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

DRG 2018-10-03

Caretaker Remote Display App and Caretaker Software Library

Applicant Caretaker Medical, LLC

K-Number K181196

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LNH 2018-10-03

uMR 790

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K181371

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PQC 2018-10-03

FIREFLY® Midline Navigation Guide

Applicant Mighty Oak Medical, Inc.

K-Number K181883

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OUR 2018-10-03

Outlet Sacroiliac Joint Fusion System

Applicant Sij Surgical

K-Number K181881

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IYE 2018-10-03

Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch

Applicant Siemens Medical Solutions USA, Inc.

K-Number K182050

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LNH 2018-10-03

uMR 780

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K181370

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LYZ 2018-10-03

Vinyl Patient Examination Gloves

Applicant Pingan Medical Products Co., Ltd.

K-Number K182115

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MRN 2018-10-02

NOxBOXi Nitric Oxide Delivery System

Applicant Praxair Distribution, Inc.

K-Number K171696

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KCT 2018-10-02

KLOCKNER SURGICAL BOX

Applicant SOADCO, S.L.

K-Number K173642

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FDT 2018-10-02

FUJIFILM Duodenoscope Model

Applicant Fujifilm Corporation

K-Number K182051

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GEX 2018-10-02

Deka Smartxide2 Trio

Applicant El.En Electronic Engineering Spa

K-Number K181867

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FLL 2018-10-02

Infrared Ear Thermometer

Applicant Joytech Healthcare Co. , Ltd.

K-Number K181081

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