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Menicon U.S.A., Inc. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Menicon U.S.A., Inc. has 0 FDA recalls, 0 inspections, 3 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Menicon U.S.A., Inc." is on file.

What these totals cover: FDA records filed under the name "Menicon U.S.A., Inc." and its spelling variant "Menicon U.S.A".

Latest 510(k): May 19, 2000

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	3	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	0	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 510(k) clearances

3 510(k) clearances from Mar 25, 1997 to May 19, 2000.

K-Number	Device	Date
K000133	MENICON Z	May 19, 2000
K972443	MENICON SF-P AND MENICON Z RIGID GAS PERMEABLE CONTACT LENS	Aug 22, 1997
K970019	MENICON Z BIFOCAL DESIGN LENS/MENICON Z TRIFOCAL DESIGN LENS	Mar 25, 1997

Menicon U.S.A., Inc. and the FDA: common questions

Has Menicon U.S.A., Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "Menicon U.S.A., Inc." 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 U.S.A., Inc. received an FDA Form 483?

FDA has not published a Form 483 for "Menicon U.S.A., Inc." in its reading room. FDA publishes some Form 483s, not all of them.

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