Withings FDA Approvals

0 new drug approvals and 4 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Withings BeamO (SCT02)510(k)Nov 10, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Nov 10, 2025
Withings ECG App510(k)Jun 15, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jun 15, 2025
Withings Sleep Rx510(k)Sep 6, 2024Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Sep 6, 2024
Withings Scan Monitor 2.0510(k)Aug 23, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Aug 23, 2023