BEUDAMED
    19 results · 25ms · Sources: EU EUDAMED, US FDA

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    Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1

    FDA 510(k)
    FDA Class 2 ·Radiology

    FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES

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

    HELENA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·March 6, 2023

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·July 18, 2019

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·August 13, 2021

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code ONU·September 17, 2018

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code ONU·September 17, 2018

    ADVANTA V12 VASCULAR STENTS

    FDA Adverse Event
    Death ·ATRIUM MEDICAL·Product code NIO·October 1, 2018

    ADVANTA V12 VASCULAR STENTS

    FDA Adverse Event
    Injury ·ATRIUM MEDICAL·Product code NIO·October 1, 2018

    CURRENT PLUS DR, DF-4 CONNECTOR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 13, 2014

    MCGHAN 420 CC BREAST IMPLANTS (RIGHT & LEFT)

    FDA Adverse Event
    Injury ·MCGHAN MED CORP·Product code FWM·June 13, 2013

    SUPER POLIGRIP

    FDA Adverse Event
    Other ·GLAXOSMITHKLINE·Product code KOL·June 27, 2011

    METRIX AIR

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·November 6, 2017

    BLUE RELOAD FOR ECHELON 45

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 31, 2018

    ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN)

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·July 31, 2018

    ONYX

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·August 21, 2023

    BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155, PAK5240, PAK5255, PAK5340, PAK5355, PAK5440, PAK5455, PAK6140, PAK6155, PAK6240, PAK6255, PAK6340, PAK6355, PAK6440, and PAK6455 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·January 13, 2016

    Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used with affected systems. Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD10C 722001; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039; (Allura Centron - 722400 is impacted by this recall, but Allura Centron systems are not distributed in the United States.)

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024