BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    CADENCE, MODELS 2001 AND 2002

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

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496040903·CATHERINE CCL.1, SIZE ML, NERO, GRADUATED COMPR...

    FX V135 Shoulder Prosthesis

    FDA UDI
    FX SOLUTIONS·03701037315422·FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V ...

    ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    TRI-FIX SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code NPT·April 8, 2013

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 6, 2011

    KIMBERLY-CLARK MIC GASTROSTOMY FEEDING TUBE

    FDA Adverse Event
    Other ·AVENT SA DE R.L. DE C.V.·Product code KNT·April 25, 2008

    PF-VIRTEC SYSTEM CMTED LAT.6

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code LZO·August 6, 2019

    Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013

    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