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

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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LNH 2021-11-19

MR 5300

Applicant Philips Medical Systems Nederland B.V.

K-Number K212673

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OHT 2021-11-19

Leaf Smooth

Applicant Shenzhen Leaflife Technology Co., Ltd.

K-Number K212697

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MAX 2021-11-19

Catalyft LS Expandable Interbody System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K212653

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OVE 2021-11-19

Velofix SA Cervical Cage

Applicant U&I Corporation

K-Number K210573

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FXX 2021-11-18

Savvy Mask - Level 3 Surgical Face Mask

Applicant Texas Medplast, LLC

K-Number K213406

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GZL 2021-11-18

DIXI Medical Microdeep Micro-Macro Depth Electrodes

Applicant Dixi Medical

K-Number K202087

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OHT 2021-11-18

IPL Hair Removal, Model: OBT-02

Applicant Glan Electronics Co., Ltd.

K-Number K213041

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