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

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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ORZ 2019-10-22

LipiFlow Thermal Pulsation System

Applicant Tearscience, Inc.

K-Number K192623

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FRC 2019-10-22

Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device

Applicant Sterilucent, Inc.

K-Number K192001

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NIG 2019-10-22

Lumpipulse G CA19-9-N

Applicant Fujirebio Dianostics, Inc.

K-Number K191973

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