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

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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DAP 2026-08-11

INNOVANCE® D-Dimer 2.0 (SMN 10873803)

Applicant Siemens Healthcare Diagnostic Products GmbH

K-Number K253985

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FRO 2026-08-11

Vashe Plus Antimicrobial Solution

Applicant Urgo Medical North America, LLC

K-Number K253665

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QPC 2026-08-11

VR® Personal Protective Level 4 Gown (VR Gowns)

Applicant PolyConversions, Inc.

K-Number K261115

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GEX 2026-08-11

Q Switched Nd:YAG Laser machine (QLQW-01)

Applicant Beijing Nubway S&T Co., Ltd.

K-Number K261841

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ITX 2026-08-10

EM-TECH Passive Ultrasound Probe Strap

Applicant EM-TECH Solutions, Inc.

K-Number K254143

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NIG 2026-08-10

Atellica IM CA 19-9 II

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K253528

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INI 2026-08-10

Mobility Scooter (W3483, W3483A)

Applicant Zhejiang Innuovo Rehabilitation Devices Co.,Ltd

K-Number K260176

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OHS 2026-08-10

Eye Recovery Pro (PH-e03)

Applicant Shenzhen Goodwind Technology Development Co., Ltd.

K-Number K261602

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