BEUDAMED
    21 results · 22ms · Sources: EU EUDAMED, US FDA

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    GE LIGHTSPEED XTRA CT SCANNER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0600120·Tray Insert 5, Cosmolock Deformity

    MATIRA ANTERIOR CERVICAL SYSTEM

    FDA UDI
    Kalitec Direct LLC·B07307K0600020·Tray Insert, Level 2

    Persona® PPS®

    FDA UDI
    Zimmer, Inc.·00889024631441·

    Persona® PPS®

    FDA UDI
    Zimmer, Inc.·00889024631434·

    X-RAY MONOBLOCK, MONOBLOCK XRS-60-330

    FDA 510(k)
    FDA Class 1 ·Radiology

    RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    S5 CONTROL DISPLAY MODULE

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·August 8, 2012

    S5 DOUBLE HEAD PUMP

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·September 14, 2012

    S5 DOUBLE HEAD PUMP

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·September 14, 2012

    S5 DOUBLE HEAD PUMP

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·August 29, 2012

    S5 CONTROL DISPLAY MODULE

    FDA Adverse Event
    Malfunction ·SORIN GROUP DEUTSCHLAND·Product code DTQ·May 16, 2012

    S5 CONTROL PANEL

    FDA Adverse Event
    Malfunction ·SORIN GROUP DEUTSCHLAND·Product code DTQ·May 15, 2012

    S5 CONTROL DISPLAY MODULE

    FDA Adverse Event
    Malfunction ·SORIN GROUP DEUTSCHLAND·Product code DTQ·May 16, 2012

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)·Product code MCX·April 16, 2013

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·April 15, 2011

    COAGUCHEK XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·June 12, 2008

    Applied Medical's Inzii¿ 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·November 20, 2013

    Applied Medical's Inzii 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.

    FDA Recall
    Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·October 21, 2013

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012