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

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    BigEasy Non-Rebreathing Valve

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694026567·MFx Angulated Locking Fracture Plate, 4 Hole, 34mm

    SacroFuse

    FDA UDI
    SPINEFRONTIER, INC.·00190361023470·Ø12MM SLOTTED FUSION SCREW, GEN II, SACROFUSE, ...

    SacroFuse

    FDA UDI
    SPINEFRONTIER, INC.·00190361023517·Ø12MM SLOTTED FUSION SCREW, GEN II, SACROFUSE, ...

    SacroFuse

    FDA UDI
    SPINEFRONTIER, INC.·00190361023500·Ø12MM SLOTTED FUSION SCREW, GEN II, SACROFUSE, ...

    SacroFuse

    FDA UDI
    SPINEFRONTIER, INC.·00190361023531·Ø12MM SLOTTED FUSION SCREW, GEN II, SACROFUSE, ...

    SacroFuse

    FDA UDI
    SPINEFRONTIER, INC.·00190361023524·Ø12MM SLOTTED FUSION SCREW, GEN II, SACROFUSE, ...

    SacroFuse

    FDA UDI
    SPINEFRONTIER, INC.·00190361023487·Ø12MM SLOTTED FUSION SCREW, GEN II, SACROFUSE, ...

    SacroFuse

    FDA UDI
    SPINEFRONTIER, INC.·00190361023494·Ø12MM SLOTTED FUSION SCREW, GEN II, SACROFUSE, ...

    SacroFuse

    FDA UDI
    SPINEFRONTIER, INC.·00190361023463·Ø12MM SLOTTED FUSION SCREW, GEN II, SACROFUSE, ...

    SacroFuse

    FDA UDI
    SPINEFRONTIER, INC.·00190361023548·Ø12MM SLOTTED FUSION SCREW, GEN II, SACROFUSE, ...

    MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UNKNOWN COOLSCULPTING SYSTEM

    FDA Adverse Event
    Injury ·ALLERGAN PLEASANTON·Product code OOK·January 10, 2024

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code LZG·October 5, 2014

    PELVICOL ACELLULAR COLLAGEN MATRIX

    FDA Adverse Event
    Injury ·TISSUE SCIENCE LABORATORIES·Product code FTL·May 2, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·June 21, 2011

    CONNECTOR C35-O

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code ONB·September 16, 2024

    BD SAFETY-LOK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·September 30, 2024

    SOLUS Anterior Lumbar Interbody Fusion Spinal Spacer System, Solus Proximal/Distal Deployment Wrenches, 510(k) K102402. The Alphatec Solus Anterior Lumbar Interbody Fusion (AUF) System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DOD) at one or two contiguous levels from L2-S1 with up to Grade 1 spondyiolisthesis or retrolisthesis at the involved level(s). DOD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Alphatec Solus implant is intended to be used with autograft. The device is intended for use with supplemental fixation that is in addition to the integrated blades. The Alphatec Solus implant is intended for use with supplemental spinal fixation. Specifically, the Alphatec Solus implant is to be used with the Alphatec's Zodiac Spinal Fixation System, Aspida" Anterior Lumbar Plating System, or the ILLlCO MIS Posterior Fixation System. Intervertebral body fusion device.

    FDA Recall
    Terminated ·Alphatec Spine, Inc.·Product code MAX·March 19, 2012