Reference Source

Instrumed GmbH · 89-08 · GERMANY

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
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 | 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 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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

— accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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