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 microspheres radionuclide
Definition Approved PMA: P990065
Product CodeNAW
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
3 2 3 5 3 4

MDR Year MDR Reports MDR Events
2021 76 76
2022 23 23
2023 37 37
2024 53 53
2025 77 77
2026 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 253 253
Insufficient Device Problem Information 4 4
Device Contamination with Chemical or Other Material 4 4
Radiation Underexposure 4 4
Contamination 2 2
Fluid/Blood Leak 2 2
No Apparent Adverse Event 1 1
Device Contaminated During Manufacture or Shipping 1 1
Failure to Prime 1 1
Improper Flow or Infusion 1 1
Connection Problem 1 1
Air/Gas in Device 1 1
Migration 1 1
Labelling, Instructions for Use or Training Problem 1 1
Infusion or Flow Problem 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Abdominal Pain 72 72
Nausea 55 55
Liver Damage/Dysfunction 47 47
Ascites 46 46
Unintended Radiation Exposure 45 45
Inflammation 40 40
Fatigue 35 35
No Clinical Signs, Symptoms or Conditions 33 33
Fever 30 30
Dyspnea 29 29
Pain 29 29
Low White Blood Cell Count 26 26
Vomiting 20 20
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 19 19
Decreased Appetite 18 18
Hyperbilirubinemia 18 18
Constipation 17 17
Hemorrhage/Blood Loss/Bleeding 16 16
Ulcer 15 15
Muscle Weakness/Atrophy 13 13
Swelling/ Edema 12 12
Unspecified Infection 11 11
Cough 10 10
Anemia 10 10
High Blood Pressure/ Hypertension 9 9
Pleural Effusion 9 9
Pneumonia 9 9
Thrombocytopenia 8 8
Necrosis 8 8
Chills 8 8
Abscess 8 8
Bacterial Infection 7 7
Encephalopathy 7 7
Liver Failure 7 7
Insufficient Information 7 7
Jaundice 6 6
Weight Changes 6 6
Thrombosis/Thrombus 6 6
Heartburn/Indigestion 6 6
Blood Protein Abnormal 5 5
Discomfort 5 5
Malaise 5 5
Renal Failure 4 4
Sepsis 4 4
Abdominal Distention 4 4
Pseudoaneurysm 4 4
Respiratory Insufficiency 4 4
Confusion/ Disorientation 3 3
Fistula 3 3
Stenosis 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Aug-19-2021
-
-