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

MAI 2025-03-14

Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor

Applicant Arthrex, Inc.

K-Number K250526

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QKQ 2025-03-14

Viewer+

Applicant Lumea, Inc.

K-Number K242244

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QZB 2025-03-14

Maestro System (REF100)

Applicant Moon Surgical

K-Number K242323

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OUR 2025-03-14

NEXXT MATRIXX® SI System

Applicant Nexxt Spine

K-Number K243838

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KIF 2025-03-14

One-Fil Putty

Applicant Mediclus Co., Ltd.

K-Number K243353

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LLZ 2025-03-14

PLANET Onco Dose (3.2)

Applicant Dosisoft SA

K-Number K241765

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LON 2025-03-14

VITEK COMPACT PRO

Applicant bioMerieux, Inc.

K-Number K234012

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OLO 2025-03-14

mBôs (Monogram mBôs TKA System)

Applicant Monogram Orthopaedics, Inc.

K-Number K242121

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FLL 2025-03-14

AION TempShield™

Applicant Aion Biosystems, Inc.

K-Number K250401

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PTI 2025-03-14

Promisemed Safety Huber Needles

Applicant Promisemed Hangzhou Meditech Co., Ltd.

K-Number K243332

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PGM 2025-03-14

VerteGlide Spinal Growth Guidance System

Applicant OrthoPediatrics Corp.

K-Number K241816

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EOQ 2025-03-14

Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8; Electronic Endoscope Imaging Processor: SP-TXCLQ12.1)

Applicant Shenzhen Sanping Image Technology Co., Ltd.

K-Number K242010

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