BEUDAMED
    127 results · 13ms · 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 ×

    GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis

    FDA Recall
    Open, Classified ·GE HEALTHCARE AUSTRIA GMBH & CO Tiefenbach 15 Pfaffing Austria·Product code IYN·December 22, 2023

    Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx Only, Sterile

    FDA Recall
    Open, Classified ·Folsom Metal Products, Inc.·Product code GCZ·August 21, 2025

    Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 10 single packs , Rx Only, Sterile

    FDA Recall
    Open, Classified ·Folsom Metal Products, Inc.·Product code GCZ·August 21, 2025

    Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile

    FDA Recall
    Open, Classified ·Folsom Metal Products, Inc.·Product code GCZ·August 21, 2025

    Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile

    FDA Recall
    Open, Classified ·Folsom Metal Products, Inc.·Product code GCZ·August 21, 2025

    Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile

    FDA Recall
    Open, Classified ·Folsom Metal Products, Inc.·Product code GCZ·August 21, 2025

    Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile

    FDA Recall
    Open, Classified ·Folsom Metal Products, Inc.·Product code GCZ·August 21, 2025

    REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap REF CH2000S-PC Spinning Spiros Closed Male Luer, Purple Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

    FDA Recall
    Open, Classified ·ICU Medical, Inc.·Product code N/A·March 16, 2021

    REF CH2020 20mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

    FDA Recall
    Open, Classified ·ICU Medical, Inc.·Product code ONB·March 16, 2021

    6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;

    FDA Recall
    Open, Classified ·ICU Medical, Inc.·Product code FMG·August 1, 2022

    ASM Replacement Battery, Component Number SUB0000594

    FDA Recall
    Open, Classified ·ICU Medical Inc·Product code FRN·March 22, 2023

    Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion System, Pump List Number 30010; Plum A+ & Plum A+3" Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 1197

    FDA Recall
    Open, Classified ·ICU Medical, Inc.·Product code FRN·October 22, 2024

    Plum Duo Precision IV Pump, 40002-0403

    FDA Recall
    Open, Classified ·ICU Medical, Inc.·Product code FRN·April 29, 2026

    Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24

    FDA Recall
    Open, Classified ·ICU Medical Inc.·Product code FPA·August 6, 2025

    Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included 100mL, Product Code 21-7300-24

    FDA Recall
    Open, Classified ·ICU Medical Inc.·Product code FPA·August 6, 2025

    ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951

    FDA Recall
    Open, Classified ·ICU Medical, Inc.·Product code ONB·September 8, 2025

    ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950

    FDA Recall
    Open, Classified ·ICU Medical, Inc.·Product code ONB·September 8, 2025

    ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176

    FDA Recall
    Open, Classified ·ICU Medical, Inc.·Product code ONB·September 8, 2025

    ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955

    FDA Recall
    Open, Classified ·ICU Medical, Inc.·Product code ONB·September 8, 2025

    ASM Replacement Battery, Component Number SUB0000864

    FDA Recall
    Open, Classified ·ICU Medical Inc·Product code FRN·March 22, 2023