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

FAJ 2018-01-30

Uro-V Cystoscope

Applicant Uroviu Corporation

K-Number K171500

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OAP 2018-01-30

Irradiation Aesthetic Device

Applicant Chongqing Peninsula Medical Technology Co., Ltd.

K-Number K171835

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NKB 2018-01-29

DeGen Medical E3 MIS Pedicle Screw System

Applicant Degen Medical

K-Number K173814

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KWY 2018-01-29

40-42mm BiPolar Head and 22mm Femoral Head

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K163081

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GEX 2018-01-29

JOULE SYSTEM

Applicant Sciton, Inc

K-Number K173285

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EZC 2018-01-29

Rusch Intermittent Urethral Catheters

Applicant Teleflex Medical

K-Number K173596

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LNH 2018-01-26

SyMRI

Applicant Syntheticmr AB

K-Number K173558

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IZL 2018-01-26

DRAGON X SPSL4HC, DRAGON X SPSL8HC

Applicant Sedecal., Sa.

K-Number K173299

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DQY 2018-01-26

Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm

Applicant Inneuroco, Inc.

K-Number K173709

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KNT 2018-01-26

Mic-Key* SF Over-the-Wire Stoma Measuring Device

Applicant Halyard Health, Inc.

K-Number K173955

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DQO 2018-01-26

SeQure® NF and SeQure® Microcatheters

Applicant Accurate Medical Therapeutics, Ltd.

K-Number K173430

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DXN 2018-01-26

Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312

Applicant Shenzhen Jiacom Technology CO ., Ltd.

K-Number K172896

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