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

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    TrueRelief Device

    FDA 510(k)
    FDA Class 2 ·Neurology

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112755·BARRON VACUUM PUNCH 7.5MM

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112915·CORNEAL TREPHINE BLADE7.5MM

    Tissue Holder

    FDA UDI
    KATENA PRODUCTS, INC.·00841668111192·STEEL BASE FOR BARRON AAC

    SCLERAL PLUGS, 19 AND 20 GAUGE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    VASCULAR ASSIST

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    KIT CONTAINING CC1.P1 AND THE IP2 INTRODUCER

    FDA Adverse Event
    Malfunction ·INTEGRA NEUROSCICENCS IMPLANTS SA·Product code GWM·June 22, 2018

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MRU·November 8, 2021

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 5, 2011

    RESTORE ADVANCED RECHARGEABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·October 16, 2008

    UNIVERSAL ASEPTIC TRANSFER KIT HOUSING

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL S.A·Product code GCJ·June 28, 2013

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NGV·July 9, 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