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