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

DHX 2020-04-13

ADVIA Centaur CEA Assay

Applicant Siemens Healthcare Disgnostics, Inc.

K-Number K200215

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DZE 2020-04-13

s-Clean SQ-SL Implant System Mini

Applicant Dentis Co., Ltd.

K-Number K200099

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DWA 2020-04-13

Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure

Applicant Spectrum Medical , Ltd.

K-Number K192838

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GEI 2020-04-13

VivAer Stylus

Applicant Aerin Medical, Inc.

K-Number K200300

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IZL 2020-04-13

AcuityPDR

Applicant Radmedix, LLC

K-Number K200726

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ONN 2020-04-12

VERASENSE for Stryker Triathlon

Applicant Orthosensor, Inc.

K-Number K200665

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IPF 2020-04-11

Nerve and Muscle Stimulator

Applicant Shenzhen Xft Medical Limited

K-Number K193275

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MEG 2020-04-10

Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use

Applicant Gemtier Medical (Shanghai), Inc.

K-Number K192679

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IYN 2020-04-10

ACUSON Freestyle Diagnostic Ultrasound System

Applicant Siemens Medical Solutions USA, Inc.

K-Number K200644

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PLC 2020-04-10

Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac

Applicant Residential Home Sleep Services

K-Number K190353

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QAI 2020-04-10

SkinStylus SteriLock MicroSystem

Applicant Esthetic Education, LLC

K-Number K200044

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OLO 2020-04-10

OrthAlign Plus System

Applicant Orthalign, Inc.

K-Number K200642

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