Hygeia II Medical Group, Inc.

FDA Regulatory Profile

Hygeia II Medical Group, Inc. appears in FDA public data with 0 recalls, 4 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent FDA inspection ended on Aug 2, 2023 (Voluntary Action Indicated (VAI)). Its most recent 510(k) clearance was granted on Mar 13, 2024.

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Summary

Total Recalls
0
510(k) Clearances
4
Inspections
2
Compliance Actions
0

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 2, 2023Carlsbad, CADevicesVoluntary Action Indicated (VAI)3006774448
Sep 15, 2015Carlsbad, CADevicesNo Action Indicated (NAI)3006774448

FDA Data Dashboard classifications: NAI (no action indicated), VAI (voluntary action indicated), OAI (official action indicated).

Recent 510(k) Clearances

K-NumberDeviceDate
K233136Hygeia Express Powered Breast PumpMar 13, 2024
K212955Fit Pro Breast PumpMar 15, 2022
K200406Evolve Breast PumpMar 18, 2020
K190465Evolve Breast PumpOct 18, 2019