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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lithotriptor, electro-hydraulic
Product CodeFFK
Regulation Number 876.4480
Device Class 2


Premarket Reviews
ManufacturerDecision
CYBERSONICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
ELMED USA
  SUBSTANTIALLY EQUIVALENT 1
EMS ELECTRO MEDICAL SYSTEMS SA
  SUBSTANTIALLY EQUIVALENT 2
MED-SONICS CORP
  SUBSTANTIALLY EQUIVALENT 2
MED-SONICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
NORTHGATE TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 2
WALZ ELEKTRONIK GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 9 9
2015 7 7
2016 7 7
2017 9 9
2018 18 18
2019 10 10
2020 39 39
2021 22 22
2022 13 13
2023 10 10
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 49 49
Output Problem 14 14
No Device Output 11 11
Detachment of Device or Device Component 10 10
Overheating of Device 9 9
Adverse Event Without Identified Device or Use Problem 7 7
Insufficient Information 7 7
Device Packaging Compromised 5 5
Defective Device 5 5
Sparking 4 4
Metal Shedding Debris 4 4
Electrical Power Problem 4 4
Therapeutic or Diagnostic Output Failure 3 3
No Apparent Adverse Event 3 3
Activation Problem 3 3
Device Inoperable 3 3
Tear, Rip or Hole in Device Packaging 3 3
Detachment Of Device Component 3 3
Failure to Power Up 2 2
Loose or Intermittent Connection 2 2
Mechanical Problem 2 2
Use of Device Problem 2 2
Connection Problem 2 2
Separation Problem 2 2
Unintended Electrical Shock 2 2
Device Contamination with Chemical or Other Material 2 2
Operating System Becomes Nonfunctional 2 2
Device Operates Differently Than Expected 2 2
Packaging Problem 1 1
Gas/Air Leak 1 1
Material Deformation 1 1
Suction Failure 1 1
Misassembled During Installation 1 1
Appropriate Term/Code Not Available 1 1
Activation, Positioning or Separation Problem 1 1
Device Disinfection Or Sterilization Issue 1 1
Communication or Transmission Problem 1 1
Device Displays Incorrect Message 1 1
Failure To Adhere Or Bond 1 1
Improper or Incorrect Procedure or Method 1 1
Suction Problem 1 1
Arcing of Electrodes 1 1
Defective Component 1 1
Device Emits Odor 1 1
Charred 1 1
Increase in Pressure 1 1
Material Puncture/Hole 1 1
Difficult to Remove 1 1
Crack 1 1
Material Discolored 1 1
Electrical /Electronic Property Problem 1 1
Material Erosion 1 1
Fire 1 1
Material Fragmentation 1 1
Image Display Error/Artifact 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 39 39
No Clinical Signs, Symptoms or Conditions 33 33
No Known Impact Or Consequence To Patient 24 24
No Patient Involvement 23 23
No Code Available 5 5
Insufficient Information 4 4
No Information 4 4
Electric Shock 3 3
Burn(s) 3 3
Bacterial Infection 2 2
Hepatitis 2 2
Device Embedded In Tissue or Plaque 2 2
Foreign Body In Patient 1 1
Numbness 1 1
Eye Burn 1 1
Burn, Thermal 1 1
Hypovolemic Shock 1 1
Internal Organ Perforation 1 1
Perforation 1 1
Sepsis 1 1
Abdominal Pain 1 1
Death 1 1
Hemorrhage/Bleeding 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corp II Nov-11-2009
2 Cook Inc. II May-02-2018
3 Northgate Technologies, Inc. II Jun-03-2022
4 Northgate Technologies, Inc. II Dec-03-2021
5 Northgate Technologies, Inc. II Mar-24-2020
6 Northgate Technologies, Inc. II Nov-08-2017
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