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

HWC 2020-05-05

Healix Compression Screw System

Applicant Nvision Biomedical Technologies, Inc.

K-Number K200914

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LNH 2020-05-05

uMR 780

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K193176

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EBG 2020-05-05

AA temp temporary restoration 3D printing photoreactive resin

Applicant Enlighten Materials Co., Ltd.

K-Number K191590

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NUH 2020-05-04

LIVIA

Applicant Lifecare , Ltd.

K-Number K183110

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QEZ 2020-05-04

Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator

Applicant Control Medical Technology

K-Number K200871

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HWC 2020-05-04

Headless Compression Screw System

Applicant Osteocentric Extremities, LLC

K-Number K200259

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CBK 2020-05-04

Hamilton-G5

Applicant Hamilton Medical AG

K-Number K193228

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PQM 2020-05-04

Ultravision Visual Field Clearing System

Applicant Alesi Surgical, Ltd.

K-Number K200035

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KNF 2020-05-04

Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1

Applicant Gynesonics, Inc.

K-Number K193516

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OKO 2020-05-04

Anscare SIMO Negative Pressure Wound Therapy (NPWT) System

Applicant Benq Materials Corporation

K-Number K193185

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NGX 2020-05-04

Revitive Medic Plus, Revitive Advanced 2

Applicant Actegy , Ltd.

K-Number K192887

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QJP 2020-05-02

BOSS Balloon Guide Catheter

Applicant Marblehead Medical

K-Number K200910

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