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

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    MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964022621·The ENDO CARRY-ON Procedure Kit contains all of...

    Alpha-Tec Systems

    FDA UDI
    Alpha-TEC Systems, Inc.·00816085020075·CELL-BOND Slides, 2 wells [15mm], red background

    Alpha-Tec Systems

    FDA UDI
    Alpha-TEC Systems, Inc.·00816085020433·CELL-BOND Slides, 2 wells [15mm], red background

    OTW MEGALINK SDS BILLIARY STENT SYSTEM, MODELS 1005509-18, 1005510-18, 1005511-18, 1005512-18, 1005509-28, 1005510-28, 1

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    UM-L25

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

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 19, 2024

    BIO-CORKSCREW SUTURE ANCHOR

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code MAI·February 21, 2007

    USERS MANUALS

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·February 28, 2011

    H-TRONPLUS

    FDA Adverse Event
    Malfunction ·DISETRONIC MEDICAL SYSTEMS·Product code LZG·February 21, 2008

    smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    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

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: 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