BEUDAMED
    1,030 results · 19ms · 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 Status: Open, Classified ×

    Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: IFX-20R, IFX-20SP, IFX-20MP, IFX-20C

    FDA Recall
    Open, Classified ·Invacare Corporation·Product code ITI·November 12, 2021

    Power Wheelchair

    FDA Recall
    Open, Classified ·Merits Holdings Co. dba Merits Health Products, Inc.·Product code ITI·April 1, 2021

    Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: TDX SP2: TDXSP2, TDXSP2-CG, TDXSP2X-CG, TDXSP2-MCG, TDXSP2X-MCG, TDXSP2V, TDXSP2V-HD, TDXSP2HD, TDXSP2HD-CG, TDXSP2HD-MCG

    FDA Recall
    Open, Classified ·Invacare Corporation·Product code ITI·November 12, 2021

    Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

    FDA Recall
    Open, Classified ·Max Mobility LLC·Product code ITI·August 12, 2025

    Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V

    FDA Recall
    Open, Classified ·Invacare Corporation·Product code ITI·March 30, 2022

    Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

    FDA Recall
    Open, Classified ·Max Mobility LLC·Product code ITI·August 12, 2025

    Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

    FDA Recall
    Open, Classified ·Max Mobility LLC·Product code ITI·December 20, 2024

    Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

    FDA Recall
    Open, Classified ·Max Mobility LLC·Product code ITI·December 20, 2024

    PushTracker E3 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K, MX2-32P, MX2-32PK, MX2-33D, MX2-33P, MX2-33PK, MX2-33S, MX2-150, MX2-167, MX2-32D); a wearable watch that communicates with a SmartDrive Power Assist Device via the SmartDrive MX2+ Application

    FDA Recall
    Open, Classified ·Permobil·Product code ITI·May 10, 2023

    WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor, foldable battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.

    FDA Recall
    Open, Classified ·WHILL, INC. 2 Chome 1-11 Higashishinagawa Shinagawa Japan·Product code ITI·December 29, 2025

    WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.

    FDA Recall
    Open, Classified ·WHILL, INC. 2 Chome 1-11 Higashishinagawa Shinagawa Japan·Product code ITI·December 29, 2025

    Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

    FDA Recall
    Open, Classified ·Max Mobility LLC·Product code ITI·August 12, 2025

    Invacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: SRX-20R, SRX-20SP, SRX-20MP

    FDA Recall
    Open, Classified ·Invacare Corporation·Product code ITI·November 12, 2021

    PushTracker E2 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K, MX2-32P, MX2-32PK, MX2-33D, MX2-33P, MX2-33PK, MX2-33S, MX2-150, MX2-167, MX2-32D); a wearable watch that communicates with a SmartDrive Power Assist Device via the SmartDrive MX2+ Application

    FDA Recall
    Open, Classified ·Permobil·Product code ITI·May 10, 2023

    My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device

    FDA Recall
    Open, Classified ·Onkos Surgical, Inc.·Product code QHQ·May 20, 2025

    CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is introduced percutaneously in the setting of an Electrophysiology or Catheterization Laboratory Model: 18-5000

    FDA Recall
    Open, Classified ·CardioFocus, Inc.·Product code OAE·February 7, 2025

    Plastic Cannula HOLDEX Item # 450216 - Product Usage: - Product Usage: It is intended for use in routine specimen withdrawal from specimen collection bags or bottles through needleless cannula ports.

    FDA Recall
    Open, Classified ·C.A. Greiner & Sohne Gesellschaftmbh Greiner St. # 70 Kremsmunster Austria·Product code FMI·July 27, 2020

    B. Braun Introcan IV Safety Catheters, sterile - Product Usage: It is a single-use device to generate intravascular and tissue access to sample blood, monitor blood pressure, or administer fluids and blood intravascular.

    FDA Recall
    Open, Classified ·Braxton Medical Corporation·Product code FOZ·September 4, 2020

    The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade plastics and not made with natural rubber latex. Model Number(s): KCP-30-2

    FDA Recall
    Open, Classified ·CooperSurgical, Inc.·Product code HEW·April 23, 2021

    TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or introducer. The devices affected by this recall are 3F and 4F..

    FDA Recall
    Open, Classified ·LeMaitre Vascular, Inc.·Product code DXE·September 30, 2022