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

MHX 2025-10-17

IntelliVue Patient monitors MX400, MX450, MX500, MX550

Applicant Philips Medizin Systeme Boeblingen GmbH

K-Number K251146

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HCG 2025-10-17

InZone IST Detachment System; IZDS Connecting Cable

Applicant Stryker Neurovascular

K-Number K251832

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IYE 2025-10-17

MOSkin Radiation Measurement System

Applicant Electrogenics Labs, Ltd.

K-Number K250911

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JZO 2025-10-17

ADVIA Centaur Anti-Thyroid Peroxidase II

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K250250

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OBR 2025-10-17

Remi Custom Night Guard

Applicant Remi

K-Number K251778

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KNS 2025-10-17

Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)

Applicant Olympus Medical Systems Corp.

K-Number K250945

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NHA 2025-10-17

Adin Customized Abutments

Applicant Adin Dental Implant Systems , Ltd.

K-Number K250178

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PLF 2025-10-17

Osteotomy Wedge System

Applicant Sinaptic Surgical

K-Number K252254

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DQX 2025-10-17

SureAx-Guide

Applicant Sureax Medical, LLC

K-Number K250203

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NFO 2025-10-17

JOVS Electric Stimulation Beauty Device (JE2)

Applicant Shenzhen Qianyu Technology Co., Ltd.

K-Number K250227

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SGH 2025-10-17

X9 Ultrasound System

Applicant X9, Inc.

K-Number K251673

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LZA 2025-10-17

Program insite® Powder-Free, Disposable Nitrile Exam Gloves

Applicant Program Insite, LLC

K-Number K252075

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