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 illuminator, fiberoptic, surgical field
Regulation Description Surgical lamp.
Product CodeHBI
Regulation Number 878.4580
Device Class 2


Premarket Reviews
ManufacturerDecision
OLYMPUS WINTER & IBE GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 4 4
2022 2 2
2023 1 1
2024 2 2
2025 1 1
2026 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4 4
Break 3 3
Melted 2 2
Material Split, Cut or Torn 1 1
No Display/Image 1 1
Use of Device Problem 1 1
Thermal Decomposition of Device 1 1
Optical Problem 1 1
Overheating of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
Burn(s) 5 5
Superficial (First Degree) Burn 1 1
Blister 1 1
Insufficient Information 1 1
Full thickness (Third Degree) Burn 1 1

-
-