BEUDAMED
    11 results · 33ms · Sources: EU EUDAMED, US FDA

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    OMNIDIRECTIONAL POWERED WHEEL CHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SOLE MEDIAL COLUMN FUSION PLATE

    FDA UDI
    ORTHOFIX SRL·18053340347945·SS VA LOCKING SCREW L42MM D5MM

    SOLE MEDIAL COLUMN FUSION PLATE

    FDA UDI
    ORTHOFIX SRL·18053340346825·SS VA LOCKING SCREW L42MM D5MM STERILE

    NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS )

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CT-C3000DUAL AND CT-C2800DUAL FAMILY OF DUAL-SLICE CT SCANNER SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Radiology

    RUBY COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·May 30, 2014

    LPS TIB HINGE INSERT MED 31MM

    FDA Adverse Event
    Injury ·DEPUY RAYNHAM·Product code KRO·November 21, 2012

    NEXGEN LPS-MOBILE ARTICULAR SURFACE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code LXH·September 14, 2010

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024