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

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    EK Implants and Abutments System

    FDA 510(k)
    FDA Class 2 ·Dental

    Accufit

    FDA UDI
    Ortho Organizers, Inc.·00190707184384·Accufit Molar Bands Lower Right Second Molar 36

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113387·ALIO MICS TRAP KNIFE (BX/5)

    DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LEFORTE SYSTEM BONE PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DHS®/DCS® GUIDE SHAFT

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code FZX·March 19, 2018

    DHS®/DCS® GUIDE SHAFT

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code FZX·March 19, 2018

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 17, 2014

    SIGMA 300 D

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code DXY·August 11, 2011

    TOTAL ASR ACET IMP SIZE 62

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD.·Product code KWA·July 2, 2013

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·September 2, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·September 2, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·September 2, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·September 2, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·September 2, 2022

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·May 3, 2016

    ACROM XL 44-41 STD HMRL BRNG

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·May 16, 2018

    COMP RVRS SHLDR GLNSP STD 41MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PAO·May 16, 2018

    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