BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    RANDOX VALPROIC ACID

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD PHASEAL¿ INFUSION SYSTEM ADAPTOR

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·October 18, 2018

    BD PLASTIPAK¿ LUER-LOK¿ SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 28, 2018

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code FNL·April 22, 2013

    STERLING ES PTA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·April 28, 2011

    SYNCHROMED II

    FDA Adverse Event
    Death ·MEDTRONIC, INC., NEUROLOGICAL DIV.·Product code LKK·July 9, 2008

    THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·March 20, 2022

    Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·October 7, 2020

    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