BEUDAMED
    10 results · 29ms · 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 ×

    Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation

    FDA Recall
    Open, Classified ·Ion Beam Applications S.A. 3 Chemin Du Cyclotron Louvain-la-neuve Belgium·Product code LHN·April 20, 2022

    ADVIA 120/2120/2120i SETpoint Calibrator

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code KRZ·June 4, 2025

    US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Number: 24-090A-1

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code FIP·May 16, 2024

    ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JCN·June 4, 2025

    ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JCN·June 4, 2025

    ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JCN·June 4, 2025

    Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B, BR2200X18B, KR2200X15B, IA2200X15B, FR2200X14B, ND2200X15B, IT2200X21B, ES2200X15B, DE2200X13B, BL2200X15B, GB2200X15B, EU2200X15B, EU2200X19, EE2200X15B, TR2200X15B, RU2200X15B

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code CBK·March 1, 2023

    Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code CBK·March 1, 2023

    Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, JP2100X16B, AU2100X15B, LA2100X15B, CA2100X12B, CN2100X17B, BR2100X18B, KR2100X15B, IA2100X15B, PP2100X10, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2100X15B, DE2100X13B, BL2100X15B, GB2100X15B, EU2100X15B, EU2100X19, EE2100X15B, TR2100X15B, UDS2100X11B, RDS2100X11B, and SP2100X26B

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code CBK·March 1, 2023

    The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to permanently eliminate the vein from blood circulation. The catheter has a long shaft for insertion into a vein, a handle with start/stop button, and a connector cable. The catheter shaft has a heating element that is energized by the digiRF radiofrequency generator, which is a multi-voltage energy delivery system with touchscreen control that automatically sets the non-adjustable treatment parameters for the catheter. A button on the catheter (or a foot pedal attached to the generator) begins an automated treatment cycle of 20 seconds long at a set temperature of 120 C, and the treatment stops automatically when complete. The catheter is used within a sterile operative field, while the generator remains outside the sterile operative field at all times.

    FDA Recall
    Open, Classified ·Bard Peripheral Vascular Inc 1625 W 3rd St Bldg 1 850 W. Rio Salado Prkwy. Tempe AZ 85281-2438·Product code GEI·September 4, 2024