BEUDAMED
    24 results · 22ms · Sources: EU EUDAMED, US FDA

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    MPP

    FDA 510(k)
    FDA Class 2 ·Neurology

    Port Access Needle

    FDA UDI
    Bard Access Systems, Inc.·00801741047329·PowerLoc Max 19G x 1 inch with y-site

    Port Access Kit

    FDA UDI
    Bard Access Systems, Inc.·00801741044151·PowerLoc MAX 19G x 1" with Y-Site PAK

    Oticon

    FDA UDI
    Oticon A/S·05707131259387·NERA, KIT 312 WL DIR 85 L V BE

    STAINLESS STEEL AQUATIC WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    3M ATTEST RAPID READOUT STEAM PROCESS CHALLENGE DEVICE, MODEL 1296V, 3M ATTEST RAPID READOUT STEAM-PLUS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GMK-PRIMARY FEMUR PS CEMENTED SIZE 6 L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 16, 2020

    GMK-PRIMARY FEMUR PS CEMENTED SIZE 4

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 22, 2019

    POWERLOC MAX POWER-INJECTIBLE INFUSION SET 19G X 1.0 IN

    FDA Adverse Event
    Malfunction ·BARD ACCESS SYSTEMS·Product code FPA·March 12, 2020

    GMK-PRIMARY FEMUR PS CEMENTED SIZE 4 LEFT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 23, 2017

    GMK-PRIMARY FEMUR PS CEMENTED SIZE 6 L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 25, 2018

    POWERLOC

    FDA Adverse Event
    Malfunction ·BARD ACCESS SYSTEMS, INC.·Product code FPA·February 4, 2020

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·May 29, 2013

    ENRHYTHM DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code DXY·June 16, 2011

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code KRH·August 20, 2008

    PowerLoc MAX Power Injectable Infusion Port Access Kit; Catalog Numbers 2131910 (UDI 00801741044151), 2131915 (UDI 00801741044168), 2131975 (UDI 00801741044175), 2132010 (UDI 00801741044151), 2132015 (UDI 00801741044199), 2132075 (UDI 00801741044205), 2132210 (UDI 00801741044212), 2132275 (UDI 00801741044236), 2141910 (UDI 00801741044243), 2141915 (UDI 00801741044250), 2141975 (UDI 00801741044267), 2142010 (UDI 00801741044274), 2142015 (UDI 00801741044281), 2142075 (UDI 00801741044298), 2142210 (UDI 00801741044304), 2142215 (UDI 00801741044311), 2142275 (UDI 00801741044328)

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·July 29, 2020

    ROD, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·May 9, 2019

    PEDICLE SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·May 9, 2019

    PEDICLE SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code NKB·May 9, 2019

    PowerLoc MAX Power Injectable Infusion Set; Catalog Numbers 0131910 (UDI 00801741047329), 0131915 (UDI 00801741047336), 0131975 (UDI 00801741047343), 0132010 (UDI 00801741047350), 0132015 (UDI 00801741047367), 0132075 (UDI 00801741047374), 0132210 (UDI 00801741047381), 0132215 (UDI 00801741047398), 0132275 (UDI 00801741047404), 0141910 (UDI 00801741047411), 0141915 (UDI 00801741047428), 0141975 (UDI 00801741047435), 0142010 (UDI 00801741047442), 0142015 (UDI 00801741047459), 0142075 (UDI 00801741047466), 0142210 (UDI 00801741047473), 0142215 (UDI 00801741047480), 0142275 (UDI 00801741047497)

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·July 29, 2020