RegWardenFDA facility compliance records
Facility

BROSMED MEDICAL CO.,LTD

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

Activity by year

FDA actions on record by year2018: 1 recalls, 1 inspections20172201820192020202120222023202420252026
  • Recalls (1)
  • Inspections (1)

Devices registered here (1)

  • Syringe, Balloon Inflation, Exempt
    Product code PTM (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1650

Recalls & enforcement

FDA inspections (1)

  • NAI2018-04-26
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “BROSMED MEDICAL CO.,LTD (FEI 3010391265) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010391265-brosmed-medical-co-ltd/

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