On-X Life Technologies Inc.
Austin, TX, US
On-X Life Technologies Inc. appears in FDA device records in Austin, TX. FDA records list one 510(k) clearance, 66 PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for On-X Life Technologies Inc. in 2014.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1649833 | 3001584317 | On-X Life Technologies Inc. | 1300 East anderson Lane, Austin, TX 78752 US | 2026 | and 4 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- OFACardiovascular Surgical Instruments Tray
- NEGFinger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis
- LWQHeart-Valve, Mechanical
- OMXHigh Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis
- DTJHolder, Heart-Valve, Prosthesis
- MDMInstrument, Manual, Surgical, General Use
- DWSInstruments, Surgical, Cardiovascular
- PAWNonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
- LXNProbe, Test, Heart-Valve
- KWIProsthesis, Elbow, Hemi-, Radial, Polymer
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- KWNProsthesis, Wrist, Carpal Lunate
- KYIProsthesis, Wrist, Carpal Trapezium
- DTISizer, Heart-Valve, Prosthesis
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2133-2026 | On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33 | Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications. | Class II | Open, Classified | |
| Z-1057-2017 | Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve repair. | Four issues were uncovered by the recalling firm's CAPA: 1) Burrs were found to be present on Left Housing, Right Housing and Barrel components, 2) Loose plastic particulate was found within sealed primary packages, 3) Loose hair was discovered within four sealed primary packages and 4) Assembly error, wherein Left and Right Housing components were acceptably press-fit together, was discovered within one sealed primary package. One of the Left Housing press-fit pins was not pressed into the associated hole of the Right Housing, resulting in a small gap in the housing assembly. | Class II | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets On-X Life Technologies Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain