BEUDAMED
    17 results · 25ms · Sources: EU EUDAMED, US FDA

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    J-Plasma Precise FLEX Handpiece

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    NA

    FDA UDI
    Synthes GmbH·10886982145093·2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE R...

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112656·BARRON CORNEAL PUNCH 8.5MM

    GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    300LC ULTRASOUND IMAGING SYSTEMS, MODEL 300LC

    FDA 510(k)
    FDA Class 2 ·Radiology

    BASIX COMPAK INFLATION SYRINGE KIT

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DXT·December 15, 2011

    BASIX COMPAK INFLATION SYRINGE KIT

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code MAV·December 15, 2011

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 31, 2015

    OLYMPUS

    FDA Adverse Event
    Death ·OLYMPUS·Product code FDT·August 26, 2016

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·October 17, 2008

    FREESTYLE FREEDOM LITE

    FDA Adverse Event
    Injury ·Product code NBW·August 11, 2011

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·July 2, 2013

    OLYMPUS

    FDA Adverse Event
    Death ·OLYMPUS·Product code FDT·August 26, 2016

    Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    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

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021