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 elevator, surgical, dental
Regulation Description Dental hand instrument.
Product CodeEMJ
Regulation Number 872.4565
Device Class 1

MDR Year MDR Reports MDR Events
2021 65 65
2022 46 46
2023 45 45
2024 27 27
2025 43 43
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 182 182
Naturally Worn 21 21
Break 12 12
Crack 8 8
Material Fragmentation 4 4
Material Integrity Problem 2 2
Degraded 1 1
Material Twisted/Bent 1 1
Material Separation 1 1
Detachment of Device or Device Component 1 1
Corroded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 201 201
No Consequences Or Impact To Patient 11 11
Foreign Body In Patient 7 7
No Known Impact Or Consequence To Patient 5 5
Insufficient Information 2 2
No Patient Involvement 2 2
Needle Stick/Puncture 1 1
Pain 1 1
Laceration(s) 1 1
Device Embedded In Tissue or Plaque 1 1

-
-