Bd Sigma · 89-08 · ISRAEL
For Bd Sigma, 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 Tripollar POSE; Tripollar STOP; product code is 89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat; date published is 08/02/2011; address is Yagur St 2 , Haifa, ISRAEL, verified against its source on 2026-09-30.
- Firm
- Bd Sigma 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
- Yagur St 2 , Haifa, ISRAEL verified
- Date published
- 08/02/2011 verified
- Product code
- 89 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat verified
- Product
- Tripollar POSE; Tripollar STOP verified
- FDA notes
- Class II verified
What the source says
Bd Sigma Date Published : 08/02/2011 Yagur St 2 , Haifa, 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 H - - PH Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat Date Published: 08/02/2011 Desc: Tripollar POSE; Tripollar STOP Notes: Class II
— 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.