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

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    MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526189751·LEVAMED ACTIVE ANKLE SUP BLACK L VI

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526189812·LEVAMED ACTIVE ANKLE SUP BLACK R VI

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040010754·Zirlux 16+ A1 100X22

    SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code MQP·October 30, 2017

    ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY

    FDA 510(k)
    FDA Class 2 ·Immunology

    ACUMATCH GXL 15DEG LINER 36MM SZ J

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·April 19, 2024

    VERTE-STACK SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·SOFAMOR DANEK DEGGENDORF GMBH·Product code MQP·January 21, 2010

    VERTE-STACK SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·SOFAMOR DANEK DEGGENDORF GMBH·Product code ODP·November 20, 2009

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·March 8, 2013

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 16, 2007

    CONSERVE(R) TOTAL A-CLASS HEAD

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code JDL·March 19, 2013

    AUTOTOME RX SPHINCTEROTOME

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code KNS·March 9, 2011

    AS LVP 20D LOW SORB 2SS 0.2M CV

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·February 10, 2021

    ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 7, 2016

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·March 27, 2024