5585 NE Cornelius Pass Road, Hillsboro, United States, 97124
Showing 1–20 of 598 devices
| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| 2.0mm Auto-Drive® MMF Screws, M3/M4/CFx™ Rigid Fixation System | 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) |
| 2.0 Orthognathic Rigid Fixation System | 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) |
| 2.0 Orthognathic Rigid Fixation System, M3/M4/CFx™ Rigid Fixation System | 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) |
| 2.0 Orthognathic Rigid Fixation System, ManFrac/MFx™ Rigid Fixation System, M3/M4/CFx™ Rigid Fixation System | 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) |
| 2.0 Orthognathic Rigid Fixation System, Orthognathic Supra Advancement (OSA) System, M3/M4/CFx™ Rigid Fixation System | 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) |
| 2.0 Orthognathic Rigid Fixation System, Orthognathic Supra Advancement (OSA) System, ManFrac/MFx™ Rigid Fixation System, M3/M4/CFx™ Rigid Fixation System | 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) |
| 2.3MM LOCKING CORTICAL PEG | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| 2.3MM LOCKING CORTICAL SCREW | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| 2.3MM NON-TOGGLING CORTICAL SCREW | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| Acu-Loc 2 | 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) |
| AcuLoc 2 | 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) |
| ACU-LOC 2 VOLAR DISTAL RADIAL PLATING SYSTEM - BUTTRESS PLATE | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| ACU-LOC 2 VOLAR DISTAL RADIAL PLATING SYSTEM - LOCKING CORTICAL SCREW | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| ACU-LOC 2 VOLAR DISTAL RADIAL PLATING SYSTEM - LUNATE PLATE | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| ACU-LOC 2 VOLAR DISTAL RADIAL PLATING SYSTEM - NON-TOGGLING CORTICAL SCREW | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| ACU-LOC 2 VOLAR DISTAL RADIAL PLATING SYSTEM - STYLOID PLATE | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| ACU-LOC 2 VOLAR DISTAL RADIAL PLATING SYSTEM - SUTURE PLATE | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| ACU-LOC 2 VOLAR DISTAL RADIUS PLATING SYSTEM - CANNULATED DRIVER ASSY | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| ACU-LOC 2 VOLAR DISTAL RADIUS PLATING SYSTEM - COMPRESSION SCREW | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| ACU-LOC 2 VOLAR DISTAL RADIUS PLATING SYSTEM - COMPRESSION SLEEVE | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
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