• 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 lithotriptor, electro-hydraulic
Regulation Description Electrohydraulic lithotriptor.
Product CodeFFK
Regulation Number 876.4480
Device Class 2


Premarket Reviews
ManufacturerDecision
EMS ELECTRO MEDICAL SYSTEMS SA
  SUBSTANTIALLY EQUIVALENT 1
MED-SONICS CORP
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 14
Probe 8
Device Packaging Compromised 5
Adverse Event Without Identified Device or Use Problem 4
No Device Output 4
Activation Problem 3
Device Contamination with Chemical or Other Material 2
Overheating of Device 2
Increase in Pressure 1
Device Inoperable 1
Use of Device Problem 1
Detachment of Device or device Component 1
Charred 1
Material Fragmentation 1
Device Emits Odor 1
Packaging Problem 1
Insufficient Information 1
Unintended Electrical Shock 1
Electrical Power Problem 1
Seal 1
Total Device Problems 54

Recalls
Manufacturer Recall Class Date Posted
1 Cook Inc. II May-02-2018
2 Northgate Technologies, Inc. II Mar-24-2020
3 Northgate Technologies, Inc. II Nov-08-2017

-
-