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

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    MMS PTA Balloon Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INFRARED EAR THERMOMETER, MODEL IR-04MT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    INFINION CX

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·October 24, 2024

    ROI-C IMPLANT, UNKNOWN SIZE

    FDA Adverse Event
    Malfunction ·LDR MEDICAL·Product code OVE·February 4, 2020

    ROI-C BI-PACK CAGE PRE-FILLED WITH BF+ BONE SUBSTITUTE H6MM 14X17MM

    FDA Adverse Event
    Malfunction ·LDR MÉDICAL·Product code OVE·April 13, 2020

    ROI-C BI-PACK CAGE PRE-FILLED WITH BF+ BONE SUBSTITUTE H5MM 14X15.5MM

    FDA Adverse Event
    Malfunction ·LDR MEDICAL·Product code OVE·August 6, 2020

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/14 MM LEFT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 1, 2016

    ENTRUST VR

    FDA Adverse Event
    Malfunction ·IPG MFG SWITZERLAND·Product code LWS·June 8, 2013

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 8, 2014

    BV PULSERA, REL. 2

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code IZL·June 17, 2011

    ROI-C IMPLANT, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·LDR MÉDICAL·Product code OVE·August 24, 2021

    SPACER, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·LDR MEDICAL·Product code ODP·August 23, 2019

    ROI-C IMPLANT, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·LDR MÉDICAL·Product code OVE·September 21, 2021

    ROI-C BI-PACK CAGE PRE-FILLED WITH BF+ BONE SUBSTITUTE H6MM 14X15,5MM

    FDA Adverse Event
    Malfunction ·LDR MÉDICAL·Product code OVE·August 17, 2022

    ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012