BEUDAMED
    13 results · 25ms · 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.

    NOVA 12 NA/K/C1/TOTAL CARBON DIOXIDE/GLUCOSE/UREA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TLX

    FDA UDI
    Nuvasive, Inc.·00887517730398·TLX Implant, 8x11x26mm 15°

    LinkSymphoKnee - Instruments

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575309757·Knee tibia prosthesis trial - LinkSymphoKnee Sy...

    LinkSymphoKnee - Instruments

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575309511·Knee tibia prosthesis trial - LinkSymphoKnee Sy...

    LinkSymphoKnee - Instruments

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575309658·Knee tibia prosthesis trial - LinkSymphoKnee Sy...

    LinkSymphoKnee - Instruments

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575309894·Knee tibia prosthesis trial - LinkSymphoKnee Sy...

    SCRAMBLER ST 5 TENS DEVICE

    FDA 510(k)
    FDA Class 2 ·Neurology

    PRODENSE Bone Graft Substitute

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MND·October 25, 2010

    ARTICULEZE M HEAD 36MM -2

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·December 20, 2012

    ACCU-CHEK ® SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LZG·June 18, 2014

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020

    Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013