BEUDAMED
    23 results · 21ms · Sources: EU EUDAMED, US FDA

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    PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)

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

    GIBSON HEALTHCARE

    FDA UDI
    BENCO DENTAL SUPPLY CO.·00366975012746·

    ceraMotion®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011251256200·ceraMotion® Ti Touch Up Dentin medium, 20 g / d...

    SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Arthrex BioSync® Bone Wedge

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GDC POWER SUPPLY

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - FREMONT·Product code HCG·July 20, 2010

    UNKNOWN PARIETEX PRODUCT

    FDA Adverse Event
    Injury ·COVIDIEN LP LLC NORTH HAVEN·Product code FTL·July 8, 2019

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 1, 2013

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·August 11, 2011

    32MM -4 LFIT V40 HEAD

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDI·November 14, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 29, 2013

    UNK SHOULDER GLENOID GLOBAL

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code HSD·July 25, 2022

    UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SàRL CH·Product code MNH·January 3, 2020

    UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SàRL CH·Product code MNH·January 6, 2020

    UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SàRL CH·Product code MNH·January 6, 2020

    COREVALVE TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 24, 2019

    Niobe ES System, Models 001-006000-1 and 001-006100-1

    FDA Enforcement
    Class II ·Terminated·Stereotaxis Inc·November 18, 2020

    Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: FlexViewing PC Azurion Model Name - Model Number: Azurion 7 B12 722067; Azurion 7 B20 722068; Azurion 7 M12 722078 722223; Azurion 7 M20 722079;

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

    Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used with affected systems. Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD10C 722001; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039; (Allura Centron - 722400 is impacted by this recall, but Allura Centron systems are not distributed in the United States.)

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

    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