BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    DERMATEC ZONE TRANSPARENT DRESSING

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    EasyTouch Safety Pen Needle

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PROMOS MODULAR SHOULDER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 10, 2014

    ENDOTAK ENDURANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·October 11, 2010

    PROXIMATE** RELOADABLE LINEAR STAPLER - 30 MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·December 10, 2012

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·October 6, 2017

    TPRLC XR MP T1 PPS 14X113MM 113MM T1

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LPH·February 18, 2020

    TPRLC 133 T1 PPS HO 12X144MM 4MM T1

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code OQG·February 18, 2020

    TPRLC 133 T1 PPS SO 13X146MMTP

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·February 18, 2020

    TPRLC 133 MP TYPE1 PPS HO 15.0

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·February 18, 2020

    TPRLC 133 MP TYPE1 PPS SO 17.0 1

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·February 18, 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