BEUDAMED
    11 results · 28ms · 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 Regulation: Us FDA ×

    Planmeca Viso

    FDA 510(k)
    FDA Class 2 ·Radiology

    Lumipulse G Specimen Diluent 2

    FDA UDI
    FUJIREBIO INC.·04987270230985·

    1717FCC

    FDA 510(k)
    FDA Class 2 ·Radiology

    BREAS PV 10I CPAP SYSTEM, MODEL PV 10I

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNT·October 28, 2008

    DUAL SPEED CEMENT INJECTION GUN

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code JDZ·July 19, 2011

    1.8MM TI LOCKING SCREW

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code KWP·July 17, 2013

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Enforcement
    Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

    Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula Art. No. 06-06-285 and 06-06-285MOD. surgical instrument.

    FDA Enforcement
    Class II ·Ongoing·Medagent Inc·March 6, 2024

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016