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FDA 510(k) Applications for Medical Device Product Code "QAU"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K242250
3-D Matrix Europe SAS
PuraStat
10/22/2024
K222481
3-D Matrix, Inc.
PuraStat
02/28/2023
K210098
3-D Matrix, Inc.
PuraStat-GI
06/25/2021
K190677
EndoClot Plus Co., Ltd.
EndoClot
01/29/2021
K234131
Hemostasis LLC
Resolv Endoscopic Hemostat System
07/26/2024
K202929
Nextbiomedical Co., Ltd.
Nexpowder
09/16/2022
K240994
Nextbiomedical Co., Ltd.
Nexpowder
11/27/2024
DEN170015
Wilson-Cook Medical, Inc
Hemospray Endoscopic Hemostat
05/07/2018
K200972
Wilson-Cook Medical, Inc
Hemospray Endoscopic Hemostat
06/10/2020
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