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

MWI 2016-03-15

AlertWatch: OR

Applicant Alertwatch, LLC

K-Number K153335

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OLZ 2016-03-14

Sleep Profiler

Applicant Advanced Brain Monitoring, Inc.

K-Number K153412

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KPR 2016-03-14

Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography SystemAmrad Medical FRS Digital Radiography System,

Applicant Summit Industries, LLC

K-Number K153119

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LYR 2016-03-14

ImmunoCard STAT! HpSA

Applicant Meridian Bioscience, Inc.

K-Number K153661

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NHA 2016-03-14

Allied Biocompat Abutment for Nobel Replace Interface

Applicant Allied Dental Solutions

K-Number K152845

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JXG 2016-03-14

Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling

Applicant Integra LifeSciences Corporation

K-Number K153041

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NLH 2016-03-14

Reprocessed Electrophysiology Catheter

Applicant Innovative Health, LLC

K-Number K153153

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MQK 2016-03-14

Cryotop US

Applicant Kitazato Biopharma Co., Ltd.

K-Number K153027

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KGN 2016-03-14

MicroMatrix

Applicant Acell, Inc.

K-Number K153754

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LZO 2016-03-14

UCP Stem

Applicant United Orthopedic Corporation

K-Number K152530

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DXN 2016-03-13

Full Automatic (NIBP) Blood Pressure Monitor

Applicant Health & Life Co., Ltd.

K-Number K160145

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FOZ 2016-03-11

20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System

Applicant Tangent Medical Technologies, Inc.

K-Number K160374

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