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

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    LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    16PW - Cal OSHA

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588025971·16PW - Cal OSHA

    BISCEM GI

    FDA 510(k)
    FDA Class 2 ·Dental

    BLACK COLOURED CONDOM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code MDS·August 24, 2011

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·September 11, 2014

    AXIUM NYLON HELICAL DETACHABLE COIL

    FDA Adverse Event
    Malfunction ·EV3 NEUROVASCULAR·Product code HCG·July 18, 2013

    MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·February 25, 2026

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

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