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

HSB 2026-04-24

AUTOBAHN™ Nailing System

Applicant Globus Medical, Inc.

K-Number K261043

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JKR 2026-04-24

Elecsys Calcitonin

Applicant Roche Diagnostics GmbH

K-Number K252431

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SHU 2026-04-24

Visualized Access and Delivery Catheter; PB Digital Controller

Applicant Micro-Tech (Nanjing) Co., Ltd.

K-Number K252492

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LGZ 2026-04-24

°M Warmer System with °M Station

Applicant Mequ A/S

K-Number K260988

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JOW 2026-04-24

Compression Therapy Device (LGT-2202DVT)

Applicant Guangzhou Longest Medical Technology Co., Ltd.

K-Number K250242

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QEW 2026-04-24

INDIGO® Aspiration System – INDIGO Link

Applicant Penumbra, Inc.

K-Number K260599

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ODP 2026-04-24

ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System

Applicant Zsfab, Inc.

K-Number K260549

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OWB 2026-04-24

ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno

Applicant Siemens Medical Solutions USA, Inc.

K-Number K254173

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MHX 2026-04-24

Vista CMS

Applicant Shanghai Draeger Medical Instrument Co., Ltd.

K-Number K250349

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LLZ 2026-04-24

LungPoint Virtual Bronchoscopic Navigation (VBN) Software

Applicant Broncus Medical, Inc.

K-Number K260009

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MEB 2026-04-24

SMARTeZ™ Elastomeric Infusion Pump (RS series)

Applicant Epic Medical Pte. , Ltd.

K-Number K250234

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MUI 2026-04-24

EdgeFlow Gel Pad

Applicant Edgecare, Inc.

K-Number K252337

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