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

OHT 2026-03-11

Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025)

Applicant Shenzhen Chuangtong Yigou Technology Co., Ltd.

K-Number K254047

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EBF 2026-03-11

Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One

Applicant Kulzer, LLC

K-Number K260783

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NAY 2026-03-11

da Vinci Force Feedback Instruments

Applicant Intuitive Surgical, Inc.

K-Number K253986

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HRS 2026-03-11

Xpert Hand

Applicant Newclip Technics

K-Number K253906

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DWF 2026-03-11

Venous Return Cannulae

Applicant LivaNova USA, Inc.

K-Number K250937

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FRO 2026-03-11

LUOFUCON® Antimicrobial Wound Gel

Applicant Huizhou Foryou Medical Co., Ltd.

K-Number K252028

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GEX 2026-03-11

Picasso Pro Diode Laser (002-00460)

Applicant CAO Group, Inc.

K-Number K254197

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PHX 2026-03-11

INHANCE™ Reverse Shoulder System

Applicant Depuy Ireland UC

K-Number K253624

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MBI 2026-03-11

Strut Suture; No-Tie Button

Applicant Riverpoint Medical, LLC

K-Number K253693

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IYN 2026-03-10

Sonosite iLOOK Ultrasound System

Applicant FUJIFILM Sonosite, Inc.

K-Number K260595

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OWB 2026-03-10

Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)

Applicant Canon Medical Systems Corporation

K-Number K253584

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NVK 2026-03-10

Gemini NOVA 810+980 Soft Tissue Laser

Applicant Azena Medical, LLC

K-Number K260765

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