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

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    WATER RESISTANT FOOTSWITCH W/CABLE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Marienfeld Superior

    FDA UDI
    Paul Marienfeld GmbH & Co. KG·04064279017509·

    VistaTablet

    FDA UDI
    Vital Connect, Inc.·00850490007207·VistaTablet is a tablet which will be running t...

    MicroAire®

    FDA UDI
    Microaire Surgical Instruments LLC·00847399005755·Standard (U) Blade Assembly 1pk

    MicroAire

    FDA UDI
    Provision·B5048101010·

    MicroAire®

    FDA UDI
    Microaire Surgical Instruments LLC·00847399017239·Standard Blade Assembly, SmartRelease

    SMARTRELEASE

    FDA Adverse Event
    Injury ·MICROAIRE SURGICAL INSTRUMENTS·Product code EMF·March 18, 2026

    Resectoscopy sheath

    FDA UDI
    SOPRO-COMEG GmbH·04059082031613·

    Cystoscopy sheath

    FDA UDI
    SOPRO-COMEG GmbH·04059082030487·

    iNSitu™ Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00816127020179·Neck Trial, Size 1, Standard

    TheRay Collared and Collarless Femoral Stem

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00816127026386·NECK TRIAL, COLLARED STEM, LATERAL, SIZE 1

    GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TAPER OXINIUM FEMORAL HEAD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GMK-SPHERE 02.12.0005L FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 7, 2021

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 4, 2014

    3.5MM LCP LOW BEND MEDIAL DSTLTIBIA PLATE/14H/RIGHT/239MM

    FDA Adverse Event
    Injury ·SYNTHES ELMIRA·Product code HRS·October 31, 2012

    PUMP MMT-722LNAP PRDGM INS PL EN ML

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·August 16, 2010

    Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781271

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021

    Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q; Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q; Fortify Assura DR, Model Numbers: CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q; Fortify Assura ST DR, Model Numbers: CD2263-40, CD2263-40Q, CD2363-40C, CD2363-40Q Product Usage Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·October 18, 2017

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023