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Theraclion wins a De Novo for treating varicose veins with focused ultrasound Onkos Surgical extends its antibacterial coating to more ELEOS titanium parts Siemens Healthineers names its diagnostics carve-out Olyrian and sets mid-2028 FX Shoulder clears the first stemless reverse shoulder system sold in the US Edwards raises its 2026 outlook a third time on $1.24B of TAVR sales CMS pays non-contrast imaging the same rate in hospitals and offices from 2027 Mobia Medical lifts 2026 guidance after a 73 percent revenue quarter PulseAI clears an arrhythmia model that reads single-lead ECG from wearables Baird Medical's partner files a 510(k) for an irreversible electroporation system Theraclion wins a De Novo for treating varicose veins with focused ultrasound Onkos Surgical extends its antibacterial coating to more ELEOS titanium parts Siemens Healthineers names its diagnostics carve-out Olyrian and sets mid-2028 FX Shoulder clears the first stemless reverse shoulder system sold in the US Edwards raises its 2026 outlook a third time on $1.24B of TAVR sales CMS pays non-contrast imaging the same rate in hospitals and offices from 2027 Mobia Medical lifts 2026 guidance after a 73 percent revenue quarter PulseAI clears an arrhythmia model that reads single-lead ECG from wearables Baird Medical's partner files a 510(k) for an irreversible electroporation system

The Directory / Orthopedics & Spine

Orthopedics & Spine

FX Shoulder Solutions

Addison, TX · Unknown · 510(k) cleared

Designs shoulder arthroplasty implants and instruments, including the Easytech stemless anatomical system and Easytech Reversed, a stemless reverse shoulder system.

FDA DECISIONS ON FILE

1 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
May 1, 26	K254154510(k)	FX V135 EASYTECH® Shoulder System	FX Shoulder Solutions, Inc.	Orthopedic	PKC

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FX Shoulder Solutions

FDA DECISIONS ON FILE

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