Orbit Subretinal Delivery System— 510(k) K182274

Unknown

Orbit Biomedical, Inc.

FDA 510(k) clearance K182274 for Orbit Subretinal Delivery System, Unknown on 2018-11-20. Applicant: Orbit Biomedical, Inc..

Clearance details

Applicant: Orbit Biomedical, Inc.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2018-08-22
Decision date: 2018-11-20
Decision: Unknown
Clearance type: Traditional
Location: Ambler, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.