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

FAJ 2024-10-16

Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aBox 2

Applicant Ambu A/S

K-Number K240849

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SDB 2024-10-16

AMStent® Tracheobronchial Covered Stent System

Applicant Peytant Solutions, Inc.

K-Number DEN230087

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CJE 2024-10-16

Alkaline Phosphatase

Applicant Abbott Laboratories Diagnostics Division

K-Number K240468

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FYA 2024-10-16

Stryker Steri-Shield 8 Surgical Hoods and Togas

Applicant Stryker Instruments

K-Number K241272

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KRD 2024-10-16

ONCOZENE Microspheres

Applicant Varian Medical Systems, Inc.

K-Number K242794

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QJP 2024-10-16

CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter

Applicant Cerenovus, Inc.

K-Number K241244

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LKF 2024-10-16

RELIEEV Uterine Manipulator Injector (CUMI 5.0)

Applicant Li Medical Corporation , Ltd.

K-Number K240364

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NQW 2024-10-16

Vy Spine VyLam Laminoplasty System

Applicant Vy Spine, LLC

K-Number K242784

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FRG 2024-10-16

Safe Secure Sterilization Pouches and Rolls

Applicant Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.

K-Number K242839

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ITI 2024-10-16

Electrically powered wheelchair

Applicant Kunshan Hi-Fortune Health Products Co., Ltd.

K-Number K241632

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LLZ 2024-10-16

JLK-CTP

Applicant JLK, Inc.

K-Number K242556

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CCT 2024-10-16

UltraEzAir® (UEA1A)

Applicant Dualams, Inc., Dba Airkor

K-Number K240114

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