BEUDAMED
    16 results · 21ms · Sources: EU EUDAMED, US FDA

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    COMFORTCARE SYSTEM

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    SeaSpine Spacer System - Pacifica™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981058852·Pacifica Trial, 9mm x 24mm x 13mm

    SeaSpine Spacer System - Pacifica™

    FDA UDI
    Seaspine Orthopedics Corporation·10889910058854·Pacifica Trial, 9mm x 24mm x 13mm

    MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM

    FDA 510(k)
    FDA Unclassified ·Unknown

    K7 LUMBAR SPACERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CONVERTBL I.V.DUAL CHANNEL HSP

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·December 20, 2011

    CONVERTBL I.V..DUAL C

    FDA Adverse Event
    Malfunction ·HOSPIRA LTD.·Product code FPA·August 13, 2009

    PRIMARY PLUMSET PP YSITE 272CM NDEHP

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·March 19, 2012

    TRIAGE PROFILER SOB PANEL

    FDA Adverse Event
    Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code MMI·June 27, 2019

    CONVERTBL I.V. DUAL C

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·October 15, 2009

    CONVERTBL I.V. DUAL CHANNEL HSP

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·July 7, 2011

    UNK

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·October 15, 2009

    OES CHOLEDOCHOFIBERSCOPE

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORP·Product code FBN·December 13, 2010

    UNKNOWN DEPUY CEMENT

    FDA Adverse Event
    Injury ·DEPUY CMW ¿ REG. # 9610921·Product code LOD·January 29, 2013

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·July 14, 2014

    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