BEUDAMED
    17 results · 25ms · Sources: EU EUDAMED, US FDA

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    Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set

    FDA 510(k)
    FDA Class 2 ·Hematology

    NIPRO SAFE TOUCH HUBER INFUSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PANTHER GROUP OF SURGICAL INCLUDES: OANTHER CIRCULAR STAPLER; PANTHER HEMORRHOIDAL CIRCULAR STAPLER; PANTHER LINEAR STAP

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 17, 2024

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·April 8, 2016

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·April 8, 2016

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·July 31, 2017

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 29, 2017

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 29, 2017

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 12, 2019

    POLY GIA* 75-.060 STAPLER (ABSORBABLE)

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GDW·October 6, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·June 29, 2011

    ASR ACETABULAR CUPS 50

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·June 3, 2013

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·April 14, 2020

    SOLARICE RX

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO·Product code LOX·August 26, 2019

    LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC; DISC XS ULNA POR; DISC SEG ULNA POR; and Custom devices Item Nos. 114754 114755 114744 114745 114704 114705 114756 114757 114714 114715 114746 114747 114706 114707 114758 114759 114716 114717 114748 114749 114708 114709 114718 114719 CP561429 CP561430 CP561431 CP561432 CP561442 CP561449 CP561488 CP561489 CP561709 CP561710 CP561714 CP561715 PM555203 Product Usage: Total Elbow Replacement

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·October 13, 2021