520 results
·
71ms
·
Sources: EU EUDAMED, US FDA
Sodium Bicarbonate, USP Provided bulk as raw material - label not applicable according to firm Dialysis Grade 1.5 Dialysis Grade 2 As an API or excipient in the manufacture of Medical Devices and Drugs
FDA Enforcement
Class II
·Terminated·Church & Dwight Inc·July 31, 2013
Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·February 5, 2020
HEMODIALYSIS BLOODLINES
FDA Adverse Event
Malfunction
·B. BRAUN MEDICAL INC.·Product code FJK·March 11, 2026
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·September 12, 2025
POTASSIUM AND CALCIUM ELECTROLYTE POWDER PACKETS
FDA Adverse Event
Other
·EDLAW PHARMACEUTICALS, INC.·Product code KPO·November 1, 2023
ACID DIALYSATE BATH
FDA Adverse Event
Other
·MEDIVATORS, INC.·Product code FKQ·November 1, 2023
TABLO X HEMODIALYSIS SYSTEM
FDA Adverse Event
Injury
·OUTSET MEDICAL, INC.·Product code KDI·April 2, 2021
TABLO HEMODIALYSIS SYSTEM
FDA Adverse Event
Death
·OUTSET MEDICAL, INC.·Product code KDI·September 22, 2020
DIALOG A + HE/BIC
FDA Adverse Event
Malfunction
·B. BRAUN AVITUM AG - MELSUNGEN·Product code FKJ·January 8, 2016
TABLO HEMODIALYSIS SYSTEM
FDA Adverse Event
Death
·OUTSET MEDICAL, INC.·Product code KDI·August 18, 2020
IMPELLA 5.5 WITH SMARTASSIST S2 SET, US
FDA Adverse Event
Injury
·ABIOMED, INC. - 1220648·Product code OZD·March 9, 2026
TEGO
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC.·Product code FPA·January 23, 2017
TABLO X HEMODIALYSIS SYSTEM
FDA Adverse Event
Injury
·OUTSET MEDICAL, INC.·Product code KDI·April 15, 2021
TABLO X HEMODIALYSIS SYSTEM
FDA Adverse Event
Injury
·OUTSET MEDICAL, INC.·Product code KDI·April 2, 2021
LOCKING TITANIUM ADAPTER FOR PERITONEAL DIALYSIS CATHETER
FDA Adverse Event
Injury
·BAXTER INTERNATIONAL INC.·Product code KDJ·September 22, 2022
DIALOG A + HE/BIC
FDA Adverse Event
Malfunction
·B. BRAUN AVITUM AG - MELSUNGEN·Product code FKJ·August 5, 2016
TABLO HEMODIALYSIS SYSTEM
FDA Adverse Event
Injury
·OUTSET MEDICAL, INC.·Product code KDI·December 22, 2020
TABLO HEMODIALYSIS SYSTEM
FDA Adverse Event
Death
·OUTSET MEDICAL, INC.·Product code KDI·December 15, 2020
TABLO X HEMODIALYSIS SYSTEM
FDA Adverse Event
Injury
·OUTSET MEDICAL, INC.·Product code KDI·February 22, 2021
TABLO HEMODIALYSIS SYSTEM
FDA Adverse Event
Death
·OUTSET MEDICAL, INC.·Product code KDI·January 12, 2021