BEUDAMED
    31 results · 9ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    Burlington Medical, Vest

    FDA Enforcement
    Class II ·Ongoing·Burlington Medical, LLC·April 8, 2026

    Burlington Medical, Kilt

    FDA Enforcement
    Class II ·Ongoing·Burlington Medical, LLC·April 8, 2026

    Burlington Medical, Frontal Aprons

    FDA Enforcement
    Class II ·Ongoing·Burlington Medical, LLC·April 8, 2026

    HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002

    FDA Enforcement
    Class II ·Ongoing·Access Vascular, Inc·February 22, 2023

    HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002

    FDA Enforcement
    Class II ·Ongoing·Access Vascular, Inc·February 22, 2023

    HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004

    FDA Enforcement
    Class II ·Ongoing·Access Vascular, Inc·May 24, 2023

    HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001

    FDA Enforcement
    Class II ·Ongoing·Access Vascular, Inc·February 22, 2023

    HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Model Number: 80004004

    FDA Enforcement
    Class II ·Ongoing·Access Vascular, Inc·March 1, 2023

    HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Number: 80004004

    FDA Enforcement
    Class II ·Ongoing·Access Vascular, Inc·March 1, 2023

    Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A

    FDA Enforcement
    Class II ·Ongoing·Karl Storz Endoscopy·December 27, 2023

    FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051

    FDA Enforcement
    Class II ·Ongoing·Richard Wolf GmbH·May 3, 2023

    FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 8735.685

    FDA Enforcement
    Class II ·Ongoing·Richard Wolf GmbH·May 3, 2023

    FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051

    FDA Enforcement
    Class II ·Ongoing·Richard Wolf GmbH·May 3, 2023

    HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004

    FDA Enforcement
    Class II ·Ongoing·Access Vascular, Inc·October 25, 2023

    Mckesson GYNECATH H/S CATHETER 5FR (10/CS) Model Number: 11-19610

    FDA Enforcement
    Class II ·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·August 31, 2022

    HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002

    FDA Enforcement
    Class II ·Ongoing·Access Vascular, Inc·October 25, 2023

    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10, Model Number 96-4176; 2) ECONO STERILE YANKAUER SUCTION TUBE 11" CS10, Model Number 96-4177; 3) ECONO STERILE FRAZIER TUBE 6FR STERILE CS/25, Model Number 96-5434; 4) ECONO STERILE FRAZIER TUBE 7FR STERILE CS/25, Model Number 96-5435; 5) ECONO STERILE FRAZIER TUBE 8FR STERILE CS/25, Model Number 96-5436; 6) ECONO STERILE FRAZIER TUBE 9FR STERILE CS/25, Model Number 96-5437; 7) ECONO STERILE FRAZIER TUBE 10FR STERILE CS25, Model Number 96-5438; 8) ECONO STERILE FRAZIER TUBE 12FR STERILE CS25, Model Number 96-5439; 9) ECONO STERILE FRAZIER TUBE 14FR STERILE CS25, Model Number 96-5440; 10) ECONO STERILE BARON SUCT TUBE 3FR STER CS25, Model Number 96-5492; 11) ECONO STERILE BARON SUCT TUBE 5FR STER CS25, Model Number 96-5493; 12) ECONO STERILE BARON SUCT TUBE 7FR STER CS25, Model Number 96-5494; suction devices

    FDA Enforcement
    Class II ·Ongoing·Sklar Instruments·January 22, 2025

    Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.

    FDA Enforcement
    Class II ·Ongoing·Arrow International Inc·July 21, 2021

    Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.

    FDA Enforcement
    Class II ·Ongoing·Arrow International Inc·July 21, 2021

    Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. introducer Product Code: AI-07155-IK - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.

    FDA Enforcement
    Class II ·Ongoing·Arrow International Inc·July 21, 2021