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

GDW 2020-03-13

GIA Stapler with Tri-Staple Technology

Applicant Covidien

K-Number K192720

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KGO 2020-03-13

Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim

Applicant Molnlycke Health Care Us, LLC

K-Number K191869

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QEW 2020-03-13

Indigo Aspiration System – Lightning Aspiration Tubing

Applicant Penumbra, Inc.

K-Number K193244

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GEX 2020-03-13

MeDioStar

Applicant Asclepion Laser Technologies GmbH

K-Number K192483

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MAX 2020-03-13

SeaSpine Skipjack System

Applicant SeaSpine Orthopedics Corporation

K-Number K193418

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LON 2020-03-13

VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)

Applicant bioMerieux, Inc.

K-Number K193572

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JWH 2020-03-13

3DMetal Diaphyseal Femoral Cones

Applicant Medacta International S.A.

K-Number K200075

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DQA 2020-03-13

Disposable SpO2 Sensor

Applicant Shenzhen Changke Connect Electronics Co., Ltd.

K-Number K200069

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LYR 2020-03-13

Curian HpSA, Curian Analyzer

Applicant Meridian Bioscience, Inc.

K-Number K192817

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LZA 2020-03-13

Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Applicant O&M Haylard, Inc.

K-Number K192241

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OAS 2020-03-13

CS 9600

Applicant Trophy

K-Number K200183

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DWF 2020-03-13

Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula

Applicant Edwards Lifesciences, LLC

K-Number K200358

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