Instrumed GmbH · 89-08 · GERMANY
For Instrumed GmbH, import alert is 89-08; country is GERMANY; 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 Thoracic Trocar | Valvulatome | Traction Tongs | Clamping Device with Ball and Socket (Item# VM NLISO) | McKenzie Enlarging Burr; 16mm (Item# VM NL270) | Hudson Burr 14mm; (Item# VM NL2SO) | McKenzie Perforating Twist Drill; 13mm (Item# VMNL200) | Adson Perforating Bur; 14mm (Item# VM NL190) | Hudson Burr; 12mm; 8 teeth; tapered (Item# VM NL180) | Uterine Tenaculum Hook | Uterine Tenaculum Forceps | Circumcision Clamps | Endometrium; 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 2026-09-30.
- Firm
- Instrumed GmbH 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
- GERMANY verified
- Address
- Unter Buchsteig 3 , Tuttlingen, Baden-Wurttemberg GERMANY verified
- Date published
- 08/28/2014 verified
- 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 each item verified
- Product
- Thoracic Trocar | Valvulatome | Traction Tongs | Clamping Device with Ball and Socket (Item# VM NLISO) | McKenzie Enlarging Burr; 16mm (Item# VM NL270) | Hudson Burr 14mm; (Item# VM NL2SO) | McKenzie Perforating Twist Drill; 13mm (Item# VMNL200) | Adson Perforating Bur; 14mm (Item# VM NL190) | Hudson Burr; 12mm; 8 teeth; tapered (Item# VM NL180) | Uterine Tenaculum Hook | Uterine Tenaculum Forceps | Circumcision Clamps | Endometrium each item verified
- 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 each item verified
What the source says
Instrumed GmbH Date Published : 08/28/2014 Unter Buchsteig 3 , Tuttlingen, Baden-Wurttemberg GERMANY
— accessdata.fda.gov, retrieved 2026-09-22
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
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: 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: 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 14mm; (Item# VM NL2SO) Notes: Class 2 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: Adson Perforating Bur; 14mm (Item# VM NL190) 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: Circumcision Clamps Notes: Class 2 85 H - - FX Clamp, Circumcision Date Published: 08/28/2014 Desc: Endometrium Notes: Class 2
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html