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

DZE 2024-10-31

Highness Implant System

Applicant Highness Co., Ltd.

K-Number K240383

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LLZ 2024-10-31

eRAD PACS

Applicant Erad, Inc.

K-Number K241223

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LJT 2024-10-31

PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports

Applicant Bard Access Systems, Inc.

K-Number K242328

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HRS 2024-10-31

Bonebridge Osteosynthesis Plating System

Applicant Bonebridge AG

K-Number K242399

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DXQ 2024-10-31

Disposable Blood Pressure cuff; Reusable Blood Pressure cuff

Applicant Shenzhen Medke Technology Co., Ltd.

K-Number K242623

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QNA 2024-10-30

Stone Clear (SC-LP9-01)

Applicant Sonomotion, Inc.

K-Number DEN230082

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HSX 2024-10-30

JOURNEY II Unicompartmental Knee System (JOURNEY II UK)

Applicant Smith & Nephew, Inc.

K-Number K242711

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FMK 2024-10-30

Safety Lancet

Applicant Ningbo Medsun Medical Co., Ltd.

K-Number K242627

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FCX 2024-10-30

MedicCO2LON (MedicCO2LON)

Applicant Ide Vision, Ltd.

K-Number K240847

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DSI 2024-10-30

Zio AT® device (A100A1001)

Applicant iRhythm Technologies, Inc.

K-Number K240177

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DZE 2024-10-30

ZENEX Implant System_Long

Applicant Izenimplant Co., Ltd.

K-Number K240560

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FLL 2024-10-30

Wearable Digital Thermometer (T31)

Applicant Guangdong Genial Technology Co., Ltd.

K-Number K240333

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