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

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    Tablet Application

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

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113998·HYDRO-DISSECT CANNULA VERTICAL 27GA

    Oph. Cystotomes

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113691·CYSTOTOME FORMED 25GA

    LSI Silver Self Adhesive, Disposable Electrodes

    FDA UDI
    COMPASS HEALTH BRANDS CORP.·00850689007865·2" Round Foam

    CODMAN ISOCOOL BIPOLAR FORCEPS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CAPSUREFIX NOVUS

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

    DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM

    FDA Adverse Event
    Injury ·CARDIOVASCULAR SYSTEMS INCORPORATED·Product code MCW·October 27, 2014

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·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