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

KWQ 2026-03-03

PathLoc Lumbar Plate System

Applicant L&K BIOMED Co., Ltd.

K-Number K251940

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KLE 2026-03-03

Bond-PR™ Universal Adhesive

Applicant Premier Dental Products Company

K-Number K260682

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MUH 2026-03-03

SOTA Cloud Smart Sensor (1.5)

Applicant Sota Cloud Corp.

K-Number K251793

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OLO 2026-03-03

TMINI® Miniature Robotic System

Applicant THINK Surgical, Inc.

K-Number K260010

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OHS 2026-03-03

LED Therapy Light (COB1400, HP1800PRO)

Applicant Shenzhen Hanhua Opto Co., Ltd.

K-Number K253874

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MQC 2026-03-02

UltraPrint-Dental Hard Splint UV

Applicant Guangzhou Heygears IMC., Inc.

K-Number K253798

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MBI 2026-03-02

Arthrex Nano FiberTak Suture Anchor

Applicant Arthrex, Inc.

K-Number K254229

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LRK 2026-03-02

Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)

Applicant Myofunctional Research Co.

K-Number K252531

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NEY 2026-03-02

Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13)

Applicant Nanjing Devin Medical Technology Co., Ltd.

K-Number K253771

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QIH 2026-03-02

Clarius Ejection Fraction AI

Applicant Clarius Mobile Health Corp.

K-Number K253593

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EWY 2026-03-02

KARL STORZ Mediastinoscopes and Instruments

Applicant Karl Storz SE & CO. KG

K-Number K260003

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GEI 2026-03-02

POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)

Applicant Gyrus Acmi, Inc.

K-Number K252487

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