BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    HEALOS BONE GRAFT MATERIAL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033444399·

    STELO GLUCOSE BIOSENSOR SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code SAF·January 15, 2025

    MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BPFONE, MODEL UA 767IT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BILATERAL DOUBLE BALLOON SET

    FDA Adverse Event
    Malfunction ·PAJUNK GMBH MEDIZINTECHNOLOGIE·Product code KOG·December 7, 2006

    FG GATEWAY OTW OUS 2.50MM X 9MM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MINN·Product code GBA·March 20, 2013

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·March 2, 2011

    ACCU-CHEK COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·March 12, 2008

    COOLSCULPTING SYSTEM

    FDA Adverse Event
    Injury ·ALLERGAN PLEASANTON·Product code OOK·May 7, 2021

    PENUMBRA SMART COIL

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code HCG·July 21, 2017

    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 VIP ambulatory Infusion Pumps, Model 2110. 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