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

KNW 2021-11-19

Arthrex Vortex Threaded Bone Marrow Recovery Needle

Applicant Arthrex, Inc.

K-Number K213213

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QIH 2021-11-19

OnQ Neuro

Applicant Cortechs Labs, Inc.

K-Number K210831

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HWC 2021-11-19

Vector® Hammertoe Correction System

Applicant Nvision Biomedical Technologies, Inc.

K-Number K213421

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ITI 2021-11-19

Frontier Series Power Wheelchairs

Applicant Magic Mobility

K-Number K213090

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KOD 2021-11-19

Urinary Catheter 12 Fr, Urinary Catheter 16 Fr

Applicant Urogen Pharma, Ltd.

K-Number K211032

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QNP 2021-11-19

EndoScreener

Applicant Chengdu Wision Medical Device Co., Ltd.

K-Number K211326

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GEX 2021-11-19

Finebeam

Applicant SNJ Co., Ltd.

K-Number K202288

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FMI 2021-11-19

BD Nano 2nd Gen Pen Needle

Applicant Becton, Dickinson and Company

K-Number K212015

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LZA 2021-11-19

Disposable Nitrile Examination Glove

Applicant Inner Mongolia Cureguard Medical Technology Co., Ltd.

K-Number K212661

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LZA 2021-11-19

HALYARD Flexaprene Green Powder-Free Exam Glove

Applicant O&M Halyard, Inc.

K-Number K211063

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LYY 2021-11-19

Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile)

Applicant Pt. Universal Gloves

K-Number K203074

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QEY 2021-11-19

EkoSonic Endovascular Device

Applicant Boston Scientific

K-Number K211080

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