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

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    AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER*

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756356770·VALVE PACK

    UCR

    FDA UDI
    Seaspine Orthopedics Corporation·10889981080051·Solid Tap, 6.75mm

    ADVIA CENTAUR VITAMIN D TOTAL ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PALAMED BONE CEMENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    *

    FDA Adverse Event
    Malfunction ·MEDTRONIC POWERED SURGICAL SOLUTIONS·Product code HBF·November 12, 2010

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC·Product code DSQ·July 2, 2014

    BATTERY 14.8V, 6.3 AH LI-ION BATTERY

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·December 3, 2012

    Hospira Acclaim Encore Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers.

    FDA Recall
    Terminated ·Hospira Inc.·Product code FRN·October 31, 2013

    Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers.

    FDA Recall
    Terminated ·Hospira Inc.·Product code FRN·October 31, 2013

    5.0MM TI SCHANZ SCREW BLUNTED TROCAR POINT 200MM

    FDA Adverse Event
    Injury ·SYNTHES RARON·Product code HWC·December 29, 2016

    5.0MM TI SCHANZ SCREW BLUNTED TROCAR POINT 150MM

    FDA Adverse Event
    Injury ·SYNTHES RARON·Product code HWC·December 29, 2016

    5.0MM TI SCHANZ SCREW BLUNTED TROCAR POINT 200MM

    FDA Adverse Event
    Injury ·SYNTHES RARON·Product code HWC·December 29, 2016

    5.0MM TI SCHANZ SCREW BLUNTED TROCAR POINT 150MM

    FDA Adverse Event
    Injury ·SYNTHES RARON·Product code HWC·December 29, 2016

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021