BEUDAMED
    21 results · 23ms · Sources: EU EUDAMED, US FDA

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    Patient Information Center iX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTELLIVUE INFO CENTER IX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·December 19, 2023

    PATIENT INFORMATION CENTER IX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·May 1, 2024

    Kompressor™ Compression Screw System

    FDA UDI
    Ascension Orthopedics, Inc.·10381780280132·STANDARD TRAILING DRIVER

    Kompressor Compression Screw System

    FDA UDI
    Smith & Nephew, Inc.·00885556869000·COMPRESSION DRIVER

    Tensoplast®

    FDA UDI
    BSN MEDICAL SAS·04042809006063·TENSOPLAST BANDAGE 4" X 5YDS WHITE 36

    Votion®

    FDA UDI
    Ortho Organizers, Inc.·00190707113230·Votion .018 MC UR 4/5 -7T 0A 0O (10PK) VOTION

    Votion

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730007476·Votion 018 MC UR 4/5 -7T 0A 0O (10PK)

    GLUCOSE (HEXOKINASE)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    AGILE ESOPHAGEAL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·December 26, 2024

    AGILE ESOPHAGEAL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·December 26, 2024

    AGILE ESOPHAGEAL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·February 14, 2025

    EVOLUT FX PLUS VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·September 10, 2024

    PROXIMATE ILS CURVED CIR STAPL

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GDW·October 23, 2008

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·August 10, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 8, 2013

    GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus 4000, Plus 4000

    FDA Enforcement
    Class I ·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020