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

NGX 2019-02-26

Body System

Applicant A-1 Engineering

K-Number K182440

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IYE 2019-02-26

GrayDuck Stent

Applicant Poll Medical, LLC

K-Number K183374

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FPA 2019-02-26

Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use

Applicant Wuhan W.E.O Science & Technology Development Co., Ltd.

K-Number K181870

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KCT 2019-02-26

Omni Instrument Tray

Applicant Hologic, Inc.

K-Number K182052

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MBI 2019-02-26

HEALIX ADVANCE SP PEEK Anchor

Applicant Medos International SARL

K-Number K182941

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OCL 2019-02-25

COBRA Fusion Ablation System

Applicant AtriCure, Inc.

K-Number K190151

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IYE 2019-02-25

Zap-X Radiosurgery System

Applicant Zap Surgical Systems

K-Number K183698

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QEY 2019-02-25

Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200

Applicant Thrombolex, Inc.

K-Number K183290

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QEW 2019-02-25

CAPERE Thrombectomy System

Applicant Vascular Medcure, Inc.

K-Number K183179

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NKG 2019-02-25

Perla® Posterior Cervico-Thoracic Fixation System

Applicant Spineart

K-Number K190071

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OKP 2019-02-25

SpringTMS

Applicant Eneura®, Inc.

K-Number K182976

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LZO 2019-02-22

Libertas Acetabular Hooded Liner

Applicant Maxx Orthopedics, Inc.

K-Number K183365

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