• 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 apparatus, suction, patient care
Regulation Description Patient care suction apparatus.
Product CodeDWM
Regulation Number 870.5050
Device Class 2


Premarket Reviews
ManufacturerDecision
CAREFUSION
  SUBSTANTIALLY EQUIVALENT 2
ROCKET MEDICAL PLC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 30
Valve 18
Leak / Splash 10
Material Separation 7
Crack 6
Product Quality Problem 5
Adverse Event Without Identified Device or Use Problem 3
Disconnection 3
Suction Problem 2
Detachment Of Device Component 2
Catheter 2
Cap 2
Tear, Rip or Hole in Device Packaging 1
Fluid Leak 1
Connector 1
Material Deformation 1
Device Sensing Problem 1
Material Integrity Problem 1
Use of Device Problem 1
Material Fragmentation 1
Inadequate or Insufficient Training 1
Off-Label Use 1
Patient-Device Incompatibility 1
Decrease in Suction 1
Unsealed Device Packaging 1
Component Missing 1
Connection Problem 1
Improper or Incorrect Procedure or Method 1
Total Device Problems 106


-
-