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

NFO 2021-02-24

Trinity ELE Plus and Trinity ELE Plus Pro

Applicant Carol Cole Company Dba Nuface

K-Number K201906

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MAI 2021-02-24

CITRESPLINE and CITRELOCK ACL Implants

Applicant Acuitive Technologies, Inc.

K-Number K210239

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PBY 2021-02-24

Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit

Applicant Sirius Medical Systems B.V.

K-Number K200734

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GCJ 2021-02-24

4K UHD Laparoscope

Applicant Scivita Medical Technology Co., Ltd.

K-Number K203255

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IYN 2021-02-23

Lumify Diagnostic Ultrasound System

Applicant Philips Ultrasound, Inc.

K-Number K203406

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QIU 2021-02-23

Lumenis Stellar M22

Applicant Lumenis, Ltd.

K-Number DEN200028

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GEX 2021-02-23

Global Med Systems Milesman Compact Laser

Applicant Global Med Systems SL

K-Number K203804

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FPA 2021-02-23

Velano ExT Extension Set

Applicant Velano Vascular

K-Number K200439

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LXB 2021-02-23

Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App

Applicant Cochlear Americas

K-Number K202048

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OAS 2021-02-23

PreXion3D Explorer PRO

Applicant Prexion Corporation

K-Number K203784

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OEB 2021-02-23

Veolity

Applicant MeVis Medical Solutions AG

K-Number K201501

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EIH 2021-02-23

GenesisZr 4Y+ (ST1100) Zirconia

Applicant United Dental Resources Corporation

K-Number K201915

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