BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

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    COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Premier Explorers

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·00348783006230·Explorer DE_PA TU 17/23

    RMO

    FDA UDI
    Rmo, Inc.·00885797100054·ORTHO IMPRESSION TRAY KIT ASST OF 10 , MX/MN TRAYS

    Alpha-Tec Systems

    FDA UDI
    Alpha-TEC Systems, Inc.·00816085021669·Kinyoun with Methylene Blue Stain Set

    MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Immunology

    LUMALITE CURE LIGHT, MODEL 2100

    FDA 510(k)
    FDA Class 2 ·Dental

    LUMA ARCH

    FDA Adverse Event
    Injury ·LUMALITE, INC.·Product code EEG·July 6, 2004

    GEL-FILL MAMMARY IMPLANT, 260 CC

    FDA Adverse Event
    MCGHAN MEDICAL CORP.·Product code FTR·October 3, 1994

    HEARTSTART MRX-EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 11, 2013

    HITH KIT

    FDA Adverse Event
    Injury ·INTEGRA PAIN MANAGEMENT·Product code HBF·February 22, 2011

    ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM

    FDA Adverse Event
    Injury ·CORDIS CORPORATION·Product code NTE·February 25, 2008

    smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: 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