1300 E Anderson Ln, Austin, United States, 78752
Showing 1–20 of 33 devices
| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| CHORD-X CHORDAL SIZER | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | Registered with AU (TGA) | Not registered with EU (EUDAMED) |
| CHORD-X EPTFE SUTURE (SUTURE WITH CIRCLE NEEDLE) | 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) |
| CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT | Registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | Registered with AU (TGA) | Not registered with EU (EUDAMED) |
| CHORD-X SUTURE SYSTEM FOR MITRAL CHORDAL REPLACEMENT | 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) |
| INSTRUMENT HANDLE | 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) |
| LEAFLET PROBE | 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) |
| On-X AAP | 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) |
| On-X Aortic Heart Valve | 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) |
| ON-X AORTIC PROSTHETIC HEART VALVE WITH ANATOMIC SEWING RING | 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) |
| On-X® Ascending Aortic Prosthesis | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Registered with EU (EUDAMED) |
| On-X Conform-X Aortic Prosthetic Heart Valve | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Registered with AU (TGA) | Not registered with EU (EUDAMED) |
| ON-X CONFORM-X PROSTHETIC HEART VALVE - AORTIC | 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) |
| ON-X CONFORM-X PROSTHETIC HEART VALVE-AORTIC WITH EXTENDED VALVE HOLDER | 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) |
| ON-X CONFORM-X PROSTHETIC HEART VALVE - MITRAL | 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) |
| On-X HV Instruments | 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) |
| ONXI2 SIZE 19 ROTATOR | 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) |
| ONXI2 SIZE 19 SIZER | 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) |
| ONXI3 SIZE 19 SIZER | 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) |
| ONXI3 SIZE 25 MITRAL ROTATOR | 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) |
| On-X Mitral Conform-X Prosthetic Heart Valve | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Registered with AU (TGA) | Not registered with EU (EUDAMED) |
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