BEUDAMED
    23 results · 33ms · Sources: EU EUDAMED, US FDA

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    OptiComp

    FDA 510(k)
    FDA Class 2 ·Dental

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694049559·ExtremiLOCK Ankle Fracture Tray Case

    Blade Handle

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112373·CHUCK HANDLE #3KA 7.5CM LONG

    Marking Pen

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113219·MARKING PEN FOR TREPHINE & PUNCH

    MEGAVISION CPX, MEGAVISION FA, MODEL I AND II

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    M2376A DEVICELINK SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 13, 2024

    ALL IN ONE

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·October 9, 2021

    NONE

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL BRASIL LTDA·Product code LWR·October 17, 2008

    ASKU

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA INC.·Product code DTE·August 11, 2011

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·July 2, 2013

    COVID-19 TEST KIT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·September 8, 2022

    COVID-19 TEST KIT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·September 8, 2022

    COVID-19 TEST KIT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·September 8, 2022

    DELTA CER HEAD 12/14 36MM +1.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LZO·May 31, 2024

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EGS·May 28, 2023

    ALL-IN-ONE

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·October 11, 2022

    Vanguard XP Tibial Tray 69 mm Item # 195248

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.

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

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012