Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

JCX 2026-05-11

Protable Phlegm Suction Unit (JMA D01)

Applicant Jiangsu Jumao X-Care Medical Equipment Co., Ltd.

K-Number K250964

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FAJ 2026-05-11

CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465)

Applicant Verathon Medical (Canada) Ulc

K-Number K253696

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EBF 2026-05-11

Dual Core

Applicant Vericom Co., Ltd.

K-Number K260805

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QJP 2026-05-11

SAYA 86 Radial Access Guide Catheter

Applicant Asahi Intecc Co., Ltd.

K-Number K254178

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GCJ 2026-05-11

KARL STORZ Trocars with Valve Seals

Applicant Karl Storz SE & CO. KG

K-Number K254228

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MAX 2026-05-09

aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra cervical plating system

Applicant Carlsmed, Inc.

K-Number K260385

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HRS 2026-05-09

Avanti Distal Elbow ORIF System

Applicant Avanti Orthopaedics, LLC

K-Number K261145

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GCA 2026-05-08

Disposable Stone Retrieval Balloon Catheter

Applicant Zhejiang Soudon Medical Technology Co., Ltd.

K-Number K253013

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IYE 2026-05-08

AerFrame Patient Immobilization System (AFPIS)

Applicant Stabilix, LLC

K-Number K260792

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HWC 2026-05-08

Arthrex Beaming System

Applicant Arthrex, Inc.

K-Number K254215

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LLZ 2026-05-08

HipGuide (V 1.0.0.0)

Applicant Orthopedic Driven Imaging, LLC

K-Number K260321

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GWG 2026-05-08

Hydro Irrigation System

Applicant Stryker Instruments

K-Number K253679

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