BEUDAMED
    19 results · 34ms · Sources: EU EUDAMED, US FDA

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    Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Inspire™/Temptation® Now 76g Syringe Mixing Tips

    FDA UDI
    CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172002110·Dental material mixing nozzle, non-sterile

    Inspire™/Temptation® Now 76g Syringe Mixing Tips

    FDA UDI
    DEN-MAT HOLDINGS, LLC·00359883004002·Dental material mixing nozzle, non-sterile

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690185413·Revision Knee Spiral Reamer- Hudson Short Flute...

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100325·INFANT WIRE SPECULUM 4MM BLADE

    OrthoMedFlex

    FDA UDI
    ORTHOMEDFLEX LLC·M7161121532500·Crossbar Acetabular Reamer - 50mm

    CPS DIRECT SL II SLITTABLE OUTER CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT

    FDA 510(k)
    FDA Class 2 ·Neurology

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·April 28, 2022

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·December 18, 2023

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·May 22, 2024

    CAPSUREFIX NOVUS

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

    ARTHREX SUTURETAK

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code MAI·June 30, 2011

    DUROM ACETABULAR COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWB·September 5, 2008

    SNORERX

    FDA Adverse Event
    Injury ·APNEA SCIENCES·Product code LRK·May 22, 2017

    ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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

    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

    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