BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    Otowave 202 Portable Tympanometer

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

    Oticon

    FDA UDI
    Oticon A/S·05707131284990·H16V2, RITE 312 WL TC

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120540·Guidewire 1.6x150mm Dbl Trocar

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120557·Guidewire 1.6x150mm Sgl Trocar

    CHATTANOOGA

    FDA UDI
    DJO, LLC·00190446780335·G16 ULTRASOUND APPLICATOR 10 CM2 USA

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197540384·Caspar Rongeur downwards angled 3x12mm 1 60mm

    HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DEXCOM G6 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·December 1, 2018

    FREESTYLE LIBRE 3

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE LTD·Product code QBJ·May 21, 2026

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 23, 2015

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011

    PINNACLE PELVIC FLOOR REPAIR KITS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 6, 2013

    PHOENIX

    FDA Adverse Event
    Injury ·GAMBRO DASCO·Product code FII·September 4, 2008

    A7 ANESTHESIA SYSTEM

    FDA Adverse Event
    Malfunction ·SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.·Product code BSZ·February 15, 2017

    BIT, DRILL

    FDA Adverse Event
    Malfunction ·SYNTHES, USA·Product code HTW·October 14, 2016

    Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: XRay PC, Suite PC, and FlexViewing PC Azurion Model Name - Model Number: Azurion 3 M12 722063 722221; Azurion 3 M15 722064 722222; Azurion 5 M20 722228; Azurion 7 B12 722067 722225; Azurion 7 B20 722068 722226; Azurion 7 M12 722078 722223; Azurion 7 M20 722079 722224;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024