BEUDAMED
    28 results · 36ms · Sources: EU EUDAMED, US FDA

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    DART-FIRE EDGE Cannulated Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114209·SILICONE TIP CANNULA 27GA (PK/10)

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113929·GIANNETTI HYDRODISS CANNULA 26GA

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A203228120·20mm H x 32mm W x 28mm L x 12 degrees ALIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A203228150·20mm H x 32mm W x 28mm L x 15 degrees ALIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A20322880·20mm H x 32mm W x 28mm L x 8 degrees ALIF

    GALILEO

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·November 20, 2008

    PARAMOUNT R IBF DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 27, 2020

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·October 9, 2008

    SCREW-IN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 2, 2013

    bvi Beaver Xstar Safety Crescent, 2.5mm, 55o Bevel Up, REF 378234 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

    FDA Enforcement
    Class II ·Terminated·Beaver-Visitec International Inc.·February 7, 2018

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·July 5, 2022

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·March 31, 2023

    GALILEO

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·November 7, 2007

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·April 8, 2021

    CD HORIZON SOLERA VOYAGER SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·May 27, 2024

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NKB·August 20, 2025