BEUDAMED
    1,379 results · 18ms · Sources: EU EUDAMED, US FDA

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    Yamaha Surface Mounter YR series, YS series, i-Pulse series, Sigma series, S series, M series. Affected models: YSM10, YSM20R(SV)-1, YSM20R(SV)-2, YSM20R-1, YSM20R-2, YSM20-1, YSM20-2, YSM20W-2, YRM20-1, YRM20-2, SIGMA-G5S2, S20, M20 ***Updated as of 6/10/2024*** Surface Mounter model S10, YC8. Component Dispenser model YSD

    FDA Recall
    Open, Classified ·YAMAHA MOTOR CORPORATION·Product code RGA·April 17, 2024

    Optical Inspection System, YSi series, YRi series. Affected models: YSi-V, YSi-V(HS2), YRi-V

    FDA Recall
    Open, Classified ·YAMAHA MOTOR CORPORATION·Product code RGA·April 17, 2024

    Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.

    FDA Recall
    Open, Classified ·Medtronic Neurosurgery·Product code PCB·January 22, 2024

    Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.

    FDA Recall
    Open, Classified ·Medtronic Neurosurgery·Product code PCB·January 22, 2024

    Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.

    FDA Recall
    Open, Classified ·Medtronic Neurosurgery·Product code PCB·January 22, 2024

    Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.

    FDA Recall
    Open, Classified ·Medtronic Neurosurgery·Product code PCB·January 22, 2024

    Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.

    FDA Recall
    Open, Classified ·Medtronic Neurosurgery·Product code PCB·January 22, 2024

    DriSate Product Code DR-145 The acid concentrate powders and liquids are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/monitor and bicarbonate concentrate.

    FDA Recall
    Terminated ·Rockwell Medical, Inc·Product code KPO·April 7, 2018

    On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position in cases that involve an ascending aortic aneurysm or other associated aortic disease.

    FDA Recall
    Terminated ·CryoLife, Inc.·Product code NPT·February 12, 2014

    Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 9736188, and the Bundle Autoguide Reg Kit.

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code HAW·November 9, 2021

    Abbott Vascular COPILOT Kit, COPILOT Bleedback Control Valve Part Number : 1003330. For use in cardiac diagnostic or therapeutic procedures.

    FDA Recall
    Terminated ·Abbott Vascular·Product code DTL·January 7, 2011

    Abbott Vascular ACS .035 Torque Device Part Number : 1003279. For use in cardiac diagnostic or therapeutic procedures.

    FDA Recall
    Terminated ·Abbott Vascular·Product code DQX·January 7, 2011

    Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000

    FDA Recall
    Terminated ·Intersurgical Inc·Product code CAI·April 25, 2018

    Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affected material number: 86566621 Intended to deliver accurate doses of 18F Fluorodeoxyglucose (FDG) or 18F Sodium Fluoride (NaF) radiopharmaceuticals and commonly used flushing solutions to patients during molecular imaging (PET Positron Emission Tomography - nuclear medicine) diagnostic procedures.

    FDA Recall
    Open, Classified ·Bayer Medical Care, Inc.·Product code FRN·November 30, 2022

    Guidant RAPIDO Cut-Away Guiding Catheter, 6F. Part Numbers: 66676-201 and 667552-100. For use in cardiac diagnostic and therapeutic procedures.

    FDA Recall
    Terminated ·Abbott Vascular·Product code DQY·January 7, 2011

    Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code DYB·February 20, 2024

    Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3503031. Airway connector.

    FDA Recall
    Terminated ·Intersurgical Inc·Product code BZA·August 7, 2019

    Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments.

    FDA Recall
    Terminated ·Micro Therapeutics Inc, Dba Ev3 Neurovascular·Product code OUT·July 19, 2013

    Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3521000. Airway connector.

    FDA Recall
    Terminated ·Intersurgical Inc·Product code BZA·August 7, 2019

    Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1996030. Airway connector.

    FDA Recall
    Terminated ·Intersurgical Inc·Product code BZA·August 7, 2019