BEUDAMED
    20 results · 26ms · Sources: EU EUDAMED, US FDA

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    SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    METHA SHORT STEM HIP SYSTEM; MODULAR HIP SYSTEM; EXCIA HIP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Medtronic Model 5392 External Pulse Generator (EPG)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BILOX PROSTHESIS HEAD 12/14 28MM L

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO. KG·Product code LWJ·May 23, 2014

    EXCIA L PLASMAPORE UCAP 8/10 SIZE 11MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO. KG·Product code LWJ·March 6, 2014

    ISODUR PROSTHESIS HEAD 12/14 32MM L

    FDA Adverse Event
    Malfunction ·AESCULAP AG&CO KG·Product code LPH·August 7, 2014

    QUINTEX SEMICONSTRAINED SCREW 4.0X16MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO. KG·Product code LWJ·March 6, 2014

    BIOLOX PROSTHESIS HEAD 12/14 28MM S

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code LWJ·April 27, 2012

    EXCIA PLASMAPORE-UCAP 8/10 SIZE 11MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code MEH·June 21, 2013

    EXCIA CEMENTED 8/10 SIZE 12MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code JDI·November 5, 2012

    BIOLOX PROSTHESIS HEAD 12/14 28MM S

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code LWJ·April 14, 2014

    BIOLOX PROSTHESIS HEAD 12/14 28MM M

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code LWJ·April 27, 2012

    BIOLOX PROSTHESIS HEAD 12/14 32MM L

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO. KG·Product code LWJ·March 6, 2014

    BIOLOX PROSTHESIS HEAD 8/10 32MM M

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO. KG·Product code LZO·June 21, 2013

    BIOLOX PROSTHESIS HEAD 12/14 28MM S

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO. KG·Product code LWJ·March 6, 2014

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 28, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·February 8, 2011

    SENSOR ENLITE

    FDA Adverse Event
    MEDTRONIC MINIMED·Product code OZO·August 5, 2014

    ISODUR PROSTHESIS HEAD 12/14 28MM M

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO. KG·Product code LPH·January 16, 2015

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS30; c) NEONATAL TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS35; d) NEONATAL TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS40

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024