BEUDAMED
    16 results · 22ms · Sources: EU EUDAMED, US FDA

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    Mimics Medical

    FDA 510(k)
    FDA Class 2 ·Radiology

    Plum

    FDA UDI
    ICU Medical, Inc.·10887787006893·LATEX-FREE MIDLENGTH SECONDARY I.V. PUMP SET, C...

    AVANOS

    FDA UDI
    Avanos Medical, Inc.·00193493935093·AVANOS* Short Bevel Needle

    Halyard

    FDA UDI
    Avanos Medical, Inc.·10680651935097·

    Easydrip Insulin Penneedle

    FDA UDI
    SteriLance Medical (Suzhou) Inc.·16945630104395·31G 5mm， 100pcs

    N/A

    FDA UDI
    Ortho Development Corporation·00822409130955·Tibial 5 deg Varus-Valgus Cut Guide w. Drop Rod...

    SAMBA 3D FIREBIRD SI FUSION

    FDA Adverse Event
    Injury ·ORTHOFIX·Product code HWC·May 31, 2024

    ORTHODONTIC SCREW

    FDA 510(k)
    FDA Class 2 ·Dental

    KNEEHAB XP CONDUCTIVE GARMENT, TYPE 411

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SAMBA SCREW SI FIXATION SYSTEM

    FDA Adverse Event
    Injury ·ORTHOFIX·Product code LXH·May 31, 2024

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 28, 2011

    MINICAP TRANSFER SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 21, 2013

    BELT CLIP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·October 17, 2014

    Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000. Airway connector.

    FDA Enforcement
    Class II ·Terminated·Intersurgical Inc·January 15, 2020

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020