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

GXY 2026-07-14

Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)

Applicant Ambu A/S

K-Number K260578

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MAX 2026-07-14

Symmetrix™ L Spinal System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K261020

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DQX 2026-07-13

Merit MAK Nitinol/Gold-Tungsten Guide Wire

Applicant Merit Medical Ireland , Ltd.

K-Number K261640

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QJP 2026-07-13

SLIM Microcatheter

Applicant Balt USA, LLC

K-Number K260199

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QAS 2026-07-13

Rapid Vessel Occlusion (Rapid VO)

Applicant iSchemaview

K-Number K261085

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FMF 2026-07-13

Ultra-Fine™ SAFETY Insulin Syringe

Applicant embecta Medical II, LLC

K-Number K260208

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GEI 2026-07-13

Volnewmer™

Applicant Classys, Inc.

K-Number K253504

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HGX 2026-07-13

Wearable Breast Pump (Model S32A)

Applicant Shenzhen TPH Technology Co., Ltd.

K-Number K261199

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SCR 2026-07-13

Hearing assist

Applicant Meta Platform Technologies, LLC

K-Number K254044

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PFO 2026-07-10

Cochlear™ Osia® 3(I) Sound Processor;Cochlear™ Osia® 3 Sound Processor;Cochlear™ Osia® 3 Charger;Cochlear™ Osia® 3 Aqua+;Cochlear™ Osia® Fitting Software 3;Cochlear™ Osia® Smart App;Cochlear™ Osia® System

Applicant Cochlear Americas

K-Number K260902

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ESW 2026-07-10

WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System

Applicant Boston Scientific Corporation

K-Number K261978

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KNT 2026-07-10

Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)

Applicant C.R. Bard, Inc.

K-Number K253514

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