BEUDAMED
    19 results · 39ms · Sources: EU EUDAMED, US FDA

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    Bio-Medicus Adult Cannulae and Introducer

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RELIANCE ENDOSCOPE PROCESSING SYSTEM

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

    FILTEK BULK FILL FLOWABLE RESTORATIVE

    FDA 510(k)
    FDA Class 2 ·Dental

    OLYMPUS EMPOWER H65

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM S.P.A.·Product code GEX·May 19, 2022

    SOF-FLEX MULTI-LENGTH URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·October 24, 2024

    NASAL SCOPE

    FDA Adverse Event
    Other ·Product code EOB·October 1, 2008

    PINNACLE PELVIC FLOOR REPAIR KITS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 20, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011

    SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FAD·September 30, 2024

    SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FAD·October 7, 2024

    SOF-FLEX MULTI-LENGTH URETERAL STENT SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FAD·October 21, 2024

    SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FAD·April 19, 2021

    SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FAD·April 19, 2021

    ENNOVATE POLYAX.SCREW 6.5X45MM FENESTR.

    FDA Adverse Event
    Injury ·AESCULAP AG·Product code NKB·December 21, 2018

    ENNOVATE POLYAX.SCREW 7.5X40MM FENESTR.

    FDA Adverse Event
    Injury ·AESCULAP AG·Product code NKB·December 21, 2018

    SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·June 28, 2022

    SOF-FLEX MULTI-LENGTH URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·October 21, 2024

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP40; b) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP45; c) PAED. TRACHEOSTOMY TUBE 5.0MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP50; d) PAED. TRACHEOSTOMY TUBE 5.5MM FLEXTEND PLUS , Product Code/List Number/Item Code 60PFP55

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

    Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017