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TPLC
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show TPLC since
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Device
stimulator, nerve, battery-powered
Product Code
BXN
Regulation Number
868.2775
Device Class
2
Premarket Reviews
Manufacturer
Decision
EASYMED INSTRUMENT CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
PAJUNK GMBH MEDIZINTECHNOLOGIE
SUBSTANTIALLY EQUIVALENT
1
XAVANT TECHNOLOGY (PTY) LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
1
1
2021
2
2
2023
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Defective Component
1
1
Therapeutic or Diagnostic Output Failure
1
1
Detachment Of Device Component
1
1
Noise, Audible
1
1
Inflation Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Wound Dehiscence
1
1
No Clinical Signs, Symptoms or Conditions
1
1
Muscle Weakness
1
1
Itching Sensation
1
1
No Known Impact Or Consequence To Patient
1
1
Insufficient Information
1
1
Bruise/Contusion
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
B Braun Medical Inc
II
Jun-11-2024
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