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 colon capsule imaging system
Definition visualization of the colon for the detection of polyps
Product CodePGD
Regulation Number 876.1330
Device Class 2

MDR Year MDR Reports MDR Events
2019 1 1
2020 1 1
2021 3 3
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2 2
Insufficient Information 1 1
Unintended Application Program Shut Down 1 1
Entrapment of Device 1 1
Patient-Device Incompatibility 1 1
Human-Device Interface Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unintended Radiation Exposure 2 2
Insufficient Information 1 1
Abdominal Pain 1 1
Dehydration 1 1
Diarrhea 1 1
Dyspnea 1 1
Fatigue 1 1
Fever 1 1
Low Blood Pressure/ Hypotension 1 1
Inflammation 1 1
Nausea 1 1
Pain 1 1
Vomiting 1 1
Dizziness 1 1
Arthralgia 1 1
Numbness 1 1
Irritability 1 1
Choking 1 1
Confusion/ Disorientation 1 1
Lethargy 1 1
Foreign Body In Patient 1 1
No Code Available 1 1
Constipation 1 1
Paresthesia 1 1
Unspecified Eye / Vision Problem 1 1

-
-