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 electrocardiograph, ambulatory, with analysis algorithm
Regulation Description Medical magnetic tape recorder.
Product CodeMLO
Regulation Number 870.2800
Device Class 2


Premarket Reviews
ManufacturerDecision
FOURTH FRONTIER TECHNOLOGIES PVT, LTD.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 1 1
2023 1 1
2024 2 2
2025 4 4
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Data Problem 3 3
Signal Artifact/Noise 1 1
Patient-Device Incompatibility 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Patient Device Interaction Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Date/Time-Related Software Problem 1 1
Product Quality Problem 1 1
Electrical /Electronic Property Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4
Itching Sensation 3 3
Blister 2 2
Burning Sensation 2 2
Skin Inflammation/ Irritation 1 1
Foreign Body Reaction 1 1
Insufficient Information 1 1
Pain 1 1
Peeling 1 1
Tachycardia 1 1
Skin Burning Sensation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Nov-07-2024
-
-