BEUDAMED
    20 results · 26ms · Sources: EU EUDAMED, US FDA

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    VisioFocus Mini, VisioFocus Smart

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ATRILAZE SURGICAL ABLATION SYSTEM

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

    ENSPIRE DISCECTOMY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

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    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 22, 2021

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    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·July 16, 2021

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    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 29, 2021

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    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 1, 2023

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·Product code OYC·June 10, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 13, 2011

    ENDPOPATH XCEL DILATING TIP TROCAR WITH STABILITY SLEEVE- 12MM DIAMETER, 100MM S

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GCJ·September 5, 2008

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    FDA Adverse Event
    Injury ·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 22, 2021

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    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 27, 2020

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    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·June 9, 2021

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    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 2, 2021

    CER OPTION TYPE 1 TPR SLEVE -6

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LZO·August 6, 2018

    CER BIOLOXD OPTION HD 36MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LZO·August 6, 2018

    EPOLY 36MM RLC LNR MROM SZ26

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·August 6, 2018

    TPRLC 133 MP TYPE1 PPS HO 12.0

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·August 6, 2018

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM, Silicone, Sterile, Item 431195.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024