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

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    POWERHEART AED G3A

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Myo/Wire II

    FDA UDI
    A & E MEDICAL CORPORATION·10841291105459·SS Suture, 7 per sleeve

    Toilet Support Arms

    FDA UDI
    Ropox A/S·05707581006630·

    K-WIRE STRYKER 3.2MM X 450MM KIRSCHNER

    FDA Adverse Event
    Malfunction ·Product code LXH·November 2, 2021

    K-WIRE GAMMA Ø3,2X450 MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code LXH·April 22, 2022

    CONTOUR CURVED CUTTER STAPLER CS

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code GDW·June 13, 2006

    MAXITEX DUPLEX POWDER FREE LATEX STERILE SURGEON GLOVES PROTEIN LABELING CLAIM (50 MICRGRAMS OR LESS)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    MULTI LUMEN SUCTION SYRINGE SPRAY DISPENSER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD NEXIVA 24 GA X 3/4 IN SINGLE PORT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·May 30, 2024

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE AG·Product code LZG·April 8, 2013

    SELECT SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code NVN·April 5, 2011

    SHILEY FEN L-P-C

    FDA Adverse Event
    Injury ·COVIDIEN/FORMERLY TYCO·Product code BTO·May 7, 2008

    Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD Inc.·December 18, 2019

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024