Menicon Co, Ltd. FDA Record
Menicon Co, Ltd. has 0 FDA recalls, 1 inspection, 19 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Menicon Co, Ltd." is on file.
- Latest inspection
- Dec 8, 2015 · NAI
- Latest 510(k)
- Sep 17, 2026
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 19 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 1 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Dec 8, 2015 | Nagoya, Japan | Devices | No Action Indicated (NAI) | 1000188353 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 1000188353 | Nagoya, Japan | 1 | Dec 8, 2015 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K262495 | Miru 1day UpSide (midafilcon A) | Sep 17, 2026 |
| K253795 | MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution | Aug 13, 2026 |
| K193399 | Miru 1day UpSide (midafilcon A) | Jun 17, 2020 |
| K191872 | Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution | Mar 2, 2020 |
| K180819 | One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens | May 16, 2018 |
| K180004 | Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens | Feb 22, 2018 |
| K173136 | Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses | Nov 16, 2017 |
| K151768 | Menicon Saline Rinse Solution | Aug 28, 2015 |
| K130805 | MENICON UNIQUE PH MULTI-PURPOSE SOLUTION | Jul 3, 2013 |
| K122273 | MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS | Jan 2, 2013 |
| K102895 | ONE DAY FLAT PACK | Apr 28, 2011 |
| K103561 | MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS | Feb 3, 2011 |
| K082855 | MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES | Mar 9, 2010 |
| K081443 | MENICON Z RIGID GAS PERMEABLE CONTACT LENS | Sep 23, 2008 |
| K020930 | MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES | May 2, 2002 |
| K002140 | MENICON PROGENT REMOVER | Oct 10, 2000 |
| K000233 | MENICON SF-P | May 19, 2000 |
| K962006 | MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS | Oct 9, 1996 |
| K943784 | MELAFOCON A/RIGID GAS PERM CONTACT LEN FOR DAILY WEAR | Oct 20, 1994 |
Menicon Co, Ltd. and the FDA: common questions
Has Menicon Co, Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Menicon Co, Ltd." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Menicon Co, Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Menicon Co, Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Menicon Co, Ltd.?
The most recent FDA inspection on file ended Dec 8, 2015 at Nagoya, Japan and was classified NAI. FDA has 1 inspection of Menicon Co, Ltd. on file.
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