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

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    Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814299·GENUMEDI PT SILVER R VI

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·August 23, 2019

    ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEMS WITH FENESTRATED CATHETER AND FLOW SPLITTER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    STERILIZATION MATS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NUCLEUS 22

    FDA Adverse Event
    Malfunction ·COCHLEAR LTD·Product code MCM·September 5, 2019

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·August 14, 2023

    T:SLIM G5 SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OYC·November 21, 2019

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 13, 2025

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·June 8, 2013

    SELUTE PICOTIP

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVN·July 7, 2011

    SALINE-FILLED TESTICULAR PROSTHESIS

    FDA Adverse Event
    Injury ·COLOPLAST MANUFACTURING US, LLC·Product code FAF·September 4, 2008

    Artis zee biplane, Model Number 10094141

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019

    ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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

    Artis zee biplane, Model Number 10094141

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

    Artis zee/ zeego systems; 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·August 26, 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