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

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    ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS

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

    AMDS Hybrid Prosthesis ("AMDS")

    FDA UDI
    Artivion, Inc.·00877234001208·40mm – 30mm Tapered Stent (24mm collar)

    Baltic Denture System BDLoad

    FDA UDI
    Merz Dental GmbH·D7091033421·Baltic Denture System BDLoad BDLoad ↓ Lm6 PLSEu...

    Symmetry Sims

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482051139·Symmetry® Scissors, Sims Operating Scissors, St...

    LIFEGUARD NASAL CPAP MASK AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DEPUY C-STEM SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RUNWAY GUIDE CATHETER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·May 8, 2013

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code DQX·April 3, 2013

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·March 23, 2011

    AED PLUS

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORP·Product code MKJ·April 21, 2008

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. 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. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide 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, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018