BEUDAMED
    17 results · 27ms · Sources: EU EUDAMED, US FDA

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    STRYKER LOCKED PLATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00505121·

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526827844·***DISC*LEVAMED ANKLE SUPPORT BLACK II

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526827905·ACHIMED ACHILLES SUPP BLACK II

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306814686·Lister Bandage Scissors, 11.5cm

    Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) ES-25x22

    FDA Enforcement
    Class II ·Terminated·TriMed Inc.·June 27, 2018

    D905 EOS PHISIO OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA S.R.L.·Product code DTZ·August 8, 2017

    TRIAGE CARDIAC TRIPLE MARKER PANEL

    FDA Adverse Event
    Injury ·ALERE SAN DIEGO, INC.·Product code MMI·May 22, 2012

    OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MTI ST#1 SILICONE PESSARY

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    D905 EOS OXYGENATOR (PHISIO TREATED)

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·July 13, 2018

    EndoVive 3s Low Profile Balloon Kits Part Number: M00548260 (XMD P/N 70-0050-512) 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

    SECURE 3 MED/SURG BEDOBS 01/13

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 10, 2013

    CENTURY BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·April 5, 2011

    TENDRIL DX

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

    EndoVive 3s Low Profile Balloon Kits Part Number: M00548260 (XMD P/N 70-0050-512) 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

    Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the Millenium Surgical, Echo Instruments, Adler Instrument, Surgical Direct, Stealth Surgical, CareFusion, and Boss Instruments brand names.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·December 17, 2014