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

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    PENTAX Medical Video Upper GI Scopes (EG Family)

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

    Oticon

    FDA UDI
    Oticon A/S·05707131338860·SIYA 1, BTE 13 PP 2.4G 105 C090 DEMO

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319705797·Hayden Mallet 11" (27.9cm), head 32oz. (908g), ...

    FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO EXPEDIUM SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 21, 2025

    HARMONIC ACE 36 CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code LFL·October 9, 2008

    RESTORE RECHARGABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·July 28, 2011

    MA204

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·June 26, 2013

    FORTRESS INTRODUCER SHEATH SYSTEM - 6FR, 45CM

    FDA Adverse Event
    Malfunction ·CONTRACT MEDICAL INTERNATIONAL GMBH·Product code DYB·November 30, 2015

    Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right, Product No. LJU813T

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·April 24, 2019

    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