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

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    MA600-IMPEDANCE AUDIOMETER

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ACCU-CHEK COMPACT TEST STRIP

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MMI/GAELTEC CATHETER TIP PRESSURE

    FDA 510(k)
    FDA Class 2 ·Neurology

    The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A paramagnetic particle, chemiluminscent immunoassay. Product Usage: The assay is a paramagnetic particle, chemiluminescent immunoassay for the quanitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·October 9, 2019

    8CM ANGLE ATTACHMENT, BLACK, MAX

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 9, 2014

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·October 29, 2020

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·October 29, 2020

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 27, 2014

    MAYFIELD MODIFIED SKULL CLAMP

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES CORPORATION OH/USA·Product code HBL·November 9, 2012

    MEDFUSION 3500 SYRINGE INFUSION PUMP

    FDA Adverse Event
    Death ·SMITHS MEDICAL MD·Product code FRN·September 7, 2010

    XMAX MOTOR

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code ERL·March 31, 2015

    The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A paramagnetic particle, chemiluminscent immunoassay. Product Usage: The assay is a paramagnetic particle, chemiluminescent immunoassay for the quanitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CGR·September 18, 2018

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025