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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 / Oncology

Oncology Orthopedics & Spine

Onkos Surgical

Parsippany, NJ · Series C · De Novo granted

Builds implants and personalized surgical solutions for musculoskeletal oncology and complex orthopaedic reconstruction, including the ELEOS limb salvage system and the NanoCept antibacterial implant coating.

FDA DECISIONS ON FILE

1 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Jun 8, 26	K253066510(k)	ELEOS with NanoCept® Technology Limb Salvage System	Onkos Surgical, Inc.	Orthopedic	QZZ

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Onkos Surgical

FDA DECISIONS ON FILE

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