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

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    PILOT SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MAXCUT CARBIDE BUR (10/pk) FGSU # 557

    FDA UDI
    SCOTT'S DENTAL SUPPLY L.L.C.·D77811117291·MAXCUT CARBIDE BUR (10/pk) Shape: Round; Size: ...

    Data Logger Bravo (G)

    FDA UDI
    Scican Ltd·07540196002387·Data logger for Bravo Chamber Autoclave

    SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NEOWIRE PTA/PTCA GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 8, 2025

    SPINEASSIST SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC·Product code HAW·August 19, 2019

    URETEX SUPPORT PP KIT X1

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code FTL·April 16, 2013

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·June 2, 2011

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM HYDRO

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·August 14, 2008

    OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM Catalog # AB081040 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

    FDA Enforcement
    Class II ·Terminated·Oscor, Inc.·December 28, 2016

    Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR WITH ONE NO. 2 WHITE/BLUE HI-FI SUTURE

    FDA Adverse Event
    Malfunction ·CONMED CORPORATION·Product code MBI·April 23, 2019

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L231, PROPONENT DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025