BEUDAMED
    11 results · 17ms · Sources: EU EUDAMED, US FDA

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    ACROMED AWL/PUNCH, DEPTH GAUGE

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074461540·INSTRUMENT 8880045 ROD GRIPPER 5.5MM

    Snowden-Pencer

    FDA UDI
    CAREFUSION 2200, INC·10885403140891·BROWN-ADSON FORCEPS MULTIPLE TEETH WORKING LENG...

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867385399·Drill / Depth Guide, 2.4mm

    Dna-Probe, Human Chromosome

    FDA Pre-Market Approval
    FDA Unclassified ·OSI TRANSPROBE-1

    ELECTRODE CAP

    FDA 510(k)
    FDA Class 2 ·Neurology

    Omnipod DASH Insulin Management System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    STENOSCOPE

    FDA Adverse Event
    Malfunction ·GE MED. SYSTEMS (INDIA) PRIVATE, LTD. (GE PRIVATE)·Product code JAA·October 13, 2010

    CURRENT RF VR

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

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·December 19, 2012

    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