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

KNW 2020-04-02

MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System

Applicant Medax Srl Unipersonale

K-Number K192099

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DQY 2020-04-02

NovaCross CTO Microcatheter

Applicant Nitiloop , Ltd.

K-Number K193322

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LLZ 2020-04-02

IntelePACS

Applicant Intelerad Medical Systems Incorporated

K-Number K192176

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FAJ 2020-04-02

Ambu aScope 4 Cysto

Applicant Ambu A/S

K-Number K193095

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NKG 2020-04-02

SYMPHONY™ OCT System

Applicant Medos International SARL

K-Number K192646

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FMT 2020-04-02

HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable

Applicant Deroyal Industries, Inc.

K-Number K200319

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MHX 2020-04-02

Patient Monitor

Applicant Edan Instruments, Inc.

K-Number K192514

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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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