BEUDAMED
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    Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Prevena Plus Incision Management System Kit with Customizable Dressing, Prevena Plus Customizable Dressing 5-Pack

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PREVENA PLUS INCISION MANAGEMENT SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC·Product code OMP·September 24, 2021

    PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·July 19, 2019

    Alleset

    FDA UDI
    GRI Medical & Electronic Technology Co., Ltd.·16931918128504·Ophthalmic Drape_Blue SMS Fabric_Oval Aperture ...

    KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KIT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT

    FDA 510(k)
    FDA Class 2 ·Neurology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 27, 2024

    METRIX AIR

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·May 7, 2019

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 8, 2013

    ZIMMER M/L TAPER FEMORAL STEM

    FDA Adverse Event
    Injury ·ZIMMER INC.·Product code LPH·June 23, 2011

    PULSE GEN MODEL UNK

    FDA Adverse Event
    Death ·CYBERONICS, INC.·Product code LYJ·September 5, 2008

    AES-50SP PARADIGM EDGE HIP PROBE, 50 DEGREE

    FDA Adverse Event
    Injury ·CONMED UTICA·Product code GEI·May 18, 2023

    AES-50SP PARADIGM EDGE HIP PROBE, 50 DEGREE

    FDA Adverse Event
    Malfunction ·CONMED UTICA·Product code GEI·May 25, 2023

    Artis zee biplane, Model Number 10094141

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019

    Artis zee biplane, Model Number 10094141

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. .

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 1, 2015

    The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 10, 2014

    Siemens Artis zee systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 12, 2015