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

LZA 2021-11-18

Disposable Medical Nitrile Examination Gloves (Non-sterile)

Applicant Suqian Linglian Medical Technology Co., Ltd.

K-Number K212600

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HRS 2021-11-18

Stratum® Ankle Fusion Plating System

Applicant Nextremity Solutions, Inc.

K-Number K212640

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PHX 2021-11-18

LINK® Embrace Shoulder System - Reverse Configuration

Applicant Waldemar Link GmbH & Co. KG

K-Number K212992

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FXX 2021-11-18

Impertech Surgical Face Mask

Applicant Impertech Industries , Ltd.

K-Number K212046

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NUC 2021-11-18

Desnuda Reflect

Applicant Good Clean Love, Inc.

K-Number K211998

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IYO 2021-11-18

MD-320W Ultrasound Biomicroscope

Applicant MEDA Co., Ltd.

K-Number K213070

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NLG 2021-11-18

Reprocessed IntellaMap Orion High Resolution Mapping Catheter

Applicant Innovative Health, LLC

K-Number K211662

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JOW 2021-11-18

SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System

Applicant Jiangsu Synecoun Medical Technology Co., Ltd.

K-Number K211937

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NUC 2021-11-18

Medley

Applicant Good Clean Love, Inc.

K-Number K212000

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NVK 2021-11-18

Gemini 2 810+980 Soft Tissue Laser

Applicant Azena Medical, LLC

K-Number K210350

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ESW 2021-11-18

HANAROSTENT Esophagus Asymmetric (CCC)

Applicant M.I.Tech Co., Ltd.

K-Number K213251

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NHA 2021-11-18

FAICO Dental Implant System and CAD/CAM Abutments

Applicant Faico Medical, LLC

K-Number K211871

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