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

FOZ 2022-03-31

BD Cathena Safety IV Catheter

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K-Number K220584

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FXX 2022-03-31

Medical Face Mask

Applicant Hangzhou Runheng Medical Co., Ltd.

K-Number K213736

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LYZ 2022-03-31

Vinyl Co-Polymer Powder-free Examination Gloves, Black

Applicant Grand Work Plastic Products Co., Ltd.

K-Number K220240

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IZL 2022-03-31

APX-24 Portable X-ray System

Applicant Aspenstate, Inc.

K-Number K220678

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NBC 2022-03-31

Elecsys proBNP II, Elecsys proBNP II STAT

Applicant Roche Diagnostics

K-Number K210546

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PDQ 2022-03-31

PediGuard Threaded

Applicant Spineguard S.A.

K-Number K220160

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LZA 2022-03-31

Nitrile Examination Gloves

Applicant Dong Tai City Huayi Gloves Co., Ltd.

K-Number K213843

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OLO 2022-03-31

NEXXT SPINE NAVIGATION System

Applicant Nexxt Spine, LLC

K-Number K220291

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HTN 2022-03-31

Hercules Syndesmosis Implant System

Applicant In2bones USA, LLC

K-Number K220260

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LZC 2022-03-31

Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs

Applicant Niujian Technology Co., Ltd.

K-Number K220353

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LKF 2022-03-31

Uterine ElevatOR PRO with OccludOR Balloon

Applicant The O R Company Pty, Ltd.

K-Number K220202

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GAR 2022-03-31

Golnit Nylon Monofilament Suture

Applicant Antarma, LLC Dba Golnit Sutures

K-Number K212888

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