BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03

    FDA 510(k)
    FDA Class 1 ·Microbiology

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065692·INTRAORAL ELASTICS 4,5 oz 3/16" green

    CLEARFIL ST OPAQUER

    FDA 510(k)
    FDA Class 2 ·Dental

    KSEA MINIATURE NEUROENDOSCOPE

    FDA 510(k)
    FDA Class 2 ·Neurology

    PENTA SURGICAL LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL- NEUROMODULATION·Product code LGW·May 10, 2011

    RESTORE SENSOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 3, 2013

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 5, 2008

    INNOVA 3100-IQ

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS SCS·Product code OWB·May 30, 2017

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 25, 2025

    ACMI REF E-5F Electrohydraulic Lithotripsy Probe, 5FR x 60CM

    FDA Recall
    Terminated ·ACMI CORPORATION·Product code FFK·April 30, 2004

    SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 28, 2026

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012