BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Polysorb

    FDA UDI
    Covidien LP·20884521126821·Absorbable Single Stitch Reload

    STAINLESS STEEL TIBIAL NAILING SYSTEM

    FDA UDI
    ORTHOFIX SRL·18053504365112·Component. Not for sale. Used for reporting Dir...

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707018254·CALIBRA 1ST MOL BANDS LOWER KIT LL

    TRILOGY RADIOTHERAPY DELIVERY SYSTEM AND TRILOGY TX DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    CARESTREAM IMAGE SUITE

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 2, 2025

    SENSOR ENLITE MMT-7008A

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OZO·October 14, 2014

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 14, 2013

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·October 23, 2015

    GALAXY G3 3MM X 8CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·August 13, 2020

    HipLOC Hip Fracture Fixation System-Hiploc System 140¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-140-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures

    FDA Enforcement
    Class II ·Terminated·Biomet UK Ltd.·October 3, 2018

    Jackson-Pratt Silicone Flat Drain, 10mm, Full Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·May 31, 2017