BEUDAMED
    20 results · 26ms · Sources: EU EUDAMED, US FDA

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    Nanova Flowable Composite

    FDA 510(k)
    FDA Class 2 ·Dental

    HNM Women Care

    FDA UDI
    HNM STAINLESS, LLC.·00812171028048·PESSARY, DISH #2, W/SUPPORT, 60mm

    AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    FDA Adverse Event
    Malfunction ·ORGENICS LTD·Product code MZF·December 7, 2015

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    FDA Adverse Event
    Malfunction ·ORGENICS LTD·Product code MZF·December 7, 2015

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    FDA Adverse Event
    Malfunction ·ORGENICS LTD·Product code MZF·December 7, 2015

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 12, 2025

    ADULT NASAL INTERFACE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code CAT·January 28, 2016

    PENUMBRA SYSTEM MAX ASPIRATION TUBING

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·June 24, 2015

    F/G WINGSPAN STENT SYSTEM 3.5 X 9MM

    FDA Adverse Event
    Injury ·STRYKER NEUROVASCULAR-CALIF·Product code NJE·June 6, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·November 3, 2015

    VENTED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·December 20, 2015

    5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 75MM

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KTT·November 21, 2018

    5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 75MM

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KTT·June 25, 2018

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·January 5, 2016

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024