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Coopervision Surgical FDA Record

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

No warning letters matched by name

Inspections 0 0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 2 Latest Jul 27, 1992

Coopervision Surgical has 0 FDA recalls, 0 inspections, 2 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Coopervision Surgical" is on file.

What these totals cover: FDA records filed under the name "Coopervision Surgical". Records filed under related names are not included; see Related names.

Latest recall: Z-0204-2027 · Sep 22, 2026 · filed under Coopervision
Latest 510(k): Jul 27, 1992

Newer recall under related name Coopervision: Sep 22, 2026, Z-0204-2027.

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 11, 2026 (checked Nov 15, 2026, unchanged)	File dated Nov 10, 2026	Current
510(k) clearances	2	Nov 15, 2026	File dated Nov 9, 2026	Current
Inspections	0	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

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Related names

Each name below has its own page. Its counts cover only the records FDA filed under that name and are not part of the totals for Coopervision Surgical above.

Name	Relation	Recalls	510(k)	Inspections	Compliance actions	Most recent recall
Coopervision Combines 2 spellings Coopervision: 35 recalls, 97 510(k)s, 9 inspections, 1 compliance action Coopervision Limited: 3 inspections	Same company group	35	97	12	1	Sep 22, 2026 (Z-0204-2027)
Coopervision-Cilco	Same company group	0	2	0	0	—
Coopervision Manufacturing Costa Rica	Same company group	0	0	1	0	—

Recent 510(k) clearances

2 510(k) clearances from Sep 17, 1991 to Jul 27, 1992.

K-Number	Device	Date
K921390	XENON LIGHT SOURCE AND ACCESSORIES	Jul 27, 1992
K905747	LEEP SYSTEM 6000 ELECTROSURGICAL UNIT AND ACCESSOR	Sep 17, 1991

Coopervision Surgical and the FDA: common questions

Has Coopervision Surgical received an FDA warning letter?

No FDA warning letter addressed to the name "Coopervision Surgical" 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 Coopervision Surgical received an FDA Form 483?

FDA has not published a Form 483 for "Coopervision Surgical" in its reading room. FDA publishes some Form 483s, not all of them.

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