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

QDG 2025-11-28

Dendrite Imaging System

Applicant Dendrite Imaging, Inc.

K-Number K253303

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DYW 2025-11-27

Carriere® Motion Pro® Clear Bite Corrector

Applicant Ortho Organizers, Inc.

K-Number K252760

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KPR 2025-11-26

uDR Arria & uDR Aris

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K252000

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SGQ 2025-11-26

MuReva OM

Applicant Mureva Phototherapy, Inc.

K-Number DEN240077

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NLH 2025-11-26

Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter

Applicant Surgical Instrument Service and Savings, Inc.

K-Number K252405

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MOF 2025-11-26

0.014 Willow Guidewire

Applicant Arbor Endovascular, LLC

K-Number K253168

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NHA 2025-11-26

CEREC Tessera Abutment System

Applicant Dentsply Sirona

K-Number K252248

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OXO 2025-11-26

OEC One CFD

Applicant Ge Hualun Medical Systems Co. , Ltd.

K-Number K253269

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CGX 2025-11-26

Tru Kidney Health Test Panel; Tru Analyzer

Applicant Truvian Health

K-Number K251058

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MXA 2025-11-26

Fenom Flo FeNO Monitoring System

Applicant Mgc Diagnostics Corporation

K-Number K251674

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PTI 2025-11-26

K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing

Applicant Sb-Kawasumi Laboratories, Inc.

K-Number K252355

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LKF 2025-11-26

RELIEEV HSG Catheter (HSG7FA1)

Applicant Li Medical Corporation , Ltd.

K-Number K252260

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