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

PEM 2020-12-23

Plasdent Disposable Barrier Sleeves and Barrier Film

Applicant Plasdent Corporation

K-Number K201604

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PTA 2020-12-23

Helix Genetic Health Risk App for late-onset Alzheimer’s disease

Applicant Helix Opco, LLC

K-Number K192073

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KWS 2020-12-23

AltiVate® Anatomic Pegged Glenoid with Markers

Applicant Encore Medical L.P.

K-Number K203026

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MQP 2020-12-23

F3D Corpectomy System

Applicant Corelink, LLC

K-Number K202637

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FLL 2020-12-23

DeRoyal Temperature Monitoring Probe

Applicant Deroyal Industries, Inc.

K-Number K200631

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FWP 2020-12-23

Customized Contour Implant

Applicant Implantech Associates, Inc.

K-Number K200610

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OWB 2020-12-23

ControlRad Select Model Z

Applicant Controlrad, Inc.

K-Number K202431

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OVD 2020-12-23

Omnia Medical TiBrid-SA

Applicant Omnia Medical, LLC

K-Number K203207

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NUC 2020-12-23

LUBi Water Based Personal Lubricant

Applicant Boya Biotechnology Co., Ltd.

K-Number K203257

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FXX 2020-12-23

Medical Face mask

Applicant Jiangsu Province Jianerkang Medical Dressing Co., Ltd.

K-Number K202061

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JAK 2020-12-23

OmniTom Elite

Applicant Neurologica Corporation, A Subsidiary of Samsung Electronics

K-Number K202526

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KDI 2020-12-23

SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set

Applicant Quanta Dialysis Technologies, Ltd.

K-Number K193670

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