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

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    NONCOR INFUSION SETS; NONCOR PORT INFUSION SETS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Poly-Tape 10 mm x 800 mm

    FDA UDI
    XIROS LTD·05060267130471·

    AOS ANTI-ROTATION SCREW 5.0mm x 80mm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665019889·

    Poly-Tape 10 mm x 800 mm

    FDA UDI
    XIROS LTD·05060267132512·

    SPINE SYSTEM EVOLUTION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BRIDGE SE SELF-EXPANDING STENT DELIVERY SYSTEM

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 24, 2025

    GALILEO® CAPTURING ROD

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code HSB·June 11, 2024

    I-STAT 6+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·September 28, 2021

    COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING/STANDARD 44MM-41 MM DIA OF CURVE

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code PAO·June 7, 2017

    BELOTERO BASIC (INJECTION)

    FDA Adverse Event
    Injury ·ANTEIS S.A.·Product code LMH·March 13, 2013

    MAXCEM ELITE

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code EMA·March 16, 2011

    UNKNOWN

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·March 27, 2008

    COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY 44MM STANDARD WITH LOCK RING

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWS·June 7, 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

    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

    Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016