BEUDAMED
    15 results · 26ms · Sources: EU EUDAMED, US FDA

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    GLOBUS GENESY 1100 STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111127281·F.O. MILLER ENG STYLE SZ0 4MM

    MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)

    FDA 510(k)
    FDA Class 2 ·Neurology

    RESIN CEM

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 26, 2025

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 22, 2013

    UNKNOWN DEPUY CEMENT

    FDA Adverse Event
    Injury ·DEPUY CMW·Product code LOD·April 13, 2011

    G-PROX ENDOSCOPIC GRASPER

    FDA Adverse Event
    Injury ·USGI MEDICAL·Product code GCJ·July 9, 2008

    HAART 200 AORTIC ANNULOPLASTY RING

    FDA Adverse Event
    Injury ·CORCYM INC.·Product code KRH·May 8, 2025

    HAART 200 AORTIC ANNULOPLASTY RING

    FDA Adverse Event
    Injury ·CORCYM INC.·Product code KRH·May 9, 2025

    QUADRA-H FEMORAL STEMS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·November 10, 2025

    DREAMSTATION AUTO CPAP

    FDA Adverse Event
    Injury ·RESPIRONICS, INC.·Product code BZD·November 24, 2021

    Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;

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

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

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