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

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    TRIAGE PROFILER S.O.B. PANEL

    FDA 510(k)
    FDA Class 2 ·Hematology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257141137·15-20 MFW VITALITY CALF CT CHARC VII

    Myo/Wire II

    FDA UDI
    A & E MEDICAL CORPORATION·10841291105480·SS Suture, 7 per sleeve

    Toilet Support Arms

    FDA UDI
    Ropox A/S·05707581006623·

    K-WIRE STRYKER 3.2MM X 450MM KIRSCHNER

    FDA Adverse Event
    Malfunction ·Product code LXH·November 2, 2021

    K-WIRE GAMMA Ø3,2X450 MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code LXH·April 22, 2022

    INTERVENTIONAL BODY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO EBI XFIX DFS RAIL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CONTOUR NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code JJX·April 8, 2013

    CAPSUREFIX NOVUS LEAD MRI SURESCAN

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·April 5, 2011

    HI LO EVAC

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TYCO·Product code BTR·May 7, 2008

    Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD Inc.·December 18, 2019

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) 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