510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MIXClass II

System, Vocal Cord Medialization

21 CFR 874.3620 / Ear, Nose, Throat
FDA source (opens on fda.gov)

MIX is the FDA product code for System, Vocal Cord Medialization, a class II device type, regulated under 21 CFR 874.3620. As of , FDA records hold 17 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
MIX
Device name
System, Vocal Cord Medialization
Regulation
21 CFR 874.3620
Device class
Class II
Review panel
Ear, Nose, Throat
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
17
Ingested recalls
1

Clearances, product code MIX

By decision year
17 clearances under product code MIX with a decision year between 1997 and 2024, 2009 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code MIX by decision year
YearClearances
19971
19981
20002
20011
20031
20061
20071
20082
20093
20131
20151
20181
20241

Applicants with the most clearances

Product code MIX
Applicants holding the most 510(k) clearances under product code MIX
ApplicantClearances
Cytophil, Inc4
Coapt Systems, Inc.3
Bioform Medical, Inc.2
Smith & Nephew, Inc.2
Sofregen Medical, Inc.2
Bioform, Inc.1
Zimmer GmbH1
Boston Medical Products, Inc.1
W. L. Gore & Associates, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code