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 antiserum, pseudomonas pseudomallei
Product CodeGST
Regulation Number 866.3415
Device Class 2

MDR Year MDR Reports MDR Events
2023 1 1
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4 4
Patient Device Interaction Problem 3 3
Failure to Form Staple 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fever 2 2
Hemorrhage/Bleeding 2 2
Unspecified Infection 2 2
Pleural Effusion 2 2
Pneumothorax 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Failure to Anastomose 1 1
Chest Pain 1 1

-
-