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

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    FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756614566·Knee Immobilizer

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169631809·RASP 2143005 OLIF25 DOUBLE SIDED FLAT

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776128913·Device Tip Ellick Evac. wTubing

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694009096·5 Hole Straight Compression Plate

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707011637·CALIBRA 1ST MOL BANDS W/G8025-03 n.UL 5

    DDRVERSA MOTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO MBCP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BELLATEK® ABUTMENT TSV 3.5MM

    FDA Adverse Event
    Malfunction ·ZIMVIE US CORP LLC·Product code NHA·March 3, 2026

    BELLATEK ABUTMENT TSV 4.5MM

    FDA Adverse Event
    Malfunction ·ZIMMER DENTAL·Product code NHA·February 5, 2021

    ABUTMENT, PATIENT SPECIFIC, TITANIUM

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·June 26, 2017

    BELLATEK ABUTMENT TSV 4.5MM

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·October 30, 2020

    BELLATEK ABUTMENT TSV 4.5MM

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·October 30, 2020

    ACCENT DR RF

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CRMD·Product code DXY·January 13, 2014

    MONARC SLING SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code OTN·May 30, 2013

    RESTORE PRIME ADVANCED

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·June 23, 2011

    ZERO-P VA IMPLANT 8MM HEIGHT LORDOTIC-STERILE

    FDA Adverse Event
    Injury ·SYNTHES MEZZOVICO·Product code OVE·November 9, 2017

    Baxter Tamper Resistant Anti-Siphon Combination Set, 101'', product code 2L3507; An Rx sterile, nonpyrogenic fluid pathway, 101'', 2.5 mL Vol., with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FPA·August 3, 2005

    da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·April 15, 2015

    da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·April 15, 2015