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

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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NQX 2024-10-25

Xpert® SA Nasal Complete

Applicant Cepheid®

K-Number K243070

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LPL 2024-10-25

Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia; Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Astigmatism

Applicant Bruno Vision Care, LLC

K-Number K240918

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LOX 2024-10-25

Pantera Pro; Pantera LEO

Applicant Biotronik, Inc.

K-Number K242969

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OYK 2024-10-25

Salto Talaris Ankle PSI System

Applicant 3D Systems, Inc.

K-Number K243173

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