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

DZE 2017-05-17

MRI Compatibility for Existing Zimmer Dental Implant Systems

Applicant Zimmer Dental, Inc.

K-Number K160398

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LTJ 2017-05-17

FREND PSA PLUS (reagent cartridge)

Applicant Nanoentek USA, Inc.

K-Number K162378

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DRT 2017-05-17

Cardiac Trigger Monitor

Applicant Ivy Biomedical Systems, Inc.

K-Number K170828

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PHX 2017-05-17

Humeris Shoulder

Applicant Fx Solutions

K-Number K163669

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CAF 2017-05-17

AirLife Misty Finity Nebulizer

Applicant Care Fusion

K-Number K153748

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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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