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 stool, operating-room
Product CodeFZM
Regulation Number 878.4950
Device Class 1

MDR Year MDR Reports MDR Events
2019 4 10
2020 13 26
2021 13 27
2022 10 26
2023 12 25
2024 1 5

Device Problems MDRs with this Device Problem Events in those MDRs
Device Slipped 19 56
Unstable 15 32
Device Fell 11 17
Unintended Movement 3 9
Sharp Edges 2 2
Vibration 2 2
Device Tipped Over 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 39 94
No Patient Involvement 14 25
Fall 1 2

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Medical Division of Stryker Corporation II Aug-06-2021
-
-