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

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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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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KNS 2025-11-26

Vanquish Water Vapor Ablation Device

Applicant Francis Medical, Inc.

K-Number K252388

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GTY 2025-11-26

Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip

Applicant ACON Laboratories, Inc.

K-Number K251697

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