BEUDAMED
    14 results · 24ms · Sources: EU EUDAMED, US FDA

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    DYNAGRAFT II

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Premier

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·D6911040419·CUBE PESSARY W/O DRAINAGE HOLES #9

    Myo/Wire II

    FDA UDI
    A & E MEDICAL CORPORATION·10841291102274·SS Suture, 1 per sleeve

    AQUESURE FILTER HUMIDIFIER

    FDA UDI
    BOMImed Inc·10629160012608·Breathing circuit filter with built-in humidifi...

    MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    V SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    1ST RESPONSE ADULT MANUAL RESUSCITATOR

    FDA Adverse Event
    Malfunction ·GALEMED CORPORATION, MANUFACTURED FOR SMITHS MEDICAL ASD, INC.·Product code BTM·April 2, 2009

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code HET·April 8, 2013

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2

    FDA Adverse Event
    Malfunction ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·May 7, 2008

    STERLING ES PTA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·April 5, 2011

    PKG, GRASPER FORCEPS, SERRSTED FENESTRATED, P/N 0250080318. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17/30 10 pcs; AC TenderLink I 17/60 10 pcs; AC TenderLink I 17/80 10 pcs; AC TenderLink I 13/110 10 pcs The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Enforcement
    Class II ·Terminated·Unomedical As·November 9, 2016

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; 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