BEUDAMED
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    SYNTHECEL DURA REPLACEMENT DEVICES

    FDA 510(k)
    FDA Class 2 ·Neurology

    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·April 20, 2016

    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·April 20, 2016

    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·April 20, 2016

    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·April 20, 2016

    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·April 20, 2016

    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code GXQ·December 8, 2015

    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code GXQ·December 8, 2015

    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code GXQ·December 8, 2015

    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code GXQ·December 8, 2015

    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code GXQ·December 8, 2015

    Prosplints

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357130719·

    8960 MASK

    FDA UDI
    HANS RUDOLPH, INC.·00817136020709·8960 PED SM MASK W/MED 2630 2W

    CapSure® Spine System

    FDA UDI
    Spine Wave, Inc.·10840642104073·Rod Curved 5.5 x 70mm

    E.M Adams co, inc.

    FDA UDI
    E.M. ADAMS, INC.·18100013401043·VAGINAL DELIVERY TRAY

    E.M Adams co, inc.

    FDA UDI
    E.M. ADAMS, INC.·10840200301043·VAGINAL DELIVERY TRAY

    SECURCUT ASPIRATION BIOPSY NEEDLE

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

    COR ANALYZER

    FDA 510(k)
    FDA Class 2 ·Radiology

    CARDINAL HEALTH

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA MEDICAL CO., LTD.·Product code FMF·April 12, 2024

    CARDINAL HEALTH

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA MEDICAL CO., LTD.·Product code FMF·April 12, 2024