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Unnamed device
Medela AG
UDILibrary device dossier · generated 2026-09-11 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
No dated reports to chart.
Regulatory clearances
- None linked in the loaded window.
Manufacturer compliance record — Medela AG
- Warning Letter 2011-02-25 Medela Inc
- Warning Letter 2011-02-25 Medela Inc
- NAI 2014-08-27 Medela Inc · 0 citations
- NAI 2014-08-27 Medela Inc · 0 citations
- NAI 2014-02-26 Medela Inc · 0 citations
- NAI 2014-02-26 Medela Inc · 0 citations
- OAI 2012-05-25 Medela Inc · 7 citations
- OAI 2012-05-25 Medela Inc · 7 citations
- NAI 2011-11-21 Medela Inc · 0 citations
- NAI 2011-11-21 Medela Inc · 0 citations
- VAI 2011-08-09 Medela Inc · 0 citations
- VAI 2011-08-09 Medela Inc · 0 citations
- OAI 2010-11-01 Medela Inc · 0 citations
- OAI 2010-11-01 Medela Inc · 0 citations
- VAI 2010-01-21 Medela Inc · 7 citations
- VAI 2010-01-21 Medela Inc · 7 citations