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

Depressor, Orbital

21 CFR 886.4350 / Ophthalmic
FDA source (opens on fda.gov)

HNX is the FDA product code for Depressor, Orbital, a class I device type, regulated under 21 CFR 886.4350. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HNX
Device name
Depressor, Orbital
Regulation
21 CFR 886.4350
Device class
Class I
Review panel
Ophthalmic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code HNX

By decision year
2 clearances under product code HNX with a decision year between 1995 and 1995, 1995 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HNX by decision year
YearClearances
19952

Applicants with the most clearances

Product code HNX
Applicants holding the most 510(k) clearances under product code HNX
ApplicantClearances
Future Medical Systems, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 77 companies shown, in name order