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

KPO 2026-08-19

Nipro Dry Acid Concentrate Mixer

Applicant Nipro Technical Solutions, Incoporated

K-Number K260799

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HIF 2026-08-19

ENDOFLATOR+; Smart Smoke Evacuation

Applicant Karl Storz SE & CO. KG

K-Number K260209

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ORZ 2026-08-18

TearCare System

Applicant Sight Sciences, Inc.

K-Number K262479

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LZA 2026-08-18

NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLOR

Applicant Kossan International Sdn Bhd

K-Number K260794

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QSZ 2026-08-18

LUOFUCON® Wound Matrix

Applicant Huizhou Foryou Medical Devices Co., Ltd.

K-Number K254256

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QUW 2026-08-18

TeKBrace Solo Soft Tissue Reinforcement Device

Applicant Theramicro

K-Number K262729

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HIH 2026-08-18

HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)

Applicant Axora Medical, Inc.

K-Number K260984

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QIH 2026-08-18

Lower Limb AI (LLAI)

Applicant AI Planning Logic, Inc.

K-Number K261641

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QJP 2026-08-18

p17 XR Microcatheter

Applicant Wallaby Medical

K-Number K254071

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KHJ 2026-08-18

Tympendi™ (810)

Applicant Grace Medical, Inc.

K-Number K260266

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QRL 2026-08-18

Lancing device

Applicant Tianjin Huahong Technology Co., Ltd.

K-Number K262135

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ODP 2026-08-18

BluEX Cervical Expandable Cage System

Applicant L&K BIOMED Co., Ltd.

K-Number K262489

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