118 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·June 17, 2026
Bicarby Dialysate; Model number: RFP-400-G;
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·June 17, 2026
5008X CAREsystem +CLiC +CDX;
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·December 24, 2025
Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, (3) 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, (4) 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·October 15, 2025
Dialyzer Optiflux 160NRe
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·January 15, 2025
Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 190895, 190908, 191124, 191126, 191128, and 191130
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·September 18, 2024
RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·July 17, 2024
190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·July 17, 2024
RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·July 17, 2024
190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·July 17, 2024
RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·July 17, 2024
191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·July 17, 2024
RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·July 17, 2024
190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·July 17, 2024
Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blood in adults with acute respiratory failure or acute cardiopulmonary failure Product Code: F30000163
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·May 22, 2024
US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Number: 24-090A-1
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·June 19, 2024
2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·May 29, 2024
Stay Safe Cap
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·December 13, 2023
2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 190713 2008T HEMODIALYSIS SYS., with CDX; (2) 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG W/CDX ; (3) 191124 2008T HD SYS. CDX BLUESTAR; (4) 191126 2008T HD SYS. CDX W/BIBAG BLUESTAR
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·December 28, 2022
AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022