Atlas FDA

MIX

17 FDA 510(k) clearances · Product code

63 daysmedian time to decision
248 days90th percentile
17clearances measured

FDA profile

Official device name
System, Vocal Cord Medialization
Device class
Class II (moderate risk)
Regulation
21 CFR 874.3620
Medical specialty
Ear, Nose, Throat
Flags
Implant
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RecordFirmDate
Silk Voice (SMI-04) (K240919)Sofregen Medical2024-05-03
Silk Voice (K180631)Sofregen Medical, Inc.2018-11-08
Renu Gel (K150400)Cytophil, Inc.2015-04-06
CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT (K121795)Cytophil, Inc.2013-02-22
VF LIQUIGEL (K083783)Coapt Systems, Inc.2009-09-11
VOCALIS AND VOCALIS SM (K081816)Cytophil, Inc.2009-01-05
VOCALIS GEL (K081815)Cytophil, Inc.2009-01-05
MODIFICATION TO VF GEL PLUS (K080956)Coapt Systems, Inc.2008-04-25
VF GEL PLUS (K071663)Coapt Systems, Inc.2008-02-15
RADIESSE LARYNGEAL IMPLANT (K070090)Bioform Medical, Inc.2007-03-01
JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT (K060815)Bioform Medical, Inc.2006-04-18
LARYNGEAL AUGMENTATION IMPLANT (K033398)Bioform, Inc.2003-12-12
LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT (K011554)Biomet, Inc.2001-06-26
VOCOM SILICONE SYSTEM (K001466)Smith & Nephew, Inc.2000-07-26
VOCOM IMPLANT- 8MM (K000533)Smith & Nephew, Inc.2000-03-01
GORE REVOX THYROPLASTY IMPLANT (K983525)W. L. Gore & Associates, Inc.1998-12-10
MONTGOMERY THYROPLASTY IMPLANT SYSTEM (K972317)Boston Medical Products, Inc.1997-09-18

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Every clearance here is in the API, with alerts when new ones post.