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

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    HEMOSIL FACTOR VIII DEFICIENT PLASMA

    FDA 510(k)
    FDA Class 2 ·Hematology

    Baltic Denture System BDLoad

    FDA UDI
    Merz Dental GmbH·D7091034007·Baltic Denture System BDLoad BDLoad ↓ Sm7 PLSEu...

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0140070·T-Handle, T30, Locking Cap Adjuster

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710820340070·Zadik Calcaneal Guide, 34mm x 7°

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710620340070·Quad Channel Met-Traverse, 34mm x 7mm

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710610340070·Tri-Channel Met-Traverse, 34mm x 7mm

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710450340070·,Medial Guide, Closing Wedge Osteotomy, 34mm x 7mm

    TRANSDUCER, S8-3T MICRO TEE

    FDA Adverse Event
    Malfunction ·PHILIPS ULTRASOUND, INC.·Product code IYO·August 8, 2014

    DYNALINK .018 BILLARY SELF-EXPANDING STENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DR180+OXY

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TRANSDUCER, S8-3T MICRO TEE

    FDA Adverse Event
    Malfunction ·PHILIPS ULTRASOUND, INC.·Product code IYO·March 28, 2014

    TRANSDUCER, S8 3T MICRO TEE

    FDA Adverse Event
    Malfunction ·PHILIPS ULTRASOUND, INC·Product code IYO·June 27, 2014

    TRANSDUCER S8-3T MICRO TEE

    FDA Adverse Event
    Malfunction ·PHILIPS ULTRASOUND, INC.·Product code IYO·January 24, 2014

    HDI 5000 ULTRASOUND STANDARD SYSTEM

    FDA Adverse Event
    Malfunction ·PHILIPS ULTRASOUND, INC.·Product code IYO·March 30, 2012

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·April 3, 2013

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·March 30, 2011

    PINN MAR +4 NEUT 36IDX54OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·April 25, 2008

    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

    OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370

    FDA Enforcement
    Class II ·Ongoing·Osteomed, LLC·December 15, 2021