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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    MODIFICATION TO: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TOTAL BILIRUBIN REAGENT-COBAS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CIG·February 24, 2000

    REPROCSSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    FASTI INTRAOSSEOUS INFUSION SYSTEM

    FDA Adverse Event
    Other ·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009

    WAVEWRITER ALPHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 15, 2022

    LINEAR 3-4

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 26, 2021

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 23, 2013

    STERLING ES PTA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·April 29, 2011

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·July 10, 2008

    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

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

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