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 2025-04-23

EchoGuide (Version 1)

Applicant Sonavex, Inc.

K-Number K243479

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LZA 2025-04-23

Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl

Applicant Gmp Medicare Sdn. Bhd.

K-Number K250944

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FTL 2025-04-23

Parietene™ Macroporous Mesh (PPM5050 )

Applicant Sofradim Production

K-Number K250869

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IYN 2025-04-23

eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S)

Applicant Esonic Technology (Wuhan) Co., Ltd.

K-Number K250228

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HRS 2025-04-23

Xpert Knee

Applicant Newclip Technics

K-Number K250155

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LLZ 2025-04-23

MySpine WebPlanner

Applicant Medacta International S.A.

K-Number K243697

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BTA 2025-04-23

Electric Nasal Aspirator (BC026, BC025, BC023)

Applicant Shenzhen Kingboom Technology Co., Ltd.

K-Number K250697

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OLO 2025-04-23

Dynamis Robotic Surgical System

Applicant LEM Surgical AG

K-Number K243326

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PNN 2025-04-23

Laon Ortho

Applicant Laon Medi, Inc.

K-Number K250198

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QEP 2025-04-22

BD CTGCTV2

Applicant Bd Integrated Diagnostic Solutions/Becton,

K-Number K243343

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NHA 2025-04-22

Medentika CAD/CAM Abutments

Applicant Medentika GmbH

K-Number K242542

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OVD 2025-04-22

Ventris Intervertebral Body Fusion Device

Applicant Acuity Surgical Devices, LLC

K-Number K243386

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