BEUDAMED
    29 results · 27ms · Sources: EU EUDAMED, US FDA

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    HM70 EVO Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    TWINFIX

    FDA UDI
    Smith & Nephew, Inc.·03596010539335·TWINFIX AB 6.5 MM SUTURE ANCHOR, ...

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319722305·Freeman Rake Retractor 4" (10cm), 4 sharp prong...

    WATERPAP VALVE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    EchoNavigator

    FDA 510(k)
    FDA Class 2 ·Radiology

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code NIQ·October 23, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 12, 2011

    EPIC II VR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 8, 2013

    KARDIAMOBILE

    FDA Adverse Event
    Malfunction ·ALIVECOR·Product code DPS·January 24, 2022

    TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product Number: 7210713

    FDA Recall
    Open, Classified ·Smith & Nephew, Inc.·Product code MAI·September 9, 2020

    TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product Number: 7210713

    FDA Enforcement
    Class II ·Ongoing·Smith & Nephew, Inc.·October 28, 2020

    RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3mm Liners Size 23 item XL-108323 ArComXL MaxRom +3mm Liners Size 23 item XL-108223

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·January 25, 2017

    PENTAX

    FDA Adverse Event
    Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·September 18, 2020

    PENTAX

    FDA Adverse Event
    Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·November 28, 2020

    PENTAX

    FDA Adverse Event
    Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·October 23, 2020

    PENTAX

    FDA Adverse Event
    Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·November 28, 2020

    PENTAX

    FDA Adverse Event
    Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·August 20, 2021

    PENTAX

    FDA Adverse Event
    Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·August 18, 2021

    PENTAX

    FDA Adverse Event
    Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·August 20, 2021

    PENTAX

    FDA Adverse Event
    Injury ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·August 18, 2021