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THE TAPE

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 / Women's Health

Women's Health GI & Urology

Axora Medical

Sunnyvale, CA · Unknown · 510(k) cleared

Sells devices for office-based gynecology, including the HERizon Vista hysteroscopy platform and the Symphion tissue removal system. It distributes Porter Instrument's Nitronox Plus nitrous oxide system to US gynecology practices.

FDA DECISIONS ON FILE

1 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Aug 18, 26	K260984510(k)	HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)	Axora Medical, Inc.	Obstetrics/Gynecology	HIH

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