Isopure, Corp.
Isopure, Corp. holds FDA 510(k) medical device clearances, first cleared 2000, most recent 2020, with 5 FDA device recalls on record.
Top product codes for Isopure, Corp.
FDA recalls by Isopure, Corp.
- Z-1739-2022 — Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262
- Z-1360-2022 — Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
- Z-0821-2020 — Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson Centrifugal Pump Model #110192-3
- Z-0822-2020 — Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3
- Z-0823-2020 — Finish Thompson Centrifugal Pump Model #110192-3 (sold as spare part)
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 Isopure, Corp.
Data sourced from openFDA. This site is unofficial and independent of the FDA.