Home / Import refusals / 799-6989917-9/11/1

FDA Import Refusal 799-6989917-9/11/1 — Gyrus Medical Ltd.

Gyrus Medical Ltd. — FEI 3002807134

The FDA refused shipment 799-6989917-9/11/1 from Gyrus Medical Ltd. (United Kingdom) on April 18, 2025. The refused product falls under Devices — HYSTEROSCOPE (AND ACCESSORIES). Cited charges: 118,3280,341,508 This firm has 4 other import refusals on record.

Refusal Details

Date
April 18, 2025
Country
United Kingdom
Product Category
Devices
Product Code
85HIH HYSTEROSCOPE (AND ACCESSORIES)
Charges
118,3280,341,508

Recent inspections

  • 677234 (OAI Thu Aug 05 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 510-8229674-3/401/1 (Fri Sep 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 510-8229674-3/401/2 (Fri Sep 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 510-8229674-3/401/3 (Fri Sep 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • EQ6-0008798-3/1/1 (Mon Dec 29 2008 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources