BEUDAMED
    27 results · 28ms · Sources: EU EUDAMED, US FDA

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    SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526827844·***DISC*LEVAMED ANKLE SUPPORT BLACK II

    CERASMART™

    FDA UDI
    Gc America Inc.·14548161320962·CERASMART™ 270 14L Universal A3.5 LT 5p Block

    CERASMART®

    FDA UDI
    Gc America Inc.·D0470125121·CERASMART 270 14L Unsvl A3.5 LT 5p

    n/a

    FDA UDI
    Ortho Development Corporation·00822409072637·Blunt Tip Broach Size 12

    Zavation

    FDA UDI
    Zavation LLC·00842166114678·TLIF 25, 6deg -12

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0120120·Screwdriver, NIDO Assembled Screws, Sleeved

    MMODIFICATION TO LAMINARIA

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

    TORAYSULFONE DIALYZER

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

    True Position®

    FDA UDI
    ATLAS SPINE, INC.·M68112080125120·25mm x 12mm Lordotic Spacer

    OsteoFlo-G

    FDA UDI
    BIOMATLANTE·03700501806725·Synthetic Bone Substitute Stick 5 x 5 x 10mm (x2)

    CAPTURE-R READY-ID

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·January 16, 2019

    CAPTURE-R READY-ID

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·January 16, 2019

    UNKNOWN SYMBOTEX MESH

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION SAS·Product code FTL·May 31, 2022

    UNKNOWN PROGRIP MESH PRODUCT

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION SAS·Product code FTL·May 31, 2022

    UNKNOWN PARIETENE MESH PRODUCT

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION SAS·Product code FTL·May 31, 2022

    CAPTURE-R READY-SCREEN (3)

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·August 20, 2019

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL COMPANY·Product code HQL·March 9, 2011

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE INC.·Product code LZG·August 12, 2014

    EMBRACE PUMP

    FDA Adverse Event
    Malfunction ·ROSS PRODUCTS DIVISION·Product code LZH·March 12, 2008