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

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    Pulse Oximeter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ophthalmic Spatulas

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114322·RUBENSTEIN CORNEAL ROLLER (BX/3)

    INTRAVASCULAR ADMINISTRATION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SAMARITAN AED, MODEL SAM-01

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 27, 2014

    ATTAIN STARFIX

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

    GYNECARE TVT OBTURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 3, 2013

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    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

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021