BEUDAMED
    58 results · 7ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Enforcement × Classification: Class Ii × Clear all

    BIOTRONIK INTICA NEO 7 HF-T DF-1 IS-1 ProMRI, REF 429553, UDI: 04035479156831 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.

    FDA Enforcement
    Class II ·Terminated·BIOTRONIK Inc·April 28, 2021

    BIOTRONIK INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.

    FDA Enforcement
    Class II ·Terminated·BIOTRONIK Inc·April 28, 2021

    microTargeting" Drive System, Product Number MT-DS-01

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Product Number FC8002

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" Drive System Distributed by Medtronic, Product Number FC1006

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8),

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" Drive System, Product Number 66-ZD-MD-01

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" Drive System, Product Number 66-ZD-MD

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" STar" Drive System (Manual), Product Number ST-DS-MA

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" STar" Drive System (Motorized), Product Number 70-ZD-ME

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" Lead Adapter for microTargeting" Drive, Product Number 66-CN-DB

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate electrophysiological activity, as well as aid in the accurate placement of electrodes and other instruments. Catalogue Number: C0215 UDI: 00873263006740

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 15, 2020

    microTargeting" STar" Drive System (Motorized), Product Number ST-DS-ME

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    microTargeting" Drive System, Product Number MT-DS

    FDA Enforcement
    Class II ·Terminated·FHC, Inc.·July 11, 2018

    Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

    FDA Enforcement
    Class II ·Ongoing·Ossur H / F·October 9, 2024

    RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component

    FDA Enforcement
    Class II ·Ongoing·Ossur H / F·May 22, 2024