Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

HWC 2024-10-29

Tigon Medical Fractures, Instability, and Reconstruction (FIRE)

Applicant Tigon Medical

K-Number K240175

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NWA 2024-10-29

TRACHEOBRONXANE DUMON®

Applicant Novatech SA

K-Number K243126

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MBH 2024-10-29

Persona the Personalized Knee System

Applicant Zimmer, Inc.

K-Number K243247

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OVD 2024-10-29

DeGen Medical Patient Specific Implant (PSI) System

Applicant Degen Medical

K-Number K241077

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NRY 2024-10-29

Riptide Aspiration System

Applicant Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

K-Number K243080

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CBP 2024-10-29

QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)

Applicant Dehas Medical Systems GmbH

K-Number K241366

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KNW 2024-10-29

Mammotome AutoCore Single Insertion Core Biopsy System

Applicant Devicor Medical Products, Inc.

K-Number K243095

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GXH 2024-10-29

AtriCure cryoICE BOX (ACM)

Applicant AtriCure, Inc.

K-Number K243157

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QRK 2024-10-28

Sterile Lancets for Single Use

Applicant Ningbo Caremed Medical Products Co., Ltd.

K-Number K242622

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NQW 2024-10-28

Curiteva Porous PEEK Laminoplasty System

Applicant Curiteva, Inc.

K-Number K243137

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GDW 2024-10-28

ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T)

Applicant Ethicon Endo-Surgery, LLC

K-Number K241630

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OVD 2024-10-28

Catalyft LS Expandable Interbody System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K241992

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