BEUDAMED
    15 results · 25ms · Sources: EU EUDAMED, US FDA

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    Artimes pro Balloon Dilatation Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ARCHITECT I2000SR ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·January 30, 2017

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114148·SIMCOE I/A SYSTEM 23GA (PK/3)

    Accufit

    FDA UDI
    Ortho Organizers, Inc.·00190707184445·Accufit Molar Bands Lower Right Second Molar 39

    Disposable Iris Retract

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114339·FLEXIBLE IRIS RETRACTORS 1 PK of 5

    MY BREAST FRIEND, BREAST SELF-EXAM PAD

    FDA 510(k)
    FDA Class 1 ·Radiology

    V.A.C. DERMATAC Drape

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

    MATRIXMANDIBLE/THORAX SCRWDRVR BLADE SELF RETAINING-MEDIUM

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·July 22, 2019

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 30, 2025

    PROGRAMMING WAND

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·October 15, 2008

    ATTAIN ABILITY PLUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·August 11, 2011

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·July 2, 2013

    AVID TruCustom PV MINOR PACK convenience kits, Item Code: MADN017-02 and MADN017-03

    FDA Enforcement
    Class II ·Terminated·Avid Medical, Inc.·March 7, 2018

    Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·November 20, 2013

    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