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

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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HSB 2026-03-10

Reselute Tibial Nail

Applicant Reselute, Inc.

K-Number K253517

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N/A 2026-03-10

DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System

Applicant Synthes GmbH

K-Number K254093

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DZE 2026-03-10

Straumann® BLC Implants - Indication Widening

Applicant Institut Straumann AG

K-Number K252168

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EIH 2026-03-10

IPS e.max Zirconia

Applicant Ivoclar Vivadent, Inc.

K-Number K253953

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