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

BZD 2026-01-07

DeltaWave Nasal Pillow System

Applicant RemSleep Holdings, Inc.

K-Number K253939

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NXC 2026-01-07

Clear Aligner (SCF-3348)

Applicant Beame Medical Technology (Shenzhen) Limited

K-Number K251454

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IYN 2026-01-07

LOGIQ Fortis

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K253366

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NKB 2026-01-07

CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K253941

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PNE 2026-01-07

Reprocessed Agilis NxT Steerable Introducer

Applicant Innovative Health

K-Number K250305

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QAS 2026-01-07

BriefCase-Triage: CARE Multi-triage CT Body

Applicant Aidoc Medical , Ltd.

K-Number K252970

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QEW 2026-01-07

Sangria™ Thrombectomy System

Applicant Avantec Vascular Corporation

K-Number K251207

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KIF 2026-01-07

ZenSeal Pro

Applicant Kerr Corporation

K-Number K252890

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MYN 2026-01-07

DS Core Detect

Applicant Dentsply Sirona, Inc.

K-Number K253009

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NHA 2026-01-07

Neodent InLab Validated Workflow

Applicant JJGC Indústria e Comércio de Materiais Dentários S.A.

K-Number K252727

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NKB 2026-01-07

KHEIRON® Spinal Fixation System, including patient specific K-ROD

Applicant S.M.A.I.O

K-Number K253990

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PNN 2026-01-07

SmileInspector

Applicant Amv Consulting, LLC

K-Number K252507

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