Falkenbergsgatan 3, Gothenburg, Sweden, 41285
Showing 1–20 of 32 devices
| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| Ortoma Treatment Solution - OTS | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| OTS™ Aufsatzadapter Fix OT | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| OTS™ Aufsatzadapter Twin OT | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| OTS™ Einführinstrument-Adapter OTD | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| OTS™ Einführinstrument-Adapter OTD gerade | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| OTS™ Einführinstrument-Adapter OTD Pinnacle gerade | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| OTS™ Fräseradapter OTD | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| OTS™ Gewindestift 4 x 150 mm | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| OTS™ Gewindestifteindreher | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| OTS Hip | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Registered with AU (TGA) | Not registered with EU (EUDAMED) |
| OTS Hip Guide | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| OTS Hip Guide Software | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| OTS Hip Plan | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| OTS™ Hüftführungs-Software | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| OTS™ Hüftführungssystem | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| OTS™ Hüftplan | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| OTS™ Kalibrieradaptereinheit OTD | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| OTS™ Kalibrieradaptereinheit OTD Emphasys | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| OTS™ Mandrin und Pin | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| OTS Medical Electrical System | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Registered with AU (TGA) | Not registered with EU (EUDAMED) |
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