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 speculum, vaginal, metal
Product CodeHDF
Regulation Number 884.4520
Device Class 1

MDR Year MDR Reports MDR Events
2019 12 12
2020 3 3
2021 2 2
2022 3 3
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 4 4
Break 3 3
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Peeled/Delaminated 2 2
Material Puncture/Hole 1 1
Naturally Worn 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Split, Cut or Torn 1 1
Separation Problem 1 1
Use of Device Problem 1 1
Defective Device 1 1
Detachment of Device or Device Component 1 1
Device Markings/Labelling Problem 1 1
Material Fragmentation 1 1
Nonstandard Device 1 1
Overheating of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 14 14
Insufficient Information 4 4
No Clinical Signs, Symptoms or Conditions 3 3
Laceration(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Carefusion 2200 Inc II Apr-21-2023
2 Centurion Medical Products Corporation II Aug-06-2019
-
-