• 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 tenaculum, uterine
Product CodeHDC
Regulation Number 884.4530
Device Class 2


Premarket Reviews
ManufacturerDecision
ASPIVIX S.A.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 1 1
2019 3 3
2020 2 2
2021 4 4
2022 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4 4
Physical Resistance/Sticking 3 3
Failure to Clean Adequately 3 3
Misconnection 2 2
Device Contamination with Body Fluid 2 2
Microbial Contamination of Device 2 2
Detachment of Device or Device Component 2 2
Residue After Decontamination 2 2
Inadequate Instructions for Healthcare Professional 1 1
Detachment Of Device Component 1 1
Device Reprocessing Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 6 6
Hemorrhage/Bleeding 3 3
No Consequences Or Impact To Patient 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Exposure to Body Fluids 2 2
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stradis Medical, LLC dba Stradis Healthcare II Oct-16-2021
-
-