FDA.reportPublic FDA data

TENEX HEALTH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30097507041000135560TENEX HEALTH1N2026-01-0126902 Vista Terrace Lake Forest CA US 92630

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00857156006123Tenex Health TX® - TX-Bone (TXB) Procedure Pack, Shelf Pack, No Supply Kit9494547500regulatory@tenexhealth.com
00857156006185Tenex Health TX® - TX2 Procedure Pack, Shelf Pack, No Supply Kit9494547500regulatory@tenexhealth.com
00857156006246Tenex Health TX® - TX1 Procedure Pack, Shelf Pack, No Supply Kit9494547500regulatory@tenexhealth.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1516401177578282K181367Tenex Health TX System with the TXP MicroTipLFL2018-08-28
1516401262886314K153299Tenex Health TX SystemLFL2016-03-03
1516401667775868K123640TX1 TISSUE REMOVAL SYSTEMLFL2013-03-20
1516401242431763

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LFL32018-08-28

PMN#

GUDID#