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

NUH 2025-12-31

TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)

Applicant Shenzhen Jiantuo Electronics Co., Ltd.

K-Number K253305

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QJQ 2025-12-31

Genesis Sleep

Applicant Neurofield, Inc.

K-Number K252951

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NEU 2025-12-31

MOLLI 2 System

Applicant Stryker Endoscopy

K-Number K253888

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DXC 2025-12-31

Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)

Applicant Arc Trauma, LLC

K-Number K243627

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CHH 2025-12-30

Lipids

Applicant Truvian Health

K-Number K251091

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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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