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

DDB 2017-01-09

Ceruloplasmin

Applicant Beckman Coulter Ireland, Inc.

K-Number K161508

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LHQ 2017-01-09

Sentinel BreastScan II System

Applicant First Sense Medical, LLC

K-Number K162767

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LLZ 2017-01-09

D2P

Applicant 3D Systems, Inc.

K-Number K161841

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KPS 2017-01-09

Symbia Intevo Bold

Applicant Siemens Medical Solutions USA, Inc.

K-Number K162483

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CFN 2017-01-09

DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent

Applicant Beckman Coulter, Inc.

K-Number K162208

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LZA 2017-01-09

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)

Applicant Hartalega Sdn Bhd

K-Number K162818

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NUC 2017-01-09

Love Alchemy's Love Lotion

Applicant Love Alchemy, LLC

K-Number K151857

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MUA 2017-01-09

Bindex BI-2

Applicant Bone Index Finland , Ltd.

K-Number K161971

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LZA 2017-01-09

Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for Use with Chemotherapy Drugs

Applicant Hartalega Sdn Bhd

K-Number K162819

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FLL 2017-01-09

RII Multi-function Infrared Thermometer, Model TH52Z

Applicant Radiant Innovation, Inc.

K-Number K162083

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LLZ 2017-01-06

Quantib Brain 1.2

Applicant Quantib B.V.

K-Number K163013

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DQY 2017-01-06

Trapper Exchange Device

Applicant Creganna Medical Aslo Business AS Cregganna Tactx Medical

K-Number K162253

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