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

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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QAI 2024-02-23

Exceed Unlimited

Applicant Mt. Derm GmbH

K-Number K233709

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OLO 2024-02-23

Navigation Tracking Instruments

Applicant SI-BONE, Inc.

K-Number K232800

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MBI 2024-02-23

Iconix Knotless Anchor

Applicant Riverpoint Medical

K-Number K240213

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DFH 2024-02-23

FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2

Applicant Sebia

K-Number K231601

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OUR 2024-02-23

PathLoc SI Joint Fusion System

Applicant L&K BIOMED Co., Ltd.

K-Number K240201

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