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 test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Product CodeMTG
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
13 7 4 9 3 3

MDR Year MDR Reports MDR Events
2020 6 6
2021 9 9
2022 4 4
2023 5 5
2024 9 9
2025 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Measurement 13 13
High Test Results 12 12
Low Test Results 11 11
Non Reproducible Results 6 6
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Signal Artifact/Noise 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 30 30
No Consequences Or Impact To Patient 6 6
No Known Impact Or Consequence To Patient 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Mckesson Medical-Surgical Inc. Corporate Office II May-27-2025
-
-