BEUDAMED
    20 results · 23ms · Sources: EU EUDAMED, US FDA

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    MASTER & FRANK SURGICAL GOWNS (STERILE)

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

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040019009·Zirlux 16+ 20x19x15 A1

    TEWA

    FDA UDI
    asia-med GmbH·04251282514419·TeWa PB-Type 1413: coated acupuncture needles ...

    Tempus Pro

    FDA UDI
    REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED·05060472441140·Tempus Pro - Printer Paper with 110mm grid

    INSET II

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 3, 2025

    INSET II

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 3, 2025

    INSET II

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 3, 2025

    INSET II

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 3, 2025

    WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VASCULAR ASSIST

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ENDOPATH ETS

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code KOG·November 7, 1997

    ULTRACISION SURG DEV, BLADES 5MM, OPEN

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.(CINCINNATI)·Product code LFL·June 15, 2006

    ULTRACISION SURG DEV, BLADES 5MM, OPEN

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code LFL·June 19, 2006

    INSET II

    FDA Adverse Event
    Malfunction ·UNOMEDICAL UM-D·Product code FPA·October 8, 2025

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 16, 2007

    LAMITRODE TRIPOLE 16

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 13, 2013

    CONSERVE PLUS

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL·Product code KWA·March 8, 2011

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

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

    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

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012