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

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    STERILE DISSECTOR SPONGES-X-RAY DETECT

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

    A-FIT®

    FDA UDI
    Gc Orthodontics America Inc.·E53581270700001·A-FIT® 2. MOLAR UPR LFT SZ 07

    GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    ESTENIA

    FDA 510(k)
    FDA Class 2 ·Dental

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES·Product code LZG·May 5, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 31, 2012

    SOFT CONE SPLASH SHIELD

    FDA Adverse Event
    Injury ·STRYKER INSTRUMENTS PUERTO RICO·Product code FQH·August 11, 2010

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·July 31, 2023

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·April 12, 2023

    MINIMED 720G OUS BLE CONNECT 3.0 MGDL

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 29, 2024

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·June 14, 2023

    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