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 curette
Product CodeHTF
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2018 3 3
2019 4 4
2020 5 5
2021 16 16
2022 8 8
2023 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Break 23 23
Material Integrity Problem 7 7
Fracture 4 4
Material Separation 2 2
Crack 2 2
Entrapment of Device 2 2
Detachment Of Device Component 1 1
Detachment of Device or Device Component 1 1
Device Contaminated During Manufacture or Shipping 1 1
Unsealed Device Packaging 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Packaging Problem 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 29 29
No Consequences Or Impact To Patient 4 4
Device Embedded In Tissue or Plaque 3 3
Insufficient Information 3 3
Foreign Body In Patient 2 2
Death 2 2
Stroke/CVA 1 1
Blood Loss 1 1

-
-