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

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    PROFEEL ANATOM SURG GLOVES (POWDER FREE/HYPOALLER)

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

    Baby Gorilla/Gorilla Plating System

    FDA UDI
    Paragon 28, Inc.·00889795153258·K-wire, Single Ended Trocar Tip, SMOOTH, 2.5 x ...

    ANCA SLIDE

    FDA Adverse Event
    Injury ·INOVA DIAGNOSTICS, INC.·Product code MOB·July 13, 2000

    BIOMET CALCANEAL PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    C2-9-D ULTRASOUND TRANSDUCER

    FDA 510(k)
    FDA Class 2 ·Radiology

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·January 14, 2013

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·February 5, 2014

    CONCERTO CRT-D DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·December 13, 2010

    SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision B) Product Usage: Intended to be used as a visual aid during the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corp.·November 20, 2013

    PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    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