BEUDAMED
    13 results · 26ms · Sources: EU EUDAMED, US FDA

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    MINIX, MINIX ST, NEW IC: L74

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Mariner

    FDA UDI
    Seaspine Orthopedics Corporation·10889981163464·Mariner 6.0 Tray, Insert 1

    OmniTrustTM

    FDA UDI
    OMNI INTERNATIONAL CORP.·00810572006177·Gauze Pads, Sterile, 3x3, 12 Ply

    Mariner

    FDA UDI
    Seaspine Orthopedics Corporation·10889997163465·Mariner 6.0 Tray, Insert 1

    STAT PACS PICTURE ARCHIVING & COMMUNICATION SYSTEM (PACS)

    FDA 510(k)
    FDA Class 2 ·Radiology

    ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    INGEVITY+

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NVN·September 6, 2024

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·September 14, 2011

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 6, 2014

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·January 8, 2013

    AUTOMATED PD SET W/CASSETTE4 PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 18, 2010

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    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