BEUDAMED
    17 results · 34ms · Sources: EU EUDAMED, US FDA

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    SUPER ORTHODONTIC SCREW

    FDA 510(k)
    FDA Class 2 ·Dental

    APPRAISE URINE MICROALBUMIN COLLECTION KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    IMAGINE H.E.

    FDA 510(k)
    FDA Class 2 ·Dental

    SMARTMONITOR 2 PS

    FDA Adverse Event
    Malfunction ·PHILLIPS RESPIRONICS - CHMV·Product code FLS·February 21, 2014

    SMART MONITOR 2 PS

    FDA Adverse Event
    Malfunction ·PHILIPS RESPIRONICS -CHMV·Product code NPF·August 26, 2014

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 14, 2025

    ELECTRODE, PACEMAKER, PERMANENT

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS, CO. VILLALBA·Product code DTB·April 16, 2013

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·March 17, 2011

    MODEL 91341, TELEMETRY TRANSMITTER 1400 MHZ

    FDA Adverse Event
    Malfunction ·SPACELABS HEALTHCARE·Product code DSI·June 13, 2008

    PASS LP - LIAPASS

    FDA Adverse Event
    Injury ·MEDICREA TECHNOLOGIES·Product code MNI·March 29, 2013

    SMARTMONITOR 2 PROFESSIONAL SERIES

    FDA Adverse Event
    Malfunction ·PHILIPS RESPIRONICS - CHMV·Product code FLS·August 23, 2013

    SMART MONITOR 2 PS

    FDA Adverse Event
    Malfunction ·PHILIPS RESPIRONICS - CHMV·Product code NPF·May 30, 2013

    SMART MONITOR 2 PS

    FDA Adverse Event
    Malfunction ·PHILIPS RESPIRONICS - CHMV·Product code NPF·September 4, 2013

    SMART MONITOR 2 PS

    FDA Adverse Event
    Malfunction ·PHILIPS RESPIRONICS - CHMV·Product code NPF·October 11, 2013

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 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