BEUDAMED
    23 results · 21ms · Sources: EU EUDAMED, US FDA

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    AQUIFY LENS COMFORT DROPS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033469149·

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0112040·Tap, 6.5 mm

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0112040·Tap, 5.50mm

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0132000·Rod Reducer, Axial, NIDO

    RESTORE

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 8, 2015

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0132080·Trial, TLIF, 27L OB CRV 7Deg, 8mm

    STRYKER NAVIGATION SYSTEM-KNEE MODULE

    FDA 510(k)
    FDA Class 2 ·Neurology

    BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    COAPTITE INJECTABLE IMPLANT

    FDA Adverse Event
    Other ·MERZ AESTHETICS, INC.·Product code LNM·October 17, 2012

    RESTORE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·January 2, 2014

    PRIMEADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 5, 2017

    SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES, PR·Product code DYG·March 20, 2013

    2.4 SL 4 HOLE L PLATE 100 DEG

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·March 10, 2011

    ICY HOT HEAT THERAPY PATCH

    FDA Adverse Event
    Other ·CHATTEM, INC.·Product code IMD·March 12, 2008

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·May 31, 2023

    Power cord for Optional Thermal Printer (For use with Model 3300 COC), Oximetrix 3 SO2/CO Computer, Q-Vue CCO Computer and Q2 CCO/SO2 Computer, List Number 50132-04-05, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.

    FDA Recall
    Terminated ·Hospira Inc·Product code dxg·August 11, 2009

    SURESCAN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·November 6, 2017

    DIALYSIS UNKNOWN

    FDA Adverse Event
    Injury ·COVIDIEN MFG SOLUTIONS S.A.·Product code FJS·April 12, 2019

    Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage: Lead Extensions are designed to connect the percutaneous leads to the Implantable Pulse Generator (IPG) for spinal cord stimulation. The extension may be added to a lead to externalize the lead for a trial procedure or to extend the lead when a permanent IPG is implanted. Package Contents: Lead Extension Kit (1) Lead Extension (1) Hex Wrench (1) Tunneling Tool Assembly (1) Device Registration Form/Temporary Patient Identification Card (1) Manual

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Neuromodulation Corporation·June 3, 2020