Gambro Renal Products, Inc.
Gambro Renal Products, Inc. holds FDA 510(k) medical device clearances, first cleared 2004, most recent 2014, with 2 FDA device recalls on record.
Top product codes for Gambro Renal Products, Inc.
FDA recalls by Gambro Renal Products, Inc.
- Z-0490-2015 — Polyflux Revaclear Max Dialyzer, Model Number 110634. The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis.
- Z-0489-2015 — Polyflux Revaclear Dialyzer, Model Number 110633. The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Gambro Renal Products, Inc.
- K133807 — MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT
- K131516 — PRISMAFLEX SYSTEM 7.10
- K130039 — REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER
- K113313 — MOLECULAR ADSORBENT RECIRCULATING(MARS)
- K110823 — PRISMAFLEX
- K103832 — PHOENIX HEMODIALYSIS DELIVERY SYSTEM
- K100451 — GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132
- K100364 — GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520
- K093608 — GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H
- K080519 — PRISMAFLEX M150 SET
- K072232 — GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL
- K063183 — PRISMA M10 PRE SET
- K040255 — POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE
Data sourced from openFDA. This site is unofficial and independent of the FDA.