BEUDAMED
    15 results · 24ms · Sources: EU EUDAMED, US FDA

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    SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER)

    FDA 510(k)
    FDA Class 2 ·Dental

    GentleYAG 6/8/10 Delivery System W/DCD

    FDA UDI
    Candela Corporation·00817495022307·Delivery System Assembly

    Spacelabs Healthcare

    FDA UDI
    SPACELABS HEALTHCARE (WASHINGTON), INC·10841522124822·4 ELECTRODE EVO RECORDER PACKED, POLISH

    EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SURGITRON IEC II

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 6, 2025

    ITREL 3

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 17, 2014

    SMALL BATTERY DRIVE

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWE·February 21, 2014

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·February 13, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·March 1, 2011

    ACCURUS 800CS

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·February 21, 2008

    TECNIS SIMPLICITY

    FDA Adverse Event
    Injury ·AMO PUERTO RICO MFG. INC.·Product code HQL·December 22, 2025

    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

    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

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024