BEUDAMED
    14 results · 31ms · Sources: EU EUDAMED, US FDA

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    Exam Vue DR

    FDA 510(k)
    FDA Class 2 ·Radiology

    SPACEVISION CAGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·August 8, 2016

    BMT GB KNEE STM 12X40

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code OIY·June 1, 2022

    LIFEPAK(R) 1000 DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·July 10, 2015

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·December 23, 2014

    SHILEY

    FDA Adverse Event
    Injury ·COVIDIEN·Product code JOH·May 29, 2013

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 12, 2014

    ACCU-CHEK RAPID D

    FDA Adverse Event
    Injury ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code FPA·June 22, 2011

    HANDPIECE MICS

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·May 23, 2018

    PKG, NEEDLE HOLDER, CURVED RIGHT, P/N 0250080342. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 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

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022