# Ortomed B V · 89-08 · NETHERLANDS — FDA import alert red lists: firms subject to detention without physical examination

For Ortomed B V · 89-08 · NETHERLANDS, 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 NETHERLANDS; product is Implantable Device | Implantable Device | Implantable Device; product code is 76 - - - -- Dental | 77 - - - -- Ear,Nose And Throat | 87 - - - -- Orthopedic; date published is 06/20/2019; address is Fruiteniersstraat 23 , Postbus 1081 , Zwijndrecht, Zuid-Holland NETHERLANDS, verified against its source on 2026-09-16.

- **Firm:** Ortomed B V _(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:** NETHERLANDS _(verified: appears in the quote below)_
- **Address:** Fruiteniersstraat 23 , Postbus 1081 , Zwijndrecht, Zuid-Holland NETHERLANDS _(verified: appears in the quote below)_
- **Date published:** 06/20/2019 _(verified: appears in the quote below)_
- **Product code:** 76 - - - -- Dental | 77 - - - -- Ear,Nose And Throat | 87 - - - -- Orthopedic _(verified: each item appears in the quote below)_
- **Product:** Implantable Device | Implantable Device | Implantable Device _(verified: each item appears in the quote below)_
- **FDA notes:** DWPE Date; 4/23/1992 | DWPE Date; 4/23/1992 | DWPE Date; 4/23/1992 _(verified: each item appears in the quote below)_

## What the source says

> Ortomed B V Date Published : 06/20/2019 Fruiteniersstraat 23 , Postbus 1081 , Zwijndrecht, Zuid-Holland NETHERLANDS 76 - - - -- Dental Date Published: 06/20/2019 Desc: Implantable Device Notes: DWPE Date; 4/23/1992 77 - - - -- Ear,Nose And Throat Date Published: 06/20/2019 Desc: Implantable Device Notes: DWPE Date; 4/23/1992 87 - - - -- Orthopedic Date Published: 06/20/2019 Desc: Implantable Device Notes: DWPE Date; 4/23/1992

## 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/).