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

JDQ 2018-08-01

SuperCable® Iso-Elastic Cerclage System

Applicant Kinamed, Incorporated

K-Number K181749

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IYN 2018-08-01

Ultrasound Scanner System bk2300

Applicant Bk Medical Aps

K-Number K180737

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EIH 2018-08-01

VITA YZ ST and VITA YZ XT

Applicant Vita Zahnfabrik H.Rauter GmbH Co.

K-Number K180703

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QAS 2018-08-01

BriefCase

Applicant Aidoc Medical , Ltd.

K-Number K180647

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BZH 2018-08-01

Smart One

Applicant Mir Medical International Research

K-Number K181666

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FXX 2018-07-31

3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield

Applicant 3M Healthcare

K-Number K180874

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JWY 2018-07-31

MTS Plazomicin 0.016-256 µg/mL

Applicant Liofilchem s.r.l.

K-Number K181708

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NHI 2018-07-31

SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit

Applicant Spr Therapeutics, Inc.

K-Number K181422

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GEX 2018-07-31

Picocare Family

Applicant Wontech Co., Ltd.

K-Number K181272

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QCR 2018-07-31

MolecuLight i:X

Applicant MolecuLight, Inc.

K-Number DEN180008

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OZE 2018-07-30

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,

Applicant Centers For Disease Control and Prevention (CDC)

K-Number K181736

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IYN 2018-07-30

TE7/TE5 Diagnostic Ultrasound System

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K180912

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