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 device, biopsy, endomyocardial
Regulation Description Endomyocardial biopsy device.
Product CodeDWZ
Regulation Number 870.4075
Device Class 2


Premarket Reviews
ManufacturerDecision
FEHLING INSTRUMENTS GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 5 5
2021 5 5
2022 14 14
2023 10 10
2024 4 4
2025 1 1
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 11 11
Mechanical Problem 4 4
Fracture 2 2
Physical Resistance/Sticking 2 2
Activation Failure 2 2
Device Markings/Labelling Problem 1 1
Defective Component 1 1
Device Contamination with Chemical or Other Material 1 1
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 17 17
Insufficient Information 8 8
Cardiac Tamponade 5 5
Cardiac Perforation 4 4
No Known Impact Or Consequence To Patient 3 3
Tachycardia 2 2
Pericardial Effusion 2 2
Unspecified Infection 1 1
Arrhythmia 1 1
Discomfort 1 1
Perforation of Vessels 1 1
Thrombosis/Thrombus 1 1
No Consequences Or Impact To Patient 1 1
Unspecified Tissue Injury 1 1
Embolism/Embolus 1 1

-
-