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

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    KOO AMERICAS VALVE PEEP, MODEL KM-809

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306814792·Gorney Scissors, Curved, 7.5"(19cm)

    ELASTYFREE SYNTHETIC POWDER-FREE SURGICAL GLOVE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    BIOLOX PROSTHESIS HEAD 12/14 28MM S

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code LWJ·April 14, 2014

    BD VACUTAINER® PLUS PLASTIC SST TUBE. GOLD BD HEMOGARD¿

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·December 1, 2017

    BIOLOX PROSTHESIS HEAD 12/14 28MM S

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO. KG·Product code LWJ·March 6, 2014

    EndoVive 3s Low Profile Balloon Kits Part Number: M00548740 (XMD P/N 70-0050-918) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

    FDA Enforcement
    Class II ·Terminated·Xeridiem Mediem Medical Devices Inc·March 2, 2016

    INTIMA-II Y 24GAX0.75IN PRN/EC SLM

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code FOZ·January 13, 2021

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·November 6, 2019

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·April 10, 2013

    ARCHITECT HAVAB IGM REAGENT

    FDA Adverse Event
    Malfunction ·ABBOTT·Product code LOL·April 12, 2011

    RIATA ST OPTIM PASSIVE FIXATION LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 27, 2008

    EndoVive 3s Low Profile Balloon Kits Part Number: M00548740 (XMD P/N 70-0050-918) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

    FDA Recall
    Terminated ·Xeridiem Mediem Medical Devices Inc·Product code PIF·December 23, 2015