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ON-X LIFE TECHNOLOGIES, INC.

United States·US-MF-000026354

Last updated May 24, 2026

Information

Country: United States
Address: 1300 , East Anderson Lane Bldg B, Austin, United States
Website: www.artivion.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 770-419-3355
PRRC Contact: Drew Green
EUDAMED SRN: US-MF-000026354
FDA FEI Number: —
DUNS Number: 844782318

Catalogue (96)

Page 2 of 2

Device	Model / Reference	Registries	Class	Status
On-X Heart Valve Instruments	ONXI3-25MR	EUDAMEDFDA UDI	Class I	Active
On-X Aortic Heart Valve with Conform-X Sewing Ring	ONXAC-21	FDA UDI	Class III	Active
On-X Heart Valve Instruments	ONXI3-27-33S	EUDAMEDFDA UDI	Class I	Active
Chord-X Premeasured Loops and Suture System	CXL-30-1838-16	FDA UDI	Class II	Active
On-X Aortic Heart Valve with Anatomic Sewing Ring and Extended Holder	ONXANE-19	FDA UDI	Class III	Active
Chord-X Premeasured Loops and Suture System	CXL-30-1838-12	FDA UDI	Class II	Active
On-X Ascending Aortic Prosthesis	ONXAAP-19	FDA UDI	Class III	Active
On-X Aortic Heart Valve with Standard Sewing Ring	ONXA-25	FDA UDI	Class III	Active
Chord-X Premeasured Loops and Suture System	CXL-20-1838-16	FDA UDI	Class II	Active
On-X Heart Valve Instruments	ONXI2-CT	EUDAMEDFDA UDI	Class I	Active
Chord-X Premeasured Loops and Suture System	CXL-30-1812-20	FDA UDI	Class II	Active
On-X Heart Valve Instruments	ONXI3-23-25S	EUDAMEDFDA UDI	Class I	Active
Chord-X Premeasured Loops and Suture System	CXL-20-1838-24	FDA UDI	Class II	Active
On-X Aortic Heart Valve with Conform-X Sewing Ring	ONXAC-27/29	FDA UDI	Class III	Active
On-X Ascending Aortic Prosthesis	ONXAAP-25	EUDAMEDFDA UDI	Class III	Active
On-X Mitral Heart Valve with Standard Sewing Ring	ONXM-25	FDA UDI	Class III	Active
Chord-X Premeasured Loops and Suture System	CXL-30-2238-16	FDA UDI	Class II	Active
Chord-X Premeasured Loops and Suture System	CXL-20-2212-0	FDA UDI	Class II	Active
On-X Aortic Heart Valve with Anatomic Sewing Ring	ONXAN-23	FDA UDI	Class III	Active
On-X Heart Valve Instruments	ONXI2-23S	EUDAMEDFDA UDI	Class I	Active
On-X Aortic Heart Valve with Conform-X Sewing Ring	ONXAC-25	FDA UDI	Class III	Active
Chord-X Premeasured Loops and Suture System	CXL-20-1812-0	FDA UDI	Class II	Active
Chord-X Premeasured Loops and Suture System	CXL-20-1812-12	FDA UDI	Class II	Active
On-X Aortic Heart Valve with Conform-X Sewing Ring	ONXAC-23	FDA UDI	Class III	Active
Chord-X Premeasured Loops and Suture System	CXL-30-1838-24	FDA UDI	Class II	Active
Chord-X Premeasured Loops and Suture System	CXL-30-1812-24	FDA UDI	Class II	Active
Chord-X Premeasured Loops and Suture System	CXL-30-1812-16	FDA UDI	Class II	Active
On-X Heart Valve Instruments	ONXI3-25S	EUDAMEDFDA UDI	Class I	Active
Chord-X Premeasured Loops and Suture System	CXL-20-2212-24	FDA UDI	Class II	Active
On-X Heart Valve Instruments	ONXI2-23R	EUDAMEDFDA UDI	Class I	Active
Chord-X Premeasured Loops and Suture System	CXL-30-2212-16	FDA UDI	Class II	Active
Chord-X Premeasured Loops and Suture System	CXL-20-2238-0	FDA UDI	Class II	Active
On-X Aortic Heart Valve with Standard Sewing Ring and Extended Holder	ONXAE-25	FDA UDI	Class III	Active
Chord-X Premeasured Loops and Suture System	CXL-30-1812-12	FDA UDI	Class II	Active
On-X Heart Valve Instruments	ONXI2-21R	EUDAMEDFDA UDI	Class I	Active
Chord-X Premeasured Loops and Suture System	CXL-30-2212-24	FDA UDI	Class II	Active
Chord-X Premeasured Loops and Suture System	CXL-20-2238-24	FDA UDI	Class II	Active
Chord-X Premeasured Loops and Suture System	CXL-20-2238-20	FDA UDI	Class II	Active
On-X Heart Valve Instruments	ONXI3-27-29S	EUDAMEDFDA UDI	Class I	Active
On-X Heart Valve Instruments	ONXI2-LP	FDA UDI	Class I	Active
On-X Mitral Heart Valve with Standard Sewing Ring	ONXM-27/29	FDA UDI	Class III	Active
Chord-X Premeasured Loops and Suture System	CXL-30-2238-24	FDA UDI	Class II	Active
Chord-X Premeasured Loops and Suture System	CXL-30-1838-20	FDA UDI	Class II	Active
Chord-X Eptfe Suture	K121173	FDA 510(k)	Class II	Active
Chord-X Pre-Measured Loops For Mitral Chordal Replacement	K141060	FDA 510(k)	Class II	Active
On-X Prosthetic Heart Valve	P000037	EUDAMEDFDA PMAFDA UDI	Class III	Active

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FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Feb 1, 2026	Z-2133-2026	—	open, classified	Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
Dec 13, 2016	Z-1057-2017	—	terminated	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.