K881049

Substantially Equivalent

BRADBURY INTRAOCULAR RETINAL KIT CAT #200

Applicant: Microline Pentax, Inc.
Product code: HNR
Advisory panel: Ophthalmic
Date received: 1988-03-11
Decision date: 1988-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Devers, MA, 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.