Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device hood, surgical
Regulation Description Surgical apparel.
Product CodeFXY
Regulation Number 878.4040
Device Class 2


Premarket Reviews
ManufacturerDecision
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
THI TOTAL HEALTHCARE INNOVATION GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 4 6
2020 1 1
2021 1 1
2022 2 2
2023 6 11
2024 11 13
2025 9 10

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contaminated During Manufacture or Shipping 14 17
Delivered as Unsterile Product 10 16
Device Contamination with Chemical or Other Material 5 5
Material Integrity Problem 3 4
Material Frayed 1 1
Material Puncture/Hole 1 1
Difficult to Remove 1 1
Adverse Event Without Identified Device or Use Problem 1 2
Biofilm coating in Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 27 33
No Consequences Or Impact To Patient 3 4
Insufficient Information 2 4
Burn, Thermal 1 2
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 O&M HALYARD, INC. III Apr-02-2024
-
-