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

JSM 2024-08-19

OmniTrans Transport System

Applicant Shenzhen Dakewe Bio-Engineering Co., Ltd.

K-Number K240235

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SBF 2024-08-19

OnPoint Augmented Reality Spine System

Applicant Onpoint Surgical, Inc.

K-Number K241870

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JAK 2024-08-19

HealthCCSng

Applicant Nano-X AI , Ltd.

K-Number K241440

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IPF 2024-08-17

BTL-899MS

Applicant BTL Industries, Inc.

K-Number K240234

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NQQ 2024-08-16

HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))

Applicant Gentuity, LLC

K-Number K242239

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NTK 2024-08-16

iTero Lumina™ Pro

Applicant Align Technology , Ltd.

K-Number K240573

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DZE 2024-08-16

JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus

Applicant Jdentalcare Srl

K-Number K233896

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NUC 2024-08-16

Human Lubricant

Applicant Jiangxi Wulinxiang Biological Technology Co., Ltd.

K-Number K240081

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LOX 2024-08-16

Sapphire NC ULTRA Coronary Dilatation Catheter

Applicant OrbusNeich Medical (Shenzhen) Co., Ltd.

K-Number K233499

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GKP 2024-08-16

ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)

Applicant Instrumentation Laboratory (IL) Co.

K-Number K242127

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DQK 2024-08-16

HeartKey® Rhythm

Applicant B-Secur Limited

K-Number K233755

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DQA 2024-08-16

Mecun SpO2 sensor

Applicant Shenzhen Mecun Medical Supply Co., Ltd.

K-Number K231979

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