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

Prosthesis, Nose, Internal

21 CFR 878.3680 / General, Plastic Surgery
FDA source (opens on fda.gov)

FZE is the FDA product code for Prosthesis, Nose, Internal, a class II device type, regulated under 21 CFR 878.3680. As of , FDA records hold 42 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FZE
Device name
Prosthesis, Nose, Internal
Regulation
21 CFR 878.3680
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
42
Ingested recalls
0

Clearances, product code FZE

By decision year
42 clearances under product code FZE with a decision year between 1978 and 2024, 1995 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code FZE by decision year
YearClearances
19781
19791
19801
19821
19851
19864
19871
19881
19905
19921
19932
19942
19956
19962
19972
19983
19991
20021
20051
20071
20091
20101
20161
20241

Applicants with the most clearances

Product code FZE
Applicants holding the most 510(k) clearances under product code FZE
ApplicantClearances
Implantech Associates Inc7
Spirit Ridge Technologies5
Hanson Medical, Inc.4
Byron Medical3
Cui Corp.2
Surgical Technology Laboratories Inc.2
Aesthetic and Reconstructive Technologies, Inc.1
Allied Biomedical Corp.1
Applied Biomaterial Technologies1
CMF Medicon Surgical Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 24 companies shown, in name order