BEUDAMED
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    VAN GOGH ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AF541

    FDA UDI
    Respironics, Inc.·00606959024649·AF541 Mask with Standard Elbow, with CapStrap, ...

    Sklar

    FDA UDI
    SKLAR CORPORATION·10649111451652·KNIFE INTEROSSEOUS BLADE 4.25 INCHES

    MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TRANSSEPTAL NEEDLE, BRK 1, 71CM

    FDA Adverse Event
    Other ·ST. JUDE MEDICAL, AF DIVISION·Product code DRC·July 2, 2009

    Widex

    FDA UDI
    Widex A/S·05706069812329·Widex EVOKE E-PA (Mediterranean turquise ) 220,...

    Widex

    FDA UDI
    Widex A/S·05706069798692·Widex D-FA P (Mediterranean turquise ) Dream 22...

    Widex

    FDA UDI
    Widex A/S·05706069886054·WIDEX MOMENT MRB0 (Mediterranean turquise ) 220...

    Widex

    FDA UDI
    Widex A/S·05706069818833·Widex UNIQUE U-FS (Mediterranean turquise ) 220...

    Widex

    FDA UDI
    Widex A/S·05706069794229·Widex UNIQUE U-PA (Mediterranean turquise ) 220...

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    FDA Adverse Event
    C.T.M. HOMECARE PRODUCT, INC·Product code INI·May 20, 2013

    PINNACLE MTL INS NEUT36IDX58OD

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·September 26, 2014

    ASR ACETABULAR CUPS 48

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·May 31, 2011

    AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM Artis zee and Q/Q.zen is a family of 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 with the AXIOM Artis zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·April 6, 2016

    Artis Q/ Q zen systems; Artis Q/ Q zen 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·April 22, 2015

    Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 10848283 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2020

    Artis Q biplane, Model Number 10848282

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

    Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281, 10848282, 10848283, 10848354 & 10848355

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 26, 2018

    Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 Product Usage: Artis is a family of 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 with the Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis can also support the acquisition of position triggered imaging for spatial data synthesis.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 22, 2018