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

EKX 2021-12-17

Cordless Prophy System, Model: i-Polish

Applicant Guilin Woodpecker Medical Instrument Co., Ltd.

K-Number K211531

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DTZ 2021-12-17

Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2

Applicant Qura S.R.L

K-Number K203424

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ONQ 2021-12-17

MED RF 4000

Applicant F Care Systems USA, LLC

K-Number K210077

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NGX 2021-12-17

Revitive Medic Coach (Model Number 5575AQ)

Applicant Actegy , Ltd.

K-Number K210825

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HSX 2021-12-16

Balanced Knee System Uni

Applicant Ortho Development Corporation

K-Number K211471

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OMP 2021-12-16

Theia NPWT Foam Wound Dressing Kit

Applicant Clear Choice Therapeutics, Inc.

K-Number K211277

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GEI 2021-12-16

Profound Matrix

Applicant Candela Corporation

K-Number K211217

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QJP 2021-12-16

MIVI Q Distal Access Catheter

Applicant Mivi Neuroscience, Inc.

K-Number K212402

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PNN 2021-12-16

ArchForm Orthodontic Software System

Applicant Archform, Inc.

K-Number K213916

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MNR 2021-12-16

NightOwl

Applicant Ectosense NV

K-Number K213463

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LZA 2021-12-16

AT

Applicant At Glove Engineering Sdn. Bhd

K-Number K212645

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HRS 2021-12-16

Activmotion S DTO

Applicant Newclip Technics

K-Number K202803

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