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

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    OPTIMUS CMF SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    Oticon

    FDA UDI
    Oticon A/S·05707131268662·ALTA PRO, DESIGNRITE 10 WL SIL

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319704424·Kelly-Rankin Hemostatic Forceps 6-1/4" (15.6cm)...

    Madduri

    FDA UDI
    COOK INCORPORATED·00827002189256·Madduri Urethrogram Catheter

    MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ADVANCED VERTEBRAL SOLUTIONS EXPRESS BFD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PALAXPRESS, CLEAR, 1000G POWDER

    FDA Adverse Event
    Injury ·HERAEUS KULZER GMBH & CO. KG, MEDICAL DIVISION·Product code EBI·February 1, 2012

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 20, 2012

    EASYTRAK 3

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code LWP·October 3, 2014

    GYNECARE GYNEMESH* PS

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTO·May 31, 2013

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 25, 2011

    STEALTHSTATION¿ S8 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·July 31, 2024

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·October 24, 2011

    EXACTECH OSSILIX FIL (MX), 10CC. Product Number: 660-02-10, UDI: 813845021013 - - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

    FDA Enforcement
    Class II ·Terminated·Skeletal Kinetics, Llc·July 22, 2020

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 7, 2021

    Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013