BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    NARKOMED AV2+ ANESTHESIA VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    THERIGRAFT TCP PUTTY BONE VOID FILLER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NMI Port, NMI Port II

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PROTECTA XT CRT-D

    FDA Adverse Event
    Malfunction ·IPG MFG SWITZERLAND·Product code NIK·February 9, 2013

    UNKNOWN HEAD

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LPH·July 23, 2014

    KIMVENT* MICROCUFF* ENDOTRACHEAL TUBE

    FDA Adverse Event
    Malfunction ·KIMBERLY-CLARK HEALTH CARE·Product code BTR·January 7, 2011

    Bone Void Filler, sterile orthopedic product, 510 (k) #K053228. The product is delivered in a syringe which is packaged in an aluminum-backed polyethylene pouch and is distributed one (1) pouch per box. The product affected by this recall was distributed by the recalling firm under six (6) different names. They are: Form-Putty; SBvFShape; Valeo BP; X-Putty; TheriGraft Putty; and SynFlow. The product is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and are intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The products are intended for use in defects of the skeletal system (i. e. the extremities, spine and pelvis).

    FDA Recall
    Terminated ·Theken Spine Llc·Product code NOX·August 26, 2010