Medispec, Ltd. · 89-08 · ISRAEL
For Medispec, Ltd., import alert is 89-08; country is ISRAEL; 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)"; 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 2026-09-30.
- Firm
- Medispec, Ltd. verified
- 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
- Address
- 40, Hataasiya Street , Yehud, ISRAEL verified
- Date published
- 05/17/2010 verified
- Product code
- 89 O - - OV Evopace system and accessories verified
- Product
- Radialspec verified
- FDA notes
- Class III verified
What the source says
Medispec, Ltd. Date Published : 05/17/2010 40, Hataasiya Street , Yehud, ISRAEL
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
89 O - - OV Evopace system and accessories Date Published: 05/17/2010 Desc: Radialspec Notes: Class III
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.