BEUDAMED
    26 results · 23ms · Sources: EU EUDAMED, US FDA

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    AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER

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

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772813148·GENUMEDI PRO SILVER SIZE I

    ICU Medical

    FDA UDI
    ICU MEDICAL, INC.·00840619043698·TD Catheter, 8F, 5 lumen, 110 cm, RA/RV, Hepari...

    e-scope® ophthalmoscope XL 2.5 V, black,

    FDA UDI
    Rudolf Riester GmbH·04045396176997·The Riester ophthalmoscope is produced for the...

    8F TD CATHETER

    FDA Adverse Event
    Malfunction ·ICU MEDICAL, INC.·Product code DYG·November 5, 2013

    ICU Medical

    FDA UDI
    ICU MEDICAL, INC.·00840619041571·TD Catheter, 8F, 5 Lumen, 110 cm, RA/RV, Hepari...

    TDCH THERMODILUTION PA CATHETER

    FDA Adverse Event
    Other ·ICU MEDICAL, INC.·Product code FOZ·March 21, 2011

    K2M General Instruments

    FDA UDI
    VB Spine LLC·10888857553477·Rod Reducer

    NARVAL CC

    FDA 510(k)
    FDA Class 2 ·Dental

    GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 26, 2020

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 22, 2024

    UNKNOWN PRODUCT - SET SCREW

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HWC·October 12, 2012

    PRECISE

    FDA Adverse Event
    Malfunction ·GALIL MEDICAL LTD.·Product code GEH·November 19, 2008

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 21, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 26, 2014

    ARTIS Q.zen biplane with Material 10848355 - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system 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 zee includes cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee can also support the acquisition of position triggered imaging for spatial data synthesis.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·November 21, 2018

    Artis Q.zen biplane, Model Number 10848355

    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