BEUDAMED
    147 results · 55ms · Sources: EU EUDAMED, US FDA

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    BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BLACKSTONE MEDICAL, INC. LAPAROSCOPIC DISC REMOVAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BLACKSTONE MEDICAL INC. ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ICON MODULAR FIXATION SYSTEM

    FDA Adverse Event
    Malfunction ·BLACKSTONE MEDICAL, INC.·Product code KWQ·September 11, 2007

    ICON MODULAR FIXATION SYSTEM

    FDA Adverse Event
    Malfunction ·BLACKSTONE MEDICAL, INC.·Product code KWQ·September 11, 2007

    SPINAL FIXATION SYSTEM, ICON MODULAR FIXATION

    FDA Adverse Event
    Injury ·BLACKSTONE MEDICAL, INC.·Product code KWQ·March 19, 2007

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·August 19, 2014

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·August 19, 2014

    Blackstone Medical Inc./ Orthofix Spinal Implants, Hallmark Anterior Cervical Plate System; Plate Bender Part number 62-0070. Non Sterile.

    FDA Recall
    Terminated ·Blackstone Medical, Inc.·Product code KWQ·March 15, 2010

    BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Bone Screw, Self Tapping, Cannulated. BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Multi-Axial Screw, Self Tapping, Cannulated. The Multi-Axial Screw is a pedicle screw which is inserted into the pedicle with the use of the Multi-Axial Screw Driver. The component is used within the Firebird Spinal Fixation System. The screw is cannulated and available modular (77-7630, pre-assembled with screw head) or non-modular (77-8630, without screw head). Product Code: NKB-Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease. Class II. Intended for use when implanted over a guide wire for additional accuracy with reference to the pedicle.

    FDA Recall
    Terminated ·Orthofix Inc·Product code NKB·October 22, 2010

    BLACKSTONE 14MM PRIMARY BONE SCREW

    FDA Adverse Event
    Malfunction ·BLACKSTONE MEDICAL, INC.·Product code KWQ·March 25, 2002

    BLACKSTONE ANTERIOR CERVICAL PLATE

    FDA Adverse Event
    Malfunction ·BLACKSTONE MEDICAL, INC.·Product code KWQ·August 22, 2000

    BLACKSTONE ANTERIOR CERVICAL PLATE

    FDA Adverse Event
    Malfunction ·BLACKSTONE MEDICAL, INC.·Product code KWQ·August 24, 2000

    BLACKSTONE MEDICAL PRIMARY SCREW

    FDA Adverse Event
    Malfunction ·BLACKSTONE MEDICAL, INC.·Product code KWQ·August 7, 2000

    BLACKSTONE TOP LOCKING PLATE

    FDA Adverse Event
    Malfunction ·BLACKSTONE MEDICAL, INC.·Product code KWQ·September 14, 2000

    BLACKSTONE 12MM PRIMARY SCREWS

    FDA Adverse Event
    Malfunction ·BLACKSTONE MEDICAL, INC.·Product code KWQ·July 18, 2000

    BLACKSTONE PRIMARY SCREW

    FDA Adverse Event
    Malfunction ·BLACKSTONE MEDICAL, INC.·Product code KWQ·August 3, 2000

    BLACKSTONE 16MM BONE SCREW

    FDA Adverse Event
    Malfunction ·BLACKSTONE MEDICAL, INC.·Product code KWQ·September 21, 2000

    BLACKSTONE 16MM BONE SCREW

    FDA Adverse Event
    Malfunction ·BLACKSTONE MEDICAL, INC.·Product code KWQ·September 21, 2000

    BLACKSTONE 12 PRIMARY SCREW

    FDA Adverse Event
    Malfunction ·BLACKSTONE MEDICAL, INC.·Product code KWQ·August 7, 2000