BEUDAMED
    11 results · 29ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 2 ·Dental

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091032470·Baltic Denture System BDLoad Sw7 PLSEbm6DFs C1 ...

    MODIFICATION TO N PROTEIN STANDARD SL

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    M2424A SONOS 5500/4500 DIAGNOSTIC ULTRASOUND SYSTEM, VERSION B.2. 21330A TRANSDUCER

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 6, 2025

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON INC·Product code OTN·April 3, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·March 25, 2011

    EDWARDS LIFESTENT NT SELF EXPANDING BILIARY STENT AND DELIVERY SYSTEM

    FDA Adverse Event
    Other ·EDWARDS LIFESCIENCES·Product code FGE·April 17, 2008

    Toshiba Excelart VANTAGE Model MRT-1503, Magnetic Resonance Imaging Systems, Regulation Number 21 CPR 892.1000, Regulatory Class II, Product Code 90-LNH and was cleared with K032490

    FDA Recall
    Terminated ·Toshiba American Med Sys Inc·Product code LNH·October 12, 2005

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

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