• 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 monitor, ultrasonic, fetal
Regulation Description Fetal ultrasonic monitor and accessories.
Product CodeKNG
Regulation Number 884.2660
Device Class 2


Premarket Reviews
ManufacturerDecision
EDAN INSTRUMENTS INC
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 3 3
2018 8 8
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4 4
Device Operates Differently Than Expected 3 3
Product Quality Problem 2 2
Inappropriate/Inadequate Shock/Stimulation 1 1
Device Inoperable 1 1
Device Sensing Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Temperature Problem 1 1
Failure to Sense 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Anxiety 5 5
Burning Sensation 2 2
Burn(s) 2 2
Rash 1 1
Cramp(s) 1 1
No Known Impact Or Consequence To Patient 1 1
Shock from Patient Lead(s) 1 1
Nausea 1 1
Burn, Thermal 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CooperSurgical, Inc. II Mar-19-2018
-
-