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 nystagmograph
Regulation Description Nystagmograph.
Product CodeGWN
Regulation Number 882.1460
Device Class 2


Premarket Reviews
ManufacturerDecision
INTERACOUSTICS A/S
  SUBSTANTIALLY EQUIVALENT 1
INVENTIS S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
NATUS MEDICAL DENMARK APS
  SUBSTANTIALLY EQUIVALENT 1
NEUROBIT TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VESTIBULAR FIRST
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 1 1
2023 3 3
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2 2
Leak/Splash 1 1
Communication or Transmission Problem 1 1
Patient Data Problem 1 1
Failure to Power Up 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Detachment of Device or Device Component 1 1
Fracture 1 1
Display or Visual Feedback Problem 1 1
False Positive Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7 7
Skin Inflammation/ Irritation 1 1
Head Injury 1 1

-
-