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

FXX 2022-01-17

Medical Face Mask

Applicant Guangzhou Quantum Laser Intelligent Equipment Co., Ltd.

K-Number K212994

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LNH 2022-01-16

SIGNA Prime

Applicant Ge Healthcare (Tianjin) Company Limited

K-Number K211980

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FXX 2022-01-16

Kangbeier Surgical Mask (Model: KBR-1001)

Applicant Xinxiang Kangbeier Medical Technology Co., Ltd.

K-Number K213920

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FXX 2022-01-16

Disposable Medical Face Mask

Applicant Zhejiang the Purples Protective Products Co.,Ltd

K-Number K211833

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NXC 2022-01-15

Precision Align

Applicant Precision Align, LLC

K-Number K212772

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LZA 2022-01-15

Disposable Nitrile Powder Free Examination Gloves (Non-sterile)

Applicant Pt. Universal Gloves

K-Number K211360

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FRO 2022-01-14

Silver Gelling Fiber Dressing

Applicant Winner Medical Co., Ltd.

K-Number K210466

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FXX 2022-01-14

Surgical Face Mask

Applicant Jiangxi Ganlong Pharmaceutical Co., Ltd.

K-Number K212913

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SBF 2022-01-14

ARAI Surgical Navigation System

Applicant Surgalign Spine Technologies

K-Number K211254

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FEB 2022-01-14

SCOPE BUDDY PLUS Endoscope Flushing Aid

Applicant Medivators, Inc.

K-Number K213833

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QHW 2022-01-14

Bio-Medicus Life Support Catheter and Introducer

Applicant Medtronic, Inc.

K-Number K201057

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OLO 2022-01-14

iASSIST Knee System

Applicant Orthosoft D/B/A Zimmer Cas

K-Number K213033

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