BEUDAMED
    16 results · 30ms · Sources: EU EUDAMED, US FDA

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    HDR 1000 PLUS WELL CHAMBER, MODEL 90008

    FDA 510(k)
    FDA Class 2 ·Radiology

    Optetrak Logic

    FDA UDI
    Exactech, Inc.·10885862268488·

    Truliant CC

    FDA UDI
    Exactech, Inc.·10885862613158·TRULIANT POST. AUG. BLOCK SIZE 3, 10MM

    JEL 15

    FDA 510(k)
    FDA Class 2 ·Dental

    OSTEOSET BVF KIT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD PRESET¿ ECLIPSE¿

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·July 7, 2025

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·March 27, 2013

    ASR 300 SPIKED CUP SIZE 56

    FDA Adverse Event
    Injury ·DEPUY INTL. LTD.·Product code KWA·April 6, 2011

    FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT

    FDA Adverse Event
    Malfunction ·ANGIOMED GMBH & CO. MEDIZINTE·Product code JCT·June 11, 2008

    E-LUMINEXX BILIARY STENT

    FDA Adverse Event
    Malfunction ·ANGIOMED GMBH & CO. MEDIZINTECHNIK KG·Product code FGE·November 17, 2015

    E-LUMINEXX BILIARY STENT

    FDA Adverse Event
    Malfunction ·ANGIOMED GMBH & CO. MEDIZINTECHNIK KG·Product code FGE·August 16, 2016

    2.0MM IMF SCREW SELF-DRILLING 8MM-STERILE

    FDA Adverse Event
    Malfunction ·SYNTHES SELZACH·Product code DZL·May 17, 2017

    enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120). The Enginivity enFlow TM IV Fluid Warmer is intended for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.

    FDA Enforcement
    Class II ·Terminated·Vital Signs Devices, a GE Healthcare Company·July 18, 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