RegWardenFDA facility compliance records
Company

IntroMedic Co., Ltd.

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 (2)

Recalls & enforcement

  • Class IITerminated2017-02-15
    When a user switches on MR1100 Receiver, even though the battery was fully charged, the LED was displayed as orange color due to momentary drop of battery voltage.

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. “IntroMedic Co., Ltd. — 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-10027343-intromedic-co-ltd/

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