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

FGB 2025-09-24

LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500)

Applicant Boston Scientific Corporation

K-Number K252703

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QIH 2025-09-23

SwiftSight-Brain

Applicant Airs Medical, Inc.

K-Number K251483

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FAJ 2025-09-23

Zenflow Spring Scope

Applicant Zenflow, Inc.

K-Number K251140

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EOQ 2025-09-23

Ion Endoluminal System (IF1000)

Applicant Intuitive Surgical, Inc.

K-Number K252045

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QIH 2025-09-23

Rapid Aortic Measurements

Applicant Ischemaview, Inc.

K-Number K251987

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EBF 2025-09-23

Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)

Applicant Hangzhou SHINING3D Dental Technology Co., Ltd.

K-Number K253053

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OKJ 2025-09-23

Luminance Red Cold Sore Device (TN1927G)

Applicant Luminance Medical Ventures, Inc.

K-Number K251973

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GEI 2025-09-23

Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)

Applicant Olympus Winter & Ibe GmbH

K-Number K252043

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NEW 2025-09-23

PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION™ PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture

Applicant M/s. Meril Endo Surgery Private Limited.

K-Number K252644

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KRH 2025-09-23

Edwards MC3 Tricuspid annuloplasty ring (4900)

Applicant Edwards Lifesciences, LLC

K-Number K251982

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KRD 2025-09-23

Polyvinyl Alcohol Embolic Microspheres

Applicant Canyon Medical, Inc.

K-Number K250209

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EOQ 2025-09-23

Himaging Bronchscope System

Applicant Himaging Technology (Shanghai) Co., Ltd.

K-Number K251894

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