BEUDAMED
    14 results · 28ms · Sources: EU EUDAMED, US FDA

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    MICROSCAN MICROSTREP PLUS PANEL VANCOMYCIN (0.06 - 8 MCG/ML)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    RAPIDIA

    FDA 510(k)
    FDA Class 2 ·Radiology

    ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PEN NEEDLE 32GX4MM 14 PACK

    FDA Adverse Event
    Malfunction ·EMBECTA MEDICAL DEVICES (SUZHOU) CO., LTD., CHINA·Product code FMI·January 15, 2025

    NEURON DELIVERY CATHETER 053

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code DQY·March 16, 2010

    PEN NEEDLE 32GX4MM 14 PACK

    FDA Adverse Event
    Malfunction ·EMBECTA MEDICAL DEVICES (SUZHOU) CO., LTD., CHINA·Product code FMI·January 15, 2025

    DXTEND GLENOSPHERE STD D42MM

    FDA Adverse Event
    Injury ·DEPUY FRANCE·Product code KWS·December 6, 2012

    SOLYX SIS SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code PAH·April 16, 2013

    WECK HEM-O-LOK CLIPS, LARGE

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code FZP·March 18, 2011

    TERUMO PERFUSION SYSTEM 8000

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code KRL·June 18, 2008

    PEN NEEDLE 32GX4MM 14 PACK

    FDA Adverse Event
    Malfunction ·EMBECTA MEDICAL DEVICES (SUZHOU) CO., LTD., CHINA·Product code FMI·May 3, 2024

    BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155, PAK5240, PAK5255, PAK5340, PAK5355, PAK5440, PAK5455, PAK6140, PAK6155, PAK6240, PAK6255, PAK6340, PAK6355, PAK6440, and PAK6455 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·January 13, 2016

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015