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

Implant, Orbital, Extra-Ocular

21 CFR 886.3340 / Ophthalmic
FDA source (opens on fda.gov)

HQX is the FDA product code for Implant, Orbital, Extra-Ocular, a class II device type, regulated under 21 CFR 886.3340. As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and 13 recalls.

Classification record

Product code
HQX
Device name
Implant, Orbital, Extra-Ocular
Regulation
21 CFR 886.3340
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
16
Ingested recalls
13

Clearances, product code HQX

By decision year
16 clearances under product code HQX with a decision year between 1980 and 2003, 1990 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code HQX by decision year
YearClearances
19801
19831
19871
19906
19952
19962
19982
20031

Applicants with the most clearances

Product code HQX
Applicants holding the most 510(k) clearances under product code HQX
ApplicantClearances
Oculo Plastik, Inc.5
Fci Ophthalmics, Inc.2
Bio-Vascular, Inc.1
Dow Corning Corp. Healthcare Industries Materials1
Microvision, Inc.1
Mira, Inc.1
Porex Medical1
Storz Instrument Co.1
Storz Ophthalmics, Inc.1
Tamcenan Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order