BEUDAMED
    14 results · 19ms · Sources: EU EUDAMED, US FDA

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    INTERCEPTOR PLUS CORONARY FILTER SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LUX 1440

    FDA Adverse Event
    Malfunction ·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012

    SILCONE COATED I/A 45 HANDHELD INSTRUMENT

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code HQC·May 7, 2019

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·April 23, 2013

    ASR ACETABULAR IMPLANT 48

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 26, 2011

    ATLAS II HF CRT-D

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2008

    GIANTURCO-ROEHM BIRD'S NEST JUGULAR VENA CAVA FILTER

    FDA Adverse Event
    Injury ·COOK INC·Product code DTK·March 25, 2016

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK INC·Product code DTK·March 23, 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

    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