BEUDAMED
    14 results · 29ms · Sources: EU EUDAMED, US FDA

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    EZ-IO Intraosseous Vascular Access System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113424·CRESCENT KNIFE BEVEL UP (BX/5)

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113561·IMPLANT BLADE 6.2MM (BX/5)

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113455·SUPER SHARPS 15 DEG 5MM (BX/5)

    PULPDENT SEMI-GEL ETCH

    FDA 510(k)
    FDA Class 2 ·Dental

    SIMPLICITY SOFT INFUSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD INTIMA II IV CATHETER PRN ADAPTER

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·July 20, 2021

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·October 8, 2008

    MOSAIC AORTIC BIOPROSTETIC HEART VAVLE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES, INC.·Product code LWR·August 5, 2011

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·July 2, 2013

    INTIMA-II Y 22GAX1.00IN PRN/EC SLM

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·November 30, 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

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025