K100998

Substantially Equivalent

1ML UNITRACT 27G X 1/2 TUBERCULIN SYRINGE, MODEL 132BY2-1

Applicant: Unilife Medical Solutions Limited
Product code: MEG
Advisory panel: General Hospital
Date received: 2010-04-12
Decision date: 2010-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lewisberry, PA, US

Adverse events under product code MEG

product code MEG

Malfunction: 1,373
Other: 1
Total: 1,374

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.