BEUDAMED
    14 results · 18ms · Sources: EU EUDAMED, US FDA

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

    Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system.

    FDA Enforcement
    Class II ·Ongoing·Medical Components, Inc dba MedComp·March 17, 2021

    Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE Lisfranc Reconstruction System.

    FDA Enforcement
    Class II ·Ongoing·Wright Medical Technology, Inc.·December 29, 2021

    Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK HARRIS METHODIST Model/Catalog Number: 555498 Software Version: N/A Product Description: CESK HARRIS METHODIST Component: No

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·June 10, 2026

    Brand Name: B. BRAUN MEDICAL INC. Product Name: BPSK, BLOCKJOCKS TRAY Model/Catalog Number: 570246 Software Version: N/A Product Description: BPSK, BLOCKJOCKS TRAY Component: No

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·June 10, 2026

    Brand Name: B. BRAUN MEDICAL INC Product Name: CESK NORTHSIDE ANESTHESIA TRAY Model/Catalog Number: 555076 Software Version: N/A Product Description: CESK NORTHSIDE ANESTHESIA TRAY Component: No

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·June 10, 2026

    Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK SHANDS JACKSONVILLE 20055717 Model/Catalog Number: 555884 Software Version: N/A Product Description: CESK SHANDS JACKSONVILLE 20055717 Component: No

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·June 10, 2026

    Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK RIVERSIDE HEALTH SYSTEM Model/Catalog Number: 552126 Software Version: N/A Product Description: CESK RIVERSIDE HEALTH SYSTEM Component: No

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·June 10, 2026

    Brand Name: B. BRAUN MEDICAL INC. Product Name: SESK UPMC DOUBLE CATHETER TRAY Model/Catalog Number: 530134 Software Version: N/A Product Description: SESK UPMC DOUBLE CATHETER TRAY Component: No

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·June 10, 2026

    Brand Name: B. BRAUN MEDICAL INC. Product Name: NES1725KFXL SPINAL EPID CLOSED TIP CATH Model/Catalog Number: 530201 Software Version: N/A Product Description: NES1725KFXL SPINAL EPID CLOSED TIP CATH Component: No

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·June 10, 2026

    Brand Name: B. BRAUN MEDICAL INC. Product Name: LYNDON B JOHNSON HOSPITAL SPINAL EPID Model/Catalog Number: 530184 Software Version: N/A Product Description: LYNDON B JOHNSON HOSPITAL SPINAL EPID Component: No

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·June 10, 2026

    Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Model/Catalog Number: TM6180CP Software Version: N/A Product Description: Dressing change tray, case of 20, lot #600032, 50 cases affected. Component: No

    FDA Enforcement
    Class II ·Ongoing·Trinity Sterile, Inc.·January 29, 2025

    Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The Inspire¿ Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the implantable pulse generator (IPG). Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Inspire Medical Systems Inc.·June 24, 2026

    Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 Software Version: N/A Product Description: The Inspire¿ Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pressure sensitive membrane that converts the mechanical energy of respiration into an electrical signal. The lead incorporates a standard connector for coupling to the implantable pulse generator (IPG). Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Inspire Medical Systems Inc.·June 24, 2026

    The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. the system consists of a self-contained x-ray generator, image receptor(s), imaging display and software for acquiring medical diagnostic images outside of standard stationary x-ray room. The DRX-Revolution system incorporates a flat-panel detector that can be used wirelessly for exams such as in-bed chest projections. The system can also be used to expose CR phosphor screens or films.

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·November 15, 2023