BEUDAMED
    16 results · 21ms · Sources: EU EUDAMED, US FDA

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    Spirit Hair Removal laser Family

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

    DYNACOR LUBRICATION GEL

    FDA 510(k)
    FDA Class 1 ·General Hospital

    NCB STRAIGHT NARROW SHAFT PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RIATA PASSIVE FIXATION

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·October 8, 2014

    ATLANTIS¿ SR PRO²

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - FREMONT·Product code DQO·July 7, 2011

    SPRINT QUATTRO SECURE S

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

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·November 6, 2020

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·November 6, 2020

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·November 6, 2020

    NESTER PLATINUM EMBOLIZATION COIL

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·June 14, 2020

    NESTER PLATINUM EMBOLIZATION COIL

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·February 19, 2020

    ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    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

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024