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

ONB 2019-10-23

Diana ChemoClave Transfer Set

Applicant Icu Medical

K-Number K190157

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FMI 2019-10-23

Intraosseous infusion device

Applicant Einstein Works, LLC

K-Number K191258

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NWA 2019-10-23

Patient-Specific Airway Stent

Applicant New Cos, Inc.

K-Number K182743

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KWQ 2019-10-23

RESONATE Anterior Cervical Plate System

Applicant Globus Medical, Inc.

K-Number K192314

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KWS 2019-10-23

Alliance Glenoid

Applicant Zimmer, Inc.

K-Number K191814

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LZO 2019-10-22

Exactech Alteon Modular Dual Mobility (MDM) System

Applicant Exactech, Inc.

K-Number K190890

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JWH 2019-10-22

Madison Total Knee System

Applicant Implanet, S.A.

K-Number K192084

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NKB 2019-10-22

Europa Pedicle Screw System

Applicant MiRus, LLC

K-Number K192268

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OAS 2019-10-22

RCT800

Applicant Ray Co., Ltd.

K-Number K192737

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IYN 2019-10-22

ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound System

Applicant Siemens Medical Solutions USA, Inc.

K-Number K192835

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NUJ 2019-10-22

Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter

Applicant Vein 360, LLC

K-Number K191073

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FTL 2019-10-22

VICRYL Mesh

Applicant ETHICON, Inc.

K-Number K191373

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