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

QLX 2021-01-29

cobas BKV

Applicant Roche Molecular Systems, Inc.

K-Number K203220

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ODP 2021-01-29

BEE Cages

Applicant NGMedical GmbH

K-Number K200429

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HKI 2021-01-29

VX650

Applicant Luneau Technology Operations

K-Number K202221

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QIH 2021-01-29

Visage Breast Density

Applicant Visage Imaging GmbH

K-Number K201411

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CBK 2021-01-29

Ventway Sparrow

Applicant Inovytech Medical Solutions , Ltd.

K-Number K202970

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GEI 2021-01-29

DEX Device

Applicant Dex Surgical

K-Number K191878

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GEX 2021-01-29

Rapid Acoustic Pulse Device

Applicant Soliton, Inc.

K-Number K201801

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MAX 2021-01-29

XYPAN Expandable Lumbar Cage System

Applicant Aegis Spine, Inc.

K-Number K203531

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BZE 2021-01-29

Sunset Heated CPAP Tube

Applicant Sunset Healthcare Solutions, Inc.

K-Number K201418

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EKX 2021-01-29

E-connect S Endo Motor with built-in Apex Locator

Applicant Changzhou Sifary Medical Technology Co., Ltd.

K-Number K201993

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ODP 2021-01-29

Ti3Z Cervical Interbody System

Applicant Zavation Medical Products, LLC

K-Number K202398

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NHA 2021-01-29

Neodent Implant System - Zirconia Implant System

Applicant Jjgc Industria E Comercio DE Materiais Dentarios S.A.

K-Number K202282

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