BEUDAMED
    18 results · 21ms · Sources: EU EUDAMED, US FDA

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    Power Wheelchair, W5907 (Q50 R Carbon)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    K-Systems

    FDA UDI
    Coopersurgical, Inc.·00888937025057·G85 Mini Incubator

    G85 MINI INCUBATOR WITH

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code PUB·May 24, 2023

    ROCHE ONLINE THEOPHYLLINE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    COLS® FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·December 25, 2024

    TAXUS® LIBERTÉ®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·August 23, 2011

    SYNERGY

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code LGW·November 3, 2014

    ACCU-CHEK ® SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE HEALTH SOLUTIONS, INC.·Product code LZG·July 11, 2013

    VANGUARD SSK FEMORAL COMPONENT ¿ RIGHT 60MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·October 3, 2018

    BIOMET INTERLOK FIXED CRUCIATE TIBIAL PLATE 71MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·October 3, 2018

    VANGUARD SSK POSTERIOR STABILIZED TIBIAL BEARING 18MM X 71/75MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·October 3, 2018

    BIOMET MODULAR TIBIAL LOCKING BAR

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·October 3, 2018

    VANGUARD FEMORAL DISTAL AUGMENT 5MM X 60MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·October 3, 2018

    BIOMET ALL POLY PATELLA BUTTON 34MM DIAMETER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·October 3, 2018

    VANGUARD POSTERIOR FEMORAL AUGMENT 5MM X 60MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·October 3, 2018

    Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No

    FDA Recall
    Open, Classified ·CooperSurgical, Inc.·Product code PUB·November 15, 2024

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025