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

OLP 2016-12-15

Pulsaderm ACE-All Blue

Applicant Nutra Luxe MD, LLC

K-Number K162371

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BZD 2016-12-15

Menai System

Applicant Resmed, Ltd.

K-Number K160836

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KXK 2016-12-15

SMD-Sr90-DA Radionuclide Brachytherapy Source

Applicant Salutaris Medical Devices, Inc.

K-Number K163206

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JAD 2016-12-15

INTRABEAM 600

Applicant Carl Zeiss Meditec, AG

K-Number K162568

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NHA 2016-12-15

IPS e.max® Press Abutment Solutions for Viteo Base Ti

Applicant Ivoclar Vivadent, AG

K-Number K160798

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FRN 2016-12-15

MRidium 3860+ MRI infusion Pump/ Monitoring System

Applicant Iradimed Corporation

K-Number K143369

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NUA 2016-12-15

xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR

Applicant Luminex Molecular Diagnostics, Inc.

K-Number K163336

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HSX 2016-12-15

Arthrex iBalance UKA System Vitamin E Tibial Bearing

Applicant Arthrex, Inc.

K-Number K161060

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IYN 2016-12-15

DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System

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

K-Number K162845

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IYN 2016-12-15

ARIETTA Prologue Diagnostic Ultrasound system and Transducers

Applicant Hitachi , Ltd.

K-Number K162902

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CCK 2016-12-14

Westmed Gas Sampling Cannula with O2 delivery

Applicant Westmed, Inc.

K-Number K162343

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LOX 2016-12-14

Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete

Applicant Boston Scientific Corporation

K-Number K163200

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