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

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    SONICEYE ULTRASOUND TRANSDUCER

    FDA 510(k)
    FDA Class 2 ·Radiology

    5570 3L SYRINGE

    FDA UDI
    HANS RUDOLPH, INC.·00817136021881·5570 3L SYR HRI VITALOGRAF-OUT

    CapSure® Spine System

    FDA UDI
    Spine Wave, Inc.·10840642105308·PS3 Screw 8.5mm x 30mm

    PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID

    FDA 510(k)
    FDA Class 2 ·Dental

    PHOENIX HEMODIALYSIS DELIVERY SYSTEM

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 14, 2024

    PROLIFT PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON, INC·Product code OTP·May 15, 2013

    PLUM XLD 110V L.A.

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·September 17, 2014

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·May 17, 2011

    SYRINGE 0.3ML 30GA 8MM

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·July 23, 2019

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

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

    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