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

QIH 2024-02-23

Overjet Charting Assist

Applicant Overjet, Inc.

K-Number K233590

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EIH 2024-02-23

rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono

Applicant Genoss Co., Ltd.

K-Number K232174

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DTR 2024-02-23

MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated

Applicant Medtronic

K-Number K240190

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BZH 2024-02-23

Electronic Peak Flow Meter

Applicant Taian Dalu Medical Instrument Co., Ltd.

K-Number K230423

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NUH 2024-02-23

ENSO (Model 2)

Applicant Hinge Health, Inc.

K-Number K233784

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JDR 2024-02-23

COGNiTiON Staple System

Applicant Ortho Solutions UK , Ltd.

K-Number K240212

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KPI 2024-02-23

Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018)

Applicant Shenzhen Konmed Technology Co., Ltd.

K-Number K233576

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PZI 2024-02-23

StatStrip Glucose Hospital Meter System

Applicant Nova Biomedical Corporation

K-Number K232075

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DJG 2024-02-23

Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card

Applicant Shanghai Accurature Diagnostics Co., Ltd.

K-Number K232228

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EBI 2024-02-23

Ivotion Base Print

Applicant Ivoclar Vivadent, Inc.

K-Number K233995

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KPR 2024-02-23

RADspeed Pro

Applicant Shimadzu Corporation

K-Number K233722

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JOW 2024-02-23

Lymphedema Compression

Applicant Jkh Health Co., Ltd.

K-Number K240011

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