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

NKB 2016-06-09

NuVasive® Reline® System

Applicant Nu Vasive, Incorporated

K-Number K160989

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LNH 2016-06-09

Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T

Applicant Ge Medical Systems, LLC

K-Number K160618

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LLZ 2016-06-09

HEPATIQ 1.1

Applicant Hepatiq, LLC

K-Number K161188

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JAK 2016-06-09

Aquilion ONE (TSX-305A/3) V7.3

Applicant Toshibamedical Systems Corporation

K-Number K160587

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MAX 2016-06-09

Lucent Intervertebral Body Fusion Device

Applicant Spinal Elements, Inc.

K-Number K152011

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MUD 2016-06-09

Masimo O3 Regional Oximeter System

Applicant Masimo Corporation

K-Number K160526

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MMK 2016-06-09

Oak Ridge Products Sharps Containers

Applicant Oak Ridge Products, LLC

K-Number K161180

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MQB 2016-06-09

BSD4343 Digital Flat Panel X-ray Detector

Applicant Bontech, Inc.

K-Number K160204

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GEX 2016-06-09

ATOVEN-Reusable Laser Fiber

Applicant Diotech CO

K-Number K152667

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GXR 2016-06-09

Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover

Applicant St Jude Medical

K-Number K152342

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HIH 2016-06-09

MAKO 7

Applicant Nvision Medical Corporation

K-Number K160510

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JGS 2016-06-09

BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer

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

K-Number K160370

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