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

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    Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776305444·Hoke Osteotome 5 12" str 58" (16mm)

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780455875·Integra® Jarit® Hoke Osteotome, Straight

    ceraMotion®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011250286200·ceraMotion® Zr Incisal Modifier Value opal viol...

    FIDIS CONNECTIVE 8

    FDA 510(k)
    FDA Class 2 ·Immunology

    Medline Enteral Feeding Sets

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

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·October 7, 2019

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·March 7, 2023

    R SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·November 6, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 15, 2011

    ASPHERE M SPEC 12/14 36 +1.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·July 26, 2013

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013