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

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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LLZ 2021-05-21

Universal Viewer

Applicant GE Healthcare

K-Number K211312

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LFL 2021-05-21

Ultrasonic Surgical Aspirator System

Applicant Smtp Technology Co., Ltd.

K-Number K202299

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MJN 2021-05-21

Neurescue device

Applicant Neurescue Aps

K-Number K210358

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IZL 2021-05-21

Rover

Applicant Micro-X Limited

K-Number K211423

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ITI 2021-05-21

JWX-1 Plus (Navigo 16/Navigo 24)

Applicant Yamaha Motor Co., Ltd.

K-Number K203806

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ONF 2021-05-21

IPL Hair Removal Device (Model: KCA423)

Applicant Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd.

K-Number K210119

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IOR 2021-05-21

Manual Wheelchair, Model A011

Applicant Ningbo Shenyu Medical Equipment Co.,Ltd

K-Number K201461

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