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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device agents, embolic, for treatment of uterine fibroids
Product CodeNAJ
Regulation Number 870.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CELONOVA BIOSCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SUZHOU HENGRUI CALLISYN BIOMEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 15 15
2015 16 16
2016 14 14
2017 11 11
2018 7 7
2019 4 4
2020 1 1
2021 4 4
2022 20 20
2023 3 3
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 65 65
Therapy Delivered to Incorrect Body Area 8 8
Insufficient Information 8 8
Device Contamination with Chemical or Other Material 4 4
Migration or Expulsion of Device 3 3
Failure to Deliver 2 2
Failure to Infuse 2 2
Device Packaging Compromised 1 1
Packaging Problem 1 1
Unsealed Device Packaging 1 1
Use of Device Problem 1 1
Device Damaged Prior to Use 1 1
Missing Value Reason 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 19 19
Unspecified Infection 10 10
Fever 10 10
Necrosis 9 9
Abdominal Pain 6 6
Sudden Cardiac Death 6 6
Blood Loss 6 6
Insufficient Information 6 6
No Patient Involvement 5 5
Vomiting 4 4
Obstruction/Occlusion 4 4
Renal Failure 4 4
Abscess 4 4
Nausea 4 4
Inflammation 4 4
Hemorrhage/Bleeding 4 4
Death 3 3
Fatigue 3 3
No Consequences Or Impact To Patient 3 3
No Known Impact Or Consequence To Patient 3 3
Fibrosis 3 3
Not Applicable 2 2
No Information 2 2
Burning Sensation 2 2
Chills 2 2
Sepsis 2 2
Urinary Tract Infection 2 2
Abnormal Vaginal Discharge 2 2
Pulmonary Embolism 2 2
Disseminated Intravascular Coagulation (DIC) 2 2
Bradycardia 2 2
Hypersensitivity/Allergic reaction 2 2
Low Blood Pressure/ Hypotension 2 2
Fistula 2 2
Liver Damage/Dysfunction 2 2
Paralysis 2 2
Pulmonary Edema 2 2
Pulmonary Infarction 2 2
Rash 2 2
Heart Failure/Congestive Heart Failure 2 2
Swelling/ Edema 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Unspecified Heart Problem 1 1
Sexual Dysfunction 1 1
Skin Infection 1 1
Skin Inflammation/ Irritation 1 1
Unspecified Tissue Injury 1 1
Decreased Appetite 1 1
Intermenstrual Bleeding 1 1
Patient Problem/Medical Problem 1 1
Weight Changes 1 1
Perforation 1 1
Micturition Urgency 1 1
Headache 1 1
Failure of Implant 1 1
High Blood Pressure/ Hypertension 1 1
Infarction, Cerebral 1 1
Cerebrospinal Fluid Leakage 1 1
Chest Pain 1 1
Anemia 1 1
Bacterial Infection 1 1
Cardiac Enzyme Elevation 1 1
Erythema 1 1
Eye Injury 1 1
Dehydration 1 1
Diarrhea 1 1
Visual Impairment 1 1
Loss of Vision 1 1
Visual Disturbances 1 1
Thrombus 1 1
Urinary Retention 1 1
Scar Tissue 1 1
Dizziness 1 1
Electrolyte Imbalance 1 1
Discharge 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Injury 1 1
Ventilator Dependent 1 1
Numbness 1 1
Multiple Organ Failure 1 1
Cancer 1 1
Constipation 1 1
Ischemia Stroke 1 1
Thrombosis/Thrombus 1 1
Palpitations 1 1
Prolapse 1 1
Weakness 1 1
Confusion/ Disorientation 1 1
Hematuria 1 1
Vascular System (Circulation), Impaired 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Sep-15-2009
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