BEUDAMED
    15 results · 25ms · Sources: EU EUDAMED, US FDA

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    MICROMEDIC NEONATAL T4 KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228710081·GC Initial™ LF Powder Opaque OB3, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556705930·GC Initial™ LF Powder Opaque OB3, 20g

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690190028·Tibial Tray Screw Drill Guide

    HP Extraction Standard Removal Case

    FDA UDI
    SYMMETRY MEDICAL INC.·00847538008654·HP Extraction Standard Removal Case

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867303584·Low Profile Screw, 1.0x8mm, Cortical, Ti

    N.A.

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011871008000·Standard Band, Tooth 47-46/36-37, Size 8

    REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Anorganic Bone Mineral with Collagen in Delivery Applicator

    FDA 510(k)
    FDA Class 2 ·Dental

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 13, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·December 12, 2012

    OCTRODE 3/4 PERCUTANEOUS LEADS

    FDA Adverse Event
    Injury ·ADVANCED NEUROMODULATION SYSTEMS·Product code LGW·October 8, 2010

    SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX

    FDA Enforcement
    Class II ·Completed·Townsend Design·January 17, 2024

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    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