BEUDAMED
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    ImPACT Version 4

    FDA 510(k)
    FDA Class 2 ·Neurology

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113554·IMPLANT BLADE 5.2MM (BX/5)

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113486·MINIATURE BLADE #65 (BX/5)

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113523·SLIT BLADE 3.0MM STR (BX/5)

    DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE02 AND L-CANE02A SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RE-TRACE URETERAL ACCESS SHEATH

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

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·December 3, 2020

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·October 8, 2008

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Injury ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·August 5, 2011

    PROMUS ELEMENT? PLUS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·July 2, 2013

    SIGMA HP UNI FEM FIN BLK SZ 5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code HWT·July 6, 2021

    SIGMA HP UNI ANTERIOR CHISEL

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code FZO·July 6, 2021

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code FOZ·March 2, 2021

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·January 7, 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