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

FQH 2023-05-16

VERSAJET Hydrosurgery System (III)

Applicant Smith & Nephew Medical Limited

K-Number K220964

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CBK 2023-05-16

Babylog VN800, Babylog VN600

Applicant Draegerwerk AG & CO Kgaa

K-Number K222207

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MMX 2023-05-16

Gunther Tulip Vena Cava Filter Retrieval Set

Applicant Cook Incorporated

K-Number K222254

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LFC 2023-05-16

BlueCheck™ Caries Detection & Monitoring

Applicant Incisive Technologies Pty, Ltd.

K-Number K222560

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EIH 2023-05-16

BruxZir™ Incisal Coloring Liquid

Applicant Prismatik Dentalcraft, Inc.

K-Number K230262

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MAX 2023-05-16

Eminent Spine 3D Lumbar Interbody Fusion Systems

Applicant Eminent Spine, LLC

K-Number K230219

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OHS 2023-05-16

Infrared Heat (Model: E0221)

Applicant Light Tree Ventures Europe B.V.

K-Number K223893

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ELC 2023-05-15

Combi Touch

Applicant Mectron S.P.A.

K-Number K231391

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QBJ 2023-05-15

Dexcom G7 Continuous Glucose Monitoring (CGM) System

Applicant Dexcom, Inc.

K-Number K231081

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NHA 2023-05-15

Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs

Applicant Institut Straumann AG

K-Number K222836

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PHW 2023-05-15

Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro); VibraCool® (models: Easy Fit, Extended, Plantar, Flex, Pro DME, Pro UE, Pro LE, Pro 200H)

Applicant Mmj Labs, LLC

K-Number K202993

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DRG 2023-05-15

HD+12, HD+15

Applicant Cardioline S.P.A

K-Number K220526

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