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

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    AQUANOVA SUPER-ABSORBENT GELLING DRESSING, OTC

    FDA 510(k)
    FDA Unclassified ·Unknown

    Clear Readers

    FDA UDI
    Diversified Products, Inc.·00842894153277·

    BR Surgical, LLC

    FDA UDI
    BR Surgical, LLC·00857556008253·Sinus Scope, autoclavable, Ø 4mm, 70º, 175mm

    VERTE-STACK ANATOMIC PEEK STRUT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MQP·May 5, 2020

    MICROLIGHT 830 LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    HARDYDISK TICARILLIN 75MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    OMNIGUIDE BEAMPATH FIBER AND ADAPTER

    FDA Adverse Event
    OMNIGUIDE, INC.·Product code GEX·October 19, 2010

    SYRINGE 10ML SALINE FILL CHINA SP

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·February 9, 2026

    HEARTSTART ONSITE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 15, 2013

    COAGUCHEK S SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JPA·July 3, 2008

    PFC SIGMA C/S NPOR FE LT SZ2.5

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code JWH·April 25, 2011

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Zeiss brand IOLMaster 500, Model 500, 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

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for 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.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015