BEUDAMED
    18 results · 28ms · Sources: EU EUDAMED, US FDA

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    ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Key Surgical K-Wires and Steinmann Pins

    FDA UDI
    KEY SURGICAL, INC.·00849771012818·K-Wires, Double diamond, .054-inch (1.4mm) diam...

    RABEA 0°

    FDA UDI
    SIGNUS Medizintechnik GmbH·04047844000052·The basic shape of the NUBIC and RABEA devices ...

    NA

    FDA UDI
    KEY SURGICAL, INC.·10849771049439·K-Wires, Double diamond, .054-inch (1.4mm) diam...

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704293067·

    VIDASHIELD/UV24

    FDA UDI
    Medical Illumination International Inc.·00816835023813·Air Purifier with LED Strip

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111090530·MILLER ENG-STYLE STAND SIZE 2

    VIDASHIELD/UV24

    FDA UDI
    Medical Illumination International Inc.·00816835023820·Air Purifier with LED Strip

    OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CYCLONE ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ADVANTA BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·April 9, 2013

    ATTAIN OTW

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 27, 2011

    NONE

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 27, 2008

    ADVIA CENTAUR XP FOLATE (FOL) ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code CGN·January 9, 2014

    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

    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

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018