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

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    Siemens 3.0T PROCURE Array Coil

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD POSIFLUSH¿ NORMAL SALINE SYRINGES,

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·August 23, 2023

    NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PROFEMUR TL CLASSIC LONG NECK HIP STEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    WAVEWRITER ALPHA 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·February 28, 2025

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code FPA·June 3, 2013

    PLUM XLM W/DATAPORT

    FDA Adverse Event
    Malfunction ·HOSPIRA HOLDINGS DE COSTA RICA LTD.·Product code FRN·September 26, 2014

    HEARTSTART MRX-EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·June 21, 2011

    Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD

    FDA Enforcement
    Class II ·Ongoing·Ventana Medical Systems, Inc.·August 28, 2024

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code CBK·April 18, 2022

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare, LLC·June 15, 2022