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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 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Break 51 51
Output Problem 14 14
No Device Output 11 11
Detachment of Device or Device Component 11 11
Overheating of Device 9 9
Insufficient Information 8 8
Adverse Event Without Identified Device or Use Problem 8 8
Defective Device 5 5
Device Packaging Compromised 5 5
Sparking 4 4
Electrical Power Problem 4 4
Metal Shedding Debris 4 4
Activation Problem 3 3
Detachment Of Device Component 3 3
No Apparent Adverse Event 3 3
Tear, Rip or Hole in Device Packaging 3 3
Device Inoperable 3 3
Connection Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Operating System Becomes Nonfunctional 2 2
Separation Problem 2 2
Mechanical Problem 2 2
Loose or Intermittent Connection 2 2
Device Contamination with Chemical or Other Material 2 2
Unintended Electrical Shock 2 2
Failure to Power Up 2 2
Use of Device Problem 2 2
Device Operates Differently Than Expected 2 2
Material Fragmentation 1 1
Failure To Adhere Or Bond 1 1
Arcing of Electrodes 1 1
Device Displays Incorrect Message 1 1
Improper or Incorrect Procedure or Method 1 1
Electrical /Electronic Property Problem 1 1
Suction Problem 1 1
Protective Measures Problem 1 1
Increase in Pressure 1 1
Appropriate Term/Code Not Available 1 1
Material Deformation 1 1
Packaging Problem 1 1
Device Handling Problem 1 1
Charred 1 1
Gas/Air Leak 1 1
Material Discolored 1 1
Smoking 1 1
Defective Component 1 1
Crack 1 1
Image Display Error/Artifact 1 1
Suction Failure 1 1
Device Emits Odor 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 37 37
No Known Impact Or Consequence To Patient 24 24
No Patient Involvement 23 23
No Code Available 5 5
No Information 4 4
Insufficient Information 4 4
Electric Shock 3 3
Burn(s) 3 3
Hepatitis 2 2
Foreign Body In Patient 2 2
Bacterial Infection 2 2
Device Embedded In Tissue or Plaque 2 2
Abdominal Pain 1 1
Hypovolemic Shock 1 1
Death 1 1
Sepsis 1 1
Hematoma 1 1
Perforation 1 1
Eye Burn 1 1
Burn, Thermal 1 1
Numbness 1 1
Hemorrhage/Bleeding 1 1
Internal Organ Perforation 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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