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

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    EYE PADS CAT.#581-599

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

    VITROS

    FDA UDI
    ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750001811·VITROS Chemistry Products COCM Reagent

    ACUMED

    FDA UDI
    Acumed LLC·10806378089886·Acu-Loc® 2 CORE Custom VDR Platter

    STRYKER VISION ELECT WHDTV (STRYKER VE WHDTV)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEARTSINE SAMARITAN 300P AND PAD PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·February 12, 2014

    OT VERIO TEST STRIPS

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 23, 2012

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·August 16, 2010

    VITROS Chemistry Products COCM Reagent

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·January 29, 2014

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    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

    Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026