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

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    Skylife

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MILLENNIUM

    FDA UDI
    Avalign Technologies, Inc.·00190776318789·House Cup Forceps

    Bernafon

    FDA UDI
    Bernafon AG·05711584063026·JU7 CIC, V2 BE JUNA 7

    Bausch + Lomb

    FDA UDI
    Bausch & Lomb Incorporated·00757770404087·FCP OVAL CUP HOUSE ANG 15 RT

    CARDINAL HEALTH

    FDA UDI
    Cardinal Health 200, LLC·10887488366081·BLOOD CULTURE KIT

    JEDMED

    FDA UDI
    JEDMED INSTRUMENT COMPANY·M633341705850·FORCEPS OVAL CUP HOUSE ANG 15 RIGHT

    MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCU-CHEK PERFORMA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 21, 2011

    KUGEL PATCH

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·June 5, 2013

    NONE

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROSURGERY·Product code JXG·September 16, 2008

    HEARTWARE VENTRICULAR ASSIST SYSTEM - SHOULDER PACK

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC.·Product code DSQ·August 17, 2021

    HEARTWARE VENTRICULAR ASSIST SYSTEM-SHOULDER PACK

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC.·Product code DSQ·January 11, 2019

    ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024