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

CCK 2026-07-14

VisuBreath

Applicant Affirm Medical Technologies II, LLC

K-Number K261633

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MSC 2026-07-14

LIXI (LXOSFM1)

Applicant Luwi, LLC

K-Number K253662

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NKB 2026-07-14

Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System

Applicant Alphatec Spine, Inc.

K-Number K261284

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INI 2026-07-14

IERO Mobility Scooter (IERO-01)

Applicant Jochu Technology Co., Ltd.

K-Number K261232

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DQX 2026-07-14

Accoat Guide Wire

Applicant Sp Medical A/S

K-Number K253667

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GCJ 2026-07-14

Universal Seal (5-12 mm)

Applicant Intuitive Surgical, Inc.

K-Number K261249

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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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