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

FRG 2016-07-27

Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap

Applicant Ahlstrom Nonwovens, LLC

K-Number K160755

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KIF 2016-07-27

Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress

Applicant Sybron Dental Specialties

K-Number K153067

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NDY 2016-07-27

Tina-quant Cystatin C Gen.2

Applicant Roche Diagnostics Operations (Rdo)

K-Number K161817

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QJL 2016-07-27

SinuBand

Applicant Bioinspire Technologies, Incorporated

K-Number K160101

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LPH 2016-07-27

The Progressive Orthopaedic Total Hip System

Applicant The Progressive Orthopaedic Company, LLC

K-Number K151424

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KTI 2016-07-27

Dillard Airway Dilatation System

Applicant Intuit Medical Products, LLC

K-Number K153484

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EIH 2016-07-27

Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Applicant Nissin-Metec China Co., Ltd.

K-Number K160367

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DZE 2016-07-27

Zeramex P6 Dental Implant System

Applicant Dentalpoint AG

K-Number K152385

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MNR 2016-07-26

Watch-PAT200U

Applicant Itamar Medical , Ltd.

K-Number K153070

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FMI 2016-07-26

Cook Intraosseous Infusion Needles

Applicant Cook Incorporated

K-Number K160887

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CDD 2016-07-26

ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)

Applicant Axis-Shield Diagnostics Limited

K-Number K160757

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CAF 2016-07-26

Hudson RCI AquaPak Sterile Prefilled Nebulizers

Applicant Teleflexmedical, Inc.

K-Number K153010

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