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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bag, hemostatic
Product CodeFCB
Regulation Number 876.5980
Device Class 2

MDR Year MDR Reports MDR Events
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Deflation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aizu Olympus Co., Ltd. II Nov-17-2023
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