BEUDAMED
    10 results · 29ms · Sources: EU EUDAMED, US FDA

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    PRO-DENSE BONE VOID FILLER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PEM-3 Probe Extend(MT2)

    FDA UDI
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06936415982539·

    StrykeFlow

    FDA UDI
    STRYKER CORPORATION·07613327051858·Reusable Suction Irrigation Tip, Aspiration Nee...

    INTERVENTIONAL BODY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO EBI XFIX DFS RAIL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STELLARIS 25GA POSTERIOR PACK W AFI & FF

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB, INC.·Product code HQC·April 17, 2013

    FOXCROSS PTA CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LIT·April 27, 2011

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·July 3, 2008

    Stryker Irrigator Reusable Tips: 5mm X 32cm Aspiration Needle Tip. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·May 15, 2013

    BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part Product Usage: The Mycobacteria Growth Indicator Tube supplemented with Bactec MGIT Growth Supplement and BBL MGIT PANTA antibiotic mixture is intended for the detection and recovery of mycobacteria using the BACTEC MGIT 960 and BACTEC MGIT 320 Systems. Acceptable specimen types are digested and decontaminated clinical specimens (except urine), and sterile body fluids (except blood).

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·October 30, 2013