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

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    BIPOLAR HF DEVICE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B5821106950·

    COLLADENTAL BARRIER

    FDA 510(k)
    FDA Class 2 ·Dental

    KOALA CLAMP

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

    BD INSYTE AUTOGUARD BL 22GA X 1.0IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·July 18, 2024

    BD INSYTE AUTOGUARD BL 22GA X 1.0IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·July 18, 2024

    BD INSYTE AUTOGUARD

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·July 30, 2024

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    ¿ZENAPRO HYBRID HERNIA REPAIR GRAFT

    FDA Adverse Event
    Injury ·COOK BIOTECH·Product code FTL·September 23, 2015

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code JDQ·May 14, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 23, 2014

    CERAMIC FEMORAL HEAD

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LZO·June 1, 2011

    ZENAPRO HYBRID HERNIA REPAIR GRAFT

    FDA Adverse Event
    Injury ·COOK BIOTECH, INC.·Product code FTL·August 8, 2014

    ¿ZENAPRO HYBRID HERNIA REPAIR GRAFT

    FDA Adverse Event
    Injury ·COOK BIOTECH·Product code FTL·November 30, 2015

    Video Duodenoscope

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·June 8, 2016

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021