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

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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LLZ 2024-11-26

RadUnity (Version 1.0.0)

Applicant Radunity Corp.

K-Number K242810

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DQX 2024-11-26

R2P Radifocus Glidewire Advantage

Applicant Terumo Corporation

K-Number K240818

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HRS 2024-11-26

HyperFlex™ Bunion Correction System

Applicant Footbridge Medical

K-Number K241995

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JWY 2024-11-26

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mL

Applicant Thermo Fisher Scientific

K-Number K242657

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