BEUDAMED
    12 results · 18ms · Sources: EU EUDAMED, US FDA

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    TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    NOBELREPLACE CC PMC RP 4.3X10MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE USA INC·Product code DZE·June 15, 2021

    NOBELPARALLEL CC NP 3.75X13MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE AB·Product code DZE·March 8, 2021

    NOBELPARALLEL CC NP 3.75X13MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE AB·Product code DZE·March 8, 2021

    DIASUS

    FDA 510(k)
    FDA Class 2 ·Radiology

    MICROMANIPULATOR

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

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 3, 2013

    SURESCAN

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·September 16, 2014

    7700

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·May 3, 2011

    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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    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