Stemcyte, Inc.

FDA Regulatory Profile

Stemcyte, Inc. appears in FDA public data with 0 recalls, 2 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent FDA inspection ended on Jul 31, 2019 (No Action Indicated (NAI)). Its most recent 510(k) clearance was granted on May 22, 2024.

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Summary

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

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 31, 2019Baldwin Park, CABiologicsNo Action Indicated (NAI)3003562296
Mar 12, 2013Baldwin Park, CABiologicsVoluntary Action Indicated (VAI)3003562296
Jul 28, 2011Baldwin Park, CABiologicsNo Action Indicated (NAI)3003562296
Feb 11, 2010Baldwin Park, CABiologicsVoluntary Action Indicated (VAI)3003562296

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

Recent 510(k) Clearances

K-NumberDeviceDate
K232655Bonvadis®May 22, 2024
K212554Bonvadis Topical CreamAug 19, 2022