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

MBI 2025-12-30

Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm

Applicant Arthrex, Inc.

K-Number K253895

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KPS 2025-12-30

AnyScan 3.0 NM Scanner Family

Applicant Mediso Medical Imaging Systems, Ltd.

K-Number K253844

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QIH 2025-12-30

TruSPECT Processing Station

Applicant Spectrum Dynamics Medical, Ltd.

K-Number K253532

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FLE 2025-12-30

Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer

Applicant Lucas Lifecare

K-Number K250168

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QCH 2025-12-30

Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN)

Applicant Techno-Path Manufacturing , Ltd.

K-Number K242492

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FGE 2025-12-29

Niti-S Biliary Stent; Niti-S Biliary Slim M Stent

Applicant Taewoong Medical Co., Ltd.

K-Number K251123

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JOH 2025-12-29

Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Disposable Inner Cannula XLT

Applicant Covidien, LLC

K-Number K251313

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OHT 2025-12-29

Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM)

Applicant Shenzhen Fansizhe Science and Technology Co., Ltd.

K-Number K253881

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HTY 2025-12-29

ZipToe Hammertoe Fusion System

Applicant Toetal Solutions

K-Number K253325

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CAW 2025-12-29

Oxygen Concentrator (J10A)

Applicant Foshan Kycare Medical Equipment Co., Ltd.

K-Number K251534

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PNN 2025-12-29

Celebrace Software

Applicant Celebrace

K-Number K253343

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BZT 2025-12-29

Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)

Applicant Covidien, LLC

K-Number K251025

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