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

KWQ 2018-08-02

Curiteva Anterior Cervical Plate System

Applicant Curiteva, LLC

K-Number K181562

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LLZ 2018-08-02

miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer

Applicant Hinacom Software and Technology, Ltd.

K-Number K171977

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GAT 2018-08-02

DYNACORD Suture

Applicant Medos International SARL

K-Number K181182

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BZE 2018-08-02

Neonatal ConchaSmart Breathing Circuits

Applicant Teleflexmedical, Inc.

K-Number K173280

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GEI 2018-08-02

PlasmaBlade X 3.0S, PlasmaBlade X 4.0

Applicant Medtronic Advanced Energy

K-Number K181257

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LDF 2018-08-02

Temporary Cardiac Pacing Wire

Applicant ETHICON, Inc.

K-Number K173923

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FTL 2018-08-02

Polydioxanone Surgical Scaffold

Applicant Lntegra Lifesciences

K-Number K181094

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CAF 2018-08-01

Propeller Sensor for Neohaler

Applicant Reciprocal Labs Corporation

K-Number K180770

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NUC 2018-08-01

TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)

Applicant Church & Dwight Co., Inc.

K-Number K180764

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GAT 2018-08-01

NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0)

Applicant Ceterix Orthopaedics, Inc.

K-Number K181772

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GEX 2018-08-01

MMD Tip

Applicant Strata Skin Sciences, Inc.

K-Number K181480

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JDQ 2018-08-01

SuperCable® Iso-Elastic™ Cerclage System

Applicant Kinamed, Incorporated

K-Number K181749

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