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

FMF 2020-07-15

BD SoloShot Mini Syringe/ BD Auto Disable Syringe

Applicant Becton, Dickinson and Company

K-Number K201234

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GZB 2020-07-15

Nalu Neurostimulation SCS system

Applicant Boston Scientific Neuromodulation

K-Number K201618

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NHA 2020-07-15

Magicore II System

Applicant Innobiosurg Co., Ltd.

K-Number K201621

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HRS 2020-07-15

CoLink Plating System

Applicant In2bones USA, LLC

K-Number K201149

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PBX 2020-07-15

V30 System, V20 System, V10 System, V-FR Handpiece

Applicant Viora , Ltd.

K-Number K201064

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GEX 2020-07-15

CO2 Laser Therapy System

Applicant Shanghai Apolo Medical Technology Co., Ltd.

K-Number K201109

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FMF 2020-07-14

Orbit Subretinal Delivery System

Applicant Orbit Biomedical

K-Number K200325

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LNH 2020-07-14

Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR

Applicant Canon Medical Systems Corporation

K-Number K193097

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NRY 2020-07-14

EMBOTRAP III Revascularization Device

Applicant Neuravi, Ltd.

K-Number K193063

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OLO 2020-07-14

Mako Total Knee Application

Applicant Mako Surgical Corp.

K-Number K193515

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LZA 2020-07-13

Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs)

Applicant Medline Industires, Inc.

K-Number K200960

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OWB 2020-07-13

Digiscan FDX

Applicant Allengers Medical Systems Limited

K-Number K200218

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