BEUDAMED
    12 results · 28ms · Sources: EU EUDAMED, US FDA

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    INFANT FEEDING TUBE

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

    PATIENT EXAMINATION GLOVES (LATEX)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    NIDEK AR-1200

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    QUALA DENTAL PRODUCTS

    FDA Adverse Event
    Malfunction ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAL·August 31, 2011

    ACE

    FDA Adverse Event
    Malfunction ·SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)·Product code GAL·August 30, 2010

    HU-FRIEDY PERMA SHARP SUTURES

    FDA Adverse Event
    Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAL·June 2, 2010

    VICTORY XL DR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·November 10, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 16, 2014

    MICRO DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·November 20, 2012

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

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

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015