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

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    SCIMED 0.014 PTCA GUIDE WIRE WITH ICE HYDROPHILIC COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MOBILEDIAGNOST WDR

    FDA 510(k)
    FDA Class 2 ·Radiology

    Cannulated PsiFGuard

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRULIANT TIB IMP PS INSERT SZ 5 11MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·June 2, 2023

    BP ADVANCED PERSONAL DOUBLE

    FDA Adverse Event
    Malfunction ·MEDELA INC.·Product code HGX·June 3, 2014

    ECHELON*FLEX60

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·February 4, 2013

    PUMP MMT-722LNAS PRDGM INS SK EN ML

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·December 22, 2010

    PKG, MARYLAND FORCEPS, CURVED LEFT, P/N 0250080282. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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