BEUDAMED
    14 results · 23ms · Sources: EU EUDAMED, US FDA

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    CARRIAZO BARRAQUER SINGLE USE MICROKERATOME

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    Leksell Stereotactic System

    FDA UDI
    Elekta Instrument AB·07340048300865·CT INDICATOR RIGHT SIDE PLATE KIT

    KALORE™

    FDA UDI
    Gc America Inc.·14548161293280·KALORE™ Syringes (2 mL/4 g) CT

    KALORE™

    FDA UDI
    Gc America Inc.·D0470035941·KALORE™ Syringes (2 mL/4 g) CT

    GRANUFLO

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·March 25, 2014

    3.5 MM LAPAROSCOPE (LG100, LG103)

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

    LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE

    FDA 510(k)
    FDA Class 2 ·Dental

    INSET GUARD

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·March 30, 2026

    CENTRA BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·February 11, 2013

    JUVEDERM ULTRA XC (2 X 0.4 ML)

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LMH·February 22, 2011

    SILICONE ADVANCED OPTIC-VIOLET SHIELD

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB·Product code HQL·February 20, 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

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; 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