UNITOX BOTOX SYRINGE— 510(k) K123710

Substantially Equivalent

Bio-Med USA, Inc.

FDA 510(k) clearance K123710 for UNITOX BOTOX SYRINGE, Substantially Equivalent on 2013-05-09. Applicant: Bio-Med USA, Inc..

Clearance details

Applicant: Bio-Med USA, Inc.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2012-12-04
Decision date: 2013-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paterson, NJ, 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.