Reprise Biomedical

FDA Regulatory Profile

Reprise Biomedical appears in FDA public data with 0 recalls, 5 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent FDA inspection ended on Nov 20, 2025 (No Action Indicated (NAI)). Its most recent 510(k) clearance was granted on Apr 19, 2024.

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Summary

Total Recalls
0
510(k) Clearances
5
Inspections
4
Compliance Actions
0

Recent FDA Inspections

DateSiteProductClassificationFEI
Nov 20, 2025Plymouth, MNDevicesNo Action Indicated (NAI)3010894343
Jul 8, 2021Plymouth, MNDevicesNo Action Indicated (NAI)3010894343
Apr 2, 2019Plymouth, MNDevicesNo Action Indicated (NAI)3010894343
Sep 18, 2015Plymouth, MNDevicesVoluntary Action Indicated (VAI)3010894343

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

Recent 510(k) Clearances

K-NumberDeviceDate
K240753Miro3D Fibers Wound MatrixApr 19, 2024
K240277MiroDry Wound MatrixMar 1, 2024
K231614MiroTract Wound MatrixDec 13, 2023
K223257Miro3D Wound MatrixNov 21, 2022
K221520Miro3D Wound MatrixAug 18, 2022