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

JAA 2019-10-04

CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield (ROI Assembly)

Applicant Omega Medical Imaging, LLC

K-Number K191713

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MEG 2019-10-04

Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe

Applicant Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.

K-Number K190183

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DQD 2019-10-04

Vivio System

Applicant Avicena, LLC

K-Number K183710

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MUI 2019-10-04

Safergel Sterile Ultrasound Gel

Applicant Safersonic Us, Inc.

K-Number K190591

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GEI 2019-10-04

Sutter Arrowtip Monopolar Electrodes

Applicant Sutter Medizintechnik GmbH

K-Number K192128

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JAK 2019-10-03

Ablation Confirmation

Applicant Neuwave Medical, Inc.

K-Number K192427

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BZG 2019-10-03

Asthma Monitor AM3

Applicant Eresearch Technology

K-Number K183479

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EIH 2019-10-03

Vintage Art Universal

Applicant Shofu Dental Corporation

K-Number K191794

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MEG 2019-10-03

Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe

Applicant Jiangsu Caina Medical Co.,Ltd

K-Number K191490

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DCK 2019-10-03

Yumizen C1200 CRP

Applicant HORIBA ABX SAS

K-Number K191993

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NQP 2019-10-03

CD Horizon Astute Spinal System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K191066

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LQY 2019-10-03

Propex IQ Apex Locator

Applicant Dentsply Sirona

K-Number K191806

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