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

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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DQO 2017-01-06

NAMIC ClearaCIL Contrast Injection Lines

Applicant AngioDynamics, Inc.

K-Number K163141

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DRE 2017-01-06

Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set

Applicant Cardiacassist, Inc.

K-Number K162181

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PKL 2017-01-06

SureClip(TM) Repositionable Hemostasis Clip

Applicant Micro-Tech (Nanjing) Co., Ltd.

K-Number K161463

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GXQ 2017-01-06

DuraGen Secure Dural Regeneration Matrix

Applicant Integra LifeSciences Corporation

K-Number K163456

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LFZ 2017-01-06

LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set

Applicant DiaSorin, Inc.

K-Number K162969

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