# GAELTEC DEVICES LTD · 89-08 · UNITED KINGDOM — FDA import alert red lists: firms subject to detention without physical examination

For GAELTEC DEVICES LTD · 89-08 · UNITED KINGDOM, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is UNITED KINGDOM; product code is 73 - - - -- Anesthesiology | 74 - - - -- Cardiovascular | 76 - - - -- Dental | 77 - - - -- Ear,Nose And Throat | 78 - - - -- Gastroenterological & Urological | 79 - - - -- General & Plastic Surgery | 80 - - - -- General Hospital/Personal Use | 84 - - - -- Neurological | 85 - - - -- Obstetrical & Gynecological | 86 - - - -- Ophthalmic | 87 - - - -- Orthopedic | 89 - - - -- Physical Medicine | 90 - - - -- Radiology; date published is 08/14/2018; address is Dunvegan Fire Station , Glendale Road , Isle Of Skye, HLD UNITED KINGDOM, verified against its source on 2026-09-16.

- **Firm:** GAELTEC DEVICES LTD _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** UNITED KINGDOM _(verified: appears in the quote below)_
- **Address:** Dunvegan Fire Station , Glendale Road , Isle Of Skye, HLD UNITED KINGDOM _(verified: appears in the quote below)_
- **Date published:** 08/14/2018 _(verified: appears in the quote below)_
- **Product code:** 73 - - - -- Anesthesiology | 74 - - - -- Cardiovascular | 76 - - - -- Dental | 77 - - - -- Ear,Nose And Throat | 78 - - - -- Gastroenterological & Urological | 79 - - - -- General & Plastic Surgery | 80 - - - -- General Hospital/Personal Use | 84 - - - -- Neurological | 85 - - - -- Obstetrical & Gynecological | 86 - - - -- Ophthalmic | 87 - - - -- Orthopedic | 89 - - - -- Physical Medicine | 90 - - - -- Radiology _(verified: each item appears in the quote below)_
- **FDA notes:** All medical devices | All medical devices | All medical devices | All medical devices | All medical devices | All medical devices | All medical devices | All medical devices | All medical devices | All medical devices | All medical devices | All medical devices | All medical devices _(verified: each item appears in the quote below)_

## What the source says

> GAELTEC DEVICES LTD Date Published : 08/14/2018 Dunvegan Fire Station , Glendale Road , Isle Of Skye, HLD UNITED KINGDOM 73 - - - -- Anesthesiology Date Published: 08/14/2018 Notes: All medical devices 74 - - - -- Cardiovascular Date Published: 08/14/2018 Notes: All medical devices 76 - - - -- Dental Date Published: 08/14/2018 Notes: All medical devices 77 - - - -- Ear,Nose And Throat Date Published: 08/14/2018 Notes: All medical devices 78 - - - -- Gastroenterological & Urological Date Published: 08/14/2018 Notes: All medical devices 79 - - - -- General & Plastic Surgery Date Published: 08/14/2018 Notes: All medical devices 80 - - - -- General Hospital/Personal Use Date Published: 08/14/2018 Notes: All medical devices 84 - - - -- Neurological Date Published: 08/14/2018 Notes: All medical devices 85 - - - -- Obstetrical & Gynecological Date Published: 08/14/2018 Notes: All medical devices 86 - - - -- Ophthalmic Date Published: 08/14/2018 Notes: All medical devices 87 - - - -- Orthopedic Date Published: 08/14/2018 Notes: All medical devices 89 - - - -- Physical Medicine Date Published: 08/14/2018 Notes: All medical devices 90 - - - -- Radiology Date Published: 08/14/2018 Notes: All medical devices

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).