MODEL #527 OPHTHALMIC STRETCHER— 510(k) K904011

Substantially Equivalent

Midmark Corp.

FDA 510(k) clearance K904011 for MODEL #527 OPHTHALMIC STRETCHER, Substantially Equivalent on 1990-10-03. Applicant: Midmark Corp..

Clearance details

Applicant: Midmark Corp.
Product code: Code FPO
Advisory panel: General Hospital
Date received: 1990-08-29
Decision date: 1990-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Versailles, OH, US

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Adverse events under product code FPO

product code FPO

Death: 29
Injury: 254
Malfunction: 5,054
Other: 10
Total: 5,347

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.