Bd Sigma · 89-08 · ISRAEL
For Bd Sigma · 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 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 2026-09-16.
- 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 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
— 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.