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

Keratoprosthesis, Permanent Implant

21 CFR 886.3400 / Ophthalmic
FDA source (opens on fda.gov)

HQM is the FDA product code for Keratoprosthesis, Permanent Implant, a class II device type, regulated under 21 CFR 886.3400. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HQM
Device name
Keratoprosthesis, Permanent Implant
Regulation
21 CFR 886.3400
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
4
Ingested recalls
0

Clearances, product code HQM

By decision year
4 clearances under product code HQM with a decision year between 1992 and 2019, 1992 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HQM by decision year
YearClearances
19921
20021
20131
20191

Applicants with the most clearances

Product code HQM
Applicants holding the most 510(k) clearances under product code HQM
ApplicantClearances
Argus Biomedical Pty, Ltd.1
Mackeen Consultants, Ltd.1
Massachusetts Eye & Ear Infirmary1
Massachusetts Eye and Ear Infirmary D/B/A Boston1

Companies listing this code with FDA

Companies whose registered establishments list this code