BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    SPI ART ABUTMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    MICROGYN PLUS STIMULATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    UBM PLUS, MODEL P45

    FDA 510(k)
    FDA Class 2 ·Radiology

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code MGB·November 14, 2023

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·December 11, 2008

    ARTICUL/EZE BALL 28 +1.5 GR

    FDA Adverse Event
    Injury ·J & J MEDICAL (DEPUY- SUZHOU)LTD. 3006356043·Product code JDI·April 23, 2013

    CRE BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code KNQ·April 29, 2011

    RIATA ST OPTIM PASSIVE-FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·April 10, 2009

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code MAF·May 17, 2019

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR·Product code MGB·December 14, 2023

    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