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

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    ACE BIO WIN TIBIAL NAILING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450561508·

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0130300·Wrench, Derotation, Double Ended

    FALLS CREEK

    FDA UDI
    FGX INTERNATIONAL INC.·00193033489390·

    PedFuse

    FDA UDI
    SPINEFRONTIER, INC.·00190361034100·PedFuse Remind LES, Quad, 7.0mm x 30mm

    FALLS CREEK

    FDA UDI
    FGX INTERNATIONAL INC.·00708820681552·

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07310K0131300·Rod Inserter, Articulating, MIS

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0134100·Trial, TLIF, 27L OB STR 7Deg, 10mm

    MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ACTIWARE-PLMS

    FDA 510(k)
    FDA Class 2 ·Neurology

    MIC J,TJ-18 INTRODUCER KIT

    FDA Adverse Event
    Malfunction ·KIMBERLY-CLARK HEALTH CARE·Product code KNT·March 20, 2013

    BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code FGE·March 10, 2011

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 10, 2008

    ORTHOPEDIC SALVAGE SYSTEM 3CM DIAPHYSEAL SEGMENT

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code JDI·December 21, 2020

    ORTHOPEDIC SALVAGE SYSTEM MODULAR PROXIMAL TIBIAL BODY 9CM

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KRO·November 25, 2020

    MDLR CNLTD TRIDRV DRVR

    FDA Adverse Event
    Malfunction ·EXACTECH, INC.·Product code LXH·August 29, 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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014