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

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    WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    WALLFLEX ESOPHAGEAL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·January 23, 2025

    WALLFLEX ESOPHAGEAL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·February 14, 2025

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690199120·AK3 Congruent Insert Trial Size 5, 10mm

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07310K0115100·Handle, Targeting Needle

    Vilex Power Accessory

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731122186·KWire .035x6" (0.9x150mm)

    Vilex Power Accessory

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731122179·KWire .035x6" (0.9x150mm) Threaded

    COVAMESH

    FDA UDI
    DILON TECHNOLOGIES FRANCE·03760193182095·Polyester mesh coated with collagen membrane

    OS-2000 OPTICAL SONOGRAPHY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MULTI HI-FLO PNEU, WISAP #7080

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    BD PRECISIONGLIDE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·December 3, 2025

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 13, 2014

    DPM 6/7

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·May 17, 2011

    BLUNT TIP SCREW, 4X38MM

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·April 26, 2023

    PROXIMAL HUMERUS, RIGHT, LONG, 8.5X240MM

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·April 26, 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