Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

HBE 2025-03-13

Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1)

Applicant Surgify Medical OY

K-Number K250380

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SBF 2025-03-13

xvision Spine system

Applicant Augmedics, Ltd.

K-Number K250255

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PBF 2025-03-13

MedCAD® AccuStride™ System

Applicant Medcad

K-Number K241811

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FTC 2025-03-13

308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)

Applicant Boston Aesthetics, Inc.

K-Number K244022

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GEX 2025-03-13

Photon Therapy Apparatus (BL-10)

Applicant Xemis Medical Technology (Shenzhen) Co., Ltd.

K-Number K243993

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GXY 2025-03-13

IceCap product line

Applicant Bioserenity Medical Devices Group

K-Number K243788

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FRO 2025-03-13

SiOxC Cream

Applicant Sioxmed, LLC

K-Number K242406

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JWH 2025-03-13

Freedom Total Knee System (All-poly Tibial Plate)

Applicant Maxx Orthopedics, Inc.

K-Number K250382

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GWL 2025-03-12

Delphi Amplifier

Applicant Quantalx Neroscience

K-Number K243746

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MUE 2025-03-12

2430TCA with Xmaru W

Applicant Rayence Co., Ltd.

K-Number K243849

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NGX 2025-03-12

Wireless TENS & EMS Unit

Applicant Changsha Anxiang Medical Technology Co., Ltd.

K-Number K243763

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PHL 2025-03-12

ReWalk® 7 Personal Exoskeleton (50-20-0005)

Applicant Rewalk Robotics Ltd. Dba Lifeward

K-Number K241822

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