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

Prosthesis, Ear, Internal

21 CFR 878.3590 / General, Plastic Surgery
FDA source (opens on fda.gov)

FZD is the FDA product code for Prosthesis, Ear, Internal, a class II device type, regulated under 21 CFR 878.3590. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FZD
Device name
Prosthesis, Ear, Internal
Regulation
21 CFR 878.3590
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code FZD

By decision year
3 clearances under product code FZD with a decision year between 1985 and 2018, 1985 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FZD by decision year
YearClearances
19851
19861
20181

Applicants with the most clearances

Product code FZD
Applicants holding the most 510(k) clearances under product code FZD
ApplicantClearances
Implantech Associates Inc1
Porex Medical1
Richards Medical Co., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code