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

Expander, Tissue, Orbital

21 CFR 886.3320 / Ophthalmic
FDA source (opens on fda.gov)

NFM is the FDA product code for Expander, Tissue, Orbital, a class II device type, regulated under 21 CFR 886.3320. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NFM
Device name
Expander, Tissue, Orbital
Regulation
21 CFR 886.3320
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code NFM

By decision year
2 clearances under product code NFM with a decision year between 2001 and 2006, 2001 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NFM by decision year
YearClearances
20011
20061

Applicants with the most clearances

Product code NFM
Applicants holding the most 510(k) clearances under product code NFM
ApplicantClearances
Innovia, LLC1
Iop, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code