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

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    TITANIUM-HIP TOOL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MicroAire®

    FDA UDI
    Microaire Surgical Instruments LLC·00847399005021·SST TWIST DRILL, DENTAL, 3.2mm Dia. x 79mm

    AB5000

    FDA UDI
    Abiomed, Inc.·00813502010282·Ventricular (Assist) Bypass

    ENDO LINEAR CUTTERS-ECHELON 60MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code GDW·June 13, 2006

    RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRAFT LIQUID APPLICATOR (DUAL LUMEN CANNULA

    FDA 510(k)
    FDA Class 2 ·Dental

    ATTAIN OTW

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·April 10, 2013

    TENDRIL SDX

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·May 27, 2008

    CAPSUREFIX

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 12, 2011

    MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079 The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where X-ray imaging modalities will be used.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·August 8, 2018

    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