BEUDAMED
    22 results · 28ms · Sources: EU EUDAMED, US FDA

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    ALBUMIN

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964022966·The ENDO CARRY-ON Procedure Kit contains all of...

    Indeflator

    FDA UDI
    ABBOTT VASCULAR INC.·08717648013973·COPILOT Kit includes Bleedback Control Valve 20...

    TruForm

    FDA UDI
    Rmo, Inc.·00885797099846·MN 1ST BI BD KT N/L R/L 134

    POWDERED LATEX EXAM GLOVES, PROTEIN LABELING (150 MICROGRAM OR LESS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    WAVESCAN WAVEFRONT SYSTEM MODEL HS 1

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    20/30 PRIORITY PACK INDEFLATOR

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR·Product code MAV·July 20, 2021

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013

    MINICAP TRANSFER SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·March 1, 2011

    STERRAD 200 STERILIZATION SYSTEM

    FDA Adverse Event
    Malfunction ·YAMATO LAB-TECH CO., LTD·Product code MLR·February 27, 2008

    INDEFLATOR

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR INC.·Product code MAV·December 17, 2024

    20/30 Priority Pack w/COPILOT - REF 1003327 WPL2122272-01 (2019-03-01)

    FDA Enforcement
    Class II ·Ongoing·Abbott Vascular·April 20, 2022

    BIO-CORKSCREW SUTURE ANCHOR

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code MAI·February 21, 2007

    20/30 PRIORITY PACK INDEFLATOR

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR·Product code MAV·July 20, 2021

    MESH - COMPOSIX KUGEL

    FDA Adverse Event
    Injury ·DAVOL INC.·Product code FTL·June 14, 2011

    INDEFLATOR

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR INC.·Product code MAV·December 2, 2024

    INDEFLATOR

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR INC.·Product code MAV·October 29, 2024

    20/30 Priority Pack w/COPILOT - REF 1003327 WPL2122272-01 (2019-03-01)

    FDA Recall
    Open, Classified ·Abbott Vascular·Product code MAV·March 11, 2022

    20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures.

    FDA Recall
    Open, Classified ·Abbott Vascular Inc·Product code MAV·November 6, 2024

    20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovascular procedures.

    FDA Enforcement
    Class II ·Ongoing·Abbott Vascular Inc·January 1, 2025