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

LLZ 2023-03-31

RadAlly

Applicant Imaging Wave, LLC

K-Number K213660

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EIH 2023-03-31

Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Applicant Topzir Biotech Co., Ltd.

K-Number K230003

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GEX 2023-03-31

Diode Laser Hair Removal System (RD-SLD600)

Applicant Shanghai Omni Laser Skinology Co., Ltd.

K-Number K223778

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QIH 2023-03-31

Formus Hip

Applicant Formus Labs, Ltd.

K-Number K213272

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LLZ 2023-03-31

CereFlow V1.2

Applicant Translational Mri, LLC

K-Number K211059

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FRN 2023-03-31

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library

Applicant Baxter Healthcare Corporation

K-Number K230022

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IYN 2023-03-31

Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0

Applicant Canon Medical Systems Corporation

K-Number K223017

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HGX 2023-03-30

ARDO Bellis

Applicant Ardo Medical AG

K-Number K230590

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GCJ 2023-03-30

HOPKINS Telescopes

Applicant KARL STORZ Endoscopy-America, Inc.

K-Number K223923

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MOJ 2023-03-30

ONLINE TDM Phenytoin - Free Phenytoin application

Applicant Roche Diagnostics

K-Number K230161

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KPS 2023-03-30

Emory Cardiac Toolbox 4.3

Applicant Syntermed

K-Number K223422

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OVD 2023-03-30

ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)

Applicant Camber Spine Technologies

K-Number K221324

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