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AmeriWater

Medical device maker. FDA records under 3 spellings of its name, each linked to the record.

  • 510(k) clearances: 12
  • Device recalls: 1

Records by Year

Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date

Latest Records

Newest first across sources; each opens the record
DateRecordSource
Feb 13, 2023AmeriWater MediQA Reverse Osmosis System (MSP3HF)K223656 · FIP510(k) clearances
Dec 10, 2014AMERIWATER OZONE DISINFECTION SYSTEMK141213 · FIN510(k) clearances
Dec 1, 2014AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hzK142285 · FIP510(k) clearances
Apr 16, 2014AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATIONK133783 · FIP510(k) clearances
Nov 13, 2013MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SAK131904 · FIP510(k) clearances
Sep 20, 2013MROZ REVERSE OSMOSIS SYSTEMK131622 · FIP510(k) clearances
Sep 17, 2012AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIVK121022 · FIP510(k) clearances
Aug 9, 2012AmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley Avenue, Dayton, OH 45404 (800) 535-5585 www.AMERIWATER.com. The AmeriWater MRClass II · The firm was notified that a malfunction of the device was caused by an incorrect fuse 32 volt 15 amp fuses instead of 2Device recalls
Oct 5, 2011AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATIONK111740 · FIP510(k) clearances

Canada and Imports

Matched by company name
Active Health Canada device licences
12, as of Nov 10, 2026

Names and Identifiers

Appears as
AmeriwaterAmeriWater, LLCAmeriWater Inc

Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.