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

HGX 2025-02-06

VIVACE

Applicant Unimom.Co

K-Number K242111

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JWH 2025-02-06

Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert Posteriorly Stabilized Insert

Applicant Howmedica Osteonics Corp., Dba Stryker Orthopaedics

K-Number K243817

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KNS 2025-02-06

Disposable Sphincterotome

Applicant Beijing Zksk Technology Co., Ltd.

K-Number K242192

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GXY 2025-02-06

Delphi MCS Electrode Cap

Applicant Quantalx Neuroscience, Ltd.

K-Number K243243

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LZA 2025-02-06

Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine

Applicant Ever Global (Vietnam) Enterprise Corporation

K-Number K244034

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FRC 2025-02-06

Celerity Incubator

Applicant STERIS Corporation

K-Number K250061

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FTC 2025-02-06

308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)

Applicant Xuzhou Kernel Medical Equipment Co., Ltd.

K-Number K242977

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DQA 2025-02-06

Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125)

Applicant Unimed Medical Supplies, Inc.

K-Number K242580

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IYN 2025-02-06

EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

Applicant Philips Ultrasound, LLC

K-Number K243794

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HRS 2025-02-06

BPS - Bone Fragment Fixation Plates, Screws and Washers

Applicant Orthonovis, Inc.

K-Number K250055

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ISA 2025-02-06

VMAT PRO

Applicant Termosalud

K-Number K243488

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LPH 2025-02-06

Stryker Orthopaedics Hip Devices Labeling Update

Applicant Howmedica Osteonics Corp., Dba Stryker Orthopaedics

K-Number K243784

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