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

Marker, Ocular

21 CFR 886.4570 / Ophthalmic
FDA source (opens on fda.gov)

HMR is the FDA product code for Marker, Ocular, a class I device type, regulated under 21 CFR 886.4570. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
HMR
Device name
Marker, Ocular
Regulation
21 CFR 886.4570
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
5
Ingested recalls
6

Clearances, product code HMR

By decision year
5 clearances under product code HMR with a decision year between 1986 and 2006, 1986 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HMR by decision year
YearClearances
19862
19871
19941
20061

Applicants with the most clearances

Product code HMR
Applicants holding the most 510(k) clearances under product code HMR
ApplicantClearances
Chiron Vision Corp.1
CooperVision, Inc.1
Innomed, Inc.1
Myocure, Inc.1
Refractec, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 90 companies shown, in name order