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

IRP 2023-10-27

Cold/Hot Compression

Applicant Jkh Health Co., Ltd.

K-Number K223541

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MEG 2023-10-27

Shina Syringe; Shina Safety Syringe

Applicant Shina Med Corporation

K-Number K231165

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OLP 2023-10-27

PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT

Applicant Dongguan Hunter Electronic Technology Co., Ltd.

K-Number K230490

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QJQ 2023-10-27

Modius Sleep

Applicant Neurovalens , Ltd.

K-Number K230826

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OLO 2023-10-27

CoreLink Robotic Navigation Instruments

Applicant Corelink, LLC

K-Number K231494

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JKA 2023-10-27

Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen

Applicant Jiangsu Rongye Technology Co., Ltd.

K-Number K213146

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EWO 2023-10-27

hearOAE

Applicant Hearx SA (Pty) , Ltd.

K-Number K231545

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JOJ 2023-10-27

Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)

Applicant Steris

K-Number K233187

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KPR 2023-10-27

PodSKAN HF Diagnostic X-ray System

Applicant Skanray Technologies Limited

K-Number K231761

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LPH 2023-10-27

OR3O Dual Mobility Liners

Applicant Smith & Nephew, Inc.

K-Number K232667

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PHR 2023-10-27

Centrix FluoroSilver Silver Diamine Fluoride 38%

Applicant Centrix, Inc.

K-Number K222459

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OUR 2023-10-27

SOLACE Sacroiliac Fixation System

Applicant Ht Medical, LLC Dba Xenix Medical

K-Number K233241

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