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

Device, Analysis, Anterior Segment

21 CFR 886.1850 / Ophthalmic
FDA source (opens on fda.gov)

MXK is the FDA product code for Device, Analysis, Anterior Segment, a class II device type, regulated under 21 CFR 886.1850. As of , FDA records hold 23 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
MXK
Device name
Device, Analysis, Anterior Segment
Regulation
21 CFR 886.1850
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
23
Ingested recalls
7

Clearances, product code MXK

By decision year
23 clearances under product code MXK with a decision year between 1999 and 2026, 2004 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code MXK by decision year
YearClearances
19992
20032
20043
20052
20061
20071
20081
20151
20161
20192
20201
20211
20221
20231
20241
20251
20261

Applicants with the most clearances

Product code MXK
Applicants holding the most 510(k) clearances under product code MXK
ApplicantClearances
Oculus Optikgerate GmbH7
Heidelberg Engineering GmbH2
Santec Corporation2
VISIA imaging S.r.l.2
Bausch & Lomb Incorporated1
Haag-Streit Holding AG1
Intelon Optics1
Massie Research Laboratories, Inc.1
Nidek, Inc.1
Sis Ag, Surgical Instrument Systems1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 18 companies shown, in name order