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TPLC
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show TPLC since
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Device
hood, surgical
Regulation Description
Surgical apparel.
Product Code
FXY
Regulation Number
878.4040
Device Class
2
Premarket Reviews
Manufacturer
Decision
STRYKER CORPORATION
SUBSTANTIALLY EQUIVALENT
1
THI TOTAL HEALTHCARE INNOVATION GMBH
SUBSTANTIALLY EQUIVALENT
1
1. K222214
ViVi® Surgical Helmet System (ViVi® Helmet, ViVi®
...
MDR Year
MDR Reports
MDR Events
2020
1
1
2021
1
1
2022
2
2
2023
6
11
2024
11
13
2025
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Delivered as Unsterile Product
10
16
Device Contaminated During Manufacture or Shipping
9
11
Device Contamination with Chemical or Other Material
5
5
Material Puncture/Hole
1
1
Material Integrity Problem
1
1
Material Frayed
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
22
27
Insufficient Information
2
4
No Consequences Or Impact To Patient
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
O&M HALYARD, INC.
III
Apr-02-2024
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