Home / Import refusals / 799-1898115-2/10001/2

FDA Import Refusal 799-1898115-2/10001/2 — Boston Scientific Corporation

Boston Scientific Corporation — FEI 3005099803

The FDA refused shipment 799-1898115-2/10001/2 from Boston Scientific Corporation (United States) on September 24, 2025. The refused product falls under Devices — SYSTEM, IMAGING, X-RAY, ELECTROSTATIC. Cited charges: 118,341,476,508 This firm has 5 or more other import refusals on record.

Refusal Details

Date
September 24, 2025
Country
United States
Product Category
Devices
Product Code
90IXK SYSTEM, IMAGING, X-RAY, ELECTROSTATIC
Charges
118,341,476,508

Recent inspections

  • 1246067 (VAI Tue Nov 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1072267 (NAI Wed Oct 31 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1068733 (VAI Thu Sep 20 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 977724 (NAI Tue Jul 12 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 853358 (NAI Thu Oct 24 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • SCS-9104782-3/11/1 (Wed May 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-9104782-3/41/1 (Wed May 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-9104782-3/21/1 (Wed May 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-9104782-3/31/1 (Wed May 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-2478758-2/11/1 (Tue May 18 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources