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

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    STERRAD 100NX TEST PACK

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MULTIPURPOSE NEUROPLUS ELECTRODE, MODEL A10005

    FDA 510(k)
    FDA Class 2 ·Neurology

    DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES, MODEL: POLYSULFONE 100 HFS, POLYSULFONE 130 HFS

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 26, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 23, 2026

    TOTAL ASR ACET IMP SIZE 50

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·April 22, 2013

    OPHTHALAS 532 EYELITE LASER SYS

    FDA Adverse Event
    Malfunction ·ALCON -IRVINE TECH CTR·Product code GEX·August 12, 2014

    UNKNOWN DEPUY 56MMX36 MOM LNR

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·April 15, 2011

    BIOLOX HEAD HIP IMPLANT

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code JDI·April 25, 2019

    UNKNOWN BIOLOX HEAD

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·February 13, 2018

    CERASUL, HEAD, M/0, TAPER 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code JDI·November 4, 2019

    Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 7, 2024

    Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-07153. 7 mm x 150 mm x 130 cm (stent diameter x stent length x delivery system length). Made in USA, Two Scimed Place, Maple Grove, MN 55311 USA. The Innova Self-Expanding Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy (Nitinol). On both the proximal and distal ends of the stent, radiopaque markers made of tantalum increase visibility of the stent to aid in placement. The stent is constrained within a 6F (2.1 mm maximum OD) delivery system. The delivery system is a triaxial design with an outer shaft to stabilize the stent delivery system, a middle shaft to protect and constrain the stent, and an inner shaft to provide a guidewire lumen. The delivery system is compatible with 0.035 in (0.89 mm) guidewires. When ready to be implanted, the stent is deployed by retracting the middle shaft of the delivery system. A radiopaque marker at the distal end of the delivery system aids in visibility during deployment. As the stent is exposed to body temperature, it expands to appose the vessel wall. The Innova Self-Expanding Stent is available in a variety of diameters and lengths. The delivery system is also offered in two working lengths (75 cm and 130 cm). The Innova Self-Expanding Stent System is indicated for the treatment of peripheral vascular lesions

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code NIP·May 19, 2011