BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    NR Line Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    OrthoMedFlex, LLC

    FDA UDI
    ORTHOMEDFLEX LLC·M7161121532680·Crossbar Acetabular Reamer - 68mm

    AUVON RECHARGEABLE TENS UNIT MUSCLE STIMULATOR

    FDA Adverse Event
    Injury ·SHENZHEN AS-TEC TECHNOLOGY CO., LTD·Product code NGX·January 27, 2025

    PVS 2000 SYNCHRO2 GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OMNI EXPRESS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYNCHRO GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORP.·Product code DQX·October 16, 2009

    PROTECTA XT CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 8, 2013

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR - REDWOOD CITY·Product code MGB·September 5, 2008

    UNKNOWN ZIMMER RHK

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·June 30, 2011

    SYNCHRO GUIDEWIRE

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·August 2, 2010

    SYNCHRO GUIDEWIRE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·May 27, 2010

    SYNCHRO GUIDEWIRE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·April 15, 2010

    SYNCHRO2-14 SUPPORT STRAIGHT 215CM

    FDA Adverse Event
    Malfunction ·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code DQX·December 14, 2023

    AUVON TENS UNIT

    FDA Adverse Event
    Injury ·SHEN ZHEN AS TEC TECHNOLOGY CO LTD·Product code NUH·December 19, 2024

    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

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

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

    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