# Medispec, Ltd. · 89-08 · ISRAEL — FDA import alert red lists: firms subject to detention without physical examination

For Medispec, Ltd. · 89-08 · ISRAEL, 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 ISRAEL; product is Radialspec; product code is 89 O - - OV Evopace system and accessories; date published is 05/17/2010; address is 40, Hataasiya Street , Yehud, ISRAEL, verified against its source on 2026-09-16.

- **Firm:** Medispec, 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:** ISRAEL _(verified: appears in the quote below)_
- **Address:** 40, Hataasiya Street , Yehud, ISRAEL _(verified: appears in the quote below)_
- **Date published:** 05/17/2010 _(verified: appears in the quote below)_
- **Product code:** 89 O - - OV Evopace system and accessories _(verified: appears in the quote below)_
- **Product:** Radialspec _(verified: appears in the quote below)_
- **FDA notes:** Class III _(verified: appears in the quote below)_

## What the source says

> Medispec, Ltd. Date Published : 05/17/2010 40, Hataasiya Street , Yehud, ISRAEL 89 O - - OV Evopace system and accessories Date Published: 05/17/2010 Desc: Radialspec Notes: Class III

## 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/).