BEUDAMED
    21 results · 24ms · Sources: EU EUDAMED, US FDA

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    DISPOSABLE O.R. TOWEL

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·34546540244384·BONE SCREWS, CROSS-FIT, SELF-TAPPING

    Malibu

    FDA UDI
    Seaspine Orthopedics Corporation·10889981080570·Polyaxial Screw Driver

    STERILE LUBRICATING JELLY

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DRI ECSTASY ENZYME IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    POLYAXIAL SCREW DRIVER

    FDA Adverse Event
    Malfunction ·SEASPINE, INC.·Product code HXX·October 25, 2013

    POLYAXIAL SCREW DRIVER

    FDA Adverse Event
    Malfunction ·SEASPINE, INC.·Product code HXX·January 18, 2014

    POLYAXIAL SCREW DRIVER

    FDA Adverse Event
    Malfunction ·SEASPINE, INC.·Product code HXX·October 25, 2013

    PREMIER ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWQ·August 12, 2011

    PREMIER® ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·March 3, 2017

    PREMIER® ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 3, 2017

    PREMIER® ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 7, 2015

    HEMOPRO2 EXTENSION CABLE

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC.·Product code GEI·May 13, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS·Product code JAA·July 10, 2015

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·January 11, 2013

    Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110. 510(k): 91-2109 K061342. 91-2110 K051942. The Malibu" System is intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. The System is comprised of single use pedicle screws of varying reduction height, rods, rod connectors, etc. and an accompanying set of reusable surgical instruments. Some of the surgical instruments are specific to the system and others are general surgical instruments. The polyaxial screwdriver is specific to the polyaxial screws in the system.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code NKB·January 22, 2014

    Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110. 510(k): 91-2109 K061342. 91-2110 K051942. The Malibu" System is intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. The System is comprised of single use pedicle screws of varying reduction height, rods, rod connectors, etc. and an accompanying set of reusable surgical instruments. Some of the surgical instruments are specific to the system and others are general surgical instruments. The polyaxial screwdriver is specific to the polyaxial screws in the system.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·February 19, 2014

    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI 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

    PM 1260 ASSURITY + 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

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025