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

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    Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DJO SURGICAL

    FDA UDI
    Encore Medical, L.P.·00190446838067·SPECIAL, EMPOWR REV KNEE MONOBLOCK TIBIAL TRAY ...

    CODMAN

    FDA UDI
    Cerenovus, Inc.·10886704001737·CODMAN SLIM-LINE Aneurysm Clip 90 Degree Angle ...

    NA

    FDA UDI
    Synthes GmbH·10886982142658·2.4MM CORTEX SCREW 3.5MM HEAD/SELF-TAPPING 58MM

    AUTOLENS CLEANING AND DISINFECTING UNIT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    RUBICON PROTHROMBIN TIME MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 27, 2014

    840 VENTILATOR

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·June 28, 2013

    HS III PROXIMAL SEAL SYSTEM 4.3MM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code DXC·August 4, 2011

    INJECTOR LOCKING N40-O

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·September 15, 2021

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·May 7, 2012

    BD PHASEAL OPTIMA INJECTOR (N40-O)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·September 14, 2021

    STEALTHSTATION S7 SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·March 1, 2017

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·December 5, 2023

    STEALTHSTATION S7 SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·March 1, 2017

    INJECTOR LOCKING N40-O

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·September 21, 2021

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·February 21, 2012

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    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