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

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    VPAP III ST-A/KIDSTA MASK SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Nova

    FDA UDI
    PURELIFE, LLC·D79010601051·Nova Nitrile Powder-Free, X-Large, Super-stretc...

    CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 105mm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665020861·

    Masel

    FDA UDI
    Ortho Organizers, Inc.·00190707045852·ADAMS CLASPS SIZE 5MM

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690190790·FEMORAL LUG TRIAL 3mm HEX DRIVER

    Medallion®

    FDA UDI
    Merit Medical Systems, Inc.·00884450021774·

    IDI Dental Implant

    FDA UDI
    AIDI BIOMEDICAL LLC·D747IDI10601051·IDI Implant Fixture 6.0mm x 10.5mm (Implant Pack)

    IDI Dental Implant

    FDA UDI
    AIDI BIOMEDICAL LLC·D747IDI106010501·IDI Implant Fixture 6.0mm x 10.5mm (Implant Only)

    IDI Dental Implant

    FDA UDI
    AIDI BIOMEDICAL LLC·D747IDI1060105A1·IDI Implant Fixture 6.0mm x 10.5mm (Practice Bu...

    MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (60 CM),

    FDA 510(k)
    FDA Class 2 ·Neurology

    ANESTHESIA MONITOR; BEDSIDE MONITOR, SERIES BSM-5130A

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MARATHON MICRO CATHETER AND ONYX

    FDA Adverse Event
    Injury ·EV3 NEUROVASCULAR·Product code KRA·December 8, 2009

    ONYX AVM

    FDA Adverse Event
    Injury ·EV3 NEUROVASCULAR·Product code MFE·October 8, 2010

    ONYX, AVM

    FDA Adverse Event
    Death ·EV3 NEUROVASCULAR DIVISION·Product code MFE·August 25, 2006

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·April 5, 2013

    ACCU-CHEK AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·June 10, 2008

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·AV-TEMECULA-CT·Product code NIQ·April 15, 2011

    2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·November 30, 2016

    Medtronic Maximo DR, model 7278 Single Chamber Implantable Cardioverter Defibrillator (ICD)devices are tiered therapy implantable arrhythmia control devices, which provide automatic detection of ventricular arrhythmias and delivery of user-selected therapies for the detected arrhythmia. Therapies are automatically delivered following detection or can be initiated via programming by the physician. These ICDs are multi-programmable and have the capability of transmitting via telemetry the programmed values, measured and collected data, and event markers.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Managment·Product code LWS·February 9, 2005

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022