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

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    Bridge Occlusion Balloon

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Needle aspiration and injection

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113646·RETROBULBAR NEEDLE 23GA 38MM

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114216·LASIK CANNULA FLATTENED 23GA

    NorthStar

    FDA UDI
    Seaspine Orthopedics Corporation·10889981197490·Smooth Shank Poly. Screw, 3.5mm x 40mm

    (DISPOSABLE) VAGINAL SPECULUM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09

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

    Gibralt

    FDA UDI
    Choice Spine, LP·10885862247582·

    Gibralt®

    FDA UDI
    INNO Holdings, Inc.·M711050002035400·Posterior Cervical Screw Assembly, 3.5mm X 40mm...

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

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

    AT500

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code DXY·August 11, 2011

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·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