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

EBF 2024-09-17

Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active

Applicant Kulzer, LLC

K-Number K240660

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PKL 2024-09-17

PADLOCK CLIP EFTR Kit (00713229)

Applicant STERIS Corporation

K-Number K240274

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OAP 2024-09-17

Robin's Egg

Applicant Telebrands Corporation

K-Number K240689

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HRS 2024-09-17

TriMed Bridge Plates

Applicant TriMed, Inc.

K-Number K241942

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DZL 2024-09-17

KLS Martin Drill-Free MMF Screw

Applicant KLS-Martin L.P.

K-Number K233721

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NGX 2024-09-17

Neo Sculptor (OF-NEO001)

Applicant Ofan Intelligent Technology (Guangzhou) Co. , Ltd.

K-Number K242186

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MAX 2024-09-17

3D Printed PEEK Interbody System

Applicant Nvision Biomedical Technologies, Inc.

K-Number K240250

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HBC 2024-09-16

Traus SSG30 Surgical System

Applicant Saeshin Precision Co., Ltd.

K-Number K232938

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ITI 2024-09-16

Powered Wheelchair (NXN20-205, NXN20-205M)

Applicant Zhejiang Nysin Medical Co., Ltd.

K-Number K241379

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IYN 2024-09-16

TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX20/Eagus TEX20T/Eagus TEX21/Eagus TEX21T/Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M/Eagus TEX11/Eagus TEX11T/EagusTEX10/Eagus TEX10T/Eagus TEX/Ares Diagnostic Ultrasound System

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K241201

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FRG 2024-09-16

HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap

Applicant O&M Halyard, Inc.

K-Number K234050

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ITI 2024-09-16

Power Wheelchair (YH-E7007)

Applicant Ningbo Youhuan Automation Technology Co., Ltd.

K-Number K240638

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