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

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    PFT CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ACUMED

    FDA UDI
    Acumed LLC·10806378050190·Polarus® 3 2.8mm Blunt Short Drill

    Symmetry MICROCARE®

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482031247·Microcare Case Flex, Medium, Length 15 1/2 Inches

    MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CONMED TROGARD FINESSE TROCAR SYSTEM, MODEL 60-6050-XXX

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ARCHITECT C8000

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code JJE·October 14, 2021

    BHR

    FDA Adverse Event
    Injury ·SMITH & NEPHEW·Product code NXT·May 9, 2014

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code NBW·October 16, 2007

    HEARTSTART ONSITE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 18, 2012

    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

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018