BEUDAMED
    7 results · 20ms · Sources: EU EUDAMED, US FDA

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    Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ACUSON S2000 AND S3000 DIAGNOSTIC ULTRASOUND SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Radiology

    CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNT·October 28, 2008

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·August 23, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021