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 Back To Search Results
Device warmer, irrigation solution
Regulation Description Powered heating unit.
Product CodeLHC
Regulation Number 890.5950
Device Class 1


Premarket Reviews
ManufacturerDecision
AUGUSTINE MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
C CHANGE SURGICAL LLC
  SUBSTANTIALLY EQUIVALENT 2
KOLSTER METHODS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAC MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
OR SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Overheating of device or device component 2
Device Issue 1
Strikethrough 1
Temperature issue 1
No Information 1
Component(s), overheating of 1
Fluid leak 1
Material fragmentation 1
Leak 1
Total Device Problems 10

-
-