Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
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
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
system, dialysate delivery, single patient
Product Code
FKP
Regulation Number
876.5820
Device Class
2
Premarket Reviews
Manufacturer
Decision
NXSTAGE MEDICAL, INC
SUBSTANTIALLY EQUIVALENT
1
NXSTAGE MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2014
1
1
2015
1
1
2018
5
5
2019
1
1
2021
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
5
5
Detachment Of Device Component
2
2
Component Falling
2
2
Device Emits Odor
1
1
Therapeutic or Diagnostic Output Failure
1
1
Smoking
1
1
Material Rupture
1
1
Device Dislodged or Dislocated
1
1
Fluid/Blood Leak
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Fungal Infection
4
4
No Known Impact Or Consequence To Patient
2
2
No Code Available
1
1
Corneal Abrasion
1
1
Test Result
1
1
No Information
1
1
Edema
1
1
Chemical Exposure
1
1
Blood Loss
1
1
Cardiopulmonary Arrest
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Baxter Healthcare Renal Div
II
Apr-12-2010
2
Fresenius Medical Care North America
II
Aug-15-2010
-
-