BEUDAMED
    13 results · 28ms · Sources: EU EUDAMED, US FDA

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    PORPHYRIN (ALA) DISK

    FDA 510(k)
    FDA Class 1 ·Microbiology

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209125333·

    8 CHANNEL CARDIAC PHASED ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    QUINTON Q-STRESS, MODEL 000483

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CYLOS VR

    FDA Adverse Event
    Malfunction ·BIOTRONIK GMBH AND CO·Product code NVZ·November 24, 2008

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DYE·May 9, 2014

    PWRD ECH FLEX 60MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 23, 2012

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 28, 2015

    HAMILTON-G5

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·October 28, 2025

    HAMILTON-G5

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·September 17, 2025

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 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