BEUDAMED
    19 results · 20ms · Sources: EU EUDAMED, US FDA

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    SONON Ultrasound Imaging System, Model: 300L

    FDA 510(k)
    FDA Class 2 ·Radiology

    RUSCH

    FDA UDI
    TELEFLEX INCORPORATED·04026704319602·SLICK SET CUFFED STERILE

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694014779·SpectrumTM LeFort III, Short Activation Rod

    Mariner Cortical

    FDA UDI
    Seaspine Orthopedics Corporation·10889987168760·CORTICAL SHANK, Cannulated, 7.0 X 85

    Mariner Cortical

    FDA UDI
    Seaspine Orthopedics Corporation·10889981168766·CORTICAL SHANK, Cannulated, 7.0 X 85

    RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095

    FDA Enforcement
    Class II ·Completed·Teleflex Medical Europe Ltd·August 25, 2021

    RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095

    FDA Recall
    Open, Classified ·Teleflex Medical Europe Ltd Ida Business Park Athlone Ireland·Product code BTR·July 16, 2021

    BALANCE REHABILITATION UNIT (BRU)

    FDA 510(k)
    FDA Unclassified ·Unknown

    VANTAGE VIEW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SM104 MSERIES W5TH WHLOBS3/07

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·June 14, 2013

    FINELINE II

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVN·July 20, 2011

    MINILINK TRANSMITTER

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·October 14, 2014

    CONICAL EXTRACTOR, MALE, LEFT HAND IMPLANT EXTRACTION SET 2.5 MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL (MDR)·Product code LXH·August 19, 2015

    CONICAL EXTRACTOR, MALE, LEFT HAND IMPLANT EXTRACTION SET 4 MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL (MDR)·Product code LXH·August 19, 2015

    UNIVERSA LOOP NEPHROSTOMY PERCUTANEOUS DRAINAGE CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code KOB·May 2, 2018

    Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170085

    FDA Recall
    Open, Classified ·TELEFLEX LLC·Product code BTR·May 25, 2023

    Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170085

    FDA Enforcement
    Class I ·Ongoing·TELEFLEX LLC·July 5, 2023

    Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal. Intended for patients requiring endotracheal intubation

    FDA Enforcement
    Class II ·Ongoing·TELEFLEX LLC·February 1, 2023

    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