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

LLZ 2017-05-17

QuantX

Applicant Quantitative Insights, Inc.

K-Number K170195

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LQD 2017-05-17

Test of Variables of Attention (T.O.V.A.) Version 9.0

Applicant The Tova Company

K-Number K170082

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DQO 2017-05-17

Surefire Precision Infusion System

Applicant Surefire Medical, Inc.

K-Number K171355

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KLW 2017-05-17

TinniLogic Mobile Tinnitus Management Device

Applicant Jiangsu Betterlife Medical Co., Ltd.

K-Number K163094

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LLZ 2017-05-17

Dynamika

Applicant Image Analysis Limited

K-Number K161601

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IYN 2017-05-17

Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley

Applicant Medisono, LLC

K-Number K170078

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GWG 2017-05-16

KARL STORZ ShuntScope

Applicant KARL STORZ Endoscopy-America, Inc.

K-Number K170462

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MQP 2017-05-16

VerteFIT Corpectomy Cage System

Applicant Ldr Spine USA, Inc.

K-Number K162133

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GEX 2017-05-16

SIROLaser Advance+

Applicant Dentsply Sirona

K-Number K170500

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ITX 2017-05-16

A-View

Applicant Stroke2prevent B.V.

K-Number K170338

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ITX 2017-05-16

iSR'obot Biopsy Kit

Applicant Biobot Surgical Pte., Ltd.

K-Number K163502

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LYZ 2017-05-16

Disposable Powder Free Vinyl Exam Glove, Clear/Yellow

Applicant Ever Global (Vietnam) Enterprise Corp

K-Number K170575

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