# Instrumed GmbH · 89-08 · GERMANY — FDA import alert red lists: firms subject to detention without physical examination

For Instrumed GmbH · 89-08 · GERMANY, 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 GERMANY; product is Thoracic Trocar | Valvulatome | Traction Tongs | Hudson Burr 14mm; (Item# VM NL2SO) | Clamping Device with Ball and Socket (Item# VM NLISO) | Adson Perforating Bur; 14mm (Item# VM NL190) | McKenzie Perforating Twist Drill; 13mm (Item# VMNL200) | McKenzie Enlarging Burr; 16mm (Item# VM NL270) | Hudson Burr; 12mm; 8 teeth; tapered (Item# VM NL180) | Uterine Tenaculum Hook | Uterine Tenaculum Forceps | Endometrium | Circumcision Clamps; product code is 74 D - - RC Trocar | 74 M - - GZ Valvulotome | 84 H - - AX Tong, Skull for Traction | 84 H - - BG Drills, Burrs, Trephines & Accessories (Manual) | 84 H - - BG Drills, Burrs, Trephines & Accessories (Manual) | 84 H - - BG Drills, Burrs, Trephines & Accessories (Manual) | 84 H - - BG Drills, Burrs, Trephines & Accessories (Manual) | 84 H - - BG Drills, Burrs, Trephines & Accessories (Manual) | 84 H - - BG Drills, Burrs, Trephines & Accessories (Manual) | 85 H - - DC Tenaculum, Uterine | 85 H - - DC Tenaculum, Uterine | 85 H - - FX Clamp, Circumcision | 85 H - - FX Clamp, Circumcision; date published is 08/28/2014; address is Unter Buchsteig 3 , Tuttlingen, Baden-Wurttemberg GERMANY, verified against its source on 2026-09-16.

- **Firm:** Instrumed GmbH _(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:** GERMANY _(verified: appears in the quote below)_
- **Address:** Unter Buchsteig 3 , Tuttlingen, Baden-Wurttemberg GERMANY _(verified: appears in the quote below)_
- **Date published:** 08/28/2014 _(verified: appears in the quote below)_
- **Product code:** 74 D - - RC Trocar | 74 M - - GZ Valvulotome | 84 H - - AX Tong, Skull for Traction | 84 H - - BG Drills, Burrs, Trephines & Accessories (Manual) | 84 H - - BG Drills, Burrs, Trephines & Accessories (Manual) | 84 H - - BG Drills, Burrs, Trephines & Accessories (Manual) | 84 H - - BG Drills, Burrs, Trephines & Accessories (Manual) | 84 H - - BG Drills, Burrs, Trephines & Accessories (Manual) | 84 H - - BG Drills, Burrs, Trephines & Accessories (Manual) | 85 H - - DC Tenaculum, Uterine | 85 H - - DC Tenaculum, Uterine | 85 H - - FX Clamp, Circumcision | 85 H - - FX Clamp, Circumcision _(verified: each item appears in the quote below)_
- **Product:** Thoracic Trocar | Valvulatome | Traction Tongs | Hudson Burr 14mm; (Item# VM NL2SO) | Clamping Device with Ball and Socket (Item# VM NLISO) | Adson Perforating Bur; 14mm (Item# VM NL190) | McKenzie Perforating Twist Drill; 13mm (Item# VMNL200) | McKenzie Enlarging Burr; 16mm (Item# VM NL270) | Hudson Burr; 12mm; 8 teeth; tapered (Item# VM NL180) | Uterine Tenaculum Hook | Uterine Tenaculum Forceps | Endometrium | Circumcision Clamps _(verified: each item appears in the quote below)_
- **FDA notes:** Class 2 | Class 2 | Class 2 | Class 2 | Class 2 | Class 2 ; | Class 2 | Class 2 ; | Class 2 | Class 2 | Class 2 | Class 2 _(verified: each item appears in the quote below)_

## What the source says

> Instrumed GmbH Date Published : 08/28/2014 Unter Buchsteig 3 , Tuttlingen, Baden-Wurttemberg GERMANY 74 D - - RC Trocar Date Published: 08/28/2014 Desc: Thoracic Trocar Notes: Class 2 74 M - - GZ Valvulotome Date Published: 08/28/2014 Desc: Valvulatome Notes: Class 2 84 H - - AX Tong, Skull for Traction Date Published: 08/28/2014 Desc: Traction Tongs Notes: Class 2 84 H - - BG Drills, Burrs, Trephines & Accessories (Manual) Date Published: 08/28/2014 Desc: Hudson Burr 14mm; (Item# VM NL2SO) Notes: Class 2 84 H - - BG Drills, Burrs, Trephines & Accessories (Manual) Date Published: 08/28/2014 Desc: Clamping Device with Ball and Socket (Item# VM NLISO) Notes: Class 2 84 H - - BG Drills, Burrs, Trephines & Accessories (Manual) Date Published: 08/28/2014 Desc: Adson Perforating Bur; 14mm (Item# VM NL190) 84 H - - BG Drills, Burrs, Trephines & Accessories (Manual) Date Published: 08/28/2014 Desc: McKenzie Perforating Twist Drill; 13mm (Item# VMNL200) Notes: Class 2 ; 84 H - - BG Drills, Burrs, Trephines & Accessories (Manual) Date Published: 08/28/2014 Desc: McKenzie Enlarging Burr; 16mm (Item# VM NL270) Notes: Class 2 84 H - - BG Drills, Burrs, Trephines & Accessories (Manual) Date Published: 08/28/2014 Desc: Hudson Burr; 12mm; 8 teeth; tapered (Item# VM NL180) Notes: Class 2 ; 85 H - - DC Tenaculum, Uterine Date Published: 08/28/2014 Desc: Uterine Tenaculum Hook Notes: Class 2 85 H - - DC Tenaculum, Uterine Date Published: 08/28/2014 Desc: Uterine Tenaculum Forceps Notes: Class 2 85 H - - FX Clamp, Circumcision Date Published: 08/28/2014 Desc: Endometrium Notes: Class 2 85 H - - FX Clamp, Circumcision Date Published: 08/28/2014 Desc: Circumcision Clamps Notes: Class 2

## 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/).