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Ardo Medical AG

FDA Regulatory Profile

Ardo Medical AG has 0 FDA recalls, 1 inspection, 6 510(k) clearances and 0 compliance actions on record.

Latest inspection
Aug 6, 2015 · VAI
Latest 510(k)
Mar 30, 2023

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances6Oct 4, 2026Not statedCurrent
Inspections1Oct 23, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 6, 2015Unterageri, SwitzerlandDevicesVoluntary Action Indicated (VAI)3003509351

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K230590ARDO BellisMar 30, 2023
K212773ARDO AlyssaApr 15, 2022
K172067One Mum PumpsetNov 29, 2017
K150721ARDO Calypso Pro Powered Breast PumpJun 17, 2015
K141742ARDO CARUM AND CALYPSO POWERED BREAST PUMPSOct 17, 2014
K011601ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XXJun 8, 2001

FDA data resources