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

IYO 2023-09-12

Velacur

Applicant Sonic Incytes

K-Number K232459

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IYE 2023-09-12

TrueBeam, TrueBeam STx, Edge, VitalBeam

Applicant Varian Medical Systems, Inc.

K-Number K231317

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JAA 2023-09-12

XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5

Applicant Canon Medical Systems Corporation

K-Number K232526

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CCK 2023-09-12

Endure ETCO2/02 Nasal Cannula

Applicant Endure Industries, Inc.

K-Number K213767

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IYO 2023-09-11

SiteRite™ 9 Ultrasound System

Applicant Bard Access Systems, Inc. (C.R. Bard, Inc.)

K-Number K231283

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MBI 2023-09-11

Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor)

Applicant Jarmon Medical, LLC (Dba Legends Orthopedics)

K-Number K230517

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CGA 2023-09-11

i-STAT G cartridge with the i-STAT 1 System

Applicant Abbott Point of Care, Inc.

K-Number K223755

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HWC 2023-09-11

TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw System

Applicant Vilex, LLC

K-Number K231504

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ONF 2023-09-11

Venus Versa PRO System

Applicant Venus Concept, Inc.

K-Number K232192

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MWI 2023-09-11

Change Healthcare Cardiology Hemodynamics™

Applicant Change Healthcare Israel , Ltd.

K-Number K230881

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HSN 2023-09-11

Vantage® Total Ankle System

Applicant Exactech, Inc.

K-Number K232002

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OVD 2023-09-11

MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation

Applicant MiRus, LLC

K-Number K232154

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