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Panels › Ear, Nose, Throat › Product code MIX · Class 2

System, Vocal Cord Medialization

Regulation 874.3620

0510(k)s in 12 months (17 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
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Top companies in MIX

Company510(k)sRecalls
Cytophil, Inc.40
Coapt Systems, Inc.30
Bioform Medical, Inc.20
Smith & Nephew, Inc.20
Sofregen Medical20
Bioform, Inc.10
Biomet, Inc.10
Boston Medical Products, Inc.10
Merz North America, Inc.01
W. L. Gore & Associates, Inc.10
Decided510(k)Device and applicantCode
May 3, 2024K240919Silk Voice (SMI-04)
Sofregen Medical
MIX
Nov 8, 2018K180631Silk Voice
Sofregen Medical, Inc.
MIX
Apr 6, 2015K150400Renu Gel
Cytophil, Inc.
MIX
Feb 22, 2013K121795CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT
Cytophil, Inc.
MIX
Sep 11, 2009K083783VF LIQUIGEL
Coapt Systems, Inc.
MIX
Jan 5, 2009K081816VOCALIS AND VOCALIS SM
Cytophil, Inc.
MIX
Jan 5, 2009K081815VOCALIS GEL
Cytophil, Inc.
MIX
Apr 25, 2008K080956MODIFICATION TO VF GEL PLUS
Coapt Systems, Inc.
MIX
Feb 15, 2008K071663VF GEL PLUS
Coapt Systems, Inc.
MIX
Mar 1, 2007K070090RADIESSE LARYNGEAL IMPLANT
Bioform Medical, Inc.
MIX
Apr 18, 2006K060815JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT
Bioform Medical, Inc.
MIX
Dec 12, 2003K033398LARYNGEAL AUGMENTATION IMPLANT
Bioform, Inc.
MIX
Jun 26, 2001K011554LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT
Biomet, Inc.
MIX
Jul 26, 2000K001466VOCOM SILICONE SYSTEM
Smith & Nephew, Inc.
MIX
Mar 1, 2000K000533VOCOM IMPLANT- 8MM
Smith & Nephew, Inc.
MIX
Dec 10, 1998K983525GORE REVOX THYROPLASTY IMPLANT
W. L. Gore & Associates, Inc.
MIX
Sep 18, 1997K972317MONTGOMERY THYROPLASTY IMPLANT SYSTEM
Boston Medical Products, Inc.
MIX

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