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

LLZ 2018-12-18

MIM - MRT Dosimetry

Applicant Mim Software, Inc.

K-Number K182624

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EIH 2018-12-18

VINTAGE PRO

Applicant Shofu Dental Corporation

K-Number K181496

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KPS 2018-12-18

Emission Computed Tomography System

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K182938

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HWC 2018-12-18

Arthrex Compression FT Screws

Applicant Arthrex, Inc.

K-Number K182361

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DHR 2018-12-18

EliA RF IgM Immunoassay

Applicant Phadia AB

K-Number K182747

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EBI 2018-12-18

Lucitone Denture Base Materials

Applicant Dentsply Sirona

K-Number K182422

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NRY 2018-12-18

Riptide Aspiration System (Riptide Large Bore Aspiration System)

Applicant Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

K-Number K183185

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FMF 2018-12-17

NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)

Applicant Novo Nordisk, Inc.

K-Number K182387

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KWQ 2018-12-17

Met One Czar Anterior Cervical Plate System

Applicant Met One Technologies

K-Number K180772

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QEW 2018-12-17

FlowTriever Retrieval/Aspiration System

Applicant Inari Medical

K-Number K183198

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MCW 2018-12-17

Phoenix 2.4mm Atherectomy Plus System

Applicant Volcano Atheromed, Inc.

K-Number K181877

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MWI 2018-12-17

Handheld VitalSigns Monitoring System

Applicant Visiomed Technology Co.,Ltd

K-Number K172965

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