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 2021-02-23

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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FRA 2021-02-23

Molekule Air Mini, Molekule Air Mini +

Applicant Molekule, Inc.

K-Number K202339

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QEW 2021-02-23

ClotTriever Thrombectomy System

Applicant Irani Medical, Inc.

K-Number K210190

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GEI 2021-02-23

Nissha Medical Technologies Neutral Electrodes

Applicant Nissha Medical Technologies, Ltd.

K-Number K203494

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MUJ 2021-02-23

Monaco Rtp System

Applicant Elekta Solutions AB

K-Number K202789

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IPF 2021-02-23

PowerDot PD-01MT2 Muscle Stimulator

Applicant Smartmissimo Technologies Pte, Ltd.

K-Number K210269

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OWB 2021-02-23

ClarifEye R1.0, ClarifEye Needle

Applicant Philips Medical Systems Nederlands B.V.

K-Number K201743

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