BEUDAMED
    17 results · 32ms · 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 ×

    MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    TruForm

    FDA UDI
    Rmo, Inc.·00885797099976·MN 1 MOL BD KT UNI/STD N/L 151

    multiSTATION™

    FDA UDI
    LSI Solutions, Inc.·00850012846376·10mm COUPLER

    iTotal® PS Tibial Keel Punch Tip

    FDA UDI
    Conformis, Inc.·00850268007460·iTotal® PS Tibial Keel Punch Tip Reusable Instr...

    NA

    FDA UDI
    Summit Medical, Inc.·00385640001625·

    OTW MEGALINK SDS BILIARY STENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428

    FDA 510(k)
    FDA Class 2 ·Immunology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 7, 2025

    WAVEWRITER ALPHA?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·July 30, 2025

    HNM MEDICAL

    FDA UDI
    HNM STAINLESS, LLC.·00842962155820·PEEK, LONGITUDINAL BLUNT BLADE, 24MMX50MM WIDE

    STYLE 20 SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·August 4, 2025

    BIO-INTERFERENCE SCREW

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code MAI·April 26, 2013

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    FDA Adverse Event
    Death ·CORDIS NEUROVASCULAR, INC.·Product code NJE·May 6, 2011

    HEARTSTREAM XL

    FDA Adverse Event
    Malfunction ·AGILENT TECHNOLOGIES, INC.·Product code MKJ·July 17, 2008

    Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018