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

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    MEBO Wound Dressing

    FDA 510(k)
    FDA Unclassified ·Unknown

    LCP

    FDA UDI
    Synthes GmbH·10886982157300·4.5MM LCP® CONDYLAR PLATE 6 HOLES/170MM-LEFT

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111175824·RAGNELL SCIS SL CRV FLT TIP 7"

    Quantum Heater-Cooler

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Javelin Tailor's Bunion Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RIGIDLOOP

    FDA Adverse Event
    Malfunction ·S.B.M. SAS·Product code MBI·September 14, 2023

    BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND CO.·Product code NGT·March 24, 2022

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 31, 2014

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·August 25, 2011

    M2A-MAGNUM 42-50MM TAPER INSERT-3

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·July 12, 2013

    REF 623401 R, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Medium, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·March 19, 2014