device 510k
saveFresenius Medical Care Renal Therapies Group, LLC — DIASAFEplusUS (F00013010) (510k cleared)
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Product code: FIP. Advisory committee: Gastroenterology, Urology. Type: Traditional
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same company · ±60 days · 6
- device recallFresenius Medical Care Holdings, Inc. device recall (Cls II)Oct 25, 2025
- device 510kFresenius Medical Care North America — AquaA (510k cleared)Sep 9, 2025
- device 510kFresenius Medical Care Renal Therapies Group, LLC — Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W) (510k cleared)Sep 9, 2025
- device 510kFresenius Medical Care Renal Therapies Group, LLC — AquaC UNO H (510k cleared)Nov 14, 2025
- device recallFresenius Medical Care Holdings, Inc. device recall (Cls II)Aug 29, 2025
- device 510kFresenius Medical Care Renal Therapies Group, LLC — BCM2-Body Composition Monitor (510k cleared)Nov 24, 2025
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top 8- drugRNS-6034 co-mentions · 20 sources
- company$FMCQFFresenius Medical Care AG26 co-mentions · 20 sources
- tag510(k) Clearance14 co-mentions · 14 sources
- tagAdCom14 co-mentions · 14 sources
- tagGastroenterology13 co-mentions · 13 sources
- tagNephrology13 co-mentions · 13 sources
- tagUrology13 co-mentions · 13 sources
- tagRecall8 co-mentions · 6 sources
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