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

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    RIVA-SELF CURE

    FDA 510(k)
    FDA Class 2 ·Dental

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526827882·***DISC*LEVAMED ANKLE SUPPORT BLACK VI

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526827943·ACHIMED ACHILLES SUPP BLACK VI

    BUSCH®, BNA®

    FDA UDI
    BUSCH & CO. GmbH & Co. KG·D8120305161·Diamond, cone flat, medium grit

    POLARIS

    FDA UDI
    HNM TOTAL RECON LLC·00841742113456·POLARIS ø3.2mm/ø2.5mm Micro High Compression Sc...

    GYROSCAN INTERA 3.0T

    FDA 510(k)
    FDA Class 2 ·Radiology

    GE LOGIQ 700

    FDA 510(k)
    FDA Class 2 ·Radiology

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·April 2, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 9, 2011

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORP·Product code MKJ·April 16, 2008

    Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on woman s areola during an ultrasound examination. Its primary purpose is for patient comfort over the loose gel and helps with nipple location during the scan, making the areola location easier to identify.

    FDA Enforcement
    Class II ·Terminated·Pharmaceutical Innovations, Inc.·August 26, 2020

    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

    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