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 2026-09-25

syngo.CT Brain Quantification

Applicant Siemens Medical Solutions USA, Inc.

K-Number K260055

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JOJ 2026-09-25

3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)

Applicant Solventum US, LLC

K-Number K261992

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BZD 2026-09-25

Altis Full Face Mask

Applicant Respironics, Inc.

K-Number K261262

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EMA 2026-09-25

EsTemp Implant

Applicant Spident Co., Ltd.

K-Number K262983

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NPM 2026-09-25

REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5)

Applicant Hyundai Bioland Co., Ltd.

K-Number K254210

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QOF 2026-09-25

Xpert Respiratory Panel

Applicant Cepheid

K-Number K261336

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IYN 2026-09-25

EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP30 Diagnostic Ultrasound System; EVO XP20 Diagnostic Ultrasound System; EVO XP10 Diagnostic Ultrasound System; EVO XC30 Diagnostic Ultrasound System; EVO XC20 Diagnostic Ultrasound System; EVO XC10 Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K263182

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HWC 2026-09-25

Arthrex Beaming System

Applicant Arthrex, Inc.

K-Number K262975

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HIH 2026-09-25

UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10)

Applicant Karl Storz SE & CO. KG

K-Number K254252

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PEN 2026-09-24

QIAstat-Dx BCID GN Plus AMR Panel

Applicant QIAGEN GmbH

K-Number K262168

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MNR 2026-09-24

Disposable Belts for Polysomnography (CNSAC)

Applicant CNSAC Medshop GmbH

K-Number K260949

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MRW 2026-09-24

Arthrex Spine Compression FT Screw

Applicant Arthrex, Inc.

K-Number K262618

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