FDA 510(k) Applications for Medical Device Product Code: MAH (Hearing Aid, Bone Conduction, Implanted)

FDA 510(k) Applications for Medical Device Product Code "MAH"
(Hearing Aid, Bone Conduction, Implanted)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K182116	Cochlear Americas	BA310 Abutment, BIA310 Implant/Abutment	12/19/2018
K150555	COCHLEAR AMERICAS	BA400 14mm Abutment	07/15/2015
K121317	COCHLEAR AMERICAS	COCHLEAR BAHA IMPLANT SYSTEM	10/12/2012
K080363	COCHLEAR BONE ANCHORED SYSTEMS AB	BAHA CORDELLE II	04/10/2008
K984162	NOBELPHARMA USA, INC.	BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE	06/28/1999
K112053	OTICON MEDICAL AB	OBC BONE ANCHORED HEARING SYSTEM	11/18/2011
K152067	OTICON MEDICAL AB	Ponto bone anchored hearing system	11/23/2015
K152820	OTICON MEDICAL AB	Ponto Bone Anchored Hearing System	01/22/2016
K121228	OTICON MEDICAL AB	PONTO BONE ANCHORED HEARING SYSTEM	09/07/2012
K203807	Oticon Medical AB	Ponto Bone Anchored Hearing System, MONO Surgery Kit	03/03/2021
K142678	OTICON MEDICAL AB	Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm	01/21/2015