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

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    DELFIA NEONATAL IRT KIT, MODEL A005-110

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALAN, MODEL ALILENT M3000A/M3046A OPTION J120

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HAND PIECE FOR BATTERY POWERED DRIVER

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWE·June 10, 2022

    SIMPULSE SOLO

    FDA Adverse Event
    Malfunction ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FQH·February 11, 2013

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·February 24, 2011

    HARMONIC ACE 36 CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code LFL·February 14, 2008

    UNKNOWN PFM-R DISTAL STEM

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code JDI·March 13, 2018

    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

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024