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

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    MEDI-STIM VERIQ SYSTEM, MODEL VQ1001 - VQ4122

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319700457·Nail Splitter 6" (15cm), straight jaws, extra n...

    Gladstone ALIF Trial Cage

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215044978·

    GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES

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

    ENTEC CONTROLLER, ENTEC PATIENT CABLE, FOOTSWITCH, POWERCORD, PLASMA WAND

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

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·September 17, 2013

    NDHP PPB 101 CLV BKC

    FDA Adverse Event
    Malfunction ·HOSPIRA LTD.·Product code FPA·April 3, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 5, 2011

    NOVOPEN3

    FDA Adverse Event
    Injury ·NOVO NORDISK A/S MEDICAL SYSTEMS·Product code FMF·May 8, 2008

    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD Inc.·December 18, 2019

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018