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

OBJ 2025-05-23

ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™

Applicant ABBOTT MEDICAL

K-Number K251211

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BZD 2025-05-23

WiZARD 520 Full Face Mask

Applicant Wellell, Inc.

K-Number K243023

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JKA 2025-05-23

Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)

Applicant Venocare, Inc.

K-Number K244047

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QIH 2025-05-23

Second Opinion® 3D

Applicant Pearl, Inc.

K-Number K243989

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HAW 2025-05-23

Stereotaxic Guiding Surgical Devices, NaoTrac S

Applicant Brain Navi Biotechnology Co., Ltd.

K-Number K242575

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MQV 2025-05-23

MagnetOs MIS

Applicant Kuros Biosciences B.V

K-Number K243474

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IYN 2025-05-23

DEEPECHO

Applicant Deepecho

K-Number K242594

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DFH 2025-05-23

Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit

Applicant The Binding Site Group , Ltd.

K-Number K250549

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MAI 2025-05-23

Knotilus+ Biocomposite Knotless Anchor

Applicant Stryker Endoscopy

K-Number K250544

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KWQ 2025-05-23

Frida™ Anterior Cervical Plate System

Applicant Spineup, Inc.

K-Number K250446

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EBF 2025-05-23

Sil-Flow

Applicant Dsi Dental Solutions, Ltd.

K-Number K250778

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QIH 2025-05-23

Clever One

Applicant Ewoosoft Co., Ltd.

K-Number K250005

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