device 510k
saveFresenius Medical Care Renal Therapies Group, LLC — 5008X Hemodialysis System (510k cleared)
community read0 votes
Product code: KDI. Advisory committee: Gastroenterology, Urology. Type: Traditional
view source ↗Data sources
last refreshed 5mo ago
Found something off?
same company · ±60 days · 4
- device 510kFresenius Medical Care Renal Therapies Group, LLC — 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130) (510k cleared)Jun 13, 2025
- recallFresenius Medical Care Holdings, Inc. recall (Cls II)Jul 2, 2025
- device 510kFresenius Medical Care Renal Therapies Group, LLC — Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G) (510k cleared)Apr 4, 2025
- device 510kFresenius Medical Care Renal Therapies Group, LLC — staysafe® catheter extension set with Safe- Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 6 inch; staysafe® catheter extension set with Luer-Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 18 inch; staysafe® to Luer-Lock Adapter, 4 inch (510k cleared)Apr 3, 2025
🐶 often sniffed alongside
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
comments(0)
5-min edit window · permanent after that