Oticon Medical AB FDA Approvals

0 new drug approvals and 5 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
Ponto 5 Mini; Ponto 5 Superpower510(k)Aug 26, 2026Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Special)	Aug 26, 2026
Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS510(k)Jul 10, 2024Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Jul 10, 2024
Ponto 5 SuperPower510(k)Dec 16, 2021Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Special)	Dec 16, 2021
Ponto 5 Mini510(k)Aug 10, 2021Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Special)	Aug 10, 2021
Ponto Bone Anchored Hearing System, MONO Surgery Kit510(k)Mar 3, 2021Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Special)	Mar 3, 2021