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

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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NKB 2024-10-28

Spinal Alignment Solutions Pelvic Incidence (PI) Rod System

Applicant Spinal Alignment Solutions, Inc.

K-Number K242350

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QKQ 2024-10-28

MetaLite DX Digital Pathology Software

Applicant Jellox Biotech, Inc.

K-Number K240303

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OHS 2024-10-28

Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)

Applicant Shenzhen Aozemei Technology Co., Ltd.

K-Number K241718

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FLL 2024-10-25

FMT Disposable and Autoclavable Temperature Probes

Applicant Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi

K-Number K240223

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OHT 2024-10-25

Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)

Applicant Ulike Co., Ltd.

K-Number K243030

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MUH 2024-10-25

VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)

Applicant VATECH Co., Ltd.

K-Number K240040

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LZA 2024-10-25

Nitrile Powder Free Examination Gloves Biodegradable (Green)

Applicant Comfort Rubber Gloves Industries Sdn. Bhd.

K-Number K240269

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HQF 2024-10-25

LYNX Photocoagulator

Applicant Norlase Aps

K-Number K242397

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