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

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    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113554·IMPLANT BLADE 5.2MM (BX/5)

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112687·BARRON CORNEAL PUNCH 9.25MM

    POWER 5000 GENERAL PURPOSE COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACTISORB SILVER 220 ANTIMICROBIAL BINDING DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NGV·October 3, 2024

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·December 17, 2020

    VASO VIEW HEMOPRO

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC.·Product code GEI·August 5, 2011

    KINETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code MHY·August 8, 2008

    MINIMAL ACCESS ATTACHMENT

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBE·July 2, 2013

    THERASPHERE Y-90

    FDA Adverse Event
    Injury ·BIOCOMPATIBLES UK LIMITED·Product code NAW·May 14, 2025

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code LEG·April 5, 2013

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code LEG·April 5, 2013

    Y-90 THERASPHERE (3 GBQ) CANADA COMM

    FDA Adverse Event
    Injury ·BIOCOMPATIBLES UK LIMITED·Product code NAW·November 27, 2024

    HANDPIECE MICS

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·July 25, 2018

    HANDPIECE MICS

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·July 25, 2018

    Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY).

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    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