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
2017 6 6
2018 3 3
2019 4 4
2020 5 5
2021 16 16
2022 8 8
2023 8 8
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Break 30 30
Material Integrity Problem 7 7
Fracture 6 6
Detachment Of Device Component 4 4
Entrapment of Device 2 2
Crack 2 2
Contamination /Decontamination Problem 2 2
Material Separation 2 2
Device Contaminated During Manufacture or Shipping 1 1
Insufficient Information 1 1
Unsealed Device Packaging 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Packaging Problem 1 1
Detachment of Device or Device Component 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 33 33
Foreign Body In Patient 5 5
Insufficient Information 5 5
No Consequences Or Impact To Patient 5 5
Device Embedded In Tissue or Plaque 3 3
Death 2 2
Stroke/CVA 1 1
No Information 1 1
Blood Loss 1 1
No Known Impact Or Consequence To Patient 1 1

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