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 |
K180631 |
Sofregen Medical, Inc. |
Silk Voice |
11/08/2018 |
K983525 |
W.L. GORE & ASSOCIATES,INC |
GORE REVOX THYROPLASTY IMPLANT |
12/10/1998 |
|
|