RegWardenFDA facility compliance records
Company

Ondamed Inc.

1 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2017: 1 recalls12017201820192020202120222023202420252026
  • Recalls (1)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2017-07-07
    The firm was marketing the Ondamed System in the US without marketing clearance. As a corrective action, the firm revised its device design to comply with regulations. The firm has notified customers that an upgrade for the device is now available, which includes the addition of …

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Ondamed Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9052444-ondamed-inc/

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