K842697

Substantially Equivalent

ROOTMAN ORBITAL SURGERY INSTRUMENT SET

Applicant: Downs Surgical , Ltd.
Product code: HNR
Advisory panel: Ophthalmic
Date received: 1984-07-11
Decision date: 1984-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Adverse events under product code HNR

product code HNR

Malfunction: 497
Other: 1
Total: 498

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.