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

Collagen Corneal Shield

21 CFR 886.4750 / Ophthalmic
FDA source (opens on fda.gov)

MOE is the FDA product code for Collagen Corneal Shield, a class I device type, regulated under 21 CFR 886.4750. As of , FDA records hold 19 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MOE
Device name
Collagen Corneal Shield
Regulation
21 CFR 886.4750
Device class
Class I
Review panel
Ophthalmic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
19
Ingested recalls
0

Clearances, product code MOE

By decision year
19 clearances under product code MOE with a decision year between 1987 and 1995, 1988 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code MOE by decision year
YearClearances
19871
19885
19894
19904
19913
19921
19951

Applicants with the most clearances

Product code MOE
Applicants holding the most 510(k) clearances under product code MOE
ApplicantClearances
Chiron Ophthalmics6
Bausch & Lomb Pharmaceutical, Inc.5
Bausch & Lomb Incorporated2
Vitaphore Corp.2
Bausch & Lomb Healthcare and Optics Worldwide1
Intermedical, Inc.1
Medical Technology Development Corp.1
Oasis Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code