BEUDAMED
    17 results · 19ms · Sources: EU EUDAMED, US FDA

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    DANNIK Disposable Monopolar Laparoscopic Instrument

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772344116·PROTECT.PRO ACTION BACK SUPPORT BLACK M

    10M - Southwest Gas Corp

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588010434·10M - Southwest Gas Corp

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694036573·HPS 2.0mm Screw & Plate Module II

    24M - Nevada Energy - Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588011639·24M - Nevada Energy - Metal

    GREAT TOE IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    KYPHX® HV-R¿ BONE CEMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SPINE LLC·Product code NDN·December 21, 2010

    2124215-2011-04011

    FDA Adverse Event
    Death ·GUIDANT PUERTO RICO BV·Product code LWS·March 7, 2011

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING·Product code HXX·August 11, 2011

    DESARA

    FDA Adverse Event
    CALDERA MEDICAL, INC.·Product code OTN·October 20, 2014

    UNKNOWN_INSTRUMENTS_PRODUCT

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·July 2, 2013

    V.A.C. DRESSING

    FDA Adverse Event
    Injury ·KCI USA INC.·Product code OMP·June 30, 2014

    Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue, Model No. STCB01, UPC N/A; 2) SOL-M Syringe Tip Cap, Red, Model No. STCB02, UPC N/A; 3) SOL-M Red Cap, Model No. 110101150020, UPC N/A 4) SOL-M Syringe Tip Cap Tray, Black, Model Number STCT01, UPC N/A

    FDA Enforcement
    Class II ·Ongoing·Sol-Millennium Medical Inc.·September 18, 2024

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

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

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

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