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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
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2024
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Device
needle, acupuncture, single use
Product Code
MQX
Regulation Number
880.5580
Device Class
2
Premarket Reviews
Manufacturer
Decision
ASIA-MED GMBH AND CO KG
SUBSTANTIALLY EQUIVALENT
1
BIOMATE MEDICAL DEVICES TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
CHANGCHUN AIK MEDICAL DEVICES CO., LTD
SUBSTANTIALLY EQUIVALENT
1
HAENGLIM SEOWON MEDICAL CO.
SUBSTANTIALLY EQUIVALENT
1
HANSOL MEDICAL CO.
SUBSTANTIALLY EQUIVALENT
1
K.M.S. INC.
SUBSTANTIALLY EQUIVALENT
1
K.S. CHOI CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MAANSHAN BOND MEDICAL INSTRUMENTS CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SMC INTL., INC.
SUBSTANTIALLY EQUIVALENT
1
WOOJEON COMPANY
SUBSTANTIALLY EQUIVALENT
1
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
1
1
2015
1
1
2016
1
1
2018
1
1
2023
1
1
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
1
1
Insufficient Information
1
1
Defective Device
1
1
Difficult to Remove
1
1
Detachment of Device or Device Component
1
1
Improper or Incorrect Procedure or Method
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pneumothorax
1
1
No Code Available
1
1
Burn, Thermal
1
1
No Known Impact Or Consequence To Patient
1
1
Burn(s)
1
1
Needle Stick/Puncture
1
1
Insufficient Information
1
1
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