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

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    RENAX A.V. FISTULA NEEDLE SETS

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

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00312391·

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00312341·

    ISOLA

    FDA UDI
    DEPUY SPINE, LLC·10705034006192·ISOLA SPINE SYSTEM CLOSED HOOK 6.35 x 9.5mm

    KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    NUVASIVE PERCUTANEOUS TRANSFACET/INTRAPEDICULAR SCREW

    FDA 510(k)
    FDA Unclassified ·Unknown

    VITROS IMMUNODIAGNOSTIC PRODUCTS NT-PROBNP II REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code NBC·February 9, 2026

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013

    ARCHITECT HAVAB IGM REAGENT

    FDA Adverse Event
    Malfunction ·ABBOTT·Product code LOL·February 28, 2011

    2250051-2008-00072

    FDA Adverse Event
    Malfunction ·Product code JTC·January 31, 2008

    MESH - COMPOSIX KUGEL

    FDA Adverse Event
    Injury ·DAVOL INC.·Product code FTL·June 14, 2011

    SYRINGE 10ML LS 21X1-1/2 AN EMERALD

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·June 23, 2020

    VITROS IMMUNODIAGNOSTIC PRODUCTS NT-PROBNP II REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code NBC·February 9, 2026

    VITROS IMMUNODIAGNOSTIC PRODUCTS NT-PROBNP II REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code NBC·February 9, 2026

    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

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    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