BEUDAMED
    13 results · 19ms · Sources: EU EUDAMED, US FDA

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    MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TSolution One w/ACG+ Surgical System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Evita (V800); Evita (V600)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    7MM TI MULTILOC HUMERAL NAIL RIGHT/CANN/225MM-STERILE

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·September 29, 2020

    APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code JDO·November 13, 2014

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·November 13, 2014

    REVEAL XT

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code DSI·February 9, 2013

    DEPUY CORAIL STEM SYSTEM

    FDA Adverse Event
    Injury ·DEPUY·Product code KWA·January 4, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 23, 2014

    VIDAS ESTRADIOL II

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code CHP·January 21, 2021

    VIDAS® ESTRADIOL II

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code CHP·September 16, 2021

    Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·July 10, 2024

    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