BEUDAMED
    13 results · 17ms · Sources: EU EUDAMED, US FDA

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    K 750 COMPUTER/DATA PROCESSOR

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Leica Biosystems

    FDA UDI
    Leica Biosystems Richmond, Inc.·10849832024849·Bio-Wraps, 5”x 3.5”, 500 Count

    NAR Kit

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209119165·KIT, HEADREST IFAK - BASIC - BLK

    ACUMED

    FDA UDI
    Acumed LLC·10806378046483·Ulnar Head Surface Reamer, 18 mm

    CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PRECISION 500D R&F X-RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·May 8, 2014

    SPINAL ANES/EPIDURAL CAT H KIT

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC·Product code CAZ·October 17, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 11, 2007

    EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Dako North America Inc.·November 11, 2015

    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

    paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024