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

MEH 2025-11-05

Allure Hip Stem and Intramedullary Plugs

Applicant Waldemar Link GmbH & Co. KG

K-Number K250375

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IMJ 2025-11-05

ViVY

Applicant Viatherm Therapeutics, LLC

K-Number K250376

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IOR 2025-11-04

Flexx Junior (FLX-J00, FLX-J50)

Applicant Karma Mobility Co, Ltd.

K-Number K250576

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MBI 2025-11-04

GMReis Suture Anchors

Applicant GM Dos Reis Industria e Comercio Ltda.

K-Number K252664

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GEI 2025-11-04

Voyant® Open Fusion Device (EB240/Open Fusion)

Applicant Applied Medical Resources Corp.

K-Number K252740

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LLZ 2025-11-04

VXvue

Applicant Vieworks Co., Ltd.

K-Number K251410

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FXX 2025-11-04

PRIMED Surgical and Procedure Masks

Applicant Primed Medical Products, Inc.

K-Number K252964

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GEX 2025-11-04

Tamburo Thulium Fiber Laser System

Applicant Menovex Medical Technology (Shenzhen) Co., Ltd.

K-Number K251303

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FMF 2025-11-04

Merit Syringe

Applicant Merit Medical Systems, Inc.

K-Number K250853

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OWB 2025-11-04

Cios Select

Applicant Siemens Medical Solutions USA, Inc.

K-Number K250241

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PBF 2025-11-04

MedCAD® AccuStride™ System

Applicant Medcad

K-Number K251709

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IYE 2025-11-03

ZAP-X Radiosurgery System (ZAP-X)

Applicant Zap Surgical Systems, Inc.

K-Number K250392

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