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

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    Vial2Bag Direct Connect

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RUSCH

    FDA UDI
    TELEFLEX INCORPORATED·04026704319626·SLICK SET CUFFED STERILE

    STAINLESS STEEL TIBIAL NAILING SYSTEM

    FDA UDI
    ORTHOFIX SRL·18053504365129·Component. Not for sale. Used for reporting Dir...

    Mariner Cortical

    FDA UDI
    Seaspine Orthopedics Corporation·10889981168780·CORTICAL SHANK, Cannulated, 7.0 X 95

    Mariner Cortical

    FDA UDI
    Seaspine Orthopedics Corporation·10889987168784·CORTICAL SHANK, Cannulated, 7.0 X 95

    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

    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

    CENTRAL VISION ANALYZER MODEL 1000

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    TRIATHLON TS KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EVOLUT R TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 4, 2018

    COREVALVE TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 4, 2018

    SENSOR ENLITE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·October 14, 2014

    ENDO GIA II 60-4.8 SULU

    FDA Adverse Event
    Injury ·COVIDIEN·Product code GDW·June 4, 2013

    CARBOMEDICS CARBO-SEAL VALSALVA

    FDA Adverse Event
    Other ·SORIN BIOMEDICA CARDIO S.R.L.·Product code LWQ·June 17, 2011

    Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170095

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

    Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170095

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

    Jackson-Pratt Silicone Flat Drain, 10mm, Full Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·May 31, 2017

    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