NIDEK OPEATING MICROSCOPE DELIVERY SYSTEM (OMDS)— 510(k) K883213

Substantially Equivalent

Nidek, Inc.

FDA 510(k) clearance K883213 for NIDEK OPEATING MICROSCOPE DELIVERY SYSTEM (OMDS), Substantially Equivalent on 1988-09-15. Applicant: Nidek, Inc..

Clearance details

Applicant: Nidek, Inc.
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 1988-07-29
Decision date: 1988-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, US

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Adverse events under product code HQF

product code HQF

Injury: 166
Other: 1
Total: 167

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.