FDA Device Intelligence
Home › Device types › MXK

Device, Analysis, Anterior Segment

FDA product code MXK · Class 2 · Ophthalmic

36
Registered devices
12
Adverse events
7
Recalls
23
510(k) clearances

Devices with this code

MYAH — VISIA IMAGING SRLHRT3 — Heidelberg Engineering GmbHVISIONIX — LUNEAU TECHNOLOGY OPERATIONSMYOPIA EXPERT 700 — VISIA IMAGING SRLMyopia Master — OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungVISIONIX — LUNEAU TECHNOLOGY OPERATIONSPentacam Cornea OCT — OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungVISIONIX — LUNEAU TECHNOLOGY OPERATIONSPentacam AXL Wave — OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungOPTICAL BIOMETER — SANTEC CORPORATIONAUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA — TOPCON CORPORATIONRODENSTOCK — LUNEAU TECHNOLOGY OPERATIONSOPTICAL BIOMETER — SANTEC CORPORATIONPentacam HR — OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungRODENSTOCK — LUNEAU TECHNOLOGY OPERATIONSVISIONIX — LUNEAU TECHNOLOGY OPERATIONSGALILEI — SIS AG, Surgical Instrument SystemsESSILOR — VISIA IMAGING SRLHRT3 — Heidelberg Engineering GmbHVISIONIX — LUNEAU TECHNOLOGY OPERATIONSMYAH — VISIA IMAGING SRLMyopia Master — OCULUS Optikgeräte Gesellschaft mit beschränkter HaftungVisionix — LUNEAU TECHNOLOGY OPERATIONSHRT3 — Heidelberg Engineering GmbH

Recent recalls

DateFirmReason
2023-08-08Oculus Optikgeraete GMBHTheir is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
2023-08-08Oculus Optikgeraete GMBHTheir is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
2023-08-08Oculus Optikgeraete GMBHTheir is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
2022-07-08Oculus Optikgeraete GMBHDue to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
2022-07-08Oculus Optikgeraete GMBHDue to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
2022-07-08Oculus Optikgeraete GMBHDue to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
2017-11-21Oculus Optikgeraete GMBHThe device software versions have an anomaly which may produce an erroneous marking for the quality specification value

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.