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

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    Coronis Fusion 4MP LED

    FDA 510(k)
    FDA Class 2 ·Radiology

    AILERON INTERSPINOUS FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DISPOSABLE PROPHY ANGLE; DISPOSABLE PROPHY ANGLE

    FDA 510(k)
    FDA Class 1 ·Dental

    OT VERIO SYNC METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 8, 2016

    ANTHEM RF

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CRMD·Product code DXY·January 13, 2014

    PARIETEX COMP 30X20CM W THR X1

    FDA Adverse Event
    Malfunction ·SOFRADIM PRODUCTION·Product code FTL·May 24, 2013

    ECHELON*FLEX60 ARTICULATING

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 28, 2011

    PATIENT INFORMATION CENTER IX

    FDA Adverse Event
    Injury ·PHILIPS MEDICAL SYSTEMS·Product code MHX·December 4, 2023

    OT VERIO IQ METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 10, 2018

    PKG, FIXATION CLAMP 5MM WITH RATCHET, P/N 0250080130 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655 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