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

Emmen Drenthe, NL

MENICON CO. LTD. appears in FDA device records in Emmen Drenthe, NL. FDA records list 18 510(k) clearances between and , 23 PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
18
PMA records
23
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 18 510(k) clearances for Menicon Co. Ltd. between 1994 and 2026. The busiest year on record is 2000, with 2. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Menicon Co. Ltd., by decision year
YearClearances
19941
19961
20002
20021
20081
20101
20112
20132
20151
20171
20182
20202
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253795MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting SolutionLPNSubstantially Equivalent
K193399Miru 1day UpSide (midafilcon A)LPLSubstantially Equivalent
K191872Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting SolutionLPNSubstantially Equivalent
K180819One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact LensLPLSubstantially Equivalent
K180004Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact LensLPLSubstantially Equivalent
K173136Menicon Progent Protein Remover for Rigid Gas Permeable Contact LensesMRCSubstantially Equivalent
K151768Menicon Saline Rinse SolutionLPNSubstantially Equivalent
K130805MENICON UNIQUE PH MULTI-PURPOSE SOLUTIONMRCSubstantially Equivalent
K122273MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSMRCSubstantially Equivalent
K102895ONE DAY FLAT PACKLPLSubstantially Equivalent
K103561MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSHQDSubstantially Equivalent
K082855MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSESMRCSubstantially Equivalent
K081443MENICON Z RIGID GAS PERMEABLE CONTACT LENSHQDSubstantially Equivalent
K020930MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSESMRCSubstantially Equivalent
K002140MENICON PROGENT REMOVERMRCSubstantially Equivalent
K000233MENICON SF-PHQDSubstantially Equivalent
K962006MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSHQDSubstantially Equivalent
K943784MELAFOCON A/RIGID GAS PERM CONTACT LEN FOR DAILY WEARHQDSubstantially Equivalent

Registered establishments

FDA registered establishments for Menicon Co. Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96147611000188353MENICON CO. LTD.21-19 AOI, 3-CHOME, NAKA-KU, NAGOYA Aichi 460-0006 JP2026
30033575773003357577Menicon B.V.Waanderweg 6, Emmen Drenthe 7812 HZ NL2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain