BEUDAMED
    14 results · 39ms · Sources: EU EUDAMED, US FDA

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    OPTIFLUX F250NR, MODEL 0500325E

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Malecot

    FDA UDI
    COOK INCORPORATED·00827002147928·Malecot Catheter

    PRIME ECG SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    WAVEWRITER ALPHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 28, 2024

    ST FRANCIS HSP TULSA OK 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DTZ·December 18, 2012

    COVEREDGE 32

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 2, 2024

    4.0MM HEXAGONAL SCREWDRIVER

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HXX·April 29, 2013

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NIQ·May 9, 2011

    GPS PROCEDURAL STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FPO·July 22, 2008

    ANGIODYNAMICS / SMART PORT

    FDA Adverse Event
    Malfunction ·ANGIODYNAMICS·Product code LJT·August 21, 2017

    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

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025