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

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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JWH 2023-03-30

Cemented Tibia Baseplate no Taper with JRNY Lock

Applicant Smith & Nephew, Inc.

K-Number K230555

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MPA 2023-03-30

ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System

Applicant Nova Eye Inc. (Business Name Nova Eye Medical)

K-Number K221872

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OYK 2023-03-30

Axiom PSR System

Applicant Restor3D

K-Number K223326

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