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

LPH 2025-12-05

Velora Acetabular System

Applicant Restor3D, Inc.

K-Number K252067

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QKB 2025-12-05

ARTAssistant

Applicant Manteia Technologies Co., Ltd.

K-Number K250780

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ODP 2025-12-05

SpineLinc Anterior Cervical Implant System

Applicant Lincotek Medical

K-Number K250764

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ONB 2025-12-05

ProSeal™ Transfer Injector (421120, 421130, 421140)

Applicant Epic Medical Pte. , Ltd.

K-Number K251722

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PBF 2025-12-05

VSP Orthopedics System

Applicant 3D Systems, Inc.

K-Number K250711

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ITI 2025-12-05

Electrically powered wheelchair (KZ301B)

Applicant Nanjing Kangni Smart Technology Co., Ltd.

K-Number K252494

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QIH 2025-12-05

Overjet CBCT Assist

Applicant Overjet, Inc.

K-Number K251514

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MQC 2025-12-05

Remvia NightGuard

Applicant Remvia

K-Number K250743

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EOQ 2025-12-05

KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)

Applicant Karl Storz SE & CO. KG

K-Number K251731

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IOR 2025-12-05

Manual Wheelchair (W47)

Applicant Jiangsu Jumao X-Care Medical Equipment Co., , Ltd.

K-Number K252828

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HRX 2025-12-05

PUREVUE™ FMS

Applicant W.O.M. World of Medicine GmbH

K-Number K250795

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EBF 2025-12-05

Any-Core

Applicant Mediclus Co., Ltd.

K-Number K252465

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