BEUDAMED
    13 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Ultravision Visual Field Clearing System

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

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code NKB·July 21, 2017

    ESTELITE COLOR

    FDA 510(k)
    FDA Class 2 ·Dental

    AESCULAP RESORBABLE PIN, MODEL FR735

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    FDA Adverse Event
    Injury ·ELLIPSE TECHNOLOGIES, INC.·Product code PGN·June 23, 2014

    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    FDA Adverse Event
    Injury ·ELLIPSE TECHNOLOGIES, INC.·Product code PGN·May 25, 2014

    RAD-57 CONFIGURABLE PULSE CO-OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·June 24, 2019

    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    FDA Adverse Event
    Injury ·ELLIPSE TECHNOLOGIES, INC.·Product code PGN·May 21, 2014

    ATLAS + VR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 13, 2014

    MEGASUTURECUT NEEDLE DRIVER INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·June 14, 2013

    SYNVISC (HYLAN G-F 20) INJECTION

    FDA Adverse Event
    Other ·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·June 24, 2011

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019

    BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155, PAK5240, PAK5255, PAK5340, PAK5355, PAK5440, PAK5455, PAK6140, PAK6155, PAK6240, PAK6255, PAK6340, PAK6355, PAK6440, and PAK6455 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·January 13, 2016