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

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    CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ArgenZ HT+ 98x18 B3

    FDA UDI
    ARGEN CORPORATION, THE·D818122042·Dental porcelain/ceramic restoration kit

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973134·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970461·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970454·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973615·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973608·

    KINGYIELD WRIST BLOOD PRESSURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO CARDEON ASCENDING BALLOON CANNULA (ABC)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WAVEWRITER ALPHA 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 31, 2023

    ADAPTA D

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code NVZ·June 12, 2018

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 21, 2013

    DASH 3000

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE·Product code MHX·May 24, 2011

    HARMONIC FOCUS CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code LFL·August 14, 2008

    DA VINCI

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code NAY·May 30, 2023

    Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model: 11007642

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

    Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·November 24, 2021

    AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, Combo 64 6623974; AXIOM Sensis, Hemo LOW 6634633; AXIOM Sensis, Combo 32 6634641; AXIOM Sensis, EP 129 6634658; Sensis 10764561; Sensis Vibe Combo 11007642; Sensis recording system is intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology.

    FDA Enforcement
    Class III ·Terminated·Siemens Medical Solutions USA, Inc·August 24, 2022

    Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283 Artis Q.zen floor- Model No. 10848353 Artis Q.zen ceiling- Model No. 10848354 Artis Q.zen biplane- Model No. 10848355

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022

    System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego 10280959 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zeego 10848283 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Fluoroscopic X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·February 8, 2023