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

NRY 2026-08-12

APRO 35 Swift Catheter and Alembic Aspiration Tubing

Applicant Alembic, LLC

K-Number K262391

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ITX 2026-08-12

BA-004CC

Applicant Fujifilm Corporation

K-Number K261170

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IRP 2026-08-12

ManaCold Compression System

Applicant Manamed, LLC

K-Number K260944

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LLZ 2026-08-12

NeuroQuant PET

Applicant Cortechs Labs, Inc.

K-Number K261916

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DQY 2026-08-12

APRO 35 Swift Catheter

Applicant Alembic, LLC

K-Number K262392

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FTM 2026-08-12

EluPro Antibiotic-Eluting BioEnvelope

Applicant Boston Scientific

K-Number K262406

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CCK 2026-08-12

GF-310R Multigas Unit (GF-310R)

Applicant Nihon Kohden Corporation

K-Number K251641

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MWI 2026-08-12

Masimo Root Monitoring System

Applicant Masimo Corporation

K-Number K253417

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OAB 2026-08-12

Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe) (SPA-C02); Disposable Sterile Steep Pulse Probe (NPA-DJ01); Probe connection line (NPA-LX-02)

Applicant Hangzhou Ruidi Biotechnology , Ltd.

K-Number K253846

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NRY 2026-08-12

Millipede System

Applicant Perfuze, Ltd.

K-Number K262399

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SBH 2026-08-11

Stelo Glucose Biosensor System

Applicant Dexcom, Inc.

K-Number K262472

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SDD 2026-08-11

Dexter L6 System

Applicant Distalmotion SA

K-Number K261398

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