Tenex Health

United States US-MF-000034123 Last updated 23 Oct 2026

Devices: 22
Registries: EUDAMEDGUDIDFDA 510(k)FDA
FDA recalls: 1

Catalogue22

Tenex Health TX® 554-2002-001 Ref 554-2002-001

Unclassified FDA UDI Active
Tenex Health TX® 554-2003-001 Ref 554-2003-001

Unclassified FDA UDI Active
Tenex Health TX® 557-1002-001 Ref 557-1002-001

Unclassified FDA UDI Active
Tenex Health TX® 554-0001-001 Ref 554-0001-001

Unclassified FDA UDI Active
Tenex Health TX® 551-7002-001 Ref 551-7002-001

Unclassified FDA UDI Active
Tenex Health TX® 554-1003-001 Ref 554-1003-001

Unclassified FDA UDI Active
Tenex Health TX 554-4003-002 Ref 554-4003-002

Unclassified FDA UDI
Tenex Health TX® 430-2215-002 Ref 430-2215-002

Unclassified FDA UDI Active
Tenex Health TX® 554-1002-001 Ref 554-1002-001

Unclassified FDA UDI Active
Tenex Health TX® 554-1006-001 Ref 554-1006-001

Unclassified FDA UDI Active
Tenex Health TX® 430-4024-001 Ref 430-4024-001

Unclassified FDA UDI Active
Tenex Health TX® 554-3003-001 Ref 554-3003-001

Unclassified FDA UDI Active
Tenex Health TX® 554-3003-002 Ref 554-3003-002

Unclassified EUDAMEDFDA UDI Active
Tenex Health TX® 554-0000-000 Ref 554-0000-000

Unclassified EUDAMEDFDA UDI Active
Tenex Health TX® 554-1001-001 Ref 554-1001-001

Unclassified FDA UDI Active
Tenex Health TX® 554-2003-002 Ref 554-2003-002

Unclassified EUDAMEDFDA UDI Active
Tenex Health TX® 430-4023-001 Ref 430-4023-001

Unclassified FDA UDI Active
Tenex Health TX® 554-1003-002 Ref 554-1003-002

Unclassified EUDAMEDFDA UDI Active
Tenex Health TX® 557-0017-001 Ref 557-0017-001

Unclassified FDA UDI Active
Tenex Health TX System with the TXP MicroTip Ref K181367

Unclassified FDA 510(k) Active
Tenex Health TX System Ref K153299

Unclassified FDA 510(k) Active
TX1 Tissue Removal System Ref K123640

Unclassified FDA 510(k) Active

FDA recalls1

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

2014
- 14 Apr 2014 Z-1552-2014 Class II Terminated The sterile barrier in the packaging may be compromised due to cracks in the thermoform tray that may occur during transport of the product in extreme cold weather conditions, in conjunction with mechanical impact.

Information

Country: United States
Address: 26902 Vista Terrace, Lake Forest, CA, United States
Website: tenexhealth.com/
Email: [email protected]
Phone: +1 949 454 7500
PRRC contact: David Vancelette
EUDAMED SRN: US-MF-000034123
FDA FEI number: 1000135560

Catalogue22

Tenex Health TX® 554-2002-001 Ref 554-2002-001

Tenex Health TX® 554-2003-001 Ref 554-2003-001

Tenex Health TX® 557-1002-001 Ref 557-1002-001

Tenex Health TX® 554-0001-001 Ref 554-0001-001

Tenex Health TX® 551-7002-001 Ref 551-7002-001

Tenex Health TX® 554-1003-001 Ref 554-1003-001

Tenex Health TX 554-4003-002 Ref 554-4003-002

Tenex Health TX® 430-2215-002 Ref 430-2215-002

Tenex Health TX® 554-1002-001 Ref 554-1002-001

Tenex Health TX® 554-1006-001 Ref 554-1006-001

Tenex Health TX® 430-4024-001 Ref 430-4024-001

Tenex Health TX® 554-3003-001 Ref 554-3003-001

Tenex Health TX® 554-3003-002 Ref 554-3003-002

Tenex Health TX® 554-0000-000 Ref 554-0000-000

Tenex Health TX® 554-1001-001 Ref 554-1001-001

Tenex Health TX® 554-2003-002 Ref 554-2003-002

Tenex Health TX® 430-4023-001 Ref 430-4023-001

Tenex Health TX® 554-1003-002 Ref 554-1003-002

Tenex Health TX® 557-0017-001 Ref 557-0017-001

Tenex Health TX System with the TXP MicroTip Ref K181367

Tenex Health TX System Ref K153299

TX1 Tissue Removal System Ref K123640

FDA recalls1

Information