BEUDAMED
    14 results · 29ms · Sources: EU EUDAMED, US FDA

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    ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489125556·PowerChem Neoprene Exam Gloves, Extra Large

    ACCUWELL TSH, MODEL KAW-TSH-960

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TAPER STACKING ADAPTER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 26, 2024

    EXPRO ELITE SNARE

    FDA Adverse Event
    Injury ·VASCULAR SOLUTIONS, INC·Product code MMX·June 19, 2017

    ENDURANT II

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·April 22, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 9, 2014

    SUMMIT CEMENTED STEM SZ2 STD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LWJ·April 13, 2011

    Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    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

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022