APOTECA DUG COMPOUNDING DOSING DEVICE,APOTECA I.V. TRANSFER SET— 510(k) K132011

Substantially Equivalent

Aea Srl

FDA 510(k) clearance K132011 for APOTECA DUG COMPOUNDING DOSING DEVICE,APOTECA I.V. TRANSFER SET, Substantially Equivalent on 2014-03-21. Applicant: Aea Srl.

Clearance details

Applicant: Aea Srl
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2013-07-01
Decision date: 2014-03-21
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Angeli Di Rosora, IT

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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.