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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, assisted reproduction
Regulation Description Assisted reproduction catheters.
Product CodeMQF
Regulation Number 884.6110
Device Class 2


Premarket Reviews
ManufacturerDecision
ALLWIN MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
FEMASYS INC.
  SUBSTANTIALLY EQUIVALENT 1
KITAZATO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI HORIZON MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN VITAVITRO BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 19 19
2021 13 13
2022 11 11
2023 12 12
2024 15 15
2025 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contaminated During Manufacture or Shipping 29 29
Contamination 14 14
Contamination /Decontamination Problem 12 12
Unsealed Device Packaging 4 4
Material Separation 4 4
Complete Blockage 3 3
Packaging Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Nonstandard Device 3 3
Entrapment of Device 1 1
Mechanical Problem 1 1
Difficult to Advance 1 1
Defective Component 1 1
Material Fragmentation 1 1
Obstruction of Flow 1 1
Infusion or Flow Problem 1 1
Detachment of Device or Device Component 1 1
Material Protrusion/Extrusion 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 50 50
No Consequences Or Impact To Patient 14 14
No Patient Involvement 6 6
Foreign Body In Patient 5 5
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Tenderneeds Fertility LLC II Aug-02-2021
2 Tenderneeds Fertility LLC II Apr-06-2021
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