K041579

Substantially Equivalent

MEDELA SINGLE USE SILC CUP, MODEL 077.0791

Applicant: Medela AG
Product code: HDB
Advisory panel: Obstetrics/Gynecology
Date received: 2004-06-14
Decision date: 2005-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baar Zug, CH

Adverse events under product code HDB

product code HDB

Death: 7
Total: 7

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.