Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

MAX 2025-03-18

FortiVy OsteoVy Lumbar IBF

Applicant Vy Spine, LLC

K-Number K241783

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OHS 2025-03-18

Aglaia LED Beauty Device (BP-D2309)

Applicant Shenzhen Perfect Idea Technology Limited

K-Number K250413

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MQC 2025-03-18

Hard Splint & Thermo-Adaptive Splint

Applicant Whip Mix Corporation

K-Number K241729

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IYE 2025-03-18

Klarity SGRT System (ARSG-E1A, ARSG-E3A)

Applicant Klarity Medical & Equipment (GZ) Co., Ltd.

K-Number K241937

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MQB 2025-03-18

Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)

Applicant Iray Imaging Technology (Haining) Limited

K-Number K243556

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DJC 2025-03-18

LYHER® Oral fluid Multi-Drug Test Kit (Cube)

Applicant Hangzhou Laihe Biotech Co., Ltd.

K-Number K240287

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HRS 2025-03-18

The OsteoCentric Bone Plate and Screw System

Applicant OsteoCentric Technologies

K-Number K250494

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POD 2025-03-18

QuikClot Control+ Hemostatic Device

Applicant Teleflex Medical

K-Number K243553

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LLZ 2025-03-18

Radlink GPS Pro Imaging

Applicant Radlink, Inc.

K-Number K242161

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HRS 2025-03-17

BPS Wrist Fracture System

Applicant Orthonovis, Inc.

K-Number K250498

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GCJ 2025-03-17

LAGIS Suction Irrigation System

Applicant Lagis Enterprise Co., Ltd.

K-Number K243867

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OVD 2025-03-17

aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation

Applicant Carlsmed, Inc.

K-Number K243802

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