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

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    PAD, HOSPITAL STRETCHER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ACUMED

    FDA UDI
    Acumed LLC·10806378052552·Polarus® 3 Tray 5

    ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100

    FDA 510(k)
    FDA Class 2 ·Radiology

    SMR GLENOID BASEPLATE STANDARD

    FDA Adverse Event
    Injury ·LIMACORPORATE SPA·Product code KWS·April 18, 2019

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 4, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 23, 2012

    MAGIC 3 FEMALE INTERMITTENT CATHETER

    FDA Adverse Event
    Malfunction ·ROCHESTER MEDICAL CORP·Product code KOD·May 27, 2015

    BREATH RIGHT ORIGINAL

    FDA Adverse Event
    Injury ·WEBTEC DIV OF SCARPA HEALTHCARE·Product code LWF·May 20, 2019

    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

    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