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

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    DC ULNAR SHORTENING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    3M COMPLY 1248 GAS PLASMA CHEMICAL INDICATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    OSTAPEK VBR CAGE

    FDA Adverse Event
    Injury ·COLIGNE AG·Product code MQP·September 19, 2019

    BURR, STRAIGHT 12 MM, DIA. 2.2 MM

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code LXH·January 3, 2025

    STAPLE, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·April 23, 2013

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·September 9, 2014

    ZEPHYR XL DR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·July 11, 2008

    GIANTURCO-ROEHM BIRD'S NEST JUGULAR VENA CAVA FILTER

    FDA Adverse Event
    Injury ·COOK INC·Product code DTK·March 25, 2016

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK INC·Product code DTK·March 23, 2018

    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

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012