BEUDAMED
    14 results · 21ms · 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 ×

    CUSTODIOL

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

    Aspira Drainage Kit

    FDA UDI
    Bard Access Systems, Inc.·10801741091145·Aspira Pleural/Peritoneal Drainage Kit

    CAPSTONE PTC™ Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169187542·SPACER 3992209 22MM X 9MM

    Aspira®

    FDA UDI
    Merit Medical Systems, Inc.·00884450620557·

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471150607·K-WIRE - DOUBLE TROCAR 2.0mm DIA x 230mm

    Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate

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

    SANDARE HEMOGLOBIN CONTROLS

    FDA 510(k)
    FDA Class 2 ·Hematology

    DESARA

    FDA Adverse Event
    Injury ·CALDERA MEDICAL, INC.·Product code FTL·February 28, 2013

    ARCHITECT IPTH REAGENT

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code CEW·February 15, 2011

    CAPSUREFIX MRI SURESCAN

    FDA Adverse Event
    Injury ·MPRI·Product code NVN·August 8, 2014

    Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992209 Version A, Sterile EO, Rx Only

    FDA Recall
    Open, Classified ·Merit Medical Systems, Inc.·Product code PNG·April 22, 2023

    Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992209 Version A, Sterile EO, Rx Only

    FDA Enforcement
    Class II ·Ongoing·Merit Medical Systems, Inc.·June 21, 2023

    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017