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

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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MBI 2024-11-26

OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct

Applicant Riverpoint Medical, LLC

K-Number K242494

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DXN 2024-11-26

Arm Blood Pressure Monitor (model: BPM-A7VL)

Applicant Shenzhen Imdk Medical Technology Co., Ltd.

K-Number K243118

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NAY 2024-11-26

da Vinci SP Surgical System (SP1098)

Applicant Intuitive Surgical, Inc.

K-Number K242318

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HRS 2024-11-26

TriMed Posterior Malleolus Fixation System

Applicant TriMed, Inc.

K-Number K243050

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DXF 2024-11-26

Cross Wise Multi-Use RF Adapter Cable

Applicant Circa Scientific, Inc.

K-Number K243193

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EZD 2024-11-26

SureCath Set

Applicant Coloplast Corp.

K-Number K242049

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NKB 2024-11-26

4CIS® Chiron Spinal Fixation System

Applicant Solco Biomedical Co., Ltd.

K-Number K231655

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EBG 2024-11-26

PrimmaArt

Applicant Dentscare Ltda

K-Number K231859

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