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 cystometric gas (carbon-dioxide) on hydraulic device
Product CodeFAP
Regulation Number 876.1620
Device Class 2


Premarket Reviews
ManufacturerDecision
NEUROVISION MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1 1
2018 2 2
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Burst Container or Vessel 1 1
Fluid/Blood Leak 1 1
Material Rupture 1 1
Device Contaminated During Manufacture or Shipping 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 1 1
Foreign Body In Patient 1 1
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Spes Medica II Jun-25-2021
2 Teleflex Medical Europe Ltd II Apr-12-2018
-
-