• 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 hemostat
Regulation Description Manual surgical instrument for general use.
Product CodeHRQ
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2020 3 3
2021 15 15
2022 8 8
2023 7 7
2024 3 3
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 11 11
Fracture 8 8
Material Integrity Problem 5 5
Material Fragmentation 3 3
Mechanics Altered 2 2
Product Quality Problem 1 1
Component Missing 1 1
Difficult to Remove 1 1
Sharp Edges 1 1
Material Separation 1 1
Detachment of Device or Device Component 1 1
Crack 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28 28
Insufficient Information 7 7
No Consequences Or Impact To Patient 2 2
Foreign Body In Patient 1 1
Laceration(s) 1 1
Hemorrhage/Bleeding 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Dec-23-2024
2 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
-
-