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

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    Lumify Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    XLP - CPRotector® Deluxe - Orange Nylon Pouch

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588030067·XLP - CPRotector® Deluxe - Orange Nylon Pouch

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113431·CRESCENT KNIFE DOUBLE BEVEL (BX/5)

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113813·VISCO CANNULA 27GA ANGLE 8MM

    Arena-C®

    FDA UDI
    SPINEFRONTIER, INC.·00190361036821·Trial Rasp, No Stop, Assembly, Lordotic, 6mm

    GUARDED NEEDLE 2000

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS

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

    USTAR II KNEE SYSTEM

    FDA Adverse Event
    Injury ·UNITED ORTHOPEDIC CORPORATION·Product code KRO·March 24, 2026

    ORTHO PROVUE

    FDA Adverse Event
    Malfunction ·MICRO TYPING SYSTEMS, INC.·Product code KSZ·October 16, 2008

    ADAPTA DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code NVZ·August 11, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 2, 2013

    VENOUS HARDSHELL CARDIOTOMY RESERVOIR

    FDA Adverse Event
    Malfunction ·Product code DTN·August 18, 2020

    BD PROTECTOR P20-O MULTIPACK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·November 11, 2022

    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