOne BTE, NoviOne RIC, NoviOne RIC R and more

Devices it lists

Device	Product code	Class	Role	Source
Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter	QUG	2	Complaint file establishment, Contract manufacturer, Manufacturer	accessdata.fda.gov
Hearing Aid, Air-Conduction, Over The Counter	QUF	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Self-Fitting Air-Conduction Hearing Aid, Over The Counter	QUH	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Self-Fitting Air-Conduction Hearing Aid, Prescription	QDD	2	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 8, 2023	K223848	Intrisound Tuned Lumen® 155 Hearing Aids	QUH	Substantially Equivalent	Tuned , Ltd.	accessdata.fda.gov

Compare with other makers

Updated September 8, 2023. 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.