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

NRY 2016-05-25

Penumbra System, Penumbra Pump MAX

Applicant Penumbra, Inc.

K-Number K160449

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OVE 2016-05-25

ArcadiusXP C Spinal System

Applicant Aesculap Implant Systems, Inc.

K-Number K153629

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PNO 2016-05-25

FLEX SCORING CATHETER

Applicant Venturemed Group

K-Number K152789

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JDX 2016-05-25

PIEZOSURGERY PLUS

Applicant Mectron S.P.A.

K-Number K153743

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LPH 2016-05-25

Stryker Orthopaedics Hip Systems Labeling Update

Applicant Stryker Orthopaedics

K-Number K153345

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JHS 2016-05-25

Creatine Kinase

Applicant Roche Diagnostics Operations (Rdo)

K-Number K160570

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IYE 2016-05-25

Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement

Applicant Medtec, Inc. D/B/A Civco Medical Solutions

K-Number K153026

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QSY 2016-05-25

Prometheus ChitoGauze XR PRO

Applicant Hem Con Medical Technologies, Inc.

K-Number K153582

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DSI 2016-05-25

EMMa Electronic Monitoring Management

Applicant Vitasystems GmbH

K-Number K153477

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JOP 2016-05-25

Smartdop XT6

Applicant Koven Technology, Inc.

K-Number K153762

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QEW 2016-05-24

Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)

Applicant Penumbra, Inc.

K-Number K160533

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NCX 2016-05-24

Hypocore

Applicant Novocor Medical Systems, Inc.

K-Number K153162

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