BEUDAMED
    16 results · 19ms · Sources: EU EUDAMED, US FDA

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    BREAS VIVO 40 SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036027070·

    TiWAVE L Lumbar Cage System

    FDA UDI
    Kalitec Direct LLC·B07323K0101130·Distractor, Smooth Paddle, Lordotic, 13mm

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0101130·Distractor, Smooth Paddle, 13mm

    LASER MECHANISMS LASER SCANNING SYSTEM

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

    PROVEN KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VERSAFITCUP DM ACETABULAR SHELL Ø 50

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·October 24, 2015

    2.7 DEGREE ANGLED SAGITAL SAW

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·May 31, 2019

    UNKNOWN LINER

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·February 10, 2015

    DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·May 2, 2013

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FPA·September 15, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·May 16, 2011

    VERSAFITCUP DM LINER O 28/56

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL, SA·Product code MEH·April 30, 2015

    Manual trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Millennium Surgical, Symmetry Surgical, Medline Industries, CareFusion, Boss Instruments, and Surgical Direct brand names.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·December 17, 2014

    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·October 8, 2014

    Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024