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

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    Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express

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

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526768451·GENUMEDI PSS GREEN I

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04064984699533·GENUMEDI PSS BLUE, SIZE I

    Oticon

    FDA UDI
    Oticon A/S·05707131283290·RIA2, BTE 13 WL 85 STG

    TIBIAL INSERT IMPACTOR TIP

    FDA Adverse Event
    Malfunction ·CONFORMIS, INC.·Product code OOG·April 28, 2017

    HUMAN IGA CSF KIT FOR USE ON SPAPLUS

    FDA 510(k)
    FDA Class 2 ·Immunology

    SYMBIQ INFUSION AND ADMINSTRATION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SPECTRANETICS QUICK-CROSS SUPPORT CATHETER

    FDA Adverse Event
    Injury ·THE SPECTRANETICS CORPORATION·Product code DQY·March 6, 2019

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 6, 2013

    MBT CEM KEEL TIB TRAY SZ2.5

    FDA Adverse Event
    Injury ·DEPUY-CORK, A DIV. OF DEPUY ORTHOPAEDICS·Product code NJL·June 29, 2011

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008

    MREYE EMBOLIZATION COIL

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·May 11, 2018

    MREYE EMBOLIZATION COIL

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·May 11, 2018

    MREYE EMBOLIZATION COIL

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·May 11, 2018

    NESTER PLATINUM EMBOLIZATION MICROCOIL

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·May 11, 2018

    MREYE EMBOLIZATION COIL

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·May 11, 2018

    MREYE EMBOLIZATION COIL

    FDA Adverse Event
    Injury ·COOK INC·Product code KRD·May 11, 2018

    STAINLESS STEEL EMBOLIZATION COIL

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRD·August 24, 2017

    EDI BZO UNCUT SHEET-CARD, Item No. 100170 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·November 25, 2015

    MISAGO RX Self Expanding Peripheral Stem

    FDA Enforcement
    Class II ·Terminated·Terumo Medical Corp·December 7, 2016