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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device media, coupling, ultrasound
Regulation Description Diagnostic ultrasonic transducer.
Product CodeMUI
Regulation Number 892.1570
Device Class 2


Premarket Reviews
ManufacturerDecision
ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
EDGECARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
FOSHAN PINGCHUANG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HONY MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
JIANERKANG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TOP-RANK HEALTH CARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ULTRAST, INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Advance Medical Designs, Inc. II Sep-09-2023
2 Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S. II Jan-20-2024
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