10,000 results
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130ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
FKX
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 29, 2016
FKX SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·May 22, 2014
NI
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·June 3, 2022
NI
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·January 6, 2017
NI
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·August 26, 2024
AMIA AUTOMATED PD CYCLER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·January 5, 2021
EMPTY STERILE CONTAINER
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·July 17, 2023
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·August 28, 2013
EMPTY STERILE CONTAINER
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·July 17, 2023
AMIA AUTOMATED PD CYCLER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·November 2, 2020
EMPTY STERILE CONTAINER
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·July 18, 2023
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 28, 2011
EMPTY STERILE CONTAINER
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·July 17, 2023
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 26, 2011
INTERGRATED APD SET
FDA Adverse Event
Malfunction
·VANTIVE US HEALTHCARE LLC·Product code FKX·April 4, 2025
System, Peritoneal, Automatic Delivery
FDA classification
FDA Class 2
·System, Peritoneal, Automatic Delivery
HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, T5C8300R
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt·Product code FKX·December 23, 2002
Automated peritoneal dialysis (APD) cycler
FDA Recall
Terminated
·Baxter Healthcare Corp.·Product code FKX·February 16, 2016
Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code FKX·November 15, 2023
AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis.
FDA Recall
Terminated
·Baxter Healthcare Corporation·Product code FKX·December 11, 2018