BEUDAMED
    25 results · 24ms · 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 ×

    VenaOne

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777679·LUMBAMED BASIC DORSAL STAYS M SILVER V

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517628176·CoRoent Ant TLIF Ti, 10x10x28mm 15°

    Fungal Serology

    FDA UDI
    MICROBIOLOGICS INC.·10634853000404·Aspergillus nidulans Antigen, 1mL

    Targeter

    FDA UDI
    Treace Medical Concepts, Inc.·00810111224055·Targeter Body Right

    CMA CEREBRAL TISSUE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    LITETOUCH MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    EDWARDS ESHEATH+ INTRODUCER SET

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DYB·April 28, 2022

    UNKNOWN EDWARDS TRANSFEMORAL SHEATH

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYB·March 12, 2026

    TF SHEATH UNKNOWN

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DYB·July 18, 2023

    UNKNOWN EDWARDS LIFESCIENCES SHEATH

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYB·May 12, 2025

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES LLC·Product code NPT·December 5, 2024

    ACCU-CHEK ® SPIRIT COMBO ADAPTER

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LZG·October 24, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 1, 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

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 24, 2016

    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

    ESHEATH INTRODUCER SHEATH

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYB·December 17, 2021

    UNKNOWN EDWARDS LIFESCIENCES SHEATH

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYB·May 30, 2024