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

PGY 2024-11-27

RadiForce RX570; RadiForce RX570-AR

Applicant Eizo Corporation

K-Number K243221

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EBF 2024-11-27

C&B Ceramic; C&B Permanent; C&B Interim

Applicant Prevest Denpro Limited

K-Number K233273

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OHS 2024-11-27

LED Light Therapy Machine (G1, G3, G4, G6)

Applicant Shenzhen Walton Technology Co., Ltd.

K-Number K242638

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JFB 2024-11-27

Ceragem Automatic Thermal Massager (CGM-MB-1902)

Applicant Ceragem Co., Ltd.

K-Number K243355

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QIH 2024-11-27

Sonix Health

Applicant Ontact Health Co., Ltd.

K-Number K240645

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FOZ 2024-11-27

SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter

Applicant Spectrum Vascular

K-Number K241115

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OHT 2024-11-27

SmoothSkin Pure Switch (SSC1)

Applicant Cyden Limited

K-Number K243362

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QPB 2024-11-27

AirSculpt Body Contouring System (AIRS-1-SYS)

Applicant Cellmyx

K-Number K241835

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PTI 2024-11-27

PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set

Applicant Bard Access Systems, Inc.

K-Number K241353

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OVD 2024-11-26

Atlas Spine Lateral Expandable Interbody System

Applicant Atlas Spine, Inc.

K-Number K243191

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KDN 2024-11-26

LungProtect

Applicant Traferox Technologies, Inc.

K-Number K240650

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OMB 2024-11-26

NeuroMatch

Applicant LVIS Corporation

K-Number K241390

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