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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    EVANS SUB-Q, MODEL MC4206

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Channels

    FDA UDI
    HENRY SCHEIN, INC.·10304040160579·Channels Flex 21mm 20.06

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·10843717106996·Gutta Percha Points, Taper .02, Size #15, 120pc...

    FloShield/Plus

    FDA UDI
    MINIMALLY INVASIVE DEVICES, INC.·00815128020355·The FloShield/Plus System is a single-use, disp...

    FloShield/Plus

    FDA UDI
    MINIMALLY INVASIVE DEVICES, INC.·00815128020348·The FloShield/Plus System is a single-use, disp...

    5.7 X 34MM LOCKING SCREW

    FDA Adverse Event
    Injury ·ACUMED LLC·Product code HRS·December 9, 2013

    BELLEGLASS HP ENAMEL

    FDA 510(k)
    FDA Class 2 ·Dental

    WELCH ALLYN SPOT CHECK DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROLENE POLYPROPYLENE MESH

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·March 26, 2013

    ENDOSCOPIC BILIARY CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code LQR·March 16, 2011

    LEXOS DR-T

    FDA Adverse Event
    Injury ·BIOTRONIK GMBH AND CO.·Product code LPQ·March 28, 2008

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 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