FDA 510(k) Applications for Medical Device Product Code: MIX (System, Vocal Cord Medialization)

FDA 510(k) Applications for Medical Device Product Code "MIX"
(System, Vocal Cord Medialization)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K060815	BIOFORM MEDICAL, INC.	JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT	04/18/2006
K070090	BIOFORM MEDICAL, INC.	RADIESSE LARYNGEAL IMPLANT	03/01/2007
K033398	BIOFORM, INC.	LARYNGEAL AUGMENTATION IMPLANT	12/12/2003
K011554	BIOMET, INC.	LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT	06/26/2001
K972317	BOSTON MEDICAL PRODUCTS, INC.	MONTGOMERY THYROPLASTY IMPLANT SYSTEM	09/18/1997
K080956	COAPT SYSTEMS, INC.	MODIFICATION TO VF GEL PLUS	04/25/2008
K071663	COAPT SYSTEMS, INC.	VF GEL PLUS	02/15/2008
K083783	COAPT SYSTEMS, INC.	VF LIQUIGEL	09/11/2009
K121795	CYTOPHIL INC	CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT	02/22/2013
K081816	CYTOPHIL INC	VOCALIS AND VOCALIS SM	01/05/2009
K081815	CYTOPHIL INC	VOCALIS GEL	01/05/2009
K150400	CYTOPHIL, INC.	Renu Gel	04/06/2015
K000533	SMITH & NEPHEW, INC.	VOCOM IMPLANT- 8MM	03/01/2000
K001466	SMITH & NEPHEW, INC.	VOCOM SILICONE SYSTEM	07/26/2000
K240919	Sofregen Medical	Silk Voice (SMI-04)	05/03/2024
K180631	Sofregen Medical, Inc.	Silk Voice	11/08/2018
K983525	W.L. GORE & ASSOCIATES,INC	GORE REVOX THYROPLASTY IMPLANT	12/10/1998