BEUDAMED
    16 results · 20ms · Sources: EU EUDAMED, US FDA

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    SSD-633 PHASED ARRAY SECTOR/LINEAR ULTRASOUND SYS.

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Portable Nebulizer

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TYGON PAC-MONITORING LINES & FLUID ADMIN

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 12, 2014

    ARTICULEZE M HEAD 36MM +5

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code JDI·October 7, 2010

    ASR ACETABULAR CUPS 52

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·December 12, 2012

    COBAS LIAT SARS-COV-2 & INFLUENZA A/B

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QJR·September 24, 2021

    COBAS LIAT SARS-COV-2 & INFLUENZA A/B

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QJR·September 24, 2021

    COBAS LIAT SARS-COV-2 & INFLUENZA A/B

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QJR·September 24, 2021

    COBAS LIAT SARS-COV-2 & INFLUENZA A/B

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QJR·September 24, 2021

    COBAS LIAT SARS-COV-2 & INFLUENZA A/B

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QJR·September 24, 2021

    COBAS LIAT SARS-COV-2 & INFLUENZA A/B

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QJR·September 24, 2021

    SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX

    FDA Enforcement
    Class II ·Completed·Townsend Design·January 17, 2024

    SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037

    FDA Enforcement
    Class II ·Completed·Townsend Design·January 17, 2024

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    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