BEUDAMED
    22 results · 25ms · Sources: EU EUDAMED, US FDA

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    ClearMet

    FDA 510(k)
    FDA Class 2 ·Dental

    Temptation NOW® A1 76g Bulk

    FDA UDI
    DEN-MAT HOLDINGS, LLC·00359883006310·Crown and Bridge Temporary Resin

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100165·KRATZ-BARRAQUER SPECULUM SMALL

    Reamer Handle – Long

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215076269·

    UNK

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC.·Product code KNS·June 13, 2014

    OMNI SPHINCTEROTOME

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PAIN BUDDY

    FDA 510(k)
    FDA Class 2 ·Neurology

    KYPHON BONE CEMENT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NDN·April 23, 2019

    1030489-2019-01423

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code NDN·December 13, 2019

    IDENTIFY ADX SR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC. CRMD·Product code DXY·January 13, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 7, 2013

    BIORAPTOR AB 2.9 MM

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW ENDOSCOPY·Product code HWC·July 7, 2011

    OSTEOCOOL RF ABLATION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code GEI·October 21, 2020

    UNIVERSA SOFT URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·January 29, 2019

    UNIVERSA SOFT URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK UROLOGICAL INC·Product code FAD·May 13, 2016

    UNIVERSA SOFT URETERAL STENT SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FAD·September 8, 2016

    UNIVERSA SOFT URETERAL STENT SET

    FDA Adverse Event
    Injury ·COOK UROLOGICAL INC·Product code FAD·May 13, 2016

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·July 23, 2019

    Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 20, 2013

    All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 12, 2014