BEUDAMED
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    3Shape Implant Studio

    FDA 510(k)
    FDA Class 2 ·Radiology

    Corneal Trephine

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

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113233·VITRECTOMY KNIFE 19GA (BX/5)

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112496·BARRON VACUUM TREPHINE 7.5MM

    ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SURGICAL FACE MASK - COLORS: WHITE, YELLOW, PINK, BLUE, AND GREEN

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

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·December 20, 2023

    GREENLIGHT MOXY FIBER OPTIC

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS·Product code GEX·June 28, 2013

    7700

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

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·October 15, 2014

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·May 19, 2022

    MEDTRONIC NAVIGATION

    FDA Adverse Event
    Death ·MEDTRONIC NAVIGATION, INC·Product code HAW·May 30, 2023

    MEDTRONIC NAVIGATION

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 13, 2023

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAT·April 30, 2024

    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