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

DSY 2021-05-25

HeRO Graft, HeRO Adapter

Applicant Merit Medical Systems, Inc.

K-Number K203724

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MXD 2021-05-25

LUX-Dx Insertable Cardiac Monitor

Applicant Boston Scientific Corporation

K-Number K210608

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FXX 2021-05-25

AirMax Procedure Mask

Applicant Premiumestore, LLC

K-Number K211275

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IRP 2021-05-25

Air Relax Plus Model AR-3.0

Applicant Diode Art Engineering Doing Business AS Air Relax

K-Number K211460

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EBF 2021-05-25

E-Dent 1000

Applicant Envisiontec GmbH

K-Number K210977

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KLE 2021-05-25

Tokuyama Universal Bond II

Applicant Tokuyama Dental Corporation

K-Number K203760

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MAX 2021-05-24

Catalyft PL Expandable Interbody System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K210425

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GEX 2021-05-24

UltraLight LED System

Applicant Rohrer Aesthetics, LLC

K-Number K210535

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LPL 2021-05-24

Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia

Applicant Bausch & Lomb, Incorporated

K-Number K210975

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MAX 2021-05-24

NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System

Applicant Nu Vasive, Incorporated

K-Number K210214

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MBH 2021-05-24

LEGION CR Porous Plus HA Femoral Components

Applicant Smith & Nephew, Inc.

K-Number K211246

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GWF 2021-05-22

Neuro-IOM system with Neuro-IOM.NET software

Applicant Neurosoft , Ltd.

K-Number K190703

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