Home › Device types › FKQ
System, Dialysate Delivery, Central Multiple Patient
FDA product code FKQ · Class 2 · Gastroenterology, Urology
67
Registered devices
19
Adverse events
2
Recalls
61
510(k) clearances
Devices with this code
Centrisol Acid Concentrate — MEDIVATORS INC.Centrisol Acid Concentrate — MEDIVATORS INC.Centrisol Acid Concentrate — MEDIVATORS INC.Centrisol Acid Concentrate — MEDIVATORS INC.Centrisol Acid Concentrate — MEDIVATORS INC.Centrisol Bicarbonate Concentrate Powder — MEDIVATORS INC.Centrisol Acid Concentrate — MEDIVATORS INC.Centrisol Acid Concentrate — MEDIVATORS INC.Centrisol Acid Concentrate — MEDIVATORS INC.Centrisol Acid Concentrate — MEDIVATORS INC.Renasol Acid Concentrate — MEDIVATORS INC.Centrisol Acid Concentrate — MEDIVATORS INC.Diacap® — B.Braun Avitum AGCentrisol Acid Concentrate — MEDIVATORS INC.Renasol Bicarbonate Concentrate Powder — MEDIVATORS INC.Actril Cold Sterilant — MEDIVATORS INC.Tablo Hemodialysis Concentrate — Outset Medical, Inc.Centrisol Acid Concentrate — MEDIVATORS INC.Centrisol Acid Concentrate — MEDIVATORS INC.Outset Acid Concentrate — MEDIVATORS INC.Centrisol Bicarbonate Concentrate Powder — MEDIVATORS INC.Centrisol Acid Concentrate — MEDIVATORS INC.Renasol Acid Concentrate — MEDIVATORS INC.Centrisol Liquid Bicarbonate Concentrate — MEDIVATORS INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-04-20 | Medivators, Inc. | The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation. |
| 2013-03-01 | B. Braun Medical, Inc. | There is the potential of the residual moisture of the Diacap Ultra membrane being reduced over time, which results in the reduction of the membrane permeabilit |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.