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

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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LLZ 2023-10-27

SwiftMR

Applicant Airs Medical, Inc.

K-Number K230854

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JFP 2023-10-27

i-STAT CG8+ cartridge with the i-STAT 1 System

Applicant Abbott Point of Care, Inc.

K-Number K230300

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DXN 2023-10-27

Electronic Blood Pressure Monitor

Applicant Shenzhen Jumper Medical Equipment Co., Ltd.

K-Number K231310

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GEX 2023-10-27

DEKA AGAIN PRO family

Applicant El.En S.P.A.

K-Number K233090

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