BEUDAMED
    14 results · 35ms · Sources: EU EUDAMED, US FDA

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    POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA @PH 5.5 AND PROTEIN LABELING CLAIMS

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DESIGN OPTICS

    FDA UDI
    FGX INTERNATIONAL INC.·00193033544785·

    OXYLOG 1000, MODEL 2M86840

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BARD LUMINEXX BILIARY STENT

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

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·November 19, 2015

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·November 19, 2015

    ITREL II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code MHY·January 19, 2012

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·December 15, 2016

    PRECISION®

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 20, 2013

    CATH-LAB SHEATH INTRO SE T:

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC·Product code DYB·February 4, 2011

    SILICONE ADVANCED OPTIC LENS

    FDA Adverse Event
    Injury ·BAUSCH & LOMB·Product code HQL·March 14, 2008

    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

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

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

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022