BEUDAMED
    11 results · 35ms · Sources: EU EUDAMED, US FDA

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    HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.T

    FDA 510(k)
    FDA Class 2 ·Immunology

    RESTORE-PF VIC; RESTORE-PF VLC CAPSULE

    FDA 510(k)
    FDA Class 2 ·Dental

    MICROSTIM 100I TENS DEVICE

    FDA 510(k)
    FDA Class 2 ·Neurology

    PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTP·September 24, 2018

    GII ARTICULAR INSERTER/EXTRACT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code MBH·February 9, 2018

    PELVISOFT ACELLULAR COLLAGEN BIOMESH

    FDA Adverse Event
    Injury ·TISSUE SCIENCE LABORATORIES·Product code FTM·March 12, 2013

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE CANADA LTD.·Product code JJE·March 4, 2011

    KIWI COMPLETE VACUUM DELIVERY SYSTEM

    FDA Adverse Event
    Death ·CLINICAL INNOVATIONS·Product code HDB·March 10, 2008

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code FMI·November 28, 2023

    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

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019