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

BZT 2020-04-02

Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French

Applicant Deroyal Industries, Inc.

K-Number K193027

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KNW 2020-04-02

Medone Ultra, Medextra

Applicant Medax Srl Unipersonale

K-Number K192101

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PNN 2020-04-02

CS Model+

Applicant Trophy

K-Number K193390

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OUR 2020-04-02

FIREBIRD SI Fusion System

Applicant Orthofix, Inc.

K-Number K200696

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PMN 2020-04-02

FilmArray BCID2 Control Panel M416

Applicant Maine Molecular Quality Controls, Inc.

K-Number K200010

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MAX 2020-04-02

EVOS Lumbar Interbody System

Applicant Cutting Edge Spine, LLC

K-Number K200552

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KOI 2020-04-02

TwitchView System

Applicant Blink Device Company

K-Number K192958

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IYN 2020-04-02

Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K200251

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IOR 2020-04-01

Manual Wheelchair

Applicant Jerry Medical Instrument (Shanghai) Co., Ltd.

K-Number K192658

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JAK 2020-04-01

SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GO

Applicant Siemens Medical Solutions USA, Inc.

K-Number K200524

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PSW 2020-04-01

CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant

Applicant Cs Medical, LLC

K-Number K192228

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IYN 2020-04-01

LOGIQ E10s

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K200119

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