Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
HONY MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
JIANERKANG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ULTRAST, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 13 32
2022 1 2
2023 2 2
2024 2 3
2025 25 25

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 23 23
Nonstandard Device 5 15
Adverse Event Without Identified Device or Use Problem 4 11
Burst Container or Vessel 1 2
Device Markings/Labelling Problem 1 1
Insufficient Information 1 2
Contamination 1 3
Microbial Contamination of Device 1 1
Excessive Heating 1 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Itching Sensation 25 26
Erythema 25 27
Rash 23 23
Pain 23 23
Bacterial Infection 10 29
Foreign Body Reaction 2 2
Insufficient Information 2 2
Unspecified Infection 1 1
Superficial (First Degree) Burn 1 1
Skin Disorders 1 1
Local Reaction 1 1
Burning Sensation 1 1
Pneumonia 1 1
Tissue Breakdown 1 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
-
-