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

SBF 2024-10-16

xvision Spine System

Applicant Augmedics, Ltd.

K-Number K241481

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DXN 2024-10-16

Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206)

Applicant Shenzhen Hbcare Technology Co.,Ltd

K-Number K241613

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MUD 2024-10-16

Cerebral Autoregulation Index (CAI) Algorithm

Applicant Edwards Lifesciences

K-Number K240596

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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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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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