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

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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DZE 2019-10-03

ALFA GATE Dental Implants System

Applicant Alfa Gate Mazen, Ltd.

K-Number K182143

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FFX 2019-10-03

Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe

Applicant Diversatek Healthcare

K-Number K190208

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MQB 2019-10-03

EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG

Applicant DRTECH Corporation

K-Number K192400

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DKZ 2019-10-03

Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel

Applicant Atlas Medical

K-Number K191099

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